Original ResearchOtology and Neurotology
Otolaryngology
Bone Conduction Hearing: Device
Auditory Capability to Aid in Device
Selection
Mark J. Syms, MD1,2, and
Kelly E. Hernandez, AuD3
Sponsorships or competing interests that may be relevant to content are dis-
closed at the end of this article.
Abstract
Objective. To obtain identical laboratory measures of 8 (sur-
gical and nonsurgical) bone conduction devices and relate
them to clinical function.
Study Design. Each device was measured with a single labora-
tory system and characterized with descriptive statistics.
Setting. Laboratory.
Subjects and Methods. Seven surgical devices (Intenso, BP110,
BP100, and Cordelle [Cochlear, Denver, Colorado]; Ponto
Pro and Ponto Pro Power [Oticon Medical, Somerset, New
Jersey]; and Alpha 2 [Sophono, Inc, Boulder, Colorado]) and
1 nonsurgical dental device (SoundBite; Sonitus Medical, Inc,
San Mateo, California) constituted the independent variables.
Measured maximum output and gain parameters were the
dependent variables.
Results. Maximum output varied across devices in the pure-
tone average (PTA; 500-3000 Hz) frequency range (mean,
109.7 dB re 1 mN; range, 98.8-119.2 dB) and in the above-
PTA (4000-8000 Hz) frequency range (mean, 102.6 dB re 1
mN; range, 88.99-119.6 dB). Maximum gain varied in the
PTA frequency range (mean, 40 dB; range, 29.1-49.1 dB) and
was higher in the frequency range above the PTA (mean,
32.0 dB; range, 20.8-46.0 dB).
Conclusion. All devices have sufficient maximum output and
gain for the PTA frequency range for single-sided deafness
(SSD). The devices differed in maximum output and gain for
the frequency range above the PTA, a consideration for
accommodating presbycusis and optimizing auditory function
for SSD. The surgical devices have less maximum output and
gain in the above-PTA range than in the PTA range. The non-
surgical dental device had the highest output (up to 30 dB
higher) and gain (up to 26 dB higher) in the above-PTA range.
Keywords
bone conduction, Baha, dental, presbycusis, single-sided
deafness
Head and Neck Surgery
2014, Vol. 150(5) 866871
American Academy of
OtolaryngologyHead and Neck
Surgery Foundation 2014
Reprints and permission:
sagepub.com/journalsPermissions.nav
DOI: 10.1177/0194599814524530
http://otojournal.org
Received September 20, 2013; revised December 24, 2013; accepted
January 29, 2014.
C
linical interest and treatment options for patients with
single-sided deafness (SSD) have increased markedly
over the recent past with many more device options
available. The clinical manifestations of SSD are multiple
and well documented.1 Patients with SSD are unable to hear
on the SSD side and often have to turn their head to engage
in conversation. In addition, patients are unable to locate
sounds and have problems with background noise. Many
patients are disturbed by the hearing struggles associated
with SSD and can be effectively rehabilitated with devices
intended to overcome the hearing difficulties.2-4
When counseling patients regarding the various available
bone conduction technologies, the mechanisms and surgical
differences can be clearly articulated. However, patients
often inquire about the hearing performance of the various
bone conduction options. The hearing performance is depen-
dent on both the specific capabilities of the device as well
as the status of the cochlea that is going to be stimulated.
Multiple systems have a simulator that can be used to
demonstrate the technology. For an osseointegrated post
system, the simulations often have limited efficacy since
there is intervening soft tissue during the simulation that is
not present in the implanted system. For a magnetically
coupled system, the simulation also has limited efficacy since
the implant placed in the bone is absent. For a dental system,
the simulator (Acoustiq; Sonitus Medical, Inc, San Mateo,
California) does directly contact the patients teeth and is not
limited by soft tissue or lack of the presence of implant but
1
Neurotology, Barrow Neurological Institute, Phoenix, Arizona, USA
2
Otology/Neurotology, Arizona Ear Center, Phoenix, Arizona, USA
3
Audiology, Arizona Ear Center, Phoenix, Arizona, USA
This article was presented at the 2013 AAO-HNSF Annual Meeting & OTO
EXPO; September 29October 3, 2013; Vancouver, British Columbia,
Canada.
Corresponding Author:
Mark J. Syms, MD, Director, Neurotology, Barrow Neurological Institute,
Arizona Ear Center, 2627 North Third St, Suite 201, Phoenix, AZ 85004,
USA.
Email: m.syms@arizonaear.com
Syms and Hernandez
Table 1. Manufacturer, Device Name, Transducer Type, and Coupling Method of 8 Bone Conduction Devices.
Manufacturer Device
1. Cochlear BP100
2. Cochlear BP110
3. Cochlear Cordelle
4. Cochlear Intenso
5. Oticon Medical Ponto Pro
6. Oticon Medical Ponto Pro Power
7. Sonitus Medical SoundBite
8. Sophono Alpha 2
also may be limited because the front teeth can be used
rather than the molars.
An additional limitation for simulation of all systems is
the status of the cochlea to be stimulated by the device. If
