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Product Comparison

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Auditory Function Screening Devices, Newborn

UMDNS information
This Product Comparison covers the following device term and product code as listed in ECRIs Universal Medical Device
Nomenclature System (UMDNS):
9 Auditory Function Screening Devices, Newborn [20-167]

Table of Contents
Scope of this Product Comparison ...............................................................................................................................3
Purpose..........................................................................................................................................................................3
Principles of operation..................................................................................................................................................3
Conventional versus automated..............................................................................................................................4
Reported problems........................................................................................................................................................4
Purchase considerations...............................................................................................................................................5
ECRI recommendations...........................................................................................................................................5
Other considerations................................................................................................................................................6
Stage of development....................................................................................................................................................7
Bibliography..................................................................................................................................................................7
Supplier information ....................................................................................................................................................8
About the chart specifications....................................................................................................................................10
Product Comparison Chart ........................................................................................................................................12

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Policy Statement

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The Healthcare Product Comparison System (HPCS) is published by ECRI, a nonprofit health
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May 2006
Auditory Function Screening Devices, Newborn

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Scope of this Product Comparison


This Product Comparison covers devices used to screen neonate and infant auditory responses.
Hearing aids and audiometers are excluded. For information on audiometers, see the Product
Comparison titled AUDIOMETERS; AUDIOMETRIC BOOTHS.
These devices are also called: universal newborn hearing screeners (UNHSs), automated
hearing screening devices.

Purpose
Worldwide, 1 to 6 of every 1,000 infants are
born with deafness or permanent hearing loss
(Yoshinaga-Itano et al. 1998). Permanent
childhood hearing loss is the most common
defect that can be diagnosed at birth. In Europe
and the United States, hospitals screen infants
within the first months of life for hearing
impairments. However, most local, state, or
national regulations require that infants be
screened within the first 48 hours of life or
before hospital discharge. UNHSs allow hearing
impairments to be detected quickly so that any
speech and language deficiencies can be
addressed with early intervention programs. If hearing impairments are not detected early in life,
social, emotional, and intellectual (e.g., speech and language acquisition, academics) development
can be affected.

Principles of operation
A UNHS consists of a main testing system with a display screen and ear tips, earmuffs, or
electrodes; the unit can be table or cart mounted. Once the ear probe(s) or electrodes are in place,
infant screening tests are performed using either auditory brainstem response (ABR) or otoacoustic
emissions (OAEs).
ABR, an electrophysiologic assessment, is used to measure the auditory systems response to
sound. A soft click (usually 35 to 50 dB) is presented (e.g., 38 clicks/sec) to the ear(s) via earphones or
probes at a certain frequency. Electrodes are used to obtain the electrical response of the auditory
nervous system and brain. A suprathreshold acoustic stimulus causes auditory cell excitement in a
listeners ear. This excitement causes chemicals from neurons to be released when the auditory
excitation moves from the peripheral receptor cells of the inner ear to the central auditory system.
This process produces electrical activity, which can be distinguished in an ongoing
electroencephalogram (EEG) as they are synchronized with or time locked to the acoustic stimulus.
This synchronized activity can be recorded from the patients scalp surface. The electrical activity in
the EEG is referred to as auditory evoked potentials (AEPs), which represent the synchronization of
the neurons activity in response to a stimulus. ABRs are a class of AEPs that measure the integrity
of the auditory system.
Within the first 20 msec after the stimulus is delivered as clicks or short tone bursts, 5 to 7
patterned and identifiable ABR waves result. Due to the combination of ear canal acoustics and
transducer characteristics, most of the energy in the stimulus is spread over a frequency range of 1
to 5 kHz to test for hearing losses greater than 30 dB.
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Auditory Function Screening Devices, Newborn

ABR testing is often considered the gold standard due to its lower referral rates. Referral rates
are the number of referrals for additional hearing tests by an audiologist because an infant failed the
initial screening.
OAE is a screening method based on measuring the integrity of the outer hair cells in the cochlea
(inner ear) and, unlike ABR testing, does not assess auditory nerve and brainstem function. A soft
click (usually 25 dB) is presented, and a small microphone measures the acoustic response that is
returned from the babys ear via a probe in the ear canal. The response is analyzed to determine the
functionality of the inner ear auditory receptor cells. OAE screeners provide valuable information on
a patients cochlear integrity and retrocochlear function. Therefore, this method has a wide variety of
applications beyond simple auditory screening. It has been found to be a highly reliable indicator of
hearing loss of approximately 20 to 30 dB or greater.
OAEs are sounds generated within the cochlea by the outer
hair cells. OAEs are not echoes; they are sounds generated by
active processes taking place within the cochlea of healthy ears in
response to acoustic stimulation. When a sound stimulus enters
the ear, a traveling wave is generated that propagates along the
basilar membrane within the cochlea. Inner and outer hair cells
located on the basilar membrane are excited by the resulting
displacement. A sensitive microphone measures the sound
excitation from the cochlea back to the ear canal.
OAE screening can be performed as transient-evoked
otoacoustic emissions (TEOAEs) or distortion product otoacoustic
emissions (DPOAEs). DPOAE measures responses at a single
frequency that corresponds to 2F1-F2 (i.e., normal cochlear
stimulation produces a DPOAE at a specific frequency predicted
by the formula 2F1-F2) for a given tone pair. Since a single
frequency is being used, signal averaging can be restricted to a
very narrow frequency band, which decreases the testing time.
For example, if it takes 5 to 10 seconds for each response using 4
to 5 preselected frequencies, the test would be completed in less
than one minute. Since the frequency is known before testing,
other artifacts in different frequencies can be ignored. This makes the DPOAE method less sensitive
to background noise. DPOAE measures at 8 kHz and higher. The TEOAE method is more complex
and is distributed over a wide frequency spectrum. Since the stimulus is more complex, the response
range is limited to frequencies below 4 kHz.
Conventional versus automated
Conventional units require a trained technician or audiologist to use the equipment and an
audiologist to interpret the results. The test must be performed manually, and the raw data must be
interpreted to obtain a pass/refer. Automated units use the conventional technology; however, the
equipment is fully automated and simply displays a pass or fail/refer result. No interpretation is
required, so the automated units allow various trained hospital personnel (e.g., nurses, technicians,
support staff, volunteers) to perform the screen with minimal training. Some automated units may
store raw data in case test information is requested.

Reported problems
With OAE techniques, users may experience difficulty inserting probes into the ear canal.
Improper probe fitting can increase the referral rate. Proper insertion technique is easily learned,
but the operator usually needs some instruction. Some units have alarms for improper probe
placement. Also, when the OAE technique is used too soon after birth, a false fail/refer result may
occur due to debris (e.g., vernix) in the ear canal.

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Auditory Function Screening Devices, Newborn

When using the automated ABR procedure, screening should be done when myogenic activity is
low. This activity is caused by muscle tension (e.g., in tense, wiggly, or restless babies). These types
of screens have artifact-rejection systems that exclude data when myogenic activity is high. High
myogenic activity will increase test time and may cause a fail/refer result.
Although the ABR technique is highly accurate, one disadvantage is that the transient stimulus
used to elicit the most robust responsenamely, a very brief click or tone burstis necessarily
broadband and therefore lacks frequency specificity.
It is possible for false positives or false negatives to occur with either technology, thereby affecting
the hospitals referral rate. However, the following can help minimize this problem:

Ensure that the baby is quiet and calm (e.g., sleeping, just fed)

Complete a second screening before discharge for infants that do not pass the initial
screening.

Test in a quiet area.

