D104096 Rev M Surgical Training Manual PDF

SURGICAL TRAINING MANUAL
Otologics LLC
In United States currently in Clinical Trials
CAUTION: Investigational Device. Limited by Federal Law (USA) to Investigational Use. In Europe CE Marked
____________________________________________________________________________________ MET Fully-Implantable Ossicular Stimulator D104096 M Surgical Training Manual Page 1 of 69 Otologics Confidential
Contact Information
Worldwide Headquarters Otologics LLC 5445 Airport Blvd Boulder, CO 80301 US Tel: +1 (303) 448-9933 US Fax: +1 (303) 448-9955 EU Tel: +33 4 92 92 52 00 Website: www.otologics.com E-Mail: Europe.info@otologics.com E-Mail: Us.info@otologics.com European Representative AR-MED Ltd Runnymede Malthouse Egham TW20 9BD United Kingdom Product: METTM (Middle Ear Transducer) Fully Implantable Ossicular Stimulator
Document: Document No:
Surgical Training Manual D104096
Copyright 2007 Otologics LLC No part of this manual may be reproduced without permission. All trademarks used in text are property of their respective owners.
Contents
INTRODUCTION......................................................................................................................................... 4 OTOLOGISTS TRAINING FOR THE FULLY-IMPLANTABLE MET OSSICULAR STIMULATOR ..... 4 MET OSSICULAR STIMULATOR DESCRIPTION .................................................................................... 5 CANDIDACY CRITERIA............................................................................................................................. 8 Technical Specifications .........................................................................................................................................9 Implant....................................................................................................................................................................9 Charger System.......................................................................................................................................................9 Transducer Loading Assistant...............................................................................................................................10 Remote..................................................................................................................................................................10 Programming System............................................................................................................................................10 NEW IMPLANTATION OF THE FULLY-IMPLANTABLE MET OSSICULAR STIMULATOR - FIMOS . 11 Step 1: Pre-Surgical Implant Preparation.............................................................................................................12 Step 2: Making the Incision .................................................................................................................................13 Step 3: Drilling the Atticotomy............................................................................................................................14 Step 4: Positioning the Mounting Bracket ...........................................................................................................15 Step 5: Fastening the Mounting Bracket..............................................................................................................19 Step 6: Creating the Laser Hole ...........................................................................................................................20 Step 7: Preparing the Bone Beds and Lead Channels ..........................................................................................22 Step 8: Placing the MET Ossicular Stimulator ....................................................................................................23 Step 9 Loading the MET Ossicular Stimulator and Diagnostics...........................................................................25 Step 10: Attaching the Electronics Capsule to the Transducer .............................................................................27 Step 11. Securing the Electronics Capsule and Closing the Incision ...................................................................30 Step 12. Post Surgical Care and Activation .........................................................................................................32 UPGRADE IMPLANTATION FROM THE SEMI-IMPLANTABLE OSSICULAR STIMULATOR (SIMOS) TO THE FULLY-IMPLANTABLE MET OSSICULAR STIMULATOR (FIMOS)....................................... 33 Step 1: Pre-Surgical Preparation for the SIMOS to FIMOS Implantation............................................................34 Step 2: Making the Incision and Removal of the Semi-Implantable Electronics.................................................35 Step 3: Connector Disassembly ...........................................................................................................................36 Step 4: Attaching the Electronics Capsule to the Transducer ...............................................................................37 Step 5: Enlarging the Bone Bed for the Electronics Capsule, Pendant Microphone, and Closing.......................40 Step 6: Post Surgical Care and Activation ...........................................................................................................41 SURGICAL STEPS FOR REPLACING THE FULLY-IMPLANTABLE MET OSSICULAR STIMULATOR (FIMOS) WITH THE FULLY-IMPLANTABLE MET OSSICULAR STIMULATOR (FIMOS).................... 42 Step 1: Pre-Surgical Preparation for FIMOS to FIMOS Surgery .........................................................................43 Step 2: Making the Incision and Removal of the FIMOS Electronics Capsule ...................................................44 Step 3: Connector Disassembly ...........................................................................................................................45 Step 4: Attaching the New FIMOS Electronics Capsule to the Old Transducer...................................................46 Step 5: Securing the Electronics Capsule, Pendant Microphone, and Closing ....................................................49 Step 6: Post Surgical Care and Activation ...........................................................................................................50 APPENDICES........................................................................................................................................... 52 Appendix 1: Otologics Surgical Equipment ........................................................................................................52 Appendix 2: Troubleshooting an Implanted Device During Surgery ..................................................................57 Appendix 3: Surgical Training Checklist.............................................................................................................58 Appendix 4: Surgical Revision Training Checklist .............................................................................................64 Appendix 5: Surgical Procedure Step By Step ....................................................................................................66
INTRODUCTION
This manual describes the surgical procedure for the implantation of the MET Fully-Implantable Ossicular Stimulator, both for a new implantation and for an upgrade implantation from the MET Semi-Implantable Ossicular Stimulator. Before implanting the device for the first time, the implanting surgeon and clinical staff responsible for the implantation must participate in a surgical course provided by Otologics, LLC and obtain certification. Certification training consists of a temporal bone course review of the Otologics device, surgical tools, and surgical procedure. An Otologics representatives presence is mandatory for at least the first two implantations. Surgical/Hospital staff training is also provided by Otologics. In addition to this manual, there is a surgical video available. It is strongly recommended that surgeons review this video before performing surgery. The surgical steps section of this manual gives key points and detailed steps to follow when implanting the device. Pictures and descriptions of the required surgical tools are included in each step. Safety instructions are also listed with each step. The Appendices contain detailed drawings of the surgical kits and instructions in case corrective action is required during the surgery. At the fitting, the patient also receives instructions on the use of the MET Fully-Implantable Ossicular Stimulator and its accessories, the Charger system and Remote Control. In order to accomplish this objective, the following protocol has been created: 1. Each implanting Otologic surgeon will go through an information protocol and hands on training including information on: a. the Otologics device b. the Otologics surgical instruments c. the Otologics implantation procedure 2. An Otologics Representative will review the above information through a temporal bone session or a half skull model demonstration, after which a surgical training checklist is completed and signed. This review session must be successfully completed before the first implantation surgery and returned to Otologics. 3. Two tools have been created to assist in the training session: a. The Otologics Surgical Training Manual (D104096 This manual) b. The Surgical Procedure Training Checklist and Signature Page (Appendix 3) NOTE: If more than six months passes without participation in a MET Ossicular Stimulator implantation surgery, the otologist will be required to go through another review session with an Otologics Representative to review the tools and procedure and to be updated on any new information. The review core will consist of, at a minimum: 1. A review of the tools and procedure using a half skull model and the actual surgical tools. An additional temporal bone session can be scheduled, if requested. The Surgical Procedure Checklist will be filled out in full and signed again. Any new information will be reviewed in detail
2.
OTOLOGISTS TRAINING FOR THE FULLYIMPLANTABLE MET OSSICULAR STIMULATOR

The objective of the Otologists Training is to provide an effective and consistent method for training otologists so they can perform the implantation of the MET Ossicular Stimulator successfully. Only otologists should be performing the implantation procedure and receiving the Otologists Training for the MET Ossicular Stimulator.
3.
MET OSSICULAR STIMULATOR DESCRIPTION

The MET Fully-Implantable Ossicular Stimulator is a fully implantable device intended for patients with moderate to severe sensorineural hearing loss. The device is designed to eliminate the receiver found in conventional hearing aids and drive the ossicles directly. The potential benefits include eliminating outer ear canal occlusion, improving sound quality, and providing greater gain without feedback for optimal speech recognition. DESCRIPTION: The Otologics MET Fully-Implantable Ossicular Stimulator consists of four primary components: the implant, the programming system, the charger, and the remote control. The implant component of the MET Fully-Implantable Ossicular Stimulator consists of two primary parts: the electronics capsule and the Middle Ear Transducer (Figure 1). The electronics capsule contains the microphone, battery, magnet, digital signal processor and connector. attached to the transducer. The fully implantable electronics capsule is secured, and the wound is closed. Two to six weeks after surgery and medical clearance the device can be programmed and activated. The Otologics Programming System (Figure 2) consists of fitting and diagnostic software, a radio frequency coil that, when placed over the implant site, magnetically adheres to the side of the wearers head, and the NOAHlink programming interface, which is worn around the neck. Using OtoFit Fitting Software, the NOAHlink interface receives signals from the computer through the wireless connection and sends the signals to the implant via the radio frequency coil. Programming the implant is done in the same manner as programming traditional digital hearing aids. In addition, the Otologics Programming System provides the ability for extensive testing and diagnostics of the MET Fully-Implantable Ossicular Stimulator.
Figure 1 Sounds are picked up by a sensitive microphone, amplified according to the wearers needs, and converted into an electrical signal. The signal is sent down the lead and into the transducer. The tip of the MET Fully-Implantable Ossicular Stimulator transducer is mounted in a laser-drilled hole in the body of the incus. The transducer translates the electrical signals into a mechanical motion that directly stimulates the ossicles and enables the wearer to perceive sound. For upgrading from the MET Semi-Implantable Ossicular Stimulator to the MET Fully-Implantable Ossicular Stimulator (not approved in the US), the size of the bone bed is increased to accommodate the fully implantable electronics capsule, which is then
Figure 2 The charger system consists of the base station, charging coil, and charger body. To charge the implant, the wearer removes the charger body from the base station and places the coil on the skin, over the implant site (Figure 3). The charger body contains a clip that allows the charger to be attached to the belt or waistband of the wearer during charging (Figure 4). Typically, charging time will be about one hour if performed daily. While recharging the implant, the wearer can perform normal daily activities, turn the implant on and off, and adjust the volume.
Figure 5 Figure 3 SURGERY OVERVIEW: The transducer is implanted through an extended atticotomy approach that exposes the incus body and malleus head and is intended to minimize the surgical risk. This technique circumvents any need to dissect close to the facial and chorda tympani nerves, associated with the facial recess approach. The implant surgery is a relatively simple procedure and not difficult in practiced hands. It does require a set of proprietary surgical instruments. The instruments are detailed in Appendix 1 of this manual. Also, each surgical step lists the instruments required for that step and has pictures where applicable. Figure 4 A remote is used for controlling the MET FullyImplantable Ossicular Stimulator when the device is not being charged. The remote allows the wearer to turn the implant on and off, and to adjust the volume. To use the remote control, the wearer simply holds the remote against the skin over the implant (Figure 5). The basic steps of the surgery are as follows: nonsterile preparation, patient preparation and incision, atticotomy drilling, mounting bracket placement, laser hole creation, device placement and closing. The surgery, from opening incision to closing, typically can take up to 2-2.5 hours for surgeons familiar with the procedure. Upgrading a wearer who already has the semiimplantable device to a fully-implantable device is approved in the EU, This procedure is not approved for the US Clinical Trial. This is a simple surgical procedure which may be performed under local anesthesia. To upgrade, the semi-implantable electronics capsule is disconnected from the transducer via the IS-1 connector, leaving the transducer and mounting bracket in place.
PROCEDURAL RISKS: The implantation of the MET Fully- Implantable Ossicular Stimulator requires a surgical procedure involving removal of tissue and bone. As with any surgical procedure involving a general anesthetic, certain risks exist. Risks that may occur during surgery:
The risks involved in surgery and complications related to surgery include the normal risks of the operative procedure and general anesthesia. These include pain, blood clots, and/or circulatory problems, infection, cardiac arrest, cholesteatoma, and even death. Specific risks related to operating on the mastoid include infection, inflammation, numbness or stiffness about the ear, disturbance of taste or balance and noticeable change in head noise. The potential risks related to inserting the implant include disarticulation of the ossicles and increased pressure on the ossicular chain. Increased pressure during insertion may cause damage to the inner ear and increased hearing loss.
SAFETY INSTRUCTIONS HIGHLIGHTED IN THIS MANUAL Important Information! Special information that supports correct handling of the implants components and helps avoid operational errors is denoted as important information and printed in italics. Important Information! This is an example of information that helps avoid intraoperative errors. CAUTION! Important information that helps prevent damage occurring to the implants components is signaled by the word CAUTION! and printed in bold type. CAUTION! This is an example that helps avoid damaging the implants components. DANGER: If the instructions have to be followed strictly to exclude the possibility of damage or injury to the MET Ossicular Stimulator, patient or to a third party, this is signaled by the word DANGER and framed for emphasis. DANGER: This is an example of instructions that help avoid damage to the implant or injury to the patient.
Risks that may occur after surgery:

Potential risks after surgery include inflammation, facial paralysis and perilymph fistula with the possible development of meningitis, tinnitus and complications associated with general anesthesia. Other postoperative problems to consider are labyrinthitis, vertigo, puncture or displacement of the eardrum, and otitis media. Potential risks related to the implant following surgery include infection, reparative granuloma and inflammatory reaction. It is possible that dislocation of the implant, a reaction to the implant materials, and/or failure of the implanted device can occur and may necessitate an operation to remove and/or replace the implant.
CANDIDACY CRITERIA
Selection Criteria for the MET FullyImplantable Ossicular Stimulator1 18 years of age or older
Hearing loss [dB HL] 0.25 0 0.5
Frequency [kHz] 1 1.5 2 3 4 6
Bilateral moderate to severe sensorineural hearing loss within the Candidacy Audiogram range shown below2 (Figure 6) Unaided NU-6 or W-22 score 40% at 80 dB HL or 40 dB SL in the ear to be implanted Post linguistic onset of hearing loss Non-fluctuating, stable hearing loss Normal middle ear anatomy Realistic expectations for the middle ear implant 3 months experience over the past year with appropriate hearing aids (either binaural amplification or a monaural fitting in the ear to be implanted).3 (Note: This criteria applies to the US Clinical Trial only.)
20
40
60
80
100
Figure 6 Contraindications Vestibular disorder, including Menieres Disease Osteodegenerative disorders, including Pagets Disease Middle ear pathology, including a history of recurrent otitis media Conductive or mixed hearing loss4 (Note: This applies to the US Clinical Trial only. Patients with a MEI in the contra lateral ear or patients that are to be upgraded from the Otologics semi-implantable device to the fully-implantable device will often exhibit conductive components) Non-organic hearing loss Retrocochlear hearing loss / central auditory nervous system disorder Pre-linguistic onset of hearing loss Medical contraindications to surgery or use of the device
1 See Audiologists Manual for further detailed information on candidacy. 2 Moderate to severe loss is defined in terms of the pure tone average (PTA) at three frequencies; 500, 1000, and 2000 Hz or a high frequency pure tone average (HFPTA = average of 1000, 2000, 3000, and 4000 Hz) of 40-80 dB HL. 3 The hearing aid(s) meet the insertion gain prescriptive target for an appropriate prescriptive formula for the hearing aid circuitry within 10 dB at 500, 1000, and 2000 Hz and within 15 dB at 4000 Hz for a 70-dB SPL input signal.
4 Air-bone gap no greater than 10 dB, 500-4000 Hz
Technical Specifications
Implant
Charger System
Charging Coil Figure 7 Charger Body
Nominal Operating Parameters Battery life: > 5 years Battery recharge time: 60 minutes (typical for daily charge) Battery recharge frequency: Daily (up to 3 days possible, but longer recharging time needed) Peak Output: 121 dB MET Frequency Range: < 200 to 6250 Hz Processor Type: 12 Band, 2 Channel Digital Processor Materials: Biocompatible titanium, gold, ceramic, epoxy, silicone elastomer, platinum-iridium alloy, ruby Connector Technology: IS-1
Figure 8 Charger Body recharges implant battery Charger Base recharges Charger Body battery Turns implant on and off Adjusts implant volume control Implant functions normally during battery charging Charger battery life: > 5 years
Transducer Loading Assistant

Assists the surgeon in loading the transducer by providing an indication of tip contact
Monitors current to the transducer to determine tip contact
Powered via USB from the computer that shows graphical loading information
Remote Programming System
Figure 9 Turns implant on and off Adjusts implant volume Range: Skin contact Keychain sized Figure 10 Performs diagnostics to assess implant and battery status Programs implant according to hearing needs of the wearer with flexibility to adjust gain, compression, and crossover frequency Uses OtoFit Fitting Software in conjunction with NOAHlink.
NEW IMPLANTATION OF THE FULLY-IMPLANTABLE MET OSSICULAR STIMULATOR - FIMOS
Step 1: Pre-Surgical Implant Preparation

Required Equipment Implant Charger System Purpose To charge prior to implantation For charging implant prior to implantation
Important Information! The MET Fully-Implantable Ossicular Stimulator must be charged prior to surgery. This should be done the day before surgery. Charging the Implant: Plug in the Charger Base Station, and make sure that the Base Station indicator light is green, verifying that the charger system is connected to a power source. Confirm that the charging system is fully charged by checking to see if the charger power indicator is green. (The charger indicator is the light on the far left side of the charger). A full recharge time for the charger body is 6 hours. To charge the implant, place the charging coil over the implant while it is still in its sterile packaging. The charging will take place through the sterile packaging. Fully charging an implant can take up to 3 hours (Figure 11). Once the implant is fully charged the Implant charger indicator will turn green. (The Implant charger indicator is the light on the far right side of the charger.) Consult the Charger User Guide for additional information (D105809).
Figures 11. Charging through the external packaging or through the internal packaging
Step 2: Making the Incision

Required Equipment Capsule Template (included in MET-1050) Purpose Determine size of incision required to allow placement
Key points: 1. Ensure that the incision is large enough to permit placement of the electronics capsule. 2. Make the incision so that the Charging Coil will not rest directly on it. Important Information! Review of a CT Scan taken prior to surgery is helpful to indicate the width of the attic space. The transducer is 6 mm in width and at least this much width is required for implantation of the device. Prior to Surgery: Prior to surgery an implant model or capsule template is used to identify the optimal implant placement and location of the incision. See dotted line in Figure 12. The optimal position of the implant capsule typically lies between lines of 30 and 90 degree angle relative to the horizontal with the silicone charging coil superior to the titanium capsule body (see Figure 12) and where the capsule and coil will sit flat on the patients skull. Although the implant capsule and coil have been designed for long term implantation, care must be taken when inserting the coil into a tissue pocket. Excessive manipulation or bending of the coil can damage it. In addition, the coil should be placed such that it is not bent more than 10 relative to the implant capsule. Place the patient on the operating room table in the standard manner for otologic surgery. Induce anesthesia. Prophylactic antibiotics can be administered at this time. The patients head may be shaved over the incision site. Any standard cochlear implant incision may be applied (Figure 13).
Figure 13 Incision Patterns Retract the auricular flap inferiorly and incise and retract the periosteum. Define the lower border of the temporalis muscle and retract it to expose the base of the zygoma anteriorly and to identify the superior edge of the canal wall and the spine of Henle. It is important to extend the incision anterior to the pinna for adequate visualization of the ossicles while drilling. Use the Capsule Template (Figure 14) to determine the extent of the incision required to properly place the electronics capsule. This template represents the size of the entire implant, including the microphone and integral fixation strap.
Figure 12 Implant Placement Prior to starting the surgery, an implant template can be placed over the skin and a sterile pen marker used to trace the shape of the implant template. Then, the incision line can be drawn with the sterile pen to assist in making sure the incision will avoid the electronics and the MET FullyImplantable Ossicular Stimulator. Preoperative Preparation of the Patient:
Figure 14 Implant Template ____________________________________________________________________________________ MET Fully-Implantable Ossicular Stimulator D104096 M Surgical Training Manual Page 13 of 69 Otologics Confidential
Step 3: Drilling the Atticotomy

Required Equipment Atticotomy Template (SUR-1110) Purpose Determine if size of atticotomy is sufficient
Key Points: 1. Ensure that the incus body and malleus head is exposed. 2. Create as wide a space as possible between the ear canal and the dura by thinning the bone down over both structures. 3. The atticotomy must extend 20-25 mm beyond the incus body posteriorly. 4. Remove bony ledges deep in the atticotomy since they will impede placement of the transducer. The atticotomy is started with a 6 mm burr at 12 oclock superior to the bony external ear canal at the root of the zygoma (Figure 15). This 12 oclock position is defined by extending a vertical tangent up from the anterior canal wall. The atticotomy should be extended anteriorly to expose the head of the malleus and posteriorly along the temporal (dural) line, approximately 20-25 mm beyond the incus body, to a width of 10-12 mm. It is not necessary to expose the dura, only to define the plane and maintain the atticotomy inferior to that plane. If the anterior edge of the atticotomy does not adequately expose the malleus head, visualization of the laser hole and placement of the probe tip will be difficult. Keep the atticotomy borders vertical in order to preserve the surrounding cortex for the mounting bracket screws.
Figure 16 - Atticotomy If required, use the Oval Fitment Gauge (Figure 17) as a guide to approximate the size and shape of the atticotomy. The oval fitment gauge represents the minimum atticotomy size. Typically the atticotomy will extend further anterior for good visualization of the incus body and malleus head. It is possible to test the width of the bottom of the atticotomy by ensuring that a 5mm burr will fit into the opening. Important Information! It is important to create as wide a space as possible between the dura and the ear canal for device insertion. Remove bony ledges near the incus. They may hamper advancement of the transducer and the probe tip into the laser hole.
Figure 15 - Atticotomy location (Left Ear) When drilling the atticotomy, skeletonize the bony external canal and tegmen down to Krners septum just superior to the incus. Krners septum forms the roof of the middle ear, is approximately 10 to 12 mm deep from the cortex. Once Krners septum is identified, it is carefully removed using a diamond burr to expose the epitympanum, proximal antrum, the incus and head of the malleus. Malleus head exposure is important in order to obtain a clear view of the incus body during laser use and probe tip placement (Figure 16).
DANGER: While it is important to create as wide a space as possible between the dura and the ear canal, it is also important to avoid penetrating the dura and to mitigate any penetration of the external ear canal.
Figure 17 - Atticotomy Template (10 mm wide x 20 mm long)
Step 4: Positioning the Mounting Bracket

Required Equipment Mounting bracket with Bending Template attached. (included in MET-1050) Laser Guide Assembly (SUR-1140) Bending Pliers (SUR-1120) Cutting Pliers (SUR-1130) Purpose Affix MET Ossicular Stimulator to skull Assess size and location of atticotomy Determine optimal placement for laser hole drilling Used to bend legs of mounting bracket (if necessary) Used to remove mounting bracket legs (if necessary)
Key Points: 1. The mounting bracket must be placed so that the tip of the Laser Guide assembly points directly at the location on the incus where the laser hole will be made (Figures 19 and 20). 2. The Laser Guide tip angle may be altered by loosening the locking ring and moving the handle. 3. The mounting bracket legs can be bent or removed (with the cutting pliers) to allow flush placement against the patients cortex. The Laser Guide Assembly, which reproduces the geometry and dimensions of the transducer assembly, is used to position the optical fiber on the body of the incus. The hospital surgical staff will place the Laser Guide Assembly (Figure 18a) in the mounting bracket assembly (Figure 18b). Test fit the mounted Laser Guide Assembly in the atticotomy (Figure 19). Locking Ring Tool Handle
Bending Template, comes pre-assembled on Bone Bracket. Bone Bracket
Laser Guide Tip Figure 18a Laser Guide Assembly. Figure 18b Bone Bracket with Bending Template.
If necessary, enlarge the atticotomy until the mounting bracket fits in the hole and the Laser Guide Assembly tip is just above the center of the body of the incus. The axis of the tip must be as perpendicular to the incus body as possible. It is important to avoid the edge of the incus, or the connection may not be secure (Figure 20). The angle of the Laser Guide Assembly can be adjusted by slightly unscrewing the locking ring tool and moving the Laser Guide tip both angularly and axially. The tip should point directly at the spot intended for the laser hole and should be able to touch the incus. Once the tip has been properly aligned, retighten the locking ring tool.
Figure 19 - Placing Mounting Bracket (Right Ear)
Figure 20 Correct Position of Laser Hole DANGER: When introducing the Laser Guide Assembly, ensure that the tip does not make contact with the incus to avoid the possibility of disarticulating the ossicles.
While holding the Laser Guide assembly in position, bend the Surgical Bending Template legs (shown blue in Figure 19) to conform to the surface of the skull. Once satisfied, remove the Mounting Bracket/Laser Guide assembly and bend the legs on the mounting bracket to match the bends previously created on the template. (See Figure 21a)
Figure 21a Bending Bone Bracket Legs to Match Template. It will be necessary to bend the legs of the mounting bracket with the Bending Pliers to achieve a flush fit at the mounting location on the cortex. (Figure 21a & 21c)
Once the Bone Bracket is fit to the surface of the cortex, the bending template (blue) can be removed from the mounting bracket using the bending pliers. The center tab is bent upwards and the blue template is pulled off the mounting bracket. (Figure 21b)
Figure 21b Removing Surgical Bending Template from Bone Bracket. DANGER: The Surgical Bending Template must be removed prior to securing the Mounting Bracket to the cortex. It is not intended to be left inside the body, due to sharp edges, though it is of the same titanium material as the bone bracket. ____________________________________________________________________________________ MET Fully-Implantable Ossicular Stimulator D104096 M Surgical Training Manual Page 17 of 69 Otologics Confidential
The bone screws should not be used to pull a mounting bracket leg down to achieve a flush fit of the mounting bracket to the skull. The legs should be bent (using bending pliers) to achieve this purpose. If necessary, one mounting bracket leg can be removed using the Cutting Pliers (Figure 22a & 22b).
Figure 21c Correct Fit of Bracket to Skull
Figure 22a Bending Pliers
Figure 22b Cutting Pliers
Step 5: Fastening the Mounting Bracket