the patient has a high-frequency hearing loss, the simulation
device needs to be programmed to match the patients hear-
ing loss. Given that programming the device is time-
consuming and consideration of the soft-tissue limitations,
the simulation is often performed without programming and
in the audiology booth. Overall, the simulation of the vari-
ous devices does demonstrate the phenomenon of bone con-
duction hearing. However, demonstrating the hearing
experience for a patient is limited.
When counseling patients regarding the various bone con-
duction technologies, clinicians should consider both the cur-
rent status of the cochlea and the natural history of hearing
loss in the functional cochlea. A patient who may be able to
be rehabilitated with a device based on the current status of
his or her cochlea should be informed of the possible progres-
sion of the hearing loss in the only hearing ear. Clinicians and
patients should consider the efficacy of the device over the
patients lifetime. The ability of a device to provide lifelong
rehabilitation should be emphasized for patients undergoing
surgery if additional surgery may be needed.
Patients considering a bone conduction option for hearing
loss often request a comparison of performance among the
various devices. Clinical studies with head-to-head compari-
sons are either compromised because they often involve ear-
lier generation technologies or unavailable because it is
virtually impossible to randomize devices that require sur-
gery specific to the device. In the hearing device dispensing
environment, the objective gains of the devices during simu-
lation are used for comparison. The purpose of this article is
to obtain identical laboratory measures for direct compari-
son of 8 bone conduction devices and relate the laboratory
measures to clinical function.
Methods
Eight bone conduction devices were investigated represent-
ing those currently cleared by the US Food and Drug
Administration (FDA) in the United States from 4 manufac-
turers. There were 7 surgical devices and 1 nonsurgical
867
Transducer Coupling Method
Electrodynamic Implanted percutaneous post
Electrodynamic Implanted percutaneous post
Electrodynamic Implanted percutaneous post
Electrodynamic Implanted percutaneous post
Electrodynamic Implanted percutaneous post
Electrodynamic Implanted percutaneous post
Piezoelectric Removable dental module
Electrodynamic Implanted subdermal plate
device, constituting the independent variable. The surgical
devices used electrodynamic transducers but differed by
coupling method, with 6 devices coupled to a percutaneous
post implanted into the temporal bone, traditionally called a
Baha (Intenso, BP110, BP100, and Cordelle [Cochlear,
Denver, Colorado] and Ponto Pro and Ponto Pro Power
[Oticon Medical Somerset, New Jersey]), and 1 held against a
magnetic subcutaneous plate screwed into a surgically pre-
pared well in the temporal bone (Alpha 2; Sophono, Inc,
Boulder, Colorado). The nonsurgical device consisted of a
piezoelectric transducer mounted in a patient-removable dental
module held against the lateral surfaces of 2 maxillary teeth
(SoundBite; Sonitus Medical, Inc). Table 1 lists the manufac-
turers, devices, transducer types, and coupling methods.
The study design consisted of a comparison of laboratory
measures from an example of each of these devices obtained
with a single laboratory measurement system. Standard
descriptive statistics (mean, range, and SD) were used to
characterize the measures for each device and to quantify
measurement variability.
Devices were characterized using a custom laboratory
system (Sonitus Medical, Inc) that enabled testing of both
implantable and nonsurgical dental devices. The system con-
sisted of a bench-top anechoic chamber (Anechoic Test Box
Type 4232; Bruel & Kjaer, Naerum, Denmark) with a loud-
speaker driven by a computer with a sound card that delivered
calibrated acoustic signals (swept frequency from 100-10,000
Hz) to the microphone of the device and a calibrated precision
force gauge (B&K 8001) that measured output of the device
(force in dB re 1 mN). The force gauge was assembled with a
vibration mount and bracket, having a total mass that pre-
sented a sufficiently high mechanical impedance load to the
transducer under test for accurate measures of output force
(.20 dB higher than transducer output impedance).
Each processor was configured to have the widest fre-
quency response, highest gain, and minimum effect from
automatic gain control and other adaptive features such as
noise or acoustic feedback suppression to ensure valid com-
parisons across devices. Maximum force output and acousto-
mechanical gain were evaluated according to methods
defined in the international standard IEC60118-9:1985 using
90-dB sound pressure level (SPL) and 60-dB SPL input
868
Figure 1. Photo of the custom laboratory measurement system
measuring a Baha device.
signals, respectively. Implantable bone-anchored devices
were tested with a Baha abutment modified with an M2/10-
