White Paper

Revision 2: 28/Feb/2018

The ADHEAR System – An innovative

non-surgical bone conduction solution

Carmen Giefing-Kröll, Dr. nat. techn.

MED-EL, Business Unit Vibrant
Fürstenweg 77a
6020 Innsbruck, AUSTRIA
Tel +43577881408

Summary The ADHEAR System

The ADHEAR System is a new non-invasive adhesive bone The ADHEAR System consists of an adhesive adapter
conduction system for the treatment of conductive which is placed behind the auricle and a bone conduction
hearing loss and single-sided deafness in subjects of any audio processor being attached to the adapter (Figure 1).
age. The ADHEAR System includes a bone conduction The audio processor is retained on the head using the
audio processor that is retained on the head with an ADHEAR Adhesive Adapter which is placed over the
adhesive adapter that is placed behind the auricle. The mastoid area behind the auricle. The ADHEAR bone
ADHEAR System represents a new type of technology conduction system is based on a new technology,
and offers several advantages compared to other developed by Otorix AB, Askim, Sweden. In 2015, MED-EL
systems that are available for the treatment of acquired the technology and since then continues with
conductive hearing loss or single-sided deafness. Bench- the development of the system. The ADHEAR bone
tests and audiologic evaluations in normal hearing conduction hearing system received its first CE mark on
subjects showed that the audio processor of the ADHEAR December 9, 2016 and has been commercially available
has similar performance features to comparative devices, since August 2017.
from a technical and user point of view. However, no
pressure is needed to transfer the vibrations to the inner
ear as required by other non-implantable bone
conduction devices e.g. a softband. Its ease of
application due to the adhesive adapter, does not
compromise the clinical performance of the ADHEAR
System. Initial clinical data show that the ADHEAR System
represents an excellent option for the treatment of
conductive hearing loss or single-sided deafness in
children and adults.

A B

Figure 1. The ADHEAR bone conduction hearing system. A. The ADHEAR Audio Pro-
cessor and ADHEAR Adhesive Adapter. B. Connecting the audio processor to the
adhesive adapter. C. The ADHEAR System in place behind the auricle (See
next page).

1
 Target groups for the ADHEAR system
The ADHEAR System is intended to treat patients with
conductive hearing loss or single-sided deafness via
bone conduction.
Individuals who have a conductive hearing loss have an
impaired ability of transmitting sound through their outer
and/or middle ears to the inner ear, but the inner ear
function itself is not affected. In cases of conductive
hearing loss, the ADHEAR can improve hearing by
transforming the sound signal into vibrations, bypassing
C the external and middle ear and transferring the signal
directly to the inner ear via bone conduction.
The ADHEAR functions by connecting the two compo-
Frequency
Frequency (Hz)
(Hz)
nents of the system together – the audio processor 125 250 500 1000 2000 4000 8000
-10
and the adhesive adapter. The system as a whole works
by converting sound into vibrations, which are relayed 0
BC
through the skin to the mastoid bone. Sound is trans- 10
mitted via bone conduction to the inner ear, providing a
20
hearing impression in patients with conductive hearing
30
loss or single-sided deafness.
Hearing level [dB HL]
Hearing level (dB HL)

40

The audio processor has dual microphones and signal 50

processing technologies and is powered by a single P13 60

battery. The audio processor’s push button allows users
70
to switch between 4 pre-defined programs. Users can
80
adjust the volume by using the small wheel on the side
90
of the audio processor. A cable can also be connected to
the audio processor and linked to devices such as mobile 100

phones or mp3 players. 110

120
The adhesive adapter is for single use only and is water
Conductive
Figure 2. Candidacy hearing
Audiogram loss users with conductive hearing loss.
for ADHEAR
resistant, which means it can remain on the skin for 3 -7 The shaded area indicates bone conduction thresholds.