Purchase considerations
ECRI recommendations
The accompanying comparison chart contains ECRIs recommendations for minimum performance
requirements for newborn auditory function screening devices. The three most important
specifications to consider are the devices configuration (e.g., ABR, OAE), the referral rate, and
whether the system is automated.
ECRI recommends that most hospitals implementing a newborn hearing screening program use
either ABR testing or a combination of the OAE and ABR methods. ABR testing alone is effective for
all applications. To minimize the cost of testing a large number of infants, however, an effective
alternative strategy is to use OAE/ABR. The cost of disposables for OAE testing is less expensive,
but the referral rate is significantly higher. Therefore, initial screening with OAE followed by ABR
for infants failing the initial screen may reduce costs while still providing a low false-referral rate,
depending on actual (versus example or list) costs as well as other factors. This method may be
beneficial for hospitals with a high birth rate.
The primary disadvantage to this approach is the additional time delay. While ABR can be
performed earlier, OAE should be conducted at least six hours after birth. Then, if a second test is
required, it must be scheduled and conducted afterward. With infants leaving hospitals ever earlier,
there may not always be time to complete the process. Failure to complete the protocol becomes an
additional concern for organizations with a high population of patients who tend not to follow up
with diagnostic testing because it creates more pressure for personnel responsible for ensuring
follow-up. Therefore, ECRI recommends performing the ABR test immediately following a failed
OAE test. ABR testing alone may be preferred in settings in which infants may not complete an
OAE/OAE or OAE/ABR protocol before discharge, particularly if the organization will need to expend
substantial resources on ensuring follow-up. ABR alone is also preferred if the facility is screening
within the first six hours of birth.
ABR alone should be used for a neonatal intensive care unit (NICU) because of its ability to screen
for neurologic hearing losses, which are more common in the NICU setting. Also, OAE screening may
give higher false-referral rates associated with ear infections, which are also common in the NICU
and will eventually clear up.
In most other settings, such as hospitals with only a well-baby nursery, a decision should be based
on cost analysis using actual costs. In most cases, the difference in the cost of disposables will
dominate the analysis. However, capital equipment costs and cost of personnel time should be
considered because they may influence which choice is least expensive if the costs of disposables are
similar.
Low referral rates are a good indicator of a successful newborn hearing screening program. The
American Academy of Pediatrics (AAP) endorsed the implementation of universal newborn hearing
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Auditory Function Screening Devices, Newborn

screening in February 1999. The AAP policy statement recommends that the referral rate to
diagnostic testing not exceed 4%.
ECRI recommends the use of automated newborn hearing screeners over manual units. With
automated technology, a trained audiologist is not needed to perform the testing. Instead, nurses or
volunteers can perform the test, which will save money on personnel costs.

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Other considerations
The typical price for UNHSs ranges from $3,000 to $20,000. Before selecting the type of
equipment, a facility must determine who will be conducting the tests (audiologists, nurses, trained
technicians, or volunteers) and what test method will be employed (OAE, ABR, or both). The type of
technology selected is typically based on the birth census for a facility, the screening provider, the
training of screening personnel, the end point being measured, and the availability of an audiologist.
Facilities should consider patient load and relative costs of the different methods before deciding
on a testing protocol. Depending on patient load, ABR may be more expensive and may involve
longer test times than OAE. OAE is increasingly becoming the initial screening method because it
can be less expensive and may have a shorter test time. However, OAEs often result in a higher
referral rate due to debris in the ear canal.
Combination OAE/ABR screening devices are available. Dual or combination testing has been
found to decrease false positives and referral rates, which lowers hospital costs. However, some
audiologists prefer either the ABR or OAE method exclusively and do not wish to use dual- or
combination-testing devices.
The cost of disposables may exceed the initial acquisition cost of the screening device in one year,
depending on patient volume. Before accepting any consumables agreements, users should request
list and discounted prices for instrumentation, service, and disposable items for outright purchases,
in addition to a lease or consumables agreement. Many users select UNHSs based only on the initial
acquisition cost and do not consider the daily, long-term testing costs for consumables. Disposable
items can cost from $3,000 to $36,000/year, depending on the testing method, patient volume, and
the supplier. Users can also negotiate for the manufacturer to absorb any costs over those indicated
by the sales representative. Annual or semiannual review of patient volume can protect the facility
in the event that volume fluctuates. Prices for consumables, when negotiated, should remain
unchanged for the contract duration, or at the very minimum, prices should remain unchanged for
the first three years of an agreement, with the price not to exceed the Consumer Price Index. Users
should also consider the following:

Type of acquisition (outright purchase, lease)

Duration of contract

Patient volume

Service coverage (24 hours/day, 7 days/week; Monday through Friday, 8 a.m. to 5 p.m.)

Price increases during contract (the amount that disposables will increase in cost, cap of
inflationary prices)

Availability of backup equipment as well as adequate consumable parts


Ease of use is also an important consideration. An automated system that provides a pass or
refer result allows nonaudiologists to complete the screening at a reduced personnel cost. The fewer
steps required to operate the system allow trained technicians to receive results more quickly and
easily. Proper earphone placement and electrode impedances during setup and continuous
monitoring during testing are important equipment checks. Obstruction in earphones (tips or muffs)
or myogenic interferences should be monitored during automatic checks to ensure that they are
within valid test ranges. Automatic self-checking procedures identify and reduce technical problems
that could increase test time. Minimization of test time is essential in accomplishing hearing
screening for newborns during the typical 48-hour hospital stay.
Equipment accuracy is necessary to ensure proper analysis of a newborns hearing. False-positive
and false-negative responses can be minimized with proper equipment use and calibration.
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Calibration testing and frequency vary by supplier; users should follow the operator manual.
Excessive referrals are costly and time-consuminguniversal screening programs should have a
referral rate of less than 4%.
Another important consideration is speaker precalibration; confirm with the manufacturer that
the instrument was calibrated using an infant-sized (0.5 cc) coupler rather than an adult-sized (2 cc)
coupler. A signal calibrated to a larger adult ear may actually be 10 to 20 dB louder in a smaller
infant ear and therefore may miss milder hearing losses that would have been detected if the
instrument were appropriately calibrated. Using insert earphones may help to alleviate this
problem. Insert earphones accurately conduct real-ear calibration, thus ensuring that the magnitude
of the actual signal delivered to the ear is equal to the magnitude set by the user.
A UNHS database is helpful in tracking follow-up procedures and recalling patient information.
Data such as the number of infants who have passed or have been referred, test information, and
raw data from automated tests by technicians should be easily located. Patient database modules
that are built-in may eliminate the need for reentry of information. Raw data from automatic test
results should be accessible to supervising audiologists to evaluate each screening procedure; this is
important for quality assurance and accountability. The equipment should be easily upgradable with
software to accommodate new features and advances in hearing screening technology. Additionally,
the ability of the system to interface with other documentation and reporting systems in the facility
should be considered. Some hospitals require that testing information be kept for statewide agencies
and patient records.
Some equipment tests infants only. If a device can test patients of various ages, it will be more
dynamic, multifunctional, and cost-effective. A 24-hour repair or replacement schedule is critical in
UNHS programs due to patient volumes and the typical time frame in which the tests are conducted.
Users should verify that suppliers have a repair, replacement, or loaner program and should
carefully assess the response times for these options. Also, users should review licensure laws, which
may have certain requirements and/or limitations regarding screening personnel.
Some suppliers may provide user reference lists, allowing potential clients to contact user
facilities and receive feedback on integration, ease of use, and reliability.

Stage of development
Newborn hearing screening programs are well implemented in Europe, and many U.S. states
currently have mandatory testing laws. Newborn hearing screening devices are a stable technology.
Newer models are focused on improving portability, lowering test times, and incorporating OAE and
ABR technologies into one system.