32 brass fitting to interface to the force gauge. Figure 1
shows an image of the force gauge assembly with the
Cochlear Intenso attached. The nonsurgical dental device was
tested using a steel fitting attached to the force gauge that
allowed coupling via a spring wire to replicate its attachment
to the teeth. Data for the dental device were compensated for
the effect of the tooth interface to the skull to provide a mea-
sure of the skull stimulation force for direct comparison to
the surgically implanted devices.
Results
Figure 2 shows the maximum output (force in dB re 1 mN)
for the measurements (solid line) and for the published man-
ufacturers results (filled circles) for each device. The mea-
sures for the subdermal surgical device were comparable to
the manufacturers published results, although only the man-
ufacturers values are shown for this device because a soft-
tissue component was not developed for the measurement
system. The nonsurgical dental device (SoundBite) response
is compensated for the effect of the tooth interface to the
skull and represents the actual skull stimulation force. The
measures for all devices were reliable (test-retest SD of
\0.5 dB) and valid (generally within 62 dB of the manu-
facturers published result). This indicates that the measures
are comparable across devices.
Figure 3 shows the maximum output for all devices dis-
played in a format that uses a standard (ANSI S3.6:2004)
clinical audiometric frequency range (250-8000 Hz) with
values at octave frequencies (250-8000 Hz) and select inter-
octave frequencies (750-6000 Hz). The maximum output
differed across devices and by frequency region. These
results can be described using the clinically relevant pure-
tone average (PTA) of the values at 500, 1000, 2000, and
3000 Hz and the average of the values above the PTA
(4000, 6000, and 8000 Hz). Maximum output varied across
devices in the PTA frequency range (mean, 109.7 dB re 1
OtolaryngologyHead and Neck Surgery 150(5)
mN; range, 98.8-119.2 dB) and in the above-PTA frequency
range (mean, 102.6 dB re 1 mN; range, 88.99-119.6 dB).
Maximum acousto-mechanical gain was also found to be
comparable to the manufacturers published data (generally
within 62 dB). As with maximum output force, gain differs
across devices and frequency region. Maximum gain varied
in the PTA frequency range (mean, 40.0 dB; range, 29.1-
49.1 dB) and in the above-PTA frequency range (mean,
32.0 dB; range, 20.8-46.0 dB). Figure 4 shows the maxi-
mum gain for each device (in dB) for the standard clinical
frequency range (PTA) and the high-frequency range (above
PTA).
Figure 5 illustrates the presbycusis consideration for all
devices. This figure shows the maximum output of each
device displayed in an audiogram format (dB hearing level
[HL]) with a frequency range indicated for the conventional
clinical description (PTA range) and the frequency range
indicated for changes in thresholds for 2 typical presbycusis
cases represented by the average hearing thresholds for
women and men aged 70 years.5 In addition, the range of
the hearing loss by frequency for these 2 groups (10th-90th
percentiles) is displayed.6
Discussion
The measures reported enable direct comparison of output
and gain among devices in a clinically relevant format and
are very useful since they can help in device selection. The
maximum output information is particularly useful for
device selection since these maximum output values suggest
a fitting range for each device. The maximum gain informa-
tion is also useful, but less so for purposes of device selec-
tion because the actual use gain is always much less than
maximum and adjusted for each patient individually.
All of these devices are FDA approved for patients with
a normal-functioning cochlea with either conductive hearing
loss or SSD. In these cases, the reported maximum output is
sufficient, but the maximum gain for all devices will far
exceed the patients gain requirements. The maximum gain
can be adjusted for all these devices down to the required 0-
dB to 10-dB target value for activating a normal cochlea.7
For the devices that are FDA approved for patients in whom
the cochlea is not normal (mixed hearing loss), the maxi-
mum gain measure will be useful in device selection
depending on the individual bone conduction sensitivity.
Two very common clinical entities also should be consid-
ered during the process of device selection. First, all of
these devices are intended to be a long-term solution for
patients, and this is especially true of the patients using a
device requiring a surgical intervention. Changes in hearing
not associated with the primary pathology, presbycusis in
particular, should be considered for all cases. Second,
patient selection is often described in terms of air conduc-
tion hearing loss over a very restricted frequency range, the
PTA, when in fact bone conduction sensitivity is the only
factor to consider for all bone conduction devices, by defini-
tion. Each of these 2 considerations will be described in a
clinical context.
Syms and Hernandez 869