Required Equipment Purpose Drill bit (included in MET- 1050) Drill proper size and depth holes for mounting bracket Mounting screwdriver (Blade, SUR-1160; Handle, SUR- Screw mounting bracket to skull 1170) 4 mm Bone screws (included in MET-1050) Affix mounting bracket to skull Oversize bone screws (included in MET-1050) Substitute for 4 mm bone screws (if necessary) Key Points: 1. Ensure that the Laser Guides tip is aligned to the exact desired location for the incus laser hole before drilling bone screw holes. 2. Screw down each leg with at least one screw per leg. 3. Use the oversize bone screws if necessary. Once the Laser Guide tip points at the location for the laser hole and the mounting bracket legs have been adjusted to fit flush against the cortex, use the drill bit provided in the surgical kit to drill a hole through one of the mounting holes located at the end of one of the mounting bracket legs. Use the Otologics screwdriver (Figure 23) and a 4 mm screw (Figure 24) to secure the mounting bracket leg to the skull. Repeat this process for all of the remaining legs of the mounting bracket utilizing one bone screw per leg. may cause probe tip movement and decrease patient performance or transducer damage (Figure 25)
Figure 25 Bend Leg to Skull If for any reason, the laser guide assembly tip cannot be properly aligned, the screws may be removed and the mounting bracket repositioned. In order to use the same hole again, it may be necessary to use the oversize bone screw. Alternatively, a new hole can be drilled into the skull through one of the other holes on the mounting bracket leg.
Figure 23 - Screwdriver It is not necessary to place more than one bone screw per mounting bracket leg, but in order to ensure a secure mount there should be at least one screw in all four legs. If it is not possible to put a screw in a particular leg, that leg should be removed using the cutting pliers.
Important Information! As the screws are fastened, ensure that the mounting bracket does not move and change the intended approach angle for the tip of the Laser Guide Assembly. The mounting bracket should be fastened Figure 24 - Bone Screw with 4mm bone screws. The oversize Important Information! bone screws should be used if the bone A minimum of 3 legs must be attached to screw holes become stripped. the skull. If 3 legs cannot be attached, Manual Drilling: If for any reason the remove and reposition the mounting drill bit provided does not fit in the bracket! otologic drill, the screwdriver blade can All legs must have at least one screw be removed from the screwdriver handle securely fastening the mounting bracket and the drill bit inserted in its place. The to the skull. If a leg is not securely proper sized hole can then be drilled by fastened to the skull pressure on the leg twisting the drill bit/handle by hand. ____________________________________________________________________________________ MET Fully-Implantable Ossicular Stimulator D104096 M Surgical Training Manual Page 19 of 69 Otologics Confidential
Step 6: Creating the Laser Hole

Required Equipment Laser guide tip Laser fiber Hypodermic Tube (included in MET-1050) Hand auger (included in MET-1050) Laser Laser fiber cutter (SUR-2110) Laser fiber stripper (SUR-2120) Purpose Used to determine laser alignment to incus. Used to deliver laser energy to precise point on the incus Used to handle and align laser fiber Used to remove debris from laser hole Used to produce energy to cut hole in incus May be required to prepare laser fiber tip May be required to prepare laser fiber tip
Key Points: 1. Line up the Laser Guide Assembly with the exact position of the laser hole 2. Verify the sheath on the end of the laser fiber has been stripped back a minimum of 2mm from then end. If not, strip the sheath using the Laser Fiber Stripper Tool. 3. Generate a laser hole at least 0.75mm deep (measured to the shoulder of the hand auger) 4. Wear appropriate eye protection. Ensure the Laser Guide Assembly is locked into position by tightening the locking ring tool. The Laser Guide Assembly should be mounted so that the tip is just touching the incus. The Laser Guide tip is then removed from the Laser Guide Assembly (Figure 26). The Hypodermic Tube (Figure 27) is placed over the end of the optical fiber. The laser fiber should extend out of the hypodermic tube no more than 1 mm (Figure 28). The Hypodermic Tube and optical fiber are then inserted through the laser guide and the optical fiber is used to deliver laser energy to the body of incus. The laser fiber should be in contact with the incus for proper laser cutting. The laser fiber may be prepared for cutting by test firing several pulses on a sterile wooden spatula. Laser Guide Tip 50 pulse sets and can take between 300 and 450
Figure 27 Hypodermic Tube
Figure 26 Laser Guide (Separated) Typical settings with a KTP 532 nm laser energy are 0.1 second pulse bursts at 0.5 second intervals with a power setting of 2.4W. This laser should be run in Figure 28 Laser Fiber Protruding 1 mm out of Hypodermic Tube
pulses on average to complete the hole. Typical settings with a DIODE 810nm laser energy are 0.2 second pulse at 0.7 pulse rate with a power setting of 3W. This laser should be run in 20 pulse sets and can take 60 to 80 pulses on average to Auger Tip
DANGER: Ensure all personnel are aware of the use of the laser and are taking proper precautions. DANGER: Ensure the correct diameter fiber is in use to avoid creating an oversized laser hole.
Figure 29 Hand Auger complete the hole. Consult your Laser representative and your Otologics representative to determine the correct settings for your laser model and type. It is recommended that irrigation be used throughout the creation of the laser hole. In order to remove the char after sufficient laser pulses, the tube and fiber are removed from the laser guide and replaced by the hand auger. Debris is removed using the manually operated hand auger (Figures 29 and 30) and suctionirrigation. The hand auger is best utilized by rolling the handle back and forth between the thumb and index finger. The laser ablation process is repeated until the hole is approximately 0.75 mm deep at the 3:00 and 9:00 positions of the hole, as determined by the shoulder at the tip of the hand auger (Figure 31). The hole should be surrounded by bone at least 0.25 mm deep on the shallowest side. The laser guide is then removed from the mounting bracket in preparation for transducer placement.
Figure 31 Correct Depth of Laser Hole Should the initial hole form a trench reposition the laser guide and cut a second hole (Figure 32)
Figure 32 Second Hole Drilled After an Incorrect Trench
Figure 30 Rotating the Hand Auger Between the Thumb and Forefinger (Right Ear) ____________________________________________________________________________________ MET Fully-Implantable Ossicular Stimulator D104096 M Surgical Training Manual Page 21 of 69 Otologics Confidential
Step 7: Preparing the Bone Beds and Lead Channels

Required Equipment Capsule Template (included in MET-1050) Purpose Determine size and location of bone bed
Key Points: 1. Cover the atticotomy during bone bed drilling 2. Use the capsule template to assess proper location for the bone bed. After removing the laser guide from the mounting bracket, fill and/or cover the atticotomy with protective material to keep the area free of debris during bone bed drilling. Using the capsule template (Figure 33) for sizing, bone-beds are created in the skull at the positions defined prior to surgery, keeping in mind the recommended location for the microphone, shown in the area without muscle, directly posterior to the external auditory canal (Figure 12, page 13).
The bone bed for the microphone may be done one of two (2) ways (Figure 34). (1) At a minimum, a circular depression may be made to accommodate the raised portion on the under or back-side of the microphone, or (2) A larger area to fit the shape for the entire device may be drilled. A lead channel should be drilled for the microphone lead in either case. Also, a channel should be drilled to accommodate the transducer lead. For performance reasons the microphone, and its straps, must not touch any of the other implant components. It is important to consider the placement of the microphone, capsule, and leads relative to the temple pieces of eyeglasses or other head gear. The microphone should not be placed under or adjacent to muscle tissue, such as the temporalis muscle, as the localized tension created by the muscle will affect the performance of the microphone. Adequate space is required to allow for the installation of the silicone straps on the implant to fit securely into the bone bed for the implant.
Figure 33- Capsule Template The Capsule bone bed (Figure 34) should be drilled to the depth represented by the thickest portion of the template, for the entire size of the implant, not including the Antenna Coil area. The intent of the bone bed is to reduce the curvature of the skull, providing the minimum attainable deflection of the coil. The capsule placement shown in Figure 12 Implant Placement represents the portion of the skull with the minimum curvature as a starting point. The capsule must not be placed so that it touches any of the other components or their mounting straps. The Capsule Antenna Coil should be centered under the position representing optimal placement of the Charging Coil. If the total thickness of the tissue flap, including skin and muscle, is greater than 6 mm, it must be thinned down to 6 mm to ensure proper magnetic fixation of the Charging Coil.
DANGER: Cover atticotomy during bone bed drilling to prevent debris from entering the atticotomy.
Figure 34 MET Fully-Implantable Ossicular Stimulator Bone Beds and Lead Channels (Right Ear)
Step 8: Placing the MET Ossicular Stimulator

Required Equipment MET Ossicular Stimulator Transducer Insertion Instrument (SUR-1190) Locking ring tool (SUR-1150) Locking Ring (included in MET-1050) Purpose Implanted into atticotomy To roughly position the MET Ossicular Stimulator tip To tighten locking ring in place when tip is aligned Tightened by locking ring tool to hold MET Ossicular Stimulator in place
Key Points: 1. When threading the MET Ossicular Stimulator into the mounting bracket, take great care with the probe tip. 2. A flatter approach to the mounting bracket may make it easier to thread the device into the bracket. 3. Position the probe tip within 2mm of the laser hole in the incus. The Transducer Insertion Instrument, Locking ring tool and Locking Ring are assembled onto the transducer (Figure 35 a & b). Insertion Instrument, make angular and gross depth adjustments to align the transducer probe tip with the laser-ablated hole in the body of the incus (Figure 36). Position the probe tip of the transducer 1-2 mm from the body of the incus. Using the locking ring tool, tighten the mounting system locking ring and lock the transducer in place. Remove locking ring tool and Transducer Insertion Instrument.
Figure 35 a Assembling the Transducer Insertion Instrument, Locking Ring tool and locking ring onto the rear of
Figure 35 c
Figure 35 b The transducer is then threaded into the mounting bracket (Figure 35 c & d) with the transducer in a fully retracted position. Slightly loosen the locking ring tool to allow the Transducer Insertion Instrument to move. Using the Transducer
Figure 35 d Installing MET Fully Implantable Ossicular Stimulator in Mounting Bracket (Right Ear)
Important Information! Position the tip within 2mm of the laser hole before attempting to advance the tip into the hole with the advancement screwdriver. Advancing the probe tip beyond 5mm (20 turns) may decouple the transducer body from the mounting shaft. The transducer motor will decouple from the mounting shaft if the transducer is extended more than 6mm (24 turns).
CAUTION! The probe tip is extremely sensitive and must not make contact with any object. DANGER: To ensure probe tip protection, fully retract the probe tip before threading the transducer into the mounting bracket. DANGER: While threading the transducer into the mounting bracket, hold the Transducer Insertion Instrument to prevent it from falling into the atticotomy and contacting the incus.
Figure 36 Aligning Probe Tip to Hole in Incus (Right Ear)
Step 9 Loading the MET Ossicular Stimulator and Diagnostics

Required Equipment Adjustment Screwdriver (SUR-1180) Transducer Loading Assistant (TLA) Diagnostic System Purpose Used to advance MET Ossicular Stimulator tip into hole in incus Used to promote appropriate loading Use to confirm operational state of the implant
Key Points: 1. Align the probe tip directly with the hole in the incus. 2. Test mobility of the incus prior to and after inserting the probe tip into the incus hole. 3. Advance the transducer probe tip until the incus moves and then advance the tip turn of the adjustment screwdriver. 4. If retraction is necessary, be sure to retract the probe tip AT LEAST TURN MORE than the stoppingpoint desired, or completely retract probe tip out of the hole and begin process again. 5. Final transducer placement should always be an ADVANCING motion. CAUTION! When using the TLA, the coil must be wrapped in a sterile bag to be placed over the implant coil. Prior to advancing the probe tip, the mobility of the incus should be tested by moving it gently with a surgical pick (Figure 39). The degree of movement should be noted.
Figure 37 Adjustment Screwdriver The Adjustment Screwdriver is fitted to the hex nut on top of the mounting shaft to make the final probe tip insertion adjustment. If using the Transducer Loading Assistant (TLA), refer to the TLA Instructions for Use (D107454-US or D106317-EU) at this point for specific instructions for loading the transducer. If not using the TLA, proceed as follows. To achieve proper loading of the ossicular chain with the transducer, the adjustment screwdriver (Figure 37) is turned clockwise to advance the transducer probe tip until it makes contact with the bottom of the hole and the incus moves (Figure 38). The tip should then be advanced an additional turn of the adjustment screwdriver. A surgical pick should be used again to test mobility of the ossicles. Upon final loading, the ossicles should demonstrate similar pre-placement mobility (Figure 39). During normal use the transducer tip vibrates in and out 4 um, thus it is essential that the tip be in contact with the bottom of the hole. If the transducer has been advanced too far, it must be retracted to avoid creating a conductive hearing loss. ____________________________________________________________________________________ MET Fully-Implantable Ossicular Stimulator D104096 M Surgical Training Manual Page 25 of 69 Otologics Confidential
When retracting the transducer, be sure to retract AT LEAST TURN MORE than the stopping-point desired. That is, if the transducer has been over-advanced by turn, then the transducer must be retracted a minimum of turn and then advanced turn to result in a net retraction. CAUTION! Final transducer placement should always be an ADVANCING motion. Once the transducer is in its final position, a pick should again be used to test the mobility of the ossicles. If there appears to be stiffening in the ossicular chain, the entire procedure should be repeated until there is minimal stiffening of the ossicular chain (Figure 39).
Figure 38 Advancing probe tip (right ear) Important Information! Do not overextend the probe tip by trying to advance it more than 20 turns (5 mm). One complete turn (360) of the screwdriver is equivalent to 0.25 mm of probe tip insertion or retraction. The transducer mounting shaft has been designed for subsequent readjustment if necessary to obtain optimum performance.
Figure 39 Incus Mobility Test DANGER: Overloading may cause a conductive hearing loss, damage to the ossicles and/or damage to the cochlea. ____________________________________________________________________________________ MET Fully-Implantable Ossicular Stimulator D104096 M Surgical Training Manual Page 26 of 69 Otologics Confidential
Step 10: Attaching the Electronics Capsule to the Transducer