days. However, if retention of the adhesive adapter to

the skin is reduced, a new one should be applied. After Those who have single-sided deafness have one
placing the adhesive adapter in the correct position perfectly normal ear while the other ear suffers from a
behind the auricle the audio processor can be connected profound hearing loss. This hearing impairment leads to a
to the adhesive adapter via the snap connector (Figure 1). head shadow effect meaning that sounds coming from
The adhesive adapter is currently available in two colours: the non-hearing side are affected by a frequency specific
beige or brown. The adhesive adapter is intended to be attenuation towards the other ear as the head causes an
used on intact, healthy skin. No skin condition that acoustic shadow. Patients with single-sided deafness
contraindicates application of an adhesive behind the have great difficulty in hearing in noisy situations, to
auricle should be present. localize sounds well, and report problems when trying to
communicate in everyday situations. In single-sided
deafness, the ADHEAR reduces the head-shadow effect,
i.e., sounds coming from the non-hearing side will be
heard on the hearing side by placing the ADHEAR System
on the deaf side. Via bone conduction, sounds are
transmitted via vibration to the other hearing inner ear.

As a non-invasive, non-implantable and low risk active

medical device the ADHEAR System is highly comparable
to other bone conduction solutions, which are offered to
treat patients with conductive hearing loss or single-

2
 OFL90
sided deafness via bone conduction. The ADHEAR is the 130

first system that is retained on the head with an

120
adhesive component thus omitting the pressure that is

Output force level (dB rel 1μN)

required by other systems e.g. bone conduction 110

headbands to transmit vibrations through the skin. It

100
also offers a more aesthetically pleasing solution.
90

80

Pre-clinical performance testing 70

60
MED-EL conducted bench testing and evaluations in

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normal hearing subjects to ensure that the ADHEAR A Frequency (Hz)
System performs as intended.
OFL60
130

Performance evaluation on a skull simulator

120
The adhesive concept of the ADHEAR System provides a Output force level (dB rel 1μN)
new working principle in bone conducted sound by 110

avoiding pressure being applied onto the skull. The audio

100
processor was coupled directly to a skull simulator which
simulated the mechanical properties of the skull bone 90

(Figure 3). The outcome measures can be found in the

80
standard “IEC 60118-9:1985 Hearing aids. Part 9: Methods
of measurement of characteristics of hearing aids with 70

bone vibrator output.”

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loudspeaker
B Frequency (Hz)

Figure 4. Output force level (OFL) frequency response for a specific input sound
Anechoic pressure level measured on the skull simulator SKS10. A. OFL at 90 dB SPL. B. OFL
test chamber at 60 dB SPL.
The output force level in dB rel 1 µN is shown as a function of the frequency in Hz.
SKS10
reference
microphone The OFL90 value of the ADHEAR Audio Processor was
comparable to that of other bone conduction audio
A B
processors that may be used on a softband (Table 1).
Figure 3. Performance Evaluation on a Skull Simulator. A. The ADHEAR Audio
Processor coupled to the skull simulator SKS10. B. Test set-up in the anechoic
test chamber. SKS10 with test device on left side, loudspeaker on top, reference Table 1. Non-implantable bone conduction hearing
microphone on right side.
aids. All devices included offer noise reduction and wide
band dynamic range compression. Technical data were
For the ADHEAR audio processor the output force level measured on a skull simulator (1), on an artificial mastoid
frequency response for an input sound pressure level of 90 according to IEC60318-6 (2), or the measurement method
dB SPL (OFL90) and an input sound pressure level of 60 dB was not further specified (3). Data of comparator devices
SPL (OFL60) were determined according to IEC 60118- were extracted from publicly available fact sheets.
9:1985. The audio processor is picking up a 90 dB SPL or 60
dB SPL input sound pressure level and transforms it into DEVICE MANUFACTURER FREQUENCY PEAK OFL
vibrations. The vibratory output of the audio processor is RANGE AT 90 dB SPL

measured in force level (dB µN). The gain setting in this Ponto Plus1 Oticon 125 – 8000 Hz 124 dB (rel 1µN)

measurement was full on gain. The Peak OFL at 90 dB SPL Baha 5 ® 1

Cochlear TM
250 – 7000 Hz 117 dB (rel 1µN)

was 124 dB rel 1 µN (Figure 4A). The peak OFL at 60 dB SPL Sophono Alpha 2 Medtronic 125 – 8000 Hz 115 dB (rel 1µN)
MPO3
was 120 dB rel 1 µN (Figure 4B).
Junior BC 8113 Bruckhoff 250 – 6000 Hz 128 dB (rel 1µN)

contact mini2 BHM-Tech 250 – 6000 Hz 114 dB (rel 1µN)