140 140

120 120

Force (dB re 1 N)

Force (dB re 1 N)
100 100

80 80

60 60

40 40
Cochlear Cochlear
20 BP100 20 BP110
0 0
250 500 1k 2k 4k 8k 250 500 1k 2k 4k 8k
Frequency (Hz) Frequency (Hz)
140 140

120 120
Force (dB re 1 N)

Force (dB re 1 N)
100 100

80 80

60 60

40
Cochlear 40 Cochlear
20 Cordelle 20 Intenso
0 0
250 500 1k 2k 4k 8k 250 500 1k 2k 4k 8k
Frequency (Hz) Frequency (Hz)
140 140

120 120
Force (dB re 1 N)

Force (dB re 1 N)

100 100

80 80

60 60

40 40
Oticon Oticon
20 Ponto Pro 20 Ponto Pro Power
0 0
250 500 1k 2k 4k 8k 250 500 1k 2k 4k 8k
Frequency (Hz) Frequency (Hz)
140 140

120 120
Force (dB re 1 N)

Force (dB re 1 N)

100 100

80 80

60 60

40 40
Sonitus Sophono
20 SoundBite 20 Alpha 2
0 0
250 500 1k 2k 4k 8k 250 500 1k 2k 4k 8k
Frequency (Hz) Frequency (Hz)
Figure 2. Maximum output force (dB re 1 mN) for 90-dB sound pressure level input for measurements (solid line) and from published
manufacturer results (filled circles) for each device.

Presbycusis, age-related progressive bilateral sensori-
neural hearing loss, affects men more than women. It is
measurable epidemiologically for frequencies .2000 Hz
beginning at 50 years of age and progresses systematically
with age.8 None of the devices considered in this study is
FDA approved for presbycusis. However, many cases will
have a presbycusis consideration. Often times, patients
with a longstanding SSD present for evaluation and rehabi-
litation with the onset of presbycusis in the only hearing
ear.9
870 OtolaryngologyHead and Neck Surgery 150(5)

20

40

dB HL
60

80

100
250 500 1k 2k 4k 8k
Frequency (Hz)
Figure 3. Maximum output force for each device (dB re 1 mN) Figure 5. Maximum output of each device (see Figure 3 for
for 90-dB sound pressure level input. Each manufacturer is repre- device identification) displayed in an audiogram format. The gray
sented by a color (Cochlear: blue, Oticon Medical: red, Sonitus circles represent the typical presbycusis audiogram of a 70-year-old
Medical: orange, and Sophono: green) and each device by a sepa- woman, and black circles represent the same for a 70-year-old
rate symbol. man. The correlating bars represent the mean change in threshold
in the 10th to 90th percentiles for women and men age 70 years.8