Required Equipment Disposable Torque Wrench Transducer with lead Electronics Capsule Purpose Used to tighten connector block set screws securing transducer lead to electronics capsule To be attached to electronics capsule to form complete unit To be attached to transducer to form complete unit
The transducer can now be attached to the electronics capsule by inserting the male connector of the transducer lead into the female connector of the electronics capsule (Figure 40). Once the connector has been fully inserted into the electronics capsule, the two screws are tightened (clockwise) with the torque wrench provided using the following procedure:
Set Screws torqued with Torque Wrench Figure 41
Tip protrusion Figure 42 Figure 40 1. The electronics capsule is constructed so that the male transducer connector may be inserted into the female electronics connector. Lubricate the male connecting pin with sterile saline. While firmly holding the electronics capsule by the pin connector block between the thumb and forefinger (taking care to not touch the microphone), insert the male connecting pin into the female connecting block until the pin hits the positive stop on the inside of the connector and can be seen protruding past the pin connector block (Figure 41 & 42). Two locking screws will be tightened with the torque wrench to hold the connector in place. (Figure 44) 4. While firmly supporting the pin connecting block between the thumb and forefinger gently push on the torque wrench while turning clockwise to engage the wrench head into the screw. Once the wrench has been felt to engage the screw, turn the wrench clockwise until the torque wrench clicks once. This will take between and turn. While still firmly supporting the pin connecting block between the thumb and forefinger remove the torque wrench, and gently pull on the lead to confirm contact. Repeat steps 5-7 above for the ring locking screw while continuing to firmly support the electronics capsule by holding the ring connecting block between the thumb and forefinger. Install the septum Plug into the connector blocks by pressing each end of the molded septum plug into the appropriate connector block.
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Caution! Over tightening may cause the screw head to be stripped and may cause the connector blocks to be pulled free from the capsule. Always support the connector blocks while tightening or loosening the screws. Failure to do so may damage the electronics capsule. Never attempt to turn the connector screws with anything other than the supplied torque wrench. Failure to do so may result in implant damage. Failing to insert the transducer connector fully into the connector blocks may cause damage to the transducer when the set screws are secured. 1. The recess above the screws will be sealed with Septum Plug ) The Septum Plug should be installed using the following procedure: a. Wipe the area with sterile wipe to assure it is dry of blood or saline solution. b. Align the septum plug with the two connector blocks.. c. Apply pressure to seat the septum plug into the screw holes. (Figure 43a and b) d. Verify septum plug is seated into the connector block surface and is covering the entire connector block and screw surfaces.
Important Information! Never tighten connector block screws without the male connecting pin inserted into the female connecting blocks. Always lubricate the male connecting pin with saline prior to insertion into the connector block. Failure to do so will result in an improper connection. Never fill the female connecting block with fluid. To do so will result in an improper connection.
Figure 43a Top View
Figure 43b Side View
Figure 44 Torque Wrench After the Septum Plugs are firmly seated, a pair of Silicone Bands must be slid over the implant to secure them and ensure a proper seal. As the Capsule is already connected to the Transducer, the Silicone Bands will need to be slid over the Coil end. Care should be exercised not to bend the Coil portion of the Capsule more than a few degrees. Sterile saline may be used as a lubricant to allow the Bands to slide completely over the Septum Plugs (Figure 45a). The bands should be placed so they do not lie on the curved portion of the Capsule. This is to prevent them from slipping off (Figure 45b).
Figure 45a Silicone Bands
Figure 45b Silicone Bands Installed
Surgical Diagnostics: Some tests should be performed during implantation. These tests help to make sure that the transducer and microphone are fully functional and will help detect if the device has been damaged, e.g. during handling or in the OR during implantation. The data collected can be used later in the clinic for diagnostics and troubleshooting. These tests are: Battery test (reads charge state) SAFI test: Microphone functionality Functional Test Transducer Impedance
CAUTION! For the surgical tests, the programming coil must be wrapped in a sterile bag to be placed over the implant coil.
Step 11. Securing the Electronics Capsule and Closing the Incision
Required Equipment Flap Thickness Gauge (SUR-1200) Key Points: 1. If the tissue flap is thicker than 6mm, it must be thinned down to ensure that the Charging Coil will remain attached to the patient during charging of the implant and the Programming Coil remains fixated during the fitting process. Only bi-polar cauterization is permitted once the implant has been placed. Purpose Used to measure skin flap thickness over the device to ensure proper device function.
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Important Information! 3. Integral straps are provided for securing the electronics capsule and the microphone pendant to the bone bed. Additional bending and fitting of the straps may be required. The straps will constrain the implant and the microphone in a fixed location following the installation of the bone screws. For this reason each strap will require the use of two bone screws. The devices should be tested for movement following the installation of the bone screws. If movement is present additional adjustment to the straps must be performed. Additional bending and shaping of the strap may be performed using the surgical pliers used to form the bone-mounting bracket. Precautions for bending are described in detail in the Instructions for Use included with the Bone Bracket.
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CAUTION! The leads of the Transducer and Microphone should not be placed in contact with the legs of the mounting bracket to avoid damage to the leads. CAUTION! Place the Microphone in the recommended location as in figure below, directly posterior to the external auditory canal and route the lead from the microphone to the Capsule so that there is no tension on either end of the lead. DO NOT pull on the leads or create tight bends on them, especially in the areas where they enter the Pendant and Capsule bodies.
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Implant Location
The thickness of the tissue flap is measured using the flap measurement tool (Figure 44) and noted. If it is thicker than 6mm, the tissue must be thinned down. If it is too thick, the magnet in the Charging Coil may not be strong enough to remain attached to the magnet in the electronics capsule and it may result in poor conduction. The tissue flap is sutured down to cover the electronics capsule and the wound is closed in layers (Figure 45). DANGER: Once the electronics capsule and pendant microphone have been implanted, only bi-polar cauterization is allowed. The use of mono-polar cauterizing equipment may damage the implanted electronics.
Important Information! Make sure that the implant is positioned with THIS SIDE OUT facing away from the skull (lateral). At the surgeon's discretion, the implant electronics may be placed under or over the muscle to achieve a total tissue thickness over the coil and magnet of 6mm (Figure 46). DANGER: Excessive manipulation or bending of the coil can damage it. In addition, the coil should be placed such that it is not bent more than 10 relative to the implant capsule. At this point, tests should be conducted using the Surgical Assistant FIMOS Implant software (SAFI) to make sure that the transducer and microphone are fully functional and whether the device has been damaged. Refer to the SAFI Instructions for Use D107455.
Figure 46, Flap Thickness Gauge
Figure 48 Cross Section Showing Capsule Placement Figure 47, Measuring Flap Thickness
Step 12. Post Surgical Care and Activation

Post Surgery Care: Follow up patient care is performed in the usual manner for otologic surgery. The patient is given the same postoperative instructions provided after standard otologic surgery. If the patient was wearing amplification prior to surgery, he or she may wear amplification in the non-implant ear, but should not wear amplification in the implant ear until after the eight week healing period is complete and medical clearance is given. Activation: Following a 8-week healing period and medical clearance, the MET Fully-Implantable Ossicular Stimulator will be programmed according to the hearing needs of the individual patient. Detailed procedures for fitting the MET Fully-Implantable Ossicular Stimulator are provided in the MET Fully-Implantable Ossicular Stimulator Fitting Guide.
UPGRADE IMPLANTATION FROM THE SEMIIMPLANTABLE OSSICULAR STIMULATOR (SIMOS) TO THE FULLY-IMPLANTABLE MET OSSICULAR STIMULATOR (FIMOS)
(E.U. ONLY)
Step 1: Pre-Surgical Preparation for the SIMOS to FIMOS Implantation

Important Information! The MET Fully-Implantable Ossicular Stimulator must be charged prior to surgery using the Charger and instructions for use for the Charger. Important Information! A CAT scan or a lateral x-ray must be performed to determine location of the implanted lead and mounting bracket. Important Information! Integral straps are provided for securing the electronics capsule and the microphone to the bone bed. Additional bending and fitting of the straps may be required. The straps should constrain the implant or the microphone in a fixed location following the installation of the bone screws. For this reason, two bone screws must be used in each strap. The devices should be tested for movement following the installation of the bone screws. If movement is present additional adjustment to the straps must be performed. Additional bending and shaping of the Bone Bracket may be performed using the surgical pliers used to form the bonemounting bracket. Precautions for bending are described in detail in the Instructions for Use included with the straps. The recommended locations for the straps are also indicated in the Instructions for Use provided with the brackets. CAUTION! The leads of the Transducer and Microphone should not be placed in contact with the legs of the mounting bracket to avoid damage to the leads. CAUTION! Place the Microphone in the recommended area (Figure 12 page 13), directly posterior to the external auditory canal, and route the lead from the microphone to the Capsule so that there is no tension on either end of the lead. DO NOT pull on the leads or create tight bends on them, especially in the areas where they enter the Pendant and Capsule bodies.
CAUTION: For an upgrade implantation, only bi-polar cauterization is permissible. The use of mono-polar cauterizing equipment may damage the implanted transducer.
Charging the Implant: Plug in the Charger Base Station, and make sure that the Base Station indicator light is green, verifying that the charger system is connected to a power source. Confirm that the charging system is fully charged by checking to see if the charger power indicator is green. (The charger indicator is the light on the far left side of the charger). A full recharge time for the charger body is 6 hours. To charge the implant, place the charging coil over the implant while it is still in its sterile packaging. The charging will take place through the sterile packaging. Fully charging an implant can take up to 3 hours. Once the implant is fully charged the Implant charger indicator will turn green. (The Implant charger indicator is the light on the far right side of the charger.) Consult the Charger User Guide for additional information. Determine location of implanted electronics: The surgeon should determine the location of the implanted electronics using a CAT scan or x-ray and manual palpation. Once the location of the electronics has been identified, the patient may be prepared for surgery. Preoperative Preparation of the Patient: The patient is placed on the operating room table in the standard manner for otologic surgery and anesthesia is induced. Prophylactic antibiotics can be administered at this time as well. The patients head may be shaved over the incision site.
Step 2: Making the Incision and Removal of the SemiImplantable Electronics

The original incision site should be utilized (Figure 48), and should allow for adequate access to the implant electronics capsule. DANGER: Care must be taken to not cut the electronics capsule during the incision or
dissection.
Figure 49 Once the implant electronics has been located, incise the sheath covering the implant electronics, and cut any sutures that may be holding the capsule in place. Remove the implant from its tissue bed taking care not to stress the transducer lead.
Step 3: Connector Disassembly

Required Equipment Disposable Torque Wrench Transducer with lead Electronics Capsule Purpose Used to tighten or loosen septum screw securing transducer lead to electronics capsule To be attached to electronics capsule to form complete unit To be attached to transducer to form complete unit
Using a scalpel, cut around the front and rear septums to expose the allen-head screws of the front and rear connector blocks (Figure 49). Place the head of the torque wrench (Figure 53 page 35) into the allen slot in the front connector block and turn counter clockwise to loosen the screw. Grasp the lead strain relief and gently pull the male connecting pin (Figure 49) from the electronics capsule.
Take care not to damage the male connecting pin in any way. Clean tissue and blood from the connecting pin and inspect the front and rear seals for cracks and tears. Measure, record and report to Otologics the tissue thickness. If the tissue that over-lies the electronics capsule is thicker than 6 mm, thin the tissue to 6mm prior to connecting the new electronics capsule.
Female connector
Male connector pin
Pin connector block
Ring Connector block
Figure 49 (left ear)
Figure 50
Step 4: Attaching the Electronics Capsule to the Transducer