ADHEAR 1
MED-EL 250 – 8000 Hz 124 dB (rel 1µN)

3
 In preclinical testing the Acousto-Mechanical Sensitivity
Level (AMSL), which is the ratio between the force
output and the sound pressure input signal, was
determined for the ADHEAR audio processor with the
skull simulator (Figure 5). By subtracting the input sound
pressure level from the corresponding output force level
the AMSL was calculated. The AMSL at a 60 dB SPL input A B
at 1600 Hz was 36 dB rel 1 µN/20 µPa.
Figure 6. Test set-up in normal hearing subjects. A. Ipsi-lateral plugged. B. Cont-
ra-lateral plugged and muffled.
Acousto-Mechanical Sensitivity
Acousto-Mechanical Sensitivity
70

An average simulated air-bone gap of 36 dB ± 6 dB

60 (mean ± standard deviation) could be achieved by using
the ear plug in the ipsi-lateral ear. No significant
AMSL [dB rel 1 µN/20 µPa

50
difference in aided sound field thresholds was detected
between the tested devices across frequencies (Figure 7).
40

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PTA4 [dB HL]

Frequency (Hz)
30
Figure 5. The Acousto-mechanical sensitivity level (AMSL) measured on the skull
simulator SKS10. The AMSL in dB rel 1 µN/20 µPa is shown as a function of the
frequency in Hz. 40

50
Evaluation of the ADHEAR System in normal hearing
subjects 60
Unaided BCD BCD ADHEAR ADHEAR
The ADHEAR System was audiologically evaluated in A Softband Headband Headband Adhesive
Adapter
normal hearing subjects. In particular the study aimed to
characterize the audiological performance of the ADHEAR
audio processor in combination with the adhesive 0
adapter or the alternative headband and to compare its
performance with other bone conduction devices (BCD)
on a steel-spring headband or softband. 20
dB HL

Eleven normal-hearing, German-speaking subjects,

specifically 5 males and 6 females with an average age of 40

34.5 years (range, 26 to 45 years), were enrolled in the

study. Repeated single subject measures were carried out
for each subject, with each subject serving as his or her 60
0.25 0.5 1 2 4 8
own control for the different devices. Five right sides and B Frequenzy [kHz]

six left sides were evaluated. In order to simulate a Figure 7. Mean aided and unaided sound field thresholds in eleven normal hea-
conductive hearing loss (CHL) the tested ear was ring subjects, shown as PTA4 (A) and across frequencies (B).
Data were analysed using a Friedman test with Dunn’s multiple comparison test.
occluded with ear plugs during the measurement (Figure The asterisks on top indicate significant differences with a corrected p≤0.05.
Black, unaided; yellow, BCD Softband; blue, BCD Headband; pink, ADHEAR Head-
6A). The contralateral untested ear was always occluded
band; purple, ADHEAR Adhesive Adapter.
and muffled using ear plugs and headphones (Figure 6B).
Testing was performed in accordance with the ISO-389 Speech performance in quiet was evaluated using the
Series; ISO-8253 Series; IEC-60645 Series. Freiburger Monosyllables test (Figure 8A). The speech level
For the speech in noise test, speech and noise were was fixed at 65 dB SPL. The word recognition score (WRS)
presented from the front with a fixed noise level of 45 significantly improved with the ADHEAR on the adhesive
dB SPL. adapter, the ADHEAR on headband and the BCD compared
to the unaided condition. No significant difference was
seen between the BCD on softband and the ADHEAR.