Bibliography
American Academy of Pediatrics. Task Force on Newborn and Infant Hearing. Newborn and infant
hearing loss: detection and intervention. Pediatrics 1999 Feb;102(2):527-30.
Dempesy D. Selection criteria for newborn hearing screening equipment. Hear Rev 1998 Feb;5(2):8,
10, 12, 60.
Dolphin WF. Overview of evoked response audiometric techniques: auditory screening and
diagnostics using otoacoustic emissions (OAE) and auditory evoked potentials (AEP) [online].
[cited 2001 Oct 19]. Available from Internet: http://www.sonamed.com.
Gabbard SA, Northern JL, Yoshinaga-Itano C. Hearing screening in newborns under 24 hours of age.
Semin Hear 1999;20(4):291-305.
Gorga MP, Preissler K, Simmons J, et al. Some issues relevant to establishing a universal newborn
hearing screening program. J Am Acad Audiol 2001 Feb;12(2):101-12.
Knott C. Universal newborn hearing screening coming soon: Hears why. Neonatal Network 2001
Dec;20(8):25-33.
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Auditory Function Screening Devices, Newborn

National Center for Hearing Assessment and Management [Web site]. [cited 2001 Oct 19]. Logan
(UT): Utah State University. Available from Internet: http://www.infanthearing.org.
Norton SJ, Khan SB, Dolphin WF. Importance of real-ear calibration for newborn hearing screening.
Hear Rev 2000 Feb;7(2):42-4, 46.

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Oudesluys-Murphy AM, van Straaten HL, Bholasingh R, et al. Neonatal hearing screening. Eur J
Pediatr 1996 Jun;155(6):429-35.
Vohr BR, Oh W, Stewart E, et al. Comparison of costs and referral rates of 3 universal newborn
hearing screening protocols. J Pediatr 2001 Aug;139(2):238-44.
Yoshinaga-Itano C, Sedey AL, Coulter DK, et al. Language of early- and later-identified children
with hearing loss. Pediatrics 1998 Nov;102(5):1161-71.
Zubick H, Ringer S, Dolphin WF. Results of infant hearing screening program using a combined,
automated ABR and OAE system [online]. [cited 2001 Oct 19]. Available from Internet:
http://www.sonamed.com.

Supplier information
Bio-logic
Bio-logic Systems Corp [104756]
One Bio-logic Plaza
Mundelein, IL 60060-3708
Phone: (847) 949-5200 (800) 323-8326
Internet: http://www.bio-logic.com
E-mail: sales@blsc.com

Fax: (847) 949-8615

Fischer-Zoth
Fischer-Zoth Diagnosesysteme GmbH, Div Natus Medical Inc [401929]
Walter-Kolbenhoff-Strasse 34
D-82110 Germering
Germany
Phone: 49 (89) 8945973
Fax: 49 (89) 89459759
Internet: http://www.fischer-zoth.de
E-mail: info@fischer-zoth.de

GSI
Invacare Corp [101976]
One Invacare Way PO Box 4028
Elyria, OH 44036-2125
Phone: (440) 329-6000 (800) 333-6900
Internet: http://www.invacare.com
E-mail: info@invacare.com

Fax: (440) 365-4558 (800) 378-4682

Intelligent Hearing Systems


Intelligent Hearing Systems [401964]
7356 SW 48th St
Miami, FL 33155
Phone: (305) 668-6102 (800) 447-9783
Internet: http://www.ihsys.com
E-mail: ihsys@ihsys.com

Fax: (305) 668-6103

Madsen
Madsen Electronics (Denmark) [139621]
Markaervej 2a Postboks 119
DK-2630 Taastrup
Denmark
Phone: 45 72111555
Fax: 45 72111348

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Internet: http://www.madsen.com
E-mail: madsen@gnotometrics.com

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Maico
Maico Diagnostic GmbH [236957]
Salzufer 13/14
D-10587 Berlin
Germany
Phone: 49 (30) 70714650
Fax: 49 (30) 70714699
Internet: http://www.maico-diagnostic.com
E-mail: export@maico-diagnostic.de
Maico Diagnostics [348943]
7625 Golden Triangle Dr
Eden Prairie, MN 55344
Phone: (952) 941-4200 (888) 941-4201 Fax: (952) 903-4200 (888) 941-4200
Internet: http://www.maico-diagnostics.com
E-mail: info@maico-diagnostics.com

Natus
Natus Medical Inc [108193]
1501 Industrial Rd
San Carlos, CA 94070-4111
Phone: (650) 802-0400 (800) 255-3901
Internet: http://www.natus.com
E-mail: customer_service@natus.com

Fax: (650) 802-0401

Otodynamics
Otodynamics Ltd UK [190718]
36 Beaconsfield Road
Hatfield Hertfordshire AL10 8BB
England
Phone: 44 (1707) 267540
Fax: 44 (1707) 262327
Internet: http://www.otodynamics.com
E-mail: sales@otodynamics.com

SonaMed
SonaMed Corp [362122]
1250 Main St
Waltham, MA 02451
Phone: (781) 899-6499 (888) 766-2633
Internet: http://www.sonamed.com
E-mail: sales@sonamed.com

Fax: (781) 899-8318

Starkey
Starkey Laboratories GmbH [285021]
Rugenbarg 69
D-22848 Norderstedt
Germany
Phone: 49 (40) 528470
Fax: 49 (40) 52847222
Internet: http://www.starkey.de
E-mail: customer_service@starkey.de

Welch Allyn
Welch Allyn Inc [101850]
4341 State Street Rd PO Box 220
Skaneateles Falls, NY 13153-0220
Phone: (315) 685-4100 (800) 535-6663
Internet: http://www.welchallyn.com
Email: info@mail.welchallyn.com

Fax: (315) 685-4091

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Welch Allyn Monitoring (New Zealand), Asia Pacific Headquarters [441593]


Level 9 Forsyth Barr House PO Box 29020
Christchurch
New Zealand
Phone: 64 (3) 3794429
Fax: 64 (3) 3792374
Internet: http://www.monitoring.welchallyn.com
Email: sales@monitoring.welchallyn.com
Welch Allyn Monitoring GmbH [441592]
Bretonischer Ring 16
D-85630 Grasbrunn/Technopark
Germany
Phone: 49 (89) 934010
Fax: 49 (89) 9302123
Internet: http://www.monitoring.welchallyn.com
Email: sales@monitoring.welchallyn.com

About the chart specifications


Abbreviations:
The following abbreviations are used in the chart:
AABR Automated auditory brainstem
response
ABR Auditory brainstem response
ARO After receipt of order
ASCII American Standard Code for
Information Interchange
BS British Standard

EMC Electromagnetic compatibility


EN European Norm
EST Eastern standard time
FDA U.S. Food and Drug Administration
HATS Hearing assessment tracking
system (software)
HD Hard drive

CD Compact disc

HDD Hard disk drive

CD-R Recordable compact disc

HL Hearing loss, hearing level

CD-RW Rewritable compact disc


CE mark Conformite Europeene mark

HW Hardware

CSA Canadian Standards Association

IEC International Electrotechnical


Commission

dB Decibels

IR Infrared

dB HL Decibels of hearing loss

ISO International Organization for


Standardization

dB SPL Sound pressure level in decibels


DMS Database management system
DP Distortion product
DPOAE Distortion product otoacoustic
emission

LCD Liquid crystal display


LED Light-emitting diode
MDD Medical Devices Directive
MOD Magneto-optical disk

DVD Digital versatile (or video) disc

Ni-Cd Nickel cadmium

EEC European Economic Community

Ni-MH Nickel metal hydride

EEPROM Electrically erasable


programmable read-only memory

NIH National Institutes of Health


OAE Otoacoustic emission
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Auditory Function Screening Devices, Newborn

PC Personal computer

SW Software

PCMCIA Personal Computer Memory Card


International Association

TE Transient evoked

POVR Point-optimized variance ratio


(algorithm used for ABaer)

TEOAE Transient-evoked otoacoustic


emission
UL Underwriters Laboratories, Inc.