Required Equipment Disposable Torque Wrench Transducer with lead Electronics Capsule Bone Wax Minimally Resorbable (E.U. Only) Purpose Used to tighten or loosen septum screw securing transducer lead to electronics capsule To be attached to electronics capsule to form complete unit To be attached to transducer to form complete unit If used in place of provided Septum plug and bands, to create a moisture barrier on outside of Implant connector block set screws
Tip protrusion 4. Figure 51 Figure 53 While firmly supporting the pin connecting block between the thumb and forefinger gently push on the torque wrench while turning clockwise to engage the wrench head into the screw. Once the wrench has been felt to engage the screw, turn the wrench clockwise until the torque wrench clicks once. This will take between and turn. While still firmly supporting the pin connecting block between the thumb and forefinger remove the torque wrench, and gently pull on the lead to confirm contact. Repeat steps 5-7 above for the ring locking screw while continuing to firmly support the electronics capsule by holding the ring connecting block between the thumb and forefinger. Install the septum Plug into the connector blocks by pressing each end of the molded septum plug into the appropriate connector block.
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The electronics capsule is constructed so that the male transducer connector may be inserted into the female electronics connector. Lubricate the male connecting pin with sterile saline. While firmly holding the electronics capsule by the pin connector block between the thumb and forefinger (taking care to not touch the microphone), insert the male connecting pin into the female connecting block until the pin hits the positive stop on the inside of the connector and can be seen protruding past the pin connector block (Figure 52 & 53). Two locking screws will be tightened with the torque wrench to hold the connector in place. (Figure 55)
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Figure 54a Top View
Figure 56b Silicone Bands Installed Figure 56a Silicone Bands ____________________________________________________________________________________ MET Fully-Implantable Ossicular Stimulator D104096 M Surgical Training Manual Page 38 of 69 Otologics Confidential
Important information: Never tighten connector block screws without the male connecting pin inserted into the female connecting blocks. Always lubricate the male connecting pin with saline prior to insertion into the connector block. Failure to do so will result in an improper connection. Never fill the female connecting block with fluid. To do so will result in an improper connection.
Surgical Diagnostics: Some tests should be performed during implantation. These tests help to make sure that the transducer and microphone are fully functional and will help detect if the device has been damaged, e.g. during handling or in the OR during implantation. The data collected can be used later in the clinic for diagnostics and troubleshooting. These tests are: Battery test (reads charge state) SAFI tests: Microphone functionality Functional Test Transducer Impedance
CAUTION! For the surgical tests, the TLA programming coil must be wrapped in a sterile bag to be placed over the implant coil.
Step 5: Enlarging the Bone Bed for the Electronics Capsule, Pendant Microphone, and Closing
The size of the bone bed is increased and a new bed is created to accommodate the fully-implantable electronics capsule and microphone. The capsule should be placed in a relatively flat location, and the bone bed should be drilled under the entire capsule. The bone bed should be enlarged to accommodate the implant with the silicone bands installed. (Figure 57, 58, 59). The microphone should not be placed under or adjacent to muscle tissue, such as the temporalis muscle, as the localized tension created by the muscle will affect the performance of the microphone. When inserting the capsule in to the bone bed, ensure that the coil is not severely bent. Secure the fullyimplantable capsule, microphone, and close the wound in the normal manner.
Figure 59 MET Fully-Implantable Ossicular Stimulator in situ Important Information! Integrated straps are provided for securing the electronics capsule and the microphone pendant to the bone bed. Additional bending and fitting may be required. The straps should constrain the implant or the microphone pendant in a fixed location following the installation of the bone screws. For this reason, two screws must be used in each strap. The devices should be tested for movement following the installation of the bone screws. If movement is present additional adjustment to the straps must be performed. Additional bending and shaping of the straps may be performed using the surgical pliers used to form the bone-mounting bracket. Precautions for bending are described in detail in the Instructions for Use included with the straps. Important Information! The bone bed for the microphone may be done one of two (2) ways (Figure 34). (1) At a minimum, a circular depression may be made to accommodate the raised portion on the under or back-side of the microphone, or (2) A larger area to fit the shape for the entire device may be drilled. A lead channel should be drilled for the microphone lead in either case. Also, a lead channel should be drilled to accommodate the transducer lead.
Figure 57 MET Semi-Implantable Ossicular Stimulator bone bed
Figure 58 Bone bed enlarged and microphone bed created for MET Fully-Implantable Ossicular Stimulator ____________________________________________________________________________________ MET Fully-Implantable Ossicular Stimulator D104096 M Surgical Training Manual Page 40 of 69 Otologics Confidential
Step 6: Post Surgical Care and Activation

Post surgery care: Follow up patient care is performed in the usual manner for otologic surgery. The patient is given the same postoperative instructions provided after standard otologic surgery. If the patient was wearing amplification prior to surgery, he or she may wear amplification in the non-implant ear, but should not wear amplification in the implant ear until after the eight week healing period is complete and medical clearance is given. Activation: Following a 8-week healing period and medical clearance, the MET Fully-Implantable Ossicular Stimulator will be programmed according to the hearing needs of the individual patient. Detailed procedures for fitting the MET Fully-Implantable Ossicular Stimulator are provided in the MET Fully-Implantable Ossicular Stimulator Fitting Guide.
SURGICAL STEPS FOR REPLACING THE FULLYIMPLANTABLE MET OSSICULAR STIMULATOR (FIMOS) WITH THE FULLY-IMPLANTABLE MET OSSICULAR STIMULATOR (FIMOS)
Step 1: Pre-Surgical Preparation for FIMOS to FIMOS Surgery Step 2: Making the Incision and Removal of the FIMOS Electronics Capsule Step 3: Connector Disassembly Step 4: Attaching the New FIMOS Electronics Capsule to the Old Transducer Step 5: Securing the Electronics Capsule, Pendant Microphone, and Closing Step 6: Post Surgical Care and Activation
Step 1: Pre-Surgical Preparation for FIMOS to FIMOS Surgery

Important Information! The MET Fully-Implantable Ossicular Stimulator must be charged prior to surgery using the Charger and instructions for use for the Charger. Important Information!
A CAT scan or a lateral x-ray must be performed to determine location of the implanted lead and mounting bracket.
Important Information! Integral straps are provided for securing the electronics capsule and the microphone pendant to the bone bed. Additional bending and fitting of the straps may be required. The straps should constrain the implant or the microphone pendant in a fixed location following the installation of the bone screws. For this reason, two bone screws must be used in each strap. The devices should be tested for movement following the installation of the bone screws. If movement is present additional adjustment to the straps must be performed. Additional bending and shaping of the Bone Bracket may be performed using the surgical pliers used to form the bone-mounting bracket. Precautions for bending are described in detail in the Instructions for Use included with the straps. The recommended locations for the straps are also indicated in the Instructions for Use provided with the brackets. CAUTION! The leads of the Transducer and Microphone Pendant should not be placed in contact with the legs of the mounting bracket to avoid damage to the leads. CAUTION! Place the Microphone Pendant in the recommended area ( Figure 12 page 13 ), directly posterior to the external auditory canal, and route the lead from the microphone to the Capsule so that there is no tension on either end of the lead. DO NOT pull on the leads or create tight bends on them, especially in the areas where they enter the Pendant and Capsule bodies.
CAUTION: For revision surgery, only bi-polar cauterization is permissible. The use of monopolar cauterizing equipment may damage the implanted transducer.
Charging the Implant: Plug in the Charger Base Station, and make sure that the Base Station indicator light is green, verifying that the charger system is connected to a power source. Confirm that the charging system is fully charged by checking to see if the charger power indicator is green. (The charger indicator is the light on the far left side of the charger). A full recharge time for the charger body is 6 hours. To charge the implant, place the charging coil over the implant while it is still in its sterile packaging. The charging will take place through the sterile packaging. Fully charging an implant can take up to 3 hours. Once the implant is fully charged the Implant charger indicator will turn green. (The Implant charger indicator is the light on the far right side of the charger.) Consult the Charger User Guide for additional information. Determine location of implanted electronics: The surgeon should determine the location of the implanted electronics using a CAT scan or X-ray and manual palpation. Once the location of the electronics has been identified, the patient may be prepared for surgery.
Required Test:
Perform SAFI Test on functional implants and save and record SAFI Impedance test results. Preoperative Preparation of the Patient: The patient is placed on the operating room table in the standard manner for otologic surgery and anesthesia is induced. Prophylactic antibiotics can be administered at this time as well. The patients head may be shaved over the incision site.
Step 2: Making the Incision and Removal of the FIMOS Electronics Capsule
The original incision site should be utilized (Figure 60), and should allow for adequate access to the implant electronics capsule. Additional incision space may be required if the implant and the microphone are relocated and new or modified bone beds are needed to be created. The incision may need to be increased in order to secure the implant capsule and the microphone with the bone screws to the attached straps. DANGER: Care must be taken to not cut the electronics capsule during the incision or
dissection.
Figure 60 Once the implant electronics has been located, incise the sheath covering the implant electronics, and cut any sutures that may be holding the capsule in place. If unattached bone straps were used, remove the Capsule and Mic strap screws and remove the straps. Remove the Implant and Microphone from its tissue and bone-bed, taking care not to stress the transducer lead.
Step 3: Connector Disassembly

Required Equipment Disposable Torque Wrench Transducer with lead Electronics Capsule Purpose Used to tighten or loosen septum screw securing transducer lead to electronics capsule To be attached to electronics capsule to form complete unit To be attached to transducer to form complete unit Take care not to damage the Transducers male connecting pin in any way. Clean tissue and blood from the connecting pin and inspect the front and rear seals for cracks and tears.
Using a pick or tweezers, remove the septum plugs or bone-wax to expose the allen-head screws of the front and rear connector blocks (Figure 62). Place the head of the torque wrench (Figure 67 page 47) into the allen slot in the tip and ring connector blocks and turn counter clockwise to loosen the screws. Grasp the lead strain relief as close as possible to the implant body and gently pull the male connecting pin (Figure 62) from the electronics capsule.
Required Tests:
Perform TLA Test on Transducer lead. Verify transducer is loaded correctly. Refer to TLA instructions for correct loading data. Re-load transducer if loading indication through TLA Testing indicates inadequate loading. If transducer is damaged thru removal from implant, transducer must be replaced with back-up transducer. Refer to Step 8 and 9 in the FIMOS Implantation Procedure for placing transducer into bone bracket. Follow instructions in TLA procedure to re-load new transducer. Measure, record, and report to Otologics the tissue thickness. If the tissue that over-lies the electronics capsule is thicker than 6 mm, thin the tissue to 6mm prior to connecting the new electronics capsule.
Figure 61 (Right Ear)
Figure 62
Step 4: Attaching the New FIMOS Electronics Capsule to the Old Transducer
Required Equipment Disposable Torque Wrench Transducer with lead Electronics Capsule Silicone Bands (2) Purpose Used to tighten or loosen septum screw securing transducer lead to electronics capsule To be attached to electronics capsule to form complete unit To be attached to transducer to form complete unit To secure the septum plug in place when installed in the implant capsule.
Tip protrusion 4. Figure 63 Figure 65 While firmly supporting the pin connecting block between the thumb and forefinger gently push on the torque wrench while turning clockwise to engage the wrench head into the screw. Once the wrench has been felt to engage the screw, turn the wrench clockwise until the torque wrench clicks once. This will take between and turn. While still firmly supporting the pin connecting block between the thumb and forefinger remove the torque wrench, and gently pull on the lead to confirm contact. Repeat steps 5-7 above for the ring locking screw while continuing to firmly support the electronics capsule by holding the ring connecting block between the thumb and forefinger. Install the septum Plug into the connector blocks by pressing each end of the molded septum plug into the appropriate connector block.
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The electronics capsule is constructed so that the male transducer connector may be inserted into the female electronics connector. Lubricate the male connecting pin with sterile saline. While firmly holding the electronics capsule by the pin connector block between the thumb and forefinger (taking care to not touch the microphone), insert the male connecting pin into the female connecting block until the pin hits the positive stop on the inside of the connector and can be seen protruding past the pin connector block (Figure 64 & 65). Two locking screws will be tightened with the torque wrench to hold the connector in place. (Figure 64)
5.
6.
7.
8.
Figure 66a Top View
Figure 68a Silicone Bands
Figure 68b Silicone Bands Installed
Important information: Never tighten connector block screws without the male connecting pin inserted into the female connecting blocks. Always lubricate the male connecting pin with saline prior to insertion into the connector block. Failure to do so will result in an improper connection. Never fill the female connecting block with fluid. To do so will result in an improper connection.
Surgical Diagnostics: Some tests must be performed during implantation. These tests make sure that the transducer and microphone are fully functional and will detect if the device has been damaged, e.g. during handling or in the OR during implantation. The data collected can be used later in the clinic for diagnostics and troubleshooting. These tests are: Battery test (reads charge state) SAFI test: Microphone functionality tests Transducer Impedance
CAUTION! For the surgical tests, the programming coil must be wrapped in a sterile bag to be placed over the implant coil.
Step 5: Securing the Electronics Capsule, Pendant Microphone, and Closing

Secure the fully-implantable capsule, microphone, and close the wound in the normal manner. The microphone should not be placed under or adjacent to muscle tissue, such as the temporalis muscle, as the localized tension created by the muscle will affect the performance of the microphone. If the original microphone placement
is under or adjacent to muscle tissue, create a new bone bed for the microphone and secure the microphone with two (2) bone screws to the attached strap.
Fully-Implantable MET Ossicular Stimulator bone beds
Maximum muscle flap thickness = 6 mm
Microphone
Figure 69 MET Fully-Implantable Ossicular Stimulator
Important Information! Integral straps are provided for securing the electronics capsule and the microphone pendant to the bone bed. Additional bending and fitting may be required. The straps constrain the implant or the microphone pendant in a fixed location following the installation of the bone screws. For this reason, two screws must be used in each strap. The devices should be tested for movement following the installation of the bone screws. If movement is present additional adjustment to the straps must be performed. Additional bending and shaping of the strap may be performed using the surgical pliers used to form the bone-mounting bracket.
Step 6: Post Surgical Care and Activation

Post surgery care: Follow up patient care is performed in the usual manner for otologic surgery. The patient is given the same postoperative instructions provided after standard otologic surgery. If the patient was wearing amplification prior to surgery, he or she may wear amplification in the non-implant ear, but should not wear amplification in the implant ear until after the eight week healing period is complete and medical clearance is given. Activation: Following a 8-week healing period and medical clearance, the MET Fully-Implantable Ossicular Stimulator will be programmed according to the hearing needs of the individual patient. Detailed procedures for fitting the MET Fully-Implantable Ossicular Stimulator are provided in the MET Fully-Implantable Ossicular Stimulator Fitting Guide.
Endnotes
1.
Ito J Fujino K Okumura T Takagi A Takahashi H Honjo I. Surgical difficulties and postoperative problems associated with cochlear implants. Annals of Otology, Rhinology, & Laryngology Supplement. 166:425-6, 1995 Sep. Hoffman RA Cohen NL. Complications of cochlear implant surgery. Annals of Otology, Rhinology, & Laryngology - Supplement. 166:420-2, 1995 Sep. Babighian G. Problems in cochlear implant surgery. Advances in Oto-Rhino-Laryngology. 48:65-9, 1993. Lesinski SG Newrock R. Carbon dioxide lasers for otosclerosis. [Review] Otolaryngologic Clinics of North America. 26(3):417-41, 1993 Jun. Rauch SD Bartley ML. Argon laser stapedectomy: comparison to traditional fenestration techniques. American Journal of Otology. 13(6):556-60, 1992 Nov. Lesinski SG Stein JA. CO2 laser stapedotomy. Laryngoscope. 99:20-3, 1989 Jun.
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APPENDICES Appendix 1: Otologics Surgical Equipment