Figure 5 illustrates that both of the typical presbycusis

PTA Frequency Range cases will require gain and maximum output increases in
>PTA Frequency Range
the frequency range well above the PTA. The Sophono
device will perhaps not have enough output to maximally
rehabilitate the typical 70-year-old male or female presbycu-
sis patient. The Sophono, Oticon Ponto Pro, or Oticon
Ponto Pro Power will not have enough output to maximally
40 rehabilitate a typical 70-year-old man. As demonstrated in
Figure 4, none of the implantable surgical devices evalu-
Maximum Gain (dB)

ated in this study is able to provide enough high-frequency

gain to maximally rehabilitate the more severe cases of
presbycusis. The SoundBite device is able to provide
enough high-frequency gain and output except at 8000 Hz
20 in the range of hearing loss that occurs in the 90th percen-
tile range and worse in 70-year-old men.
The maximum output levels are similar across the each
manufacturers family of devices. The difference in maxi-
mum output among the Cochlear BP100, Cochlear BP110,
and Cochlear Cordelle devices is not great. Similarly, the
0 difference in maximum output between the Oticon Ponto
Pro and Oticon Ponto Pro Power is not great either. This
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Single-sided deafness is a common application for these

Figure 4. Maximum acousto-mechanical gain for each device in dB
(difference between force in dB re 1 mN and 60dB sound pressure
level [SPL] input sound pressure) averaged over the standard clini-
cal pure-tone average (PTA) frequency range (solid bars, 500-3000
Hz) and the higher frequency range above the PTA (hashed bars,
4000-8000 Hz).
devices,5 a condition where the device activates a normal
cochlea. It is often reported using the air conduction hearing
sensitivity of the better hearing ear in the PTA frequency
range. Devices that produce signals in the PTA frequency
range provide a minimum signal for understanding speech
Syms and Hernandez
even though sound quality may not be optimal. Primary
complaints of patients with SSD are reductions in spatial
hearing ability and reductions in speech understanding in
noise.1 The frequency range above the PTA optimizes audi-
tory function for spatial hearing and understanding speech
in noise as well as improves sound quality.10 In fact, the fre-
quency range for optimizing function for all SSD cases
should be 1500 Hz and higher because frequencies lower
than 1500 Hz are perceived normally with no device in SSD
cases.11
Acoustic feedback has been an issue with many of these
devices. Many variables determine if a patient will experi-
ence acoustic feedback.2 When counseling patients, the
potential for acoustic feedback should be discussed. The
current investigation does not evaluate the level of gain for
each device in the context of the variables that can lead to
acoustic feedback. Although a device may have a demon-
strable level of gain in an anechoic chamber, this maximum
level may not be able to be obtained in a patient due to
acoustic feedback limitations.
Conclusion
All but one of the devices can be measured accurately with
a single custom laboratory system. All devices have suffi-
cient maximum output and gain for the PTA frequency
range (500-3000 Hz). The devices differ in maximum
output and gain for the frequency range above the PTA
(4000-8000 Hz), a consideration for accommodating presby-
cusis and for optimizing the auditory function for SSD.
The surgical devices have less output and gain in the fre-
quency range above the PTA than in the PTA frequency
range. The nonsurgical dental device has the highest output
(up to 30 dB higher) and highest gain (up to 26 dB higher)
in the frequency range above the PTA.
Acknowledgment
We thank Timothy Proulx, Vice President, Research &
Development, Sonitus Medical, Inc, for his help in conducting the
laboratory measures.
Author Contributions
Mark J. Syms, analysis and writing; Kelly E. Hernandez, analy-
sis and writing.
Disclosures
Competing interests: Mark J. Syms is a consultant and shareholder
for Cochlear, a consultant and a member of the Surgeons Advisory
Board for Sonitus, and an investigator for a protocol sponsored by
871
Sonitus. Kelly E. Hernandez is a consultant and a member of the
Surgeons Advisory Board for Sonitus and an investigator for a proto-
col sponsored by Sonitus. The protocol, which started in November
2013, is called Evaluation for Benefit for Treatment of Single Sided
Deafness Between Two Bone Conduction Prosthetic Devices:
Osseointegrated Implant versus Maxilla Anchored Removable Oral
Appliance.
Sponsorships: Sonitus performed bench-top testing.
Funding source: Internal funding.
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