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SNR Signal-to-noise ratio

VAC Volts of alternating current


Note: The data in the charts derive from suppliers specifications and have not been verified
through independent testing by ECRI or any other agency. Because test methods vary, different
products specifications are not always comparable. Moreover, products and specifications are subject
to frequent changes. ECRI is not responsible for the quality or validity of the information presented
or for any adverse consequences of acting on such information.
When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect
supplier discounts. And although we try to indicate which features and characteristics are standard
and which are not, some may be optional, at additional cost.
For those models whose prices were supplied to us in currencies other than U.S. dollars, we have
also listed the conversion to U.S. dollars to facilitate comparison among models. However, keep in
mind that exchange rates change often.

Need to know more?


For further information about the contents of this Product Comparison, contact the HPCS Hotline
at +1 (610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or hpcs@ecri.org (e-mail).

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Product Comparison Chart

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MODEL

WHERE MARKETED
FDA CLEARANCE
CE MARK (MDD)
CONFIGURATION
SCREENING METHOD
Right only
Left only
Alternating
Simultaneous
AUTOMATED/MANUAL
STIMULUS, dB
TEST TIME, AVERAGE
TEST PAUSE
Causes
REFER RATE
CALIBRATION METHOD
ALARMS

Visual/audible
REPORTS
DISPLAY
Type
INTERFACES
STORAGE
Long-term media
POWER
Line, VAC
Battery
Operating time, hr
Rechargeable
Recharge time, hr
Low-battery alarm

ECRI-RECOMMENDED
SPECIFICATIONS1
Newborn Auditory
Function Screeners

ABR or OAE/ABR
combination

Automated

<4%

BIO-LOGIC

BIO-LOGIC

BIO-LOGIC

ABaer : AOAE

ABaer Cub : AOAE Cub

AuDX I

Worldwide
Yes
Yes
Stand-alone
ABR : DPOAE, TEOAE

Worldwide
Yes
Yes
Portable
ABR : DPOAE, TEOAE

Worldwide
Yes
Yes
Portable
DPOAE, TEOAE

Yes
Yes
No
Sequential
Automated
35 : 65/55 (DP), 80 (TE)
1-2 min : 15 sec
Yes
High artifact or usercontrolled
<2% : 2-4%
Only by certified
distributors or factory
High artifact, high
impedance : High artifact,
poor probe fit
Visual and audible
Printed via PC printer or
label printer
Pass, refer, raw data
PC screen
Printer/HATS
Unlimited with hard drive

Yes
Yes
No
Sequential
Automated
35 : 65/55 (DP), 80 (TE)
1-2 min : 15 sec
Yes
High artifact or usercontrolled
<2% : 2-4%
Only by certified
distributors or factory
High artifact, high
impedance : High artifact,
poor probe fit
Visual
Infrared label printer; 2 x 4
in labels
Pass, refer, raw data
Pocket PC LCD
Infrared label printer
Pocket PC memory limit

Yes
Yes
No
No
Automated
65/55 (DP), 80 (TE)
15 sec
Yes
High artifact, poor probe fit

CD/DVD and others

Downloadable to PC
database

Pass, refer, raw data


LCD
Label printer
10 tests; optional 50-100
tests
Downloadable to PC
database

100-240, 50/60 Hz
No
NA
NA
NA
NA

100-240, 50/60 Hz
Lithium ion
2, continuous use
Yes
5
Yes

100-240, 50/60 Hz
Lithium ion
12, continuous use
Yes
5
Yes

2-4%
Only by certified
distributors
High artifact

Visual
Label via label printer

This is the first of two


pages covering the above
model(s). These
specifications continue
onto the next page.

ECRI. All Rights Reserved.


12

Comprehensive of Biomedical Engineering Site (www.dezmed.com)


Auditory Function Screening Devices, Newborn

Product Comparison Chart

WWW.DEZMED.COM

MODEL

ECRI-RECOMMENDED
SPECIFICATIONS1
Newborn Auditory
Function Screeners

PURCHASE
INFORMATION
List price, unit
Disposables/type

Warranty
Support
Training
Delivery time, ARO
Year first sold
Number sold
USA/worldwide

Model Footnotes
Data Footnotes

BIO-LOGIC

BIO-LOGIC

ABaer : AOAE

ABaer Cub : AOAE Cub

AuDX I

$12,500-14,900 with
laptop and printer1
$2.50/electrodes and ear
tips, $7.50/Ear Muffins
and electrodes2
1 year
24/7 with warranty or
extended program
Included with purchase,
user-customized
2-3 weeks; optional rush
2000

$12,0001

$3,499 with label printer

$2.50/electrodes and ear


tips, $7.50/Ear Muffins
and electrodes2
1 year
24/7 with warranty or
extended program
Included with purchase,
user-customized
2-3 weeks; optional rush
2002

$1/ear tip (only 1 required


per baby)1
1 year
24/7 with warranty or
extended program
Included with purchase,
user-customized
2-3 weeks; optional rush
1997

Not specified/~100

Not specified/>5,500 OAE

January to December
All DPOAE systems have
the option of frequency
shifting; ABaer ABR uses
the patented POVR
algorithm developed in
collaboration with House
Ear Institute based on 3year NIH study using Fsp;
can be configured to use
the probe or Ear Muffins
as the transducer.
May 2006

January to December
All DPOAE systems have
the option of frequency
shifting; TEOAE option
available.

1
Introductory promotion of
$10,900 (includes Pocket
PC and infrared label
printer); additional costs
include first OAE modality
$5,500; second OAE
modality $1,000.2 Price
information current as of
January 2005.

1
Price information current
as of January 2005.

Not specified/>800
ABaer/AOAE
January to December
All DPOAE systems have
the option of frequency
shifting; ABaer ABR uses
the patented POVR
algorithm developed in
collaboration with House
Ear Institute based on 3year NIH study using Fsp;
can be configured to use
the probe or Ear Muffins
as the transducer.
May 2006

FISCAL YEAR
OTHER
SPECIFICATIONS

Last Updated
Supplier Footnotes

BIO-LOGIC

May 2006

These recommendations
are the opinions of ECRI's
technology experts. ECRI
assumes no liability for
decisions made based on
this data.
1
Additional costs include
first modality price of
$5,500; second modality
price of $1,000; MASTER
(ASSR-Steady State) add
on $12,000.2 Price
information current as of
January 2005.

ECRI. All Rights Reserved.