4
 Clinical Performance of the ADHEAR
100
System
90

80 The ADHEAR System is a new treatment option for

70 conductive hearing loss and single-sided deafness. No
60 clinical data has been published in the literature, as it
WRS [%]

50 has only recently become available. However, three

40 research institutes already reported on their experience
30 with the ADHEAR System at various conferences. The
20 data that was presented is summarized in the following
10 section (for an overview see Table 2).
0
Unaided BCD BCD ADHEAR ADHEAR
A Softband Headband Headband Adhesive Table 2. Overview of clinical studies with the ADHEAR.
Adapter
Number of subjects used for interim analysis (1).

STUDY GROUP OBJECTIVE NUMBER OUTCOME

20 OF SUBJECTS 1 MEASURES
McDermott et al. ADHEAR in 14 • PTA4 in sound field
15 at the Birmingham children • Glasgow children’s
Children’s Hospital benefit inventory (GCBI)
• ADHEAR questionnaire
SRT [dB SNR]

10 Skarzynski et al. ADHEAR in BCI 8 • PTA4 in sound field

at the Institute of users • Word recognition
Physiology and score in quiet
5 Pathology of • Speech reception
Hearing, Warsaw threshold in quiet
• Speech reception
threshold in noise
0
Mertens et al. at the ADHEAR in SSD 17 • Speech perception
Antwerp University in noise
Hospital • Sound localization
-5
Unaided
BCD BCD ADHEAR ADHEAR • Audio Processor
B Softband Headband Headband Adhesive Satisfaction Questi-
Adapter onnaire (APSQ)
• ADHEAR questionnaire
Figure 8. Speech understanding in quiet (A) and noise (B). A. Word recognition
score (WRS) in quiet in the Freiburger Monosyllables test in eleven subjects. The
speech level was fixed at 65 dB SPL. Median values are indicated by horizontal The ADHEAR System in children
lines and mean values by crosses. B. Speech reception threshold (SRT) in noise in
the OLSA in eleven subjects. The noise level was fixed at 45 dB SPL and the spe- McDermott and co-workers from the Birmingham
ech level changed adaptively. Median values are indicated by horizontal lines and
mean values by crosses. Data were analysed using a Friedman test with Dunn’s
Children’s Hospital (McDermott 2017) reported on their
multiple comparison test. The asterisks on top indicate significant differences experience with the ADHEAR at the Osseo 2017
with a corrected p≤0.05.
(Nijmegen, The Netherlands), the ESPCI 2017 (Lisbon,
Speech understanding in noise was evaluated with the Portugal), the EFAS 2017 (Interlaken, Switzerland) and the
Oldenburger matrix sentence test (OLSA) in sound field CI 2017 (San Francisco, USA). The research group
by determining the speech reception threshold (SRT) assessed the audiological efficacy of the ADHEAR System
where 50% speech intelligibility is reached at a constant in children who had already gained experience with its
noise level (Figure 8B). predecessor, the Adjoin system, for more than one year.
The speech level was changed adaptively. The lower the This was a prospective study with single subject repeated
signal to noise ratio (SNR) the better the speech under- measures design with each subject serving as their own
standing in the respective condition can be interpreted. control. Twenty English speaking children with uni- or
SRT was significantly lower with the ADHEAR audio pro- bilateral conductive hearing loss who have used the
cessor being placed on the adhesive adapater, the ADHEAR predecessor, Adjoin system, for more than one year,
Audio Processor on a softband and the BCD on a softband, should be included in the study. The audiological testing
compared to the unaided condition. But again no signifi- was planned in three conditions: unaided, with a bone
cant differences between the BCD on headband and the conduction hearing device on a softband, and the
ADHEAR on the adhesive adapter or headband were found. ADHEAR System. Subjective outcomes from children and
their carers using the manufacturer’s comfort
In conclusion, in normal hearing subjects with simulated questionnaire as well as the Glasgow Children’s Benefit
conductive hearing loss the ADHEAR System with the Inventory was recorded after 4 weeks of use. At the
ADHEAR Adhesive Adapter performed comparably to another conference the results of 14 subjects were presented.
BCD on a softband, in sound field threshold measurements The mean age was 12 years, 10 were male, 4 female.
and speech understanding in quiet and in noise. These show comparable audiological outcomes with the