In addition to standard surgical tools, the implant surgery requires the use of the MET Ossicular Stimulator, a set of surgical tools and other equipment. These components and sterilization techniques are described in this section.
Sterilization
Unless specifically indicated otherwise, all equipment received from Otologics will be supplied non-sterile. In preparation for the surgery, all equipment in the surgical kits must be sterilized. All items contained in the surgical kits are designed to withstand high temperatures; the preferred sterilization method for the surgical kits is steam sterilization (autoclaving). Exact compliance is required with the sterilization equipment manufacturers user instructions. It is the responsibility of the user facility to make sure that the special decontamination, cleaning and sterilization methods are used for deactivation of specific pathogens and to validate sterilization cycles to account for differences in sterilization chambers, wrapping methods and load configurations. The fiber stripper must also be sterilized. Since it cannot be steam sterilized, the preferred method is gas sterilization (ethylene oxide). If the laser fiber does not arrive sterile, it should also be sterilized through a cold sterilization technique. Check with the responsible facility as to which technique may be used. The MET Ossicular Stimulator will arrive at the hospital in sterile packages. In some cases, the laser fiber will also arrive sterilized.
Otologics Proprietary Surgical Tools The set of surgical tools comes in two separate trays, the Reusable Surgical Tool Set and the Single Use Tool Set. In addition there are a few tools, used in surgical support, that come separately. Reusable Surgical Tool Set This set contains reusable tools and should be autoclaved for sterilization. Several of the tools may be disassembled for sterilization if desired. Figure 64 depicts the reusable tool set with the tools fully assembled. Figures 71through 73 depict the disassembled reusable tool set.
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.
Atticotomy Template Laser Guide Assembly Screwdriver Transducer Insertion Instrument Locking ring tool Microadjust screwdriver Flap Thickness Gauge Bending Pliers Cutting Pliers Microphone Fitment Template Screwdriver
Figure 70 Reusable Surgical Tool Set - Assembled
1. 2. 3. 4.
Atticotomy Template Laser Guide Assembly Screwdriver Transducer Insertion Instrument 5. Locking ring tool 6. Microadjust screwdriver 7. Flap Thickness Gauge 8. Bending Pliers 9. Cutting Pliers 10. Screwdriver 11. Microphone Fitment Template 12. surgical implant template
Figure 71 Reusable Surgical Tool Set Disassembled for Sterilization see Instructions for Use for details
Figure 72 #2 Laser Guide Assembly Disassembled
Figure 73 #4 Transducer Insertion Instrument Assembly Disassembled
Single Use Instruments Trays These trays contain most of the remaining instruments, is provided sterile, and is intended for single use only (Figure 74).
SINGLE USE INSTRUMENTS TRAYS

(MET-1050) 1. Mounting Bracket with Surgical Bending Template 2. Bone Screws and Oversize Screws 3. Hypodermic Tubes 4. Hand Auger 5. Drill Bit 6. Capsule Template 7. Torque Wrench
Figure 74
Additional Surgical Tools There are several tools required for steps, generally performed by the surgical staff, that are not included in either the Surgical Equipment Rack or the Surgical Equipment Tray. Item Fiber Stripper (D100631) This tool cannot be steam sterilized. It must be sterilized with a cold sterilization technique. Picture Steps When Used
Optical Fiber The fiber will generally arrive sterile If sterilization is required, cold sterilization must be used Laser Device There are several alternatives (see Step 6: Creating the Laser Hole) Transducer Loading Assistant
Will vary based on brand of laser
Will vary based on brand of laser
Step 10: Loading the MET Ossicular Stimulator and Diagnostics
Appendix 2: Troubleshooting an Implanted Device During Surgery

If transducer function cannot be confirmed after placement, retract the probe tip completely out of the hole in the incus and retest the unit. If function is confirmed redo the loading procedure as outlined in Step #9 of this manual, and re-test the unit a final time. If function is not confirmed, attempt to tighten the connections between the electronics capsule and the MET Ossicular Stimulator lead. Dip the torque wrench tip in saline and push it through the silicon septum of the pin connector block. While holding the connector block firmly between your fingers, turn the torque wrench clockwise until the torque wrench makes a loud click. Dip the torque wrench in saline and repeat for the ring connector block. Test the device. If function is still not confirmed, detach and reattach the electronics capsule. Dip the torque wrench in saline and unscrew the connectors with a counter-clockwise motion until they release the lead. Re-attach the lead to the electronics capsule, following the instructions listed in Step 10. Re-test the unit. If function is still not confirmed, remove the device, beginning with retracting the tip out of the laser hole. Repeat the function test in the sterile field. Repeat the detachment of the electronics capsule and retest. If unable to confirm function at this point, open another device and follow the required steps to implant the device.
Appendix 3: Surgical Training Checklist

The Otologics Surgical Procedure
Each item below, marked by a check box, must be reviewed in detail, before being checked off. Once the entire check sheet has been successfully completed, the surgeon is ready to perform an implantation. The Following Steps have been completed by the undersigned below (please check each item after completion): REVIEW HOW THE MET OSSICULAR STIMULATOR WORKS REVIEW SURGICAL VIDEO SHOW DEVICE, HALF SKULL, AND SURGICAL TOOLS
Show where the charging coil would affix and display proper incision and atticotomy location Quick overview and definition of surgical tools, with more detailed explanations during the following steps Include placement of capsule template and microphone to determine incision location
REVIEW PATIENT PREPARATION

REVIEW ALL STEPS IN THE SURGICAL PROCEDURE, LISTED BELOW.

If this is a temporal bone session, demonstrate each step and have the surgeon perform the steps using the surgical tools on the temporal bone. If this is a half skull presentation, explain each step in detail, and have the surgeon and staff handle the instruments and practice the steps if applicable.
Surgical Procedure Step 1 Pre-Surgical Implant Preparation Explain the need for charging the implant prior to surgery
Surgical Procedure Step 2 Making the Incision Explain incision location and need for the incision to avoid coil location Refer to appropriate page in the Surgical Manual (D104096), Ensure that the area near the atticotomy location is scraped clean of any tissue to ensure good attachment of the screws of the mounting bracket. Use Capsule Template to demonstrate the preferred location that the implant will be placed The incision should be made so that the coil does not sit on the incision line Explain the importance of placing the implant on a relatively flat area of the skull. Explain the importance of making a bone bed under the entire capsule.

Surgical Procedure Step 3 Drilling the Atticotomy Describe the rough geometry and location of the atticotomy Refer to appropriate page in the Surgical Manual Use the atticotomy template to demonstrate the approximate size of the hole The superior (top) side of the atticotomy must follow the dural plane The inferior (bottom) side must be parallel to the superior side and should be close to the external auditory canal (EAC) The surgeon can use a pen to mark the atticotomy location directly on the bone The atticotomy template leading edge should be placed over the body of the incus
The atticotomy will be larger than the template due to anterior drilling to view the head of the malleus Explain that the surgeon should drill until the atticotomy is adequate size, meaning that: o The head of the malleus is clearly visible from directly above atticotomy o Atticotomy walls are generally parallel and approximately 10-13 mm wide at the surface o Ensure that the hole is wide enough by inserting a 5 or 6mm burr fully into the atticotomy o Make sure the surgeon does not make a mastoidectomy o Be especially careful of ledges deep in the atticotomy that may block advancement of the transducer Explain how the three pieces of the laser guide fit together and what they represent. Explain how the compression assembly works: as the locking ring tightens behind the compression ball, the front and back of the compression assembly compress the ball, tightening the slices cut into the compression ball and restricting movement of the mounting shaft that runs through the ball. Show how the laser guide fits into the mounting bracket. Explain how the legs of the mounting bracket, bend and twist to allow flush placement of the legs to the skull Have the surgeon assemble the laser guide and thread the guide on the mounting bracket Explain that this step can sometimes be difficult and may require patience to thread the guide. Typically, if the laser guide will not fit in the bracket, the laser guide approach angle is too high Use the laser guide (mounted in the bracket) to determine if the atticotomy extends posterior enough to allow the guide to contact the incus at an acute angle. Explain that the surgeon will most likely need to continue drilling after these checks. o
Explain how the laser guide tip must point directly at the body of the incus The tip must be able to touch the incus when placed The tip must approach the incus at a relatively steep angle (as close to perpendicular as possible), so the laser does not cut a groove along the top of the incus. When the atticotomy is approaching the correct size and width, use a mounted laser guide to determine if placement is roughly possible Advance the laser guide until the tip can touch the incus Ensure the contact location will result in a hole, not a groove If the tip of the laser guide assembly does not reach, loosen the locking ring tool and advance laser guide If the tip comes within 1-2 mm, it is safe to proceed There must be a good view of the tip touching the incus, if there is not, the atticotomy should be extended anteriorly
Surgical Procedure Step 4 Positioning the Mounting Bracket KEY STEP
The surgeon should roughly fit the laser guide to the atticotomy, aligning the tip at the incus If required, continue drilling Explain the importance of all four legs being completely flat to the skull Explain that if that is not possible, one leg could be removed If any leg lies over tissue, that tissue must be removed Make sure that the laser guide can be removed from the mounting bracket when preparing for final positioning of the mounting bracket If it is hard to align the tip with the incus, try moving the mounting bracket further anterior to get a better angle
Demonstrate how to make the Surgical Bending template arms conform to the surface of the skull, while the bone bracket and laser guide are held in position. Demonstrate how to bend and twist legs to match the Bending Template and ensure flat placement Make sure there is a close fit between the legs and skull. Care should be taken to avoid having the body of the mounting bracket sticking out from the skull If any leg is not flush to the skull, the leg must be bent or removed No more than one leg can be removed Explain that if the legs dont fit flush to the skull and end up forced into place by a screw, there is a chance that the mounting bracket threads will lose their shape. If the mounting bracket threads are bent, it may be impossible to sufficiently tighten the compression ball to hold the transducer. To test flushness, hold each leg down separately and make sure the tip still points at the proper location on the incus Once the bracket fits flatly to the skull, ensure again that the tip is pointed at the proper point on the incus Check the location of the Laser Guide tip on the incus very carefully. It should be directed at the middle of the body of the incus. The angle of approach should be as perpendicular as possible to avoid a groove Explain that the surgeon should ensure that the tip can reach the incus by extending it while the mounting bracket is in place. Watch closely for any bone on sidewalls interfering with advancement The Surgical Bending Template (blue titanium part attached to the Bone Bracket) must be removed from the Bone Bracket prior to bone screws being used. It is removed by prying up the center locking tab, on the blue part, and then pulling up and away (some rocking may be required).
Surgical Procedure Step 5 Fastening the Mounting Bracket KEY STEP Make sure any remaining tissue is removed from the points where the legs will sit Drill screw holes using drill bit. The drill must enter the leg hole at a 90 degree angle to the skull The first hole should be drilled, the bone screw placed and tip alignment checked before moving to the next hole and these steps repeated. It is very important to check alignment after each bone screw is placed Continue until all four legs are fastened. Any leg without a bone screw must be removed. If the mounting bracket must be moved or replaced, use the oversize screws on any holes which are being reused. When the mounting bracket has been placed, make a final check to see if the Laser Guide tip is in proper position Surgical Procedure Step 6 Creating the Laser Hole Remove the mock tip from the laser guide assembly. Explain the steps for use of the laser Demonstrate and allow surgeon to perform cutting and stripping of laser fiber (in the United States only). Confirm to European surgeons that a sterile, single use fiber will be supplied. Distribute laser goggles to everyone in the room and place warning signs on the outside of each door. Explain procedure to use wooden spatula to start laser cutting by introducing char at the laser tip. It is also possible to touch the tip of the fiber with a dark felt pen or with a drop of blood. Explain that the laser fiber must be in light contact with the incus for effective cutting and to reduce charring. Insert the laser fiber into the hypodermic tube and insert the hypodermic tube into the laser guide assembly. ____________________________________________________________________________________ MET Fully-Implantable Ossicular Stimulator D104096 M Surgical Training Manual Page 60 of 69 Otologics Confidential
The laser fiber should extend about 1mm beyond the end of the hypodermic tube. If it extends further or if the surgeon too much pressure, the fiber may bend, making placement of the device difficult later. Make sure the laser fiber is placed at the exact spot desired to make the hole. Irrigation is suggested during laser drilling or after each set of pulses. Set laser to appropriate settings. Fire appropriate number of pulses and ensure the laser is cutting effectively. If it is not, make sure the laser fiber has a clean cut or edge. Use the wooden spatula technique or mark the tip of the fiber with a pen to facilitate cutting. Explain the use of the hand auger Have the surgeon view the hand auger beneath the microscope or show a drawing. Explain that the completed hole must reach shoulder depth on the auger at 3 and 9 oclock positions, or on 180 degrees of the circumference of the hole. The most effective motion in a gentle back and forth rotation The hand auger is designed to remove char (not to remove bone or deepen the hole) The hand auger has a shoulder at 0.75 mm After using the hand auger, use irrigation and suction to remove extra char from around hole Repeat the laser and hand auger steps until the hole is at depth Explain how the hand auger shoulder represents the correct depth for the hole The hole is deep enough when the hand auger is at shoulder depth (0.75 mm) for at least half of its circumference The wall around the hole must be at least 0.25 mm deep at every point Once depth is reached, the surgeon should clean the hole of char, remove the laser guide (leave the mounting bracket) and cover the Atticotomy
Surgical Procedure Step 7 Preparing the Bone Bed and Lead Channel Explain and/or drill the bone bed and the lead channel Explain importance of position of the bone bed (posterior and superior of atticotomy) Use the capsule template to identify the size, location and shape of the bone bed Explain the importance of the placing the implant in a relatively flat location on the skull. Explain the importance of providing a bone bed under the entire capsule so that the coil is not severely bent when it is placed in the bone bed. Explain issues behind thickness of tissue overlying implant Ensure lead channel is positioned so that the lead will not rub against the mounting bracket Spend some time using the surgical manual diagrams to explain how to drill the lead channel Make sure the mounting straps of the implant and the microphone do not touch the mounting bracket or each other during the placement. The lead channel must allow the lead to extend from the capsule a bit before bending Remove the gauze, thoroughly irrigate and suction the atticotomy in preparation for insertion of the device Surgical Procedure Step 8 Placing the MET Ossicular Stimulator Explain the various pieces of the transducer Explain design of the compression ball (see above) and locking ring Demonstrate how to attach the Transducer Insertion Instrument. Hold the transducer with the jaws in the fingers and the spring-loaded portion in the butt of the hand. Show how to use the mounting shaft to gain a few mm of extra advancement Show how to use the adjustment screwdriver to advance and retract the transducer body Explain positioning of the Microphone ____________________________________________________________________________________ MET Fully-Implantable Ossicular Stimulator D104096 M Surgical Training Manual Page 61 of 69 Otologics Confidential
Assemble the device and insert it into the mounting bracket Make sure the device is fully retracted Remind the surgeon that this step can be a little difficult. If the locking ring will not thread, the insertion angle is probably too high. Slightly tighten the locking ring in place, leaving it loose enough to align the tip. Align the tip directly over and approximately 2mm above the incus If necessary, move the Transducer Insertion Instrument up the mounting bracket to gain extra length (see above) Tighten the locking ring until the locking ring no longer moves. Remove the locking ring tool and Transducer Insertion Instrument
Surgical Procedure Step 9 Loading the MET Ossicular Stimulator and Diagnostics (* KEY STEP) LOADING THE MET OSSICULAR STIMULATOR Fit the micro adjust screwdriver over the end of the mounting shaft to advance the probe tip into the laser hole. Refer to the Transducer Loading Assistant User Manual for addition instructions.
Explain the Diagnostics testing and how to use an endoscope bag during surgery to maintain sterility.
Surgical Procedure Step 10 - Attaching the Electronics Capsule to the Transducer Demonstrate how to attach the transducer to the electronics Explain how the torque wrench functions Review using lubrication when inserting the torque wrench into the set screws. Explain how to determine if the lead is fully inserted into the implant capsule. Explain the importance of visualizing the pin connector past the pin connector block. Explain the limited turn required to tighten the IS1 connector Explain disconnection (only half turn required to disconnect) Allow surgeon to attach and detach the device. Explain use of the SAFI, and how to test for functionality after the device is connected. Surgical Procedure Step 11 Securing the Electronics Capsule and Closing the Incision Using the flap thickness gauge, determine if the total flap thickness is within the required 6mm. If it is too thick, thin the flap as necessary. Explain the importance of preventing the coil from being bent severely when it is placed into the bone bed. Secure the electronics capsule and microphone to the temporal bone using the welded straps on the implant and microphone using bone screws. Two (2) bone screws must be used on capsule and two (2) bone screws must be used on microphone. Surgical Procedure Step 12 Post Surgical Care and Activation The patient is given the same postoperative instructions provided after standard otologic surgery. Following an 8-week healing period and medical clearance, the MET Fully-Implantable Ossicular Stimulator will be programmed according to the hearing needs of the individual patient.
KEY POINT SUMMARY: Review each of the following items in detail POSITIONING THE MOUNTING BRACKET The surgeon should roughly fit the laser guide to the atticotomy, aligning the tip at the incus Explain the importance of all four legs being completely flat to the skull Explain that if that is not possible, one leg could be removed If any leg lies over tissue, that tissue must be removed Make sure that the laser guide can be removed from the mounting bracket when preparing for final positioning of the mounting bracket If it is hard to align the tip with the incus, try moving the mounting bracket further anterior to get a better angle Demonstrate how to bend the Bending Template to conform to the skull. Demonstrate how to bend and twist legs to ensure that they match the Bending Template and provide flat placement on the skull. Make sure there is a close fit between the legs and skull. Care should be taken to avoid having the body of the mounting bracket sticking out from the skull If any leg is not flush to the skull, the leg must be bent or removed No more than one leg can be removed Explain that if the legs dont fit flush to the skull and end up forced into place by a screw, there is a chance that the mounting bracket threads will lose their shape. If the mounting bracket threads are bent, it may be impossible to sufficiently tighten the compression ball to hold the transducer. To test flushness, hold each leg down separately and make sure the tip still points at the proper location on the incus Once the bracket fits flatly to the skull, ensure again that the tip is pointed at the proper point on the incus Check the location of the Laser Guide tip on the incus very carefully. It should be directed at the middle of the body of the incus. The angle of approach should be as perpendicular as possible to avoid a groove Explain that the surgeon should ensure that the tip can reach the incus by extending it while the mounting bracket is in place. Show how to remove the Surgical Bending template from the bone bracket, and explain that it should not be left in the body. Watch closely for any bone on sidewalls interfering with advancement FASTENING THE MOUNTING BRACKET Make sure any remaining tissue is removed from the points where the legs will sit Drill screw holes using drill bit. The drill must enter the leg hole at a 90 degree angle to the skull The first hole should be drilled, the bone screw placed and tip alignment checked before moving to the next hole and these steps repeated. It is very important to check alignment after each bone screw is placed Continue until all four legs are fastened. Any leg without a bone screw must be removed. If the mounting bracket must be moved or replaced, use the oversize screws on any hole which is being reused. When the mounting bracket has been placed, make a final check to see if the tip is in proper position LOADING THE MET OSSICULAR STIMULATOR Fit the micro adjust screwdriver over the end of the mounting shaft to advance the probe tip into the laser hole. Refer to the Transducer Loading Assistant User Manual for addition instructions. I acknowledge that the above listed information has been reviewed in detail: _______________________________________________________________ Surgical Trainee, Surgeon Title, Date ________________________________________________________________ Surgical Trainer, Title, Date ____________________________________________________________________________________ MET Fully-Implantable Ossicular Stimulator D104096 M Surgical Training Manual Page 63 of 69 Otologics Confidential
Appendix 4: Surgical Revision Training Checklist