13

Comprehensive of Biomedical Engineering Site (www.dezmed.com)


Auditory Function Screening Devices, Newborn

WWW.DEZMED.COM

Product Comparison Chart


MODEL

BIO-LOGIC
AuDX II

BIO-LOGIC
AuDX Plus

BIO-LOGIC
Scout Sport

WHERE MARKETED
FDA CLEARANCE
CE MARK (MDD)
CONFIGURATION
SCREENING METHOD
Right only
Left only
Alternating
Simultaneous
AUTOMATED/MANUAL
STIMULUS, dB

Worldwide
Yes
Yes
Portable
DPOAE, TEOAE
Yes
Yes
No
No
Automated
65/55 (DP), 80 (TE)

Worldwide
Yes
Yes
Portable
DPOAE, TEOAE
Yes
Yes
No
No
Automated
55/65 (DP), 80 (TE)

Worldwide
Yes
Yes
Stand-alone
DPOAE, TEOAE
Yes
Yes
No
No
Automated
55/65 (DP), 80 (TE)

TEST TIME, AVERAGE

15 sec

15 sec

15 sec

TEST PAUSE
Causes
REFER RATE
CALIBRATION METHOD

Yes
High artifact, poor probe fit
2-4%
Only by certified
distributors
High artifact

Yes
High artifact, poor probe fit
2-4%
Only by certified
distributors
High artifact

Yes
High artifact, poor probe fit
2-4%
Only by certified
distributors
High artifact

Visual
Printed via label printer or
PC printer
Pass, refer, raw data

Visual
Printed via label printer or
PC printer
Pass, refer, raw data

Visual
Printed via PC printer

LCD

LCD or PC screen

PC screen

INTERFACES

Label printer

Label printer

Printer/HATS

STORAGE

50 tests; optional 100


tests
Downloadable to PC
database

50 tests; optional 100


tests, unlimited with HD
Optional CD/DVD

Unlimited with hard drive


Optional CD/DVD

CD-R, DVD, MOD,


database

100-240, 50/60 Hz
Lithium ion
12, continuous use
Yes
5
Yes

100-240, 50/60 Hz
Lithium ion
12, continuous use
Yes
5
Yes

100-240, 50/60 Hz
Lithium ion
12, continuous use
Yes
5
Yes

None
Ni-MH, 6 V
10
Yes
2
Yes

ALARMS
Visual/audible
REPORTS
DISPLAY

Type

Long-term media
POWER
Line, VAC
Battery
Operating time, hr
Rechargeable
Recharge time, hr
Low-battery alarm

Pass, refer, raw data

FISCHER-ZOTH
Echo-Screen TDA : EchoScreen TDA Plus
Worldwide
Yes
Yes
Handheld, stand-alone
ABR, DPOAE, TEOAE
Yes
Yes
Yes
No
Automated
35, 45, 55 (ABR); 73 (TE);
55 (DP)
40 sec ABR, 30 sec
DPOAE, 20 sec TEOAE
Yes
Automatic artifact rejection
0.5% ABR, 2-3% OAE
Sound feedback in probe
Stimulus level impedance,
probe position, artifacts
Yes/yes
Printout label printer,
wireless link to database
Pass, refer, waveform,
noise floor, stimulus
monitoring; electrode
impedance (ABR) and
phase statistics (DPOAE)
Graphic LCD with
switchable backlight
Label printer, IR, cable
interface to PC
Up to 250 readings

This is the first of two


pages covering the above
model(s). These
specifications continue
onto the next page.

ECRI. All Rights Reserved.


14

Comprehensive of Biomedical Engineering Site (www.dezmed.com)


Auditory Function Screening Devices, Newborn

Product Comparison Chart


MODEL

WWW.DEZMED.COM

PURCHASE
INFORMATION
List price, unit

Disposables/type
Warranty
Support
Training
Delivery time, ARO
Year first sold
Number sold
USA/worldwide

BIO-LOGIC
AuDX II

BIO-LOGIC
AuDX Plus

BIO-LOGIC
Scout Sport

FISCHER-ZOTH
Echo-Screen TDA : EchoScreen TDA Plus

$6,500 without label


printer, $7,000 with label
printer
$1/ear tip (only 1 required
per baby)1
1 year
24/7 with warranty or
extended program
Included with purchase,
user-customized
2-3 weeks; optional rush
1997

$9,000-11,000 with laptop


and printer

$7,500-10,000 with laptop


and printer

$8,500 TEOAE/ABR
handheld

$1/ear tip (only 1 required


per baby)1
1 year
24/7 with warranty or
extended program
Included with purchase,
user-customized
2-3 weeks; optional rush
1997

$1/ear tip (only 1 required


per baby)1
1 year
24/7 with warranty or
extended program
Included with purchase,
user-customized
2-3 weeks; optional rush
1996

$0.50/ear tip, $1.95/ABR


electrode set
2 years
24/7 country dependent,
1-day repair
Half day on-site

Not specified/>4,000 total


OAE
January to December
All DPOAE systems have
optional frequency
shifting; SOAE
(spontaneous
capabilities); TEOAE
option available.

Not specified/>5,500 OAE

FISCAL YEAR
OTHER
SPECIFICATIONS

January to December
All DPOAE systems have
optional frequency
shifting; TEOAE option
available.

Not specified/>4,000 total


OAE
January to December
All DPOAE systems have
optional frequency
shifting; SOAE
(spontaneous
capabilities); TEOAE
option available.

Last Updated
Supplier Footnotes
Model Footnotes
Data Footnotes

May 2006

May 2006

May 2006

1
Price information current
as of January 2005.

1
Price information current
as of January 2005.

1
Price information current
as of January 2005.

ECRI. All Rights Reserved.


15

4-6 weeks
2001
0/50
January to December
Link to database (SIMS
Oz, HiTrak, MS Access);
label printer; standard
TEOAE/DPOAE probe
used for ABR. Meets
requirements of EN 46001
(1996), 60601-1 + A1 +
A2, and 60601-1-2 (1993);
EN ISO 9001 (1994); and
European Council
Directive 93/42/EEC.
January 2005

Comprehensive of Biomedical Engineering Site (www.dezmed.com)


Auditory Function Screening Devices, Newborn

WWW.DEZMED.COM

Product Comparison Chart


MODEL

FISCHER-ZOTH

GSI

GSI

AUDIOscreener

WHERE MARKETED
FDA CLEARANCE
CE MARK (MDD)
CONFIGURATION

Echo-Screen TE : EchoScreen TE Plus


Worldwide
Yes
Yes
Handheld, stand-alone

SCREENING METHOD

TEOAE

GSI-70 Single patient :


GSI-70 Multipatient
Worldwide
Yes
Yes
Stand-alone, portable,
handheld
DPOAE

Right only
Left only
Alternating
Simultaneous
AUTOMATED/MANUAL
STIMULUS, dB

Yes
Yes
Yes
No
Automated
73 dBA impulse

TEST TIME, AVERAGE

20 sec

TEST PAUSE
Causes

Yes
Automatic artifact rejection

REFER RATE
CALIBRATION METHOD

2-3%
Sound pressure level 73
3 dB
Probe error, battery
check, artifact rate
Yes/no
Printout label printer, PC
download

ALARMS
Visual/audible
REPORTS

DISPLAY
Type
INTERFACES
STORAGE

Long-term media
POWER
Line, VAC
Battery
Operating time, hr
Rechargeable
Recharge time, hr
Low-battery alarm

Pass, refer, stimulus


stability, artifact rate
LCD

Worldwide
Yes
Yes
Stand-alone, portable,
handheld
ABR, DPOAE, TEOAE

Yes
Yes
No
No
Both
35 dB nHL default (0-100
dB SPL programmable)
ABR and 65/55 dB SPL
default (45-70 dB SPL
programmable) OAE
1 min/ear OAE, 1.5
min/ear ABR
Yes
User intervention, noisy
environment
2%
Real ear, coupler
Probe-fit error, impedance
out of bounds, low battery
Yes/no
Printed, plain paper; full
sheet; short- and full-detail
forms with AUDIOtrac and
AUDIOscreener
Pass, refer, full graphics
LED

Label printer, line printer,


RS232 interface
Up to 4 readings : Up to
120 readings

IrDA

Yes
Yes
No
No
Automated
65/55 dB SPL

1 min/ear
Yes
No seal, noisy
environment
4%
Real ear, coupler
Low battery

INTELLIGENT HEARING
SYSTEMS
SmartDPOAE :
SmartTROAE
Worldwide
Yes
No
Portable
DPOAE : TROAE;
optional automated ABR
and ASSR integration
Yes
Yes
No
No
Both
0-100 dB SPL, userdefinable TROAE; 0-70
dB SPL, user-definable
DPOAE
30-60 sec, depends on
test parameters
Yes
User request, artifacts
By user protocol
Automated and manual for
in ear
Noise, probe fit

Yes/no
Internal printer for instant
results, download to DMS
software to print

Yes/no
Letters and data, userdefinable templates

Pass, refer, noise, abort

Pass, refer, raw data :


Statistics, raw data
LCD

LCD/backlight :
Touchscreen
IrDA, RS232

Any Windows-compatible
printer
Varies by hard drive

350 test results,


multipatient

Printout, any PC backup


medium

300 patient records; each


patient record contains up
to 3 OAEs/ear and up to 3
ABRs/ear; OAE test has 5
frequencies, and ABR test
has 8 stimuli; all stored in
nonvolatile flash memory
With PC, hard disk, CD,
tape backup

With PC, hard disk, CD,


tape

Optional CD-RW

None
Ni-MH, 6 V
10
Yes
2
Yes

100-240, 50/60 Hz
Ni-MH
16 continuous, 24 average
Yes
2
Yes

90-260, 50/60 Hz
Ni-Cd
90 tests/90 min
Yes
8
Yes

100-240, 50/60 Hz
No
NA
NA
NA
NA

This is the first of two


pages covering the above
model(s). These
specifications continue
onto the next page.