5
ADHEAR System and the traditional bone conduction word recognition score in quiet was comparable within
solutions on a headband. For both devices a functional the groups: in the softband group the difference
gain of approximately 18 dB was achieved in sound field between unaided and aided condition was 54% with the
measurements. Early results appeared to demonstrate device on a softband and 55% with the ADHEAR System
better high frequency outcomes for the ADHEAR System. and in the implant group 47% with the implant and 46%
The ADHEAR was comfortable and easy to use. The with the ADHEAR System. There was no significant
system was very well accepted by children and parents. difference in the improvement of the speech reception
No skin reactions occurred. Thus the system provides an threshold in quiet between the systems: (1) softband
excellent option for children with conductive hearing loss group: 21 dB with the ADHEAR and 20 dB with the
overcoming the disadvantages of conventional non- softband; (2) implant group: 25 dB with the ADHEAR
surgical bone conduction solutions. System and 24 dB with the implant. Speech
understanding in noise improved significantly by 4.6 dB in
The ADHEAR System in users of bone conduction the softband group with the ADHEAR System, by 4.8 dB
implants in the softband group with the device on softband, by
At the Institute of Physiology and Pathology of Hearing in 3.6 dB in the implant group with the ADHEAR System and
Warsaw (Poland) Skarzynski and his colleagues assessed by 4.6 dB in the implant group with their own device. In
the audiological efficacy of this hearing device in conclusion, the ADHEAR System showed comparable
experienced users with an existing transcutaneous bone audiological performance to a bone conduction implant
conduction implant and unexperienced users with a bone and a bone conduction device on a softband. The sound
conduction hearing device on a softband suffering from quality was evaluated as natural.
conductive hearing loss (Skarzynski 2017). Initial data
S0NNH
from the study were presented at the Osseo 2017
SSSDNNH
(Nijmegen, The Netherlands), the EFAS 2017 (Interlaken,
Switzerland) and the CI 2017 (San Francisco, USA). The
study was designed as a prospective study with single
subject repeated measures design with each subject
serving as its own control. Native polish adults with uni-
or bilateral conductive hearing loss have been included in
the study. The comparative device was a transcutaneous
BC implant, if the patient had used this device for more
than three months. Otherwise a bone conduction device
on a softband was used in acute testing. Unaided and S0NSSD S0N0
two aided conditions with the ADHEAR and the bone
conduction device should be compared using the
following tests: (1) Sound field audiometry with warble
tones. (2) Speech in quiet by determining the word
recognition score and speech reception threshold
(SRT50) in sound field with Polish monosyllables. (3)
Speech in noise by determining the SRT50 in sound field
at 65 dB SPL fixed noise level using the Polish Matrix Test
with speech and noise coming from the front.

The interim results were presented at the conferences Figure 9. Test set-up for the speech in noise test. The cross marks the SSD side.
Green speaker, direction of sound; red speaker, direction of noise.
and data collection continues. Data on five subjects with
a bone conduction softband (mean age 35.6 ± 10.6
years) and three with a bone conduction implant (mean The ADHEAR System in single-sided deafness
age 30.5 ± 11.6 years) were presented. The ADHEAR Mertens and co-workers at the Antwerp University
showed good audiological efficacy in this acute clinical Hospital investigated the user satisfaction and clinical
study. With the users of the softband a mean functional efficacy of the ADHEAR hearing system in SSD (Mertens
gain of 19 dB was measured with the ADHEAR System 2017). The data was presented at the ESPCI 2017 (Lisbon,
compared to 21 dB with the softband. For users with a Portugal), at the Osseo 2017 (Nijmegen, The
bone conduction implant a mean functional gain of 28 Netherlands), the EFAS 2017 (Interlaken, Switzerland) and
dB was reported with the ADHEAR System compared to the CI 2017 (San Francisco, USA). A randomized cross-
approximately 25 dB with the implant. In addition, the over study design was conducted using a CROS hearing