The Otologics Revision Surgical Procedure
Each item below, marked by a check box, must be reviewed in detail, before being checked off. Once the entire check sheet has been successfully completed, the surgeon is ready to perform an implantation. The Following Steps have been completed by the undersigned below (please check each item after completion): REVIEW PATIENT PREPARATION
Include placement of capsule template and microphone to determine incision location
REVIEW ALL STEPS IN THE REVISION SURGICAL PROCEDURE, LISTED BELOW.

Discuss each step in detail with the Surgeon prior to performing the procedure.
Surgical Procedure Step 1 Pre-Surgical Preparation for FIMOS to FIMOS Surgery

Explain the need for X-ray or CAT Scan to determine the exact location of the implant and the leads. Explain the need for performing SAFI Test prior to disconnecting or explanting device. Explain the need for re-locating and securing the microphone and how it relates to patients performance. Explain the need for charging the implant prior to surgery
Surgical Procedure Step 2 Making the Incision and Removal of the FIMOS Electronics Capsule

Explain care must be taken during the incision as to not cut the transducer lead during the incision. Explain incision location and need for the incision to avoid implant and microphone. Refer to appropriate page in the Surgical Manual (D104096), Explain the careful removal of the tissue from the implant
Surgical Procedure Step 3 Connector Disassembly

Describe the use of a pick or tweezers to remove the septum plug or Bone Wax. Describe the use of the torque wrench to loosen the set screws. Describe how the set screws can be lost during this process if backed out too far. Describe how to be careful in removing the transducer lead from implant. Explain how no strain on transducer lead is very important during this step. Explain how TLA test will be performed to verify health of transducer after removal from implant. Explain how if transducer is damaged or is in question based upon TLA data that it may have to be removed and re-placed. Explain that if the transducer is replaced that it must be re-loaded using the TLA Software. Explain if the transducer loading is not optimal that the transducer may require an additional adjustment to the existing loading.
Surgical Procedure Step 4 Attaching the NEW FIMOS electronics Capsule to the Transducer

Describe how the transducer will be attached to the implant capsule. Explain how the lead must be lubricated prior to insertion into the implant capsule. Explain how to determine if the lead is fully inserted into the implant capsule. Explain the importance of visualizing the pin connector past the pin connector block. Explain how to torque the set screws to secure the IS-1 lead. Explain how to install the septum plug and the silicone bands.
Surgical Procedure Step 5 Securing the Electronics Capsule Pendant Microphone and Closing

Explain how a new bone bed may be necessary if the microphone is moved in location. Explain how a new bone bed may be needed if the implant changes location. Explain the importance of the placing the implant in a relatively flat location on the skull. Explain the importance of creating a bone bed under the entire capsule. Explain the importance of preventing the coil from being bent severely when it is placed into the bone bed. Explain how the leads need to be in channels and covered with bone wax or secured with sutures to reduce the probability of extrusion. Describe and explain the use of the welded straps to secure the microphone and the implant capsule. Explain the requirement for the microphone and implant to be secured with 2 screws each. Explain the need for all muscle to be removed near the microphone diaphragm area. Explain the need for tissue no thicker than 6mm over the microphone diaphragm and over the programming coil of the implant. Explain the need for the SAFI functional test to verify the functionality of the connected implant. Explain the need for care when closing so to not catch any implant leads while suturing the wound closed.
Surgical Procedure Step 6 Post Surgical Care and Activation

The patient is given the same postoperative instructions provided after standard otologic surgery. Following an 8-week healing period and medical clearance, the MET Fully-Implantable Ossicular Stimulator will be programmed according to the hearing needs of the individual patient.
I acknowledge that the above listed information has been reviewed in detail:
_______________________________________________________________ Surgical Trainee, Surgeon Title, Date
________________________________________________________________ Surgical Trainer, Title, Date
Appendix 5: Surgical Procedure Step By Step

SURGICAL PROCEDURE STEP BY STEP STEP 1 PRE-SURGICAL IMPLANT PREPARATION
1. 1 Implant Charged ? Page 12 in Manual
Explain the need for charging the implant prior to surgery and confirm that the implant has an adequate charge.
Step 2 Making the Incision

2.1 Incision location ok ?
Explain incision location and need for the incision to avoid coil location and coil damage. Refer to appropriate page in the Surgical Manual (D104096) Step 2 In Manual Page 13
2.2 Bone near Atticotomy scraped ?

Ensure that the area near the atticotomy location is scraped clean of any tissue to ensure good attachment of the screws of the mounting bracket.
2.3 Identified Rough Location with Capsule Template ? Figure 12 In Manual Page 13
Use Capsule Template to determine rough location that the coil will rest The incision should be made so that the coil does not sit on the incision line and coil lies on as flat surface as possible. The optimal position typically lies with the capsule at a 45 degree angle with the coil most anterior and superior and the most inferior part of the implant capsule immediately posterior to the superior edge of the external auditory canal.
Step 3 Drilling the Atticotomy

3.1 Geometry of Atticotomy ok ? Page 14 in Manual Describe the rough geometry and location of the atticotomy
Use the atticotomy template to demonstrate the approximate size of the hole The superior (top) side of the atticotomy must follow the dural plane The inferior (bottom) side must be parallel to the superior side and should be close to the external auditory canal (EAC) The surgeon can use a sterile pen to mark the atticotomy location directly on the bone The atticotomy template leading edge should be placed over the body of the incus The atticotomy will be larger than the template due to anterior drilling to view the head of the malleus Explain that the surgeon should drill until the atticotomy is adequate size, meaning that: The head of the malleus is clearly visible from directly above atticotomy Atticotomy walls are generally parallel and approximately 10-13 mm wide at the surface Ensure that the hole is wide enough by inserting a 5 or 6mm burr fully into the atticotomy Make sure the surgeon does not make a mastoidectomy Be especially careful of ledges deep in the atticotomy that may block advancement of the transducer
3.2 Laser Guide Assembly ? Page 15 in Manual

Explain how the three pieces of the laser guide fit together and what they represent. Explain how the compression assembly works: as the locking ring tightens behind the compression ball, the front and back of the compression assembly compress the ball, tightening the slices cut into the compression ball and restricting movement of the mounting shaft that runs through the ball. Show how the laser guide fits into the mounting bracket. Explain how the legs of the mounting bracket, bend and twist to allow flush placement of the legs to the skull Have the surgeon assemble the laser guide and thread the guide on the mounting bracket Explain that this step can sometimes be difficult and may require patience to thread the guide. Typically, if the laser guide will not fit in the bracket, the laser guide approach angle is too high Use the laser guide (mounted in the bracket) to determine if the atticotomy extends posterior enough to allow the guide to contact the incus at an acute angle. Explain that the surgeon will most likely need to continue drilling after these checks.
3.3 Laser Guide Tip Pointed to body of Incus ? Page 15 in Manual