ECRI. All Rights Reserved.


16

Comprehensive of Biomedical Engineering Site (www.dezmed.com)


Auditory Function Screening Devices, Newborn

Product Comparison Chart

WWW.DEZMED.COM

MODEL

PURCHASE
INFORMATION
List price, unit

Disposables/type

FISCHER-ZOTH

GSI

GSI

Echo-Screen TE : EchoScreen TE Plus

AUDIOscreener

GSI-70 Single patient :


GSI-70 Multipatient

$3,500 basic

$16,500

$3,500 : $5,500

$0.50/ear tip

$9/comfort cup set,


$3.50/probe tip
1 year

Not specified

Warranty

2 years

Support

24/7

Included with purchase

Training

24/7 country dependent,


1-day repair
2 hr on-site

Yes

Included with purchase

Delivery time, ARO

3-5 weeks

1 week

5 days

1995

2002

1999

800/3,000
January to December
Link to database (SIMS
Oz, HiTrak, MS Access)
via PC-based "Echo-Link"
software; label or line
printer. Meets
requirements of EN 46001
(1996), 60601-1 + A1 +
A2, and 60601-1-2 (1993);
EN ISO 9001 (1994); and
European Council
Directive 93/42/EEC.

Not specified
January to December
Data can be read by staff
audiologist or e-mailed to
consulting audiologist;
wireless data transmission
to and from desktop
computer (up to 300
patient records); tests
newborns to elderly
patients.

Not specified/2,000
January to December
Multipatient version allows
downloading of your own
protocol and normative
data; up to 6 frequencies
tested; data can be
incorporated with
NCHAM, Oz systems, and
the GSI 60 diagnostic
DPOAE systems
database.

January 2005.

October 2003

October 2003

Year first sold


Number sold
USA/worldwide
FISCAL YEAR
OTHER
SPECIFICATIONS

Last Updated
Supplier Footnotes
Model Footnotes
Data Footnotes

1 year

ECRI. All Rights Reserved.


17

INTELLIGENT HEARING
SYSTEMS
SmartDPOAE :
SmartTROAE

$5,692 USB kit with 10D


probe, $18,181
SmartScreener/SmartOAE
SmartEP-ASSR
combination
$0.97/pediatric 10D OAE
ear tip
1 year; optional
extensions
Local distributors,
included 9-5 EST M-F
Half day on-site by local
distributor
4-6 weeks; rush option
available
1997 : 2003
Not specified
January to December
Can be combined with
SmartEP, SmartEPASSR, SmartScreener,
and SmartAudiometer;
integrated calibration;
network capability; report
generation; database
management and
scheduling features; userdefined passing criteria
and normative data
displays; online help menu
and manual; free software
upgrades; toll-free
customer support for
system's life; USB
Windows interface;
spontaneous OAE
capability included;
optional USB standard
model; USB standard
model can be upgraded to
include high-frequency
option, OAE suppression,
IVRA, and 4 EP channels.
May 2006

Comprehensive of Biomedical Engineering Site (www.dezmed.com)


Auditory Function Screening Devices, Newborn

Product Comparison Chart

WWW.DEZMED.COM

MODEL

WHERE MARKETED
FDA CLEARANCE
CE MARK (MDD)
CONFIGURATION
SCREENING METHOD
Right only
Left only
Alternating
Simultaneous
AUTOMATED/MANUAL
STIMULUS, dB
TEST TIME, AVERAGE
TEST PAUSE
Causes
REFER RATE
CALIBRATION METHOD
ALARMS
Visual/audible
REPORTS

DISPLAY

Type
INTERFACES
STORAGE
Long-term media
POWER
Line, VAC
Battery
Operating time, hr
Rechargeable
Recharge time, hr
Low-battery alarm

INTELLIGENT HEARING
SYSTEMS
SmartEP-ASSR

INTELLIGENT HEARING
SYSTEMS
SmartScreener

MADSEN

MAICO

AccuScreen

Worldwide
Yes
No
Portable
ASSR; optional automatic
ABR/OAE integration
Yes
Yes
No
Yes
Both
0-125 dB SPL, userdefinable
12-25 min, depends on
test parameters
Yes
User request, artifacts
SNR, p-value, residual
noise
Integrated module
Battery, transmitter status
Yes/yes
Letters and data, userdefinable templates

Worldwide
Yes
No
Portable
ABR; optional automatic
OAE/ASSR integration
Yes
Yes
No
No
Automated
0-100 dB HL, userdefinable
10-15 min, depends on
test parameters
Yes
User request, artifacts
By user protocol

Worldwide
Yes
Yes
Portable
DPOAE, TEOAE, AABR

Ero Scan Combo : Ero


Scan Screener : Ero Scan
Standard
Worldwide
Yes
Yes
Portable
DPOAE, TEOAE

Yes
Yes
Yes
No
Automated
70-85 SPL

Yes
Yes
No
No
Both
40-70 (DP), 83 (TE)

10-15 sec

<10 sec

Yes
Noise interference
<2%

Not specified
Not specified
3-5%

Integrated module
Battery/transmitter status
Yes/yes
Letters and data, userdefinable templates

Self-calibrating to ECV
Probe error
Yes/no
Label printer, full-page
printout

Raw data, response


indication, phasor
diagrams; frequency
spectrum, phase-intensity
diagrams, audiograms
LCD
Any Windows-compatible
printer
Varies by hard drive
Optional CD-RW

Probable or no response
scoring with raw data

Pass, fail, artifact wave,


stimulus stability

Automatic and built-in


Low battery, no seal
Yes/yes
OAEs and noise over
frequency range; optional
software reporting
Pass, fail, refer

LCD
Any Windows-compatible
printer
Varies by hard drive
Optional CD-RW

LCD
Label printer, standard
computer printer
Up to 120 tests
None

LCD
RS232, printer and
database software
50 measurements
EEPROM

100-240, 50/60 Hz
2 AA alkaline/USB
powered
48
Yes
Not specified
Yes

100-240, 50/60 Hz
2 AA alkaline/USB
powered
48
Yes
Not specified
Yes

None
6V

Not specified
6 V or 4 AA cells

10
Yes
3
Yes

300 tests
No
NA
Yes

This is the first of two


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model(s). These
specifications continue
onto the next page.