6
aid as a control device. As a non-surgical treatment, the Conclusion
ADHEAR system may be a good solution for SSD patients
who are unsuitable for, or who do not wish to undergo, The ADHEAR System is safe and effective at any age in
bone conduction device or cochlear implant surgery. In patients suffering from conductive hearing loss or single-
order to evaluate the user satisfaction and clinical sided deafness. Considering the treatment options that
efficacy of the ADHEAR system the following outcome are currently available on the market for the same
measurements were administered after a two-week trial: intended use, the ADHEAR System represents a state-of
(1) speech perception in noise (SSSDNNH, S0NSSD, S0NNH, and the-art treatment option. In bench tests the audio
S0N0) (Figure 9), (2) sound localization, (3) the Speech, processor achieved comparable performance data to
Spatial and Qualities of Hearing scale (12-item version) those of the competitors’ bone conduction devices used
(SSQ12) questionnaire, the Audio Processor Satisfaction on a softband. This further translated in a clinical
Questionnaire (APSQ), and the ADHEAR Adhesive Adapter performance comparable not only to devices on a
questionnaire. Using a randomized cross-over study softband but to passive transcutaneous bone conduction
design, the study compared the user satisfaction and implants based on initial data. In conclusion, the safe
clinical efficacy of the ADHEAR hearing system and a and comfortable application of the ADHEAR System did
CROS hearing aid in the same group. The data of 17 not compromise its functionality providing significant
subjects was presented. A significant improvement in benefit for subjects with conductive hearing loss and
sound localization with the ADHEAR was found. There single-sided deafness.
was a positive trend for speech perception in the SSSDNNH
condition. In the questionnaire 67% of users ranked the
ADHEAR to be partially useful or better. The results were
comparable to other bone conduction trials in SSD. The
outcome of a bone conduction device in SSD is very
subjective, but as the ADHEAR is especially easy to use, a
bone conduction trial with the ADHEAR could always be
considered.

Summary of preliminary clinical data with the ADHEAR

Three studies could be identified that reported on
performance and safety of the ADHEAR System in
prospective clinical trials. In total, data on 39 subjects
were reported. Of these, 14 were children with a mean
age of 12 years. The ADHEAR System was evaluated in
subjects with conductive hearing loss (McDermott 2017,
Skarzynski 2017) and subjects suffering from SSD
(Mertens 2017). One study (McDermott 2017) assessed
the safety of the ADHEAR System in 14 subjects and
reported that no soft tissue reactions or other adverse
events were observed. Performance of the ADHEAR
System was evaluated in all three studies. In subjects
with conductive hearing loss (McDermott 2017,
Skarzynski 2017) a mean functional gain of 18 to 21 dB
could be achieved with the ADHEAR System. This was
comparable to bone conduction devices on a softband.
An improvement in word recognition score by 46 to 55%
was reported (Skarzynski 2017). In addition, speech
understanding in quiet improved by 21 to 25 dB and the
signal-to-noise ratio decreased by 3.6 to 4.6 dB
(Skarzynski 2017). In subjects with SSD sound
localization was significantly improved and speech
understanding in noise improved if the sound was
coming from the deaf side and noise from the better
hearing side (Mertens 2017).

7
References
1. Mc Dermott, A. L. M., R.; Williams, J. S.; Gill, J.; Child, A. (2017). The ADHEAR
HEARING System. A paediatric experience. Osseo 2017 - 6th International
Congress on Bone Conduction Hearing and Related Tech-nologies. Nijmegen,
The Netherlands.
2. Mertens, G. G., A.; Bouzegta, R.; Van de Heyning, P. (2017). User satisfaction
and clinical efficacy of a new non-invasive bone conduction hearing system
in single-sided deafness. EFAS 2017, 13th Congress of the European
Federation of Audiology Societies. Interlaken, Switzerland.
3. Skarzynski, P. H. K., M.; Olszewski, L.; Ratuszniak, A.; Osinska, K.; Krol, B.
(2017). Audiological evaluation of the novel bone conduction hearing device
ADHEAR in experienced users of an existing transcutaneous bone anchored
hearing device. Osseo 2017 - 6th International Congress on Bone Conduction
Hearing and Re-lated Technologies. Nijmegen, The Netherlands.

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