Explain how the laser guide tip must point directly at the body of the incus The tip must be able to touch the incus when placed The tip must approach the incus at a relatively steep angle (as close to perpendicular as possible), so the laser does
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not cut a groove along the top of the incus.
3.4 Laser Guide Tip within 1 2 mm of body of Incus ? Page 23 in Manual

When the atticotomy is approaching the correct size and width, use a mounted laser guide to determine if placement is roughly possible Advance the laser guide until the tip can touch the incus Ensure the contact location will result in a hole, not a groove If the tip of the laser guide assembly does not reach, loosen the locking ring tool and advance laser guide If the tip comes within 1-2 mm, it is safe to proceed There must be a good view of the tip touching the incus, if there is not, the atticotomy should be extended anteriorly
Step 4 Positioning the Mounting Bracket KEY STEP

4.1 Laser Guide fits into Atticotomy ? Page 15 in Manual
The surgeon should roughly fit the laser guide to the atticotomy, aligning the tip at the incus If required, continue drilling Explain the importance of all four legs being completely flat to the skull Explain that if that is not possible, one leg could be removed If any leg lies over tissue, that tissue must be removed Make sure that the laser guide can be removed from the mounting bracket when preparing for final positioning of the mounting bracket If it is hard to align the tip with the incus, try moving the mounting bracket further anterior to get a better angle
4.2 Bending and Removing of Bracket Template ok ? Page 16 17 in Manual

Demonstrate how to make the Surgical Bending template arms conform to the surface of the skull, while the bone bracket and laser guide are held in position. Demonstrate how to bend and twist legs to match the Bending Template and ensure flat placement Make sure there is a close fit between the legs and skull. Care should be taken to avoid having the body of the mounting bracket sticking out from the skull If any leg is not flush to the skull, the leg must be bent or removed No more than one leg can be removed Explain that if the legs dont fit flush to the skull and end up forced into place by a screw, there is a chance that the mounting bracket threads will lose their shape. If the mounting bracket threads are bent, it may be impossible to sufficiently tighten the compression ball to hold the transducer. To test flushness, hold each leg down separately and make sure the tip still points at the proper location on the incus
4.3 Laser Guide Tip still properly pointed to Incus ? Page 23 - 26 in Manual
Once the bracket fits flatly to the skull, ensure again that the tip is pointed at the proper point on the incus Check the location of the Laser Guide tip on the incus very carefully. It should be directed at the middle of the body of the incus. The angle of approach should be as perpendicular as possible to avoid a groove
Explain that the surgeon should ensure that the tip can reach the incus by extending it while the mounting bracket is in place. Watch closely for any bone on sidewalls interfering with advancement The Surgical Bending Template (blue titanium part attached to the Bone Bracket) must be removed from the Bone Bracket prior to bone screws being used. It is removed by prying up the center locking tab, on the blue part, and then pulling up and away (some rocking may be required).
Step 5 Fastening the Mounting Bracket KEY STEP

5.1 Bracket sits snug before fastening ? Page 19 in Manual Make sure any remaining tissue is removed from the points where the legs will sit 5.2 Drilled Screw Holes and Bracket fastened ? Page 19 in Manual
Drill screw holes using drill bit. The drill must enter the leg hole at a 90 degree angle to the skull The first hole should be drilled, the bone screw placed and tip alignment checked before moving to the next hole and these steps repeated. It is very important to check alignment after each bone screw is placed Continue until all four legs are fastened. Any leg without a bone screw must be removed. If the mounting bracket must be moved or replaced, use the oversize screws on any holes which are being reused. When the mounting bracket has been placed, make a final check to see if the Laser Guide tip is in proper position
Step 6 Creating the Laser Hole

6.1 Laser fiber assembled into Laser guide ? Page 20 in Manual MET Fully-Implantable Ossicular Stimulator Surgical Training Manual Otologics Confidential - APPENDIX 5
D104096M Page 67 of 69
Remove the mock tip from the laser guide assembly. 6.2 All OR attendees wear laser goggles ? 6.3 Laserfiber in light contact with incus ?
Explain the steps for use of the laser Demonstrate and allow surgeon to perform cutting and stripping of laser fiber (in the United States only). Confirm to European surgeons that a sterile, single use fiber will be supplied. Distribute laser goggles to everyone in the room and place warning signs on the outside of each door. Explain procedure to use wooden spatula to start laser cutting by introducing char at the laser tip. It is also possible to touch the tip of the fiber with a sterile dark felt pen or with a drop of blood. Explain that the laser fiber must be in light contact with the incus for effective cutting and to reduce charring. Insert the laser fiber into the hypodermic tube and insert the hypodermic tube into the laser guide assembly. The laser fiber should extend about 1mm beyond the end of the hypodermic tube. If it extends further or if the surgeon too much pressure, the fiber may bend, making placement of the device difficult later. Make sure the laser fiber is placed at the exact spot desired to make the hole. Irrigation is suggested during laser drilling or after each set of pulses. Set laser to appropriate settings. Fire appropriate number of pulses and ensure the laser is cutting effectively. If it is not, make sure the laser fiber has a clean cut or edge. Use the wooden spatula technique or mark the tip of the fiber with a pen to facilitate cutting.
6.4 Hole in incus drill and augered to 0.75 mm ? Page 21 in Manual

Explain the use of the hand auger Have the surgeon view the hand auger beneath the microscope or show a drawing. Explain that the completed hole must reach shoulder depth on the auger at 3 and 9 oclock positions, or on 180 degrees of the circumference of the hole. The most effective motion in a gentle back and forth rotation The hand auger is designed to remove char (not to remove bone or deepen the hole) The hand auger has a shoulder at 0.75 mm After using the hand auger, use irrigation and suction to remove extra char from around hole Repeat the laser and hand auger steps until the hole is at depth Explain how the hand auger shoulder represents the correct depth for the hole The hole is deep enough when the hand auger is at shoulder depth (0.75 mm) for at least half of its circumference The wall around the hole must be at least 0.25 mm deep at every point Once depth is reached, the surgeon should clean the hole of char, remove the laser guide (leave the mounting bracket) and cover the Atticotomy
Step 7 Preparing the Bone Bed and Lead Channel

7.1 Bone Bed and Lead channel drilled ? Page 22 in Manual
Explain and/or drill the bone bed and the lead channel Explain importance of position of the capsule and bone bed (posterior and superior of atticotomy) Use the capsule template to identify the size, location and shape of the bone bed Explain issues behind thickness of tissue overlying implant Ensure lead channel is positioned so that the lead will not rub against the mounting bracket Spend some time using the surgical manual diagrams to explain how to drill the lead channel Make sure the mounting straps of the implant and the microphone do not touch the mounting bracket or each other during the placement. The lead channel must allow the lead to extend from the capsule a bit before bending Remove the gauze, thoroughly irrigate and suction the atticotomy in preparation for insertion of the device
Step 8 Placing the MET Ossicular Stimulator

8.1 Transducer properly placed ? Page 23-24 in Manual
Explain the importance of using suction to assure the Incus is completely dry and no saline bubble is present in the laser drilled hole. Explain that liquid in the hole will give a false indication of proper loading using TLA and the patients performance will be effected if loading of the Incus is not correct. Explain the various pieces of the transducer Explain design of the compression ball (see above) and locking ring Demonstrate how to attach the Joystick Transducer Insertion Instrument. Hold the transducer with the jaws in the fingers and the spring-loaded portion in the butt of the hand. Show how to use the mounting shaft to gain a few mm of extra advancement Show how to use the adjustment screwdriver to advance and retract the transducer body
D104096M Page 68 of 69
Assemble the device and insert it into the mounting bracket Make sure the device is fully retracted Remind the surgeon that this step can be a little difficult. If the locking ring will not thread, the insertion angle is probably too high. Slightly tighten the locking ring in place, leaving it loose enough to align the tip.
8.2 Transducer within 2 mm of Incus ? Page 23 in Manual

Align the tip directly over and approximately 2mm above the incus If necessary, move the Transducer Insertion Instrument up the mounting bracket to gain extra length Remind surgeon that the Joystick if used for retraction of the transducer may become disengaged from transducer. Transducer will then possibly fall into the attocotomy. Tighten the locking ring until the locking ring no longer moves. Remove the locking ring tool and Transducer Insertion Instrument
Step 9 Loading the MET Ossicular Stimulator and Diagnostics (* KEY STEP)
9.1 Transducer properly Loaded ? Page 25 in Manual Ref: D107454 TLA Instructions for Use loaded values of 12.2 to 14.8 mH Inductance and 200 400 Ohm Impedance ? 9.2 TLA Data recorded and saved ?
Fit the micro adjust screwdriver over the end of the mounting shaft to advance the probe tip into the laser hole. Refer to the Transducer Loading Assistant User Manual for addition instructions. Explain the Diagnostics testing and how to use an endoscope bag during surgery to maintain sterility.
Step 10 - Attaching the Electronics Capsule to the Transducer

10.1 Lead properly inserted into IS-1 (lead tip visible) ? Page 27 in Manual
Demonstrate how to attach the transducer to the electronics Explain the need to loosen the set screws to 1 turn prior to insertion of the IS-1 connector. Explain how the torque wrench functions Review using lubrication when inserting the IS-1 male connector into the capsule body. Explain the limited turn required to tighten the IS1 connector Explain disconnection (only half turn required to disconnect) Allow surgeon to attach .the IS-1 connector and verify it extends beyond the inside connector block
10.2 Set-screws tightened to torque click ? 10.3 SAFI recorded and saved ?
Explain use of the SAFI, and how to test for functionality after the device is connected.
Step 11 Securing the Electronics Capsule and Closing the Incision

11.1 Skin Flap 6mm ? Page 31 in Manual
Using the flap thickness gauge, determine if the total flap thickness is within the required 6mm. If it is too thick, thin the flap as necessary over the microphone and the implant coil areas .
11.2 Septum Plugs and Bands installed ? Page 28 in Manual Bone wax as alternative for use only in EU to seal connector block set screws.
Install the septum plug into the connector blocks Carefully stretching the silastic bands place (2) bands over the coil and slide in place securing the septum plug. Secure the electronics capsule and lead securely using the welded straps on the implant and microphone using two bone screws each. Explain the importance of exercising care while closing as to assure that the leads of the implant, microphone and transducer are not cut or damaged during the suturing of the incision.
D104096M Page 69 of 69

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SURGICAL TRAINING MANUAL

Document: Document No:

Surgical Training Manual D104096

OTOLOGISTS TRAINING FOR THE FULLYIMPLANTABLE MET OSSICULAR STIMULATOR

MET OSSICULAR STIMULATOR DESCRIPTION

Risks that may occur after surgery:

Frequency [kHz] 1 1.5 2 3 4 6

4 Air-bone gap no greater than 10 dB, 500-4000 Hz

Charging Coil Figure 7 Charger Body

Transducer Loading Assistant

Remote Programming System

NEW IMPLANTATION OF THE FULLY-IMPLANTABLE MET OSSICULAR STIMULATOR - FIMOS

Step 1: Pre-Surgical Implant Preparation

Step 2: Making the Incision

Step 3: Drilling the Atticotomy

Figure 17 - Atticotomy Template (10 mm wide x 20 mm long)

Step 4: Positioning the Mounting Bracket

Bending Template, comes pre-assembled on Bone Bracket. Bone Bracket

Figure 19 - Placing Mounting Bracket (Right Ear)

Figure 21c Correct Fit of Bracket to Skull

Figure 22a Bending Pliers

Figure 22b Cutting Pliers

Step 5: Fastening the Mounting Bracket

Step 6: Creating the Laser Hole

Figure 27 Hypodermic Tube

Figure 32 Second Hole Drilled After an Incorrect Trench

Step 7: Preparing the Bone Beds and Lead Channels

Step 8: Placing the MET Ossicular Stimulator

Figure 36 Aligning Probe Tip to Hole in Incus (Right Ear)

Step 9 Loading the MET Ossicular Stimulator and Diagnostics

Step 10: Attaching the Electronics Capsule to the Transducer

Set Screws torqued with Torque Wrench Figure 41

Figure 43a Top View

Figure 43b Side View

Figure 45a Silicone Bands

Figure 45b Silicone Bands Installed

Figure 46, Flap Thickness Gauge

Step 12. Post Surgical Care and Activation

Step 1: Pre-Surgical Preparation for the SIMOS to FIMOS Implantation

Step 2: Making the Incision and Removal of the SemiImplantable Electronics

Step 3: Connector Disassembly

Male connector pin

Pin connector block

Ring Connector block

Figure 49 (left ear)

Step 4: Attaching the Electronics Capsule to the Transducer

Set Screws torqued with Torque Wrench Figure 52

Figure 54a Top View

Figure 54b Side View

Figure 57 MET Semi-Implantable Ossicular Stimulator bone bed

Step 6: Post Surgical Care and Activation

Step 1: Pre-Surgical Preparation for FIMOS to FIMOS Surgery

Step 3: Connector Disassembly

Figure 61 (Right Ear)

Set Screws torqued with Torque Wrench Figure 64

Figure 66a Top View

Figure 66b Side View

Figure 68a Silicone Bands

Figure 68b Silicone Bands Installed

Step 5: Securing the Electronics Capsule, Pendant Microphone, and Closing

Maximum muscle flap thickness = 6 mm

Figure 69 MET Fully-Implantable Ossicular Stimulator

Step 6: Post Surgical Care and Activation