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18

Comprehensive of Biomedical Engineering Site (www.dezmed.com)


Auditory Function Screening Devices, Newborn

Product Comparison Chart

WWW.DEZMED.COM

MODEL

PURCHASE
INFORMATION
List price, unit

Disposables/type
Warranty
Support
Training
Delivery time, ARO
Year first sold
Number sold
USA/worldwide
FISCAL YEAR
OTHER
SPECIFICATIONS

Last Updated
Supplier Footnotes
Model Footnotes
Data Footnotes

INTELLIGENT HEARING
SYSTEMS
SmartEP-ASSR

INTELLIGENT HEARING
SYSTEMS
SmartScreener

MADSEN

MAICO

AccuScreen

Ero Scan Combo : Ero


Scan Screener : Ero Scan
Standard

$15,750 USB Jr. kit, 2channel SmartEP-ASSR,


$18,181
SmartScreener/SmartEPASSR/SmartOAE
combination
$2.33-10.11/disposables
and nondisposables
1 year; optional
extensions
Local distributors,
included 9-5 EST M-F
Half day on-site by local
distributor
4-6 weeks; rush option
available
2003

$10,915 USB Jr. kit,


1channel SmartScreener;
$18,181 2-channel
SmartScreener/SmartEPASSR/SmartOAE
combination
$2.33-10.11/disposables
and nondisposables
1 year; optional
extensions
Local distributors,
included 9-5 EST M-F
Half day on-site by local
distributor
4-6 weeks; rush option
available
1993

$3,995-12,995 depends
on configuration

4,000 (US$3,453);
7,000 (US$6,044)

$0.76/ear tip

$0.12/ear tip

1 year

2 years

Through local distributor

Yes

Not specified

Video, seminar

1 week

2-3 weeks

2001

2000

Not specified
January to December
Can be combined with
SmartEP (full diagnostic
EP system,
SmartScreener,
SmartAudiometer, and
SmartOAE); optional USB
standard model; USB
standard model can be
upgraded to include highfrequency diagnostic EP
and OAE option, TEOAE
Suppression, IVRA, and 4
EP channels; integrated
calibration; network
capability; report
generation; database
management and
scheduling features; userdefined passing criteria
and normative data
displays; online help
menu, manual; free
software upgrades; tollfree customer support for
system's life; USB
Windows interface.

Not specified
January to December
USB Windows interface;
can be combined with
SmartEP, SmartOAE,
SmartAudiometer and
SmartEP-ASSR;
integrated calibration;
network capability; report
generation; load data into
SmartEP to plot against
normative data; built-in
demonstrations; database
management and
scheduling features;
online help menu and
manual; free software
upgrades; toll-free
customer support for
system's life; USB
Windows interface;
optional autopeak
labeling; optional USB
standard model; USB
standard model can be
upgraded to include highfrequency option, TROAE
suppression, IVRA, and 4
EP channels.
May 2006

500/2,000
Not specified
Label printer; 2 probes; 2
batteries; carrying case.

Not specified
Not specified
External and built-in probe
available; printer available
with graphic printout;
delivers frequency-specific
information; PC software
including patient
database; test protocol
changes can be made
through OAE unit
(software and PC not
required); patented post
hoc statistical analysis
that rejects noisecontaminated samples,
allowing TEOAE
measurements in under
20 sec in speech-babble
levels from 40-70 dB SPL.

January 20051

May 2006

May 2006

1
Declined to participate;
model is currently
marketed.

ECRI. All Rights Reserved.


19

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Auditory Function Screening Devices, Newborn

Product Comparison Chart

WWW.DEZMED.COM

MODEL
WHERE MARKETED
FDA CLEARANCE
CE MARK (MDD)
CONFIGURATION

MAICO
MB 11
Worldwide
Yes
Yes
Portable

SCREENING METHOD

AABR, ABR

Right only
Left only
Alternating
Simultaneous
AUTOMATED/MANUAL
STIMULUS, dB

Yes
Yes
Sequentially
Yes
Automated
35, 40

Yes
Yes
Sequentially
Yes
Automated
35, 40

4-7 min, as low as 30 sec


Not specified
Not specified
1.3-4%
Annual for earphone cable

4-7 min, as low as 30 sec


Not specified
Not specified
1.3-4%
Annual for earphone cable

Not specified
Yes/yes
Not specified

Not specified
Yes/no
Not specified

DISPLAY

Yes
Yes
No
No
Both
40 (step simultaneously in
6 levels); ABR standard
1 min
Not specified
Not specified
<2%
Sound pressure level
meter
None
NA
ABR curves and signal
quality
Not specified

Pass, refer

Pass, refer

Type
INTERFACES
STORAGE

Mobile computer
PCMCIA
Not specified

LCD, LED
Keyboard, printer
Not specified

LCD, LED
Keypad, printer
Not specified

HDD

Diskette via ASCII

Wireless data transfer to


PC

110/240
No
NA
NA
NA
NA

Not specified
Not specified
Not specified
Not specified
Not specified
Not specified

Not specified
Not specified
Not specified
Not specified
Not specified
Not specified

TEST TIME, AVERAGE


TEST PAUSE
Causes
REFER RATE
CALIBRATION METHOD
ALARMS
Visual/audible
REPORTS

Long-term media
POWER
Line, VAC
Battery
Operating time, hr
Rechargeable
Recharge time, hr
Low-battery alarm

NATUS
ALGO 3
Worldwide
Yes
Yes
Laptop computer, label
printer, cart
AABR

NATUS
ALGO 3i
Worldwide
Yes
Yes
Handheld device, label
printer, case
AABR

NATUS
Echo-Screen
Worldwide
Yes
Yes
Handheld device, label
printer, case
TEOAE, DPOAE, AABR;
6 configurations
Yes
Yes
Sequentially
No
Automated
35, 45, 55 dB nHL
4-7 min, as low as 30 sec
Not specified
Not specified
1.3-4%
Annual for OAE ear probe,
Y-probe cable
Not specified
Yes/no
Not specified
Pass, refer results,
waveforms
LCD, LED
Keypad, printer
Wireless/cable data
transfer to PC
Not specified

Not specified
Not specified
Not specified
Not specified
Not specified
Not specified

This is the first of two


pages covering the above
model(s). These
specifications continue
onto the next page.

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20

Comprehensive of Biomedical Engineering Site (www.dezmed.com)


Auditory Function Screening Devices, Newborn

Product Comparison Chart

WWW.DEZMED.COM

MODEL
PURCHASE
INFORMATION
List price, unit
Disposables/type
Warranty
Support
Training

Delivery time, ARO


Year first sold
Number sold
USA/worldwide
FISCAL YEAR
OTHER
SPECIFICATIONS

Last Updated
Supplier Footnotes
Model Footnotes
Data Footnotes

MAICO
MB 11

NATUS
ALGO 3

NATUS
ALGO 3i

NATUS
Echo-Screen

7,500 (US$6,479)
Not specified/electrodes
2 years
Not specified

Not specified
Not specified
Not specified
Technical and customer
support
Training programs on
product equipment and
supplies, clinical
consultation, and
educational materials
Not specified
Not specified

Not specified
Not specified
Not specified
Technical and customer
support
Training programs on
product equipment and
supplies, clinical
consultation, and
educational materials
Not specified
Not specified

Not specified
Not specified
Not specified
Technical and customer
support
Training programs on
product equipment and
supplies, clinical
consultation, and
educational materials
Not specified
Not specified

Not specified
Not specified
Objective determination of
hearing threshold in 2 min;
no glueable electrodes;
only some electrode
conductivity gel is
required; patient database
included in PC software.

Not specified
January to December
Compatible with various
data management
systems. Meets the
American Academy of
Pediatrics (AAP) guideline
for a <4% refer rate,
references on file at
Natus.

Not specified
January to December
Compatible with various
data management
systems. Meets the
American Academy of
Pediatrics (AAP) guideline
for a <4% refer rate;
references on file at
Natus.

May 2006

May 2006

May 2006

Not specified
January to December
Meets the American
Academy of Pediatrics
(AAP) guideline for a <4%
refer rate and AAP/Joint
Commission on Infant
Hearing (JCIH) guidelines
for surveillance screening
of children six months to
three years of age;
references on file at
Natus.
May 2006

Not specified

2-3 weeks
2001

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21

Comprehensive of Biomedical Engineering Site (www.dezmed.com)


Auditory Function Screening Devices, Newborn

WWW.DEZMED.COM

Product Comparison Chart


MODEL

OTODYNAMICS
ECHOCHECK

OTODYNAMICS
ECHOPORT ILO288 USB

SONAMED
Clarity ABR Screener

WHERE MARKETED
FDA CLEARANCE
CE MARK (MDD)
CONFIGURATION

Worldwide
Yes
Yes
Portable, handheld

Worldwide
Yes
Yes
Portable with USB
connection to PC

USA
Yes
Not specified
Not specified

SCREENING METHOD
Right only
Left only
Alternating
Simultaneous
AUTOMATED/MANUAL
STIMULUS, dB

TEOAE
Yes
Yes
No
No
Automated
84 dB SPL

DPOAE, TEOAE
Yes
Yes
No
No
Both
0-95 dB SPL

TEST TIME, AVERAGE


TEST PAUSE
Causes

10 sec
Yes
High ambient noise

10 sec
Yes
High ambient noise

REFER RATE
CALIBRATION METHOD

Not specified
Self-checking; optional
calibration kit
Noise, probe fit

Not specified
Self-checking; optional
calibration kit
Noise, probe fit

ABR, DPOAE
Yes
Yes
No
No
Automated
30-45 dB nHL (ABR), 6555 dB SPL (DPOAE)
Varies; 2-10 min average
Yes
Removal of ear
probe/electrodes
5% (OAE), 2% (ABR)
In-ear for stimulus
frequency/intensity
Excessive rejected
sweeps

Visual/audible
REPORTS

Yes/no
Printed numeric data for 1
level, noise, test duration,
date, time

Yes/no
Printed waveforms,
histogram, numeric
results, stats

DISPLAY

Pass, fail, invalid test,


date, time, test ID, OAE
level
LED

Not specified

ALARMS

Type

PC (one system active


LED on USB unit)
USB to PC, probe

Visual
Screening outcome,
waveforms, patient refer
lists, program and user
statistics; optional SonNet
software
Pass, refer

STARKEY
DP2000 (DPOAE) : T2001
(TEOAE)
Worldwide
Yes
Yes
Stand-alone, portable;
operates usding a desktop
or laptop computer
DPOAE, TEOAE
Not specified
Not specified
Not specified
Not specified
Both
NA
<45 sec
Yes
Not specified
4%
Acoustic, electrical
Change of primary tones
(DPOAE)/stimulus
response (TEOAE)
Yes/no
User-selectable

Pass, refer, raw data

Flat-panel touchscreen

Depends on computer
Printer, files uploaded or
downloaded

INTERFACES

Printer, data download,


charger, probe

STORAGE

96 tests

No test data storage

Complete system, no
added HW/SW or
programming required;
capability to interface with
3rd-party state information
systems software
Not specified

Long-term media
POWER
Line, VAC
Battery
Operating time, hr
Rechargeable
Recharge time, hr
Low-battery alarm

Downloaded to PC

Not specified

CD-R

Depends on size of hard


drive
Not specified

NA
2 Ni-H
Up to 1 week
Yes
2-3
Visual

USB BUS powered


Not specified
Not specified
Not specified
Not specified
Not specified

120
Optional UPS
0.1
Yes
Not specified
Not specified

Depends on computer
Yes
Depends on laptop
Not specified
Not specified
Not specified

This is the first of two


pages covering the above
model(s). These
specifications continue
onto the next page.

ECRI. All Rights Reserved.


22

Comprehensive of Biomedical Engineering Site (www.dezmed.com)


Auditory Function Screening Devices, Newborn

Product Comparison Chart


MODEL

OTODYNAMICS
ECHOCHECK

OTODYNAMICS
ECHOPORT ILO288 USB

SONAMED
Clarity ABR Screener

STARKEY
DP2000 (DPOAE) : T2001
(TEOAE)

Not specified

Not specified

$25,000

Disposables/type
Warranty

Not specified
1 year

Not specified
1 year

Support
Training
Delivery time, ARO
Year first sold
Number sold
USA/worldwide
FISCAL YEAR
OTHER
SPECIFICATIONS

Local dealer
Not specified
2 weeks
Not specified

Local dealer
Not specified
2 weeks
2002

Ear tips, electrodes


1 year, extended contract
available
Phone
First in-service included
4-8 weeks
1997

$8,000; $8,950 for


combination
$0.85/ear tips
1 year, limited; 2 years for
software updates
Included with purchase
1 day on-site
1 week
1994

Not specified
Not specified
Meets requirements of BS
5724-1, CSA 22.2 No.
601-1, EMC, EN 60601-1,
IEC 601, and UL 2601.

Not specified
Not specified
Meets requirements of
CE, CSA 22.2 No. 601-1,
EMC, EN 60601-1, and
UL 2601.

Not specified
Not specified
None specified.

May 2006

May 2006

May 2006

WWW.DEZMED.COM

PURCHASE
INFORMATION
List price, unit

Last Updated
Supplier Footnotes
Model Footnotes
Data Footnotes

ECRI. All Rights Reserved.


23

Not specified
Not specified
Lightweight; Windows
based; 2 clicks of the
mouse to administer test
and observe pass/refer
result; both systems
interface with different
information management
systems, including SIMS
Oz, HiTrak, and Microsoft
Access.
January 2005

Comprehensive of Biomedical Engineering Site (www.dezmed.com)


Auditory Function Screening Devices, Newborn

Product Comparison Chart

WWW.DEZMED.COM

MODEL
WHERE MARKETED
FDA CLEARANCE
CE MARK (MDD)
CONFIGURATION
SCREENING METHOD
Right only
Left only
Alternating
Simultaneous
AUTOMATED/MANUAL
STIMULUS, dB
TEST TIME, AVERAGE
TEST PAUSE
Causes
REFER RATE
CALIBRATION METHOD
ALARMS
Visual/audible
REPORTS
DISPLAY
Type
INTERFACES
STORAGE
Long-term media
POWER
Line, VAC
Battery
Operating time, hr
Rechargeable
Recharge time, hr
Low-battery alarm

WELCH ALLYN
OAE Hearing Screener
USA
Yes
No
Portable
DPOAE
Yes
Yes
No
No
Automated
55/65 (DP)
10 sec
Yes
High artifact, poor probe fit
2-4%
Only by certified
distributors
High artifact
Visual
Label via label printer
Pass, refer, raw data
LCD
Label printer
10 tests
NA
100-240, 50/60 Hz
Lithium Ion
12, continuous use
Yes
5
Yes

This is the first of two


pages covering the above
model(s). These
specifications continue
onto the next page.

ECRI. All Rights Reserved.


24

Comprehensive of Biomedical Engineering Site (www.dezmed.com)


Auditory Function Screening Devices, Newborn

Product Comparison Chart

WWW.DEZMED.COM

MODEL
PURCHASE
INFORMATION
List price, unit
Disposables/type
Warranty
Support
Training
Delivery time, ARO
Year first sold
Number sold
USA/worldwide
FISCAL YEAR
OTHER
SPECIFICATIONS
Last Updated
Supplier Footnotes
Model Footnotes
Data Footnotes

WELCH ALLYN
OAE Hearing Screener

$3,995 with label printer


$1/ear tip
1 year
24/7 with warranty or
extended program
Included with purchase
1 week; optional rush
2006
Not specified
January to December
All DPOAE systems have
the option of frequency
shifting.
May 2006

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25