Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid
Phase: NA
Conditions: Hearing Loss, Conductive, Hearing Loss, Mixed
Sponsor: Oticon Medical

State of document: Released
Document Number: Doc-00073069
Revision: 1
Title: BC110 Clinical Investigation Report
Owner: Wassard, Christina,cwas     
NCT04761926
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COVER PAGE
Clinical Investigation Title
Investigating hearing with Ponto 4, a bone anchored hearing solution
Investigation Code
BC110
Investigational Device (s)
Ponto 4 (Oticon Medical AB, Askim, Sweden) and fitting software Genie 
Medical BAHS (Oticon Medical AB, Askim, Sweden) 
Methodology
Prospective, multi-center, single arm study
Coordinating investigator – if 
applicable
Chris L. Jacobsen
Overlæge
Audiologisk afsnit
Aalborg Universitetshospital
Havrevangen 1, 6. sal
9000 Aalborg
Principal investigator(s):
Site 2:
Chris L. Jacobsen
Audiologisk Afsnit
Aalborg Universitetshospital
Havrevangen 1, 6. sal
9000 Aalborg
Site 3:
Eva Kümmel Christensen
Oticon Medical
Kongebakken 9
2765 Smørum
Sponsor:
Oticon Medical AB
Datavägen 37 B
436 32 Askim
Sweden
Statement of compliance
This clinical investigation was performed in consistency with the current 
version of the Declaration of Helsinki, ISO 14155, the Medical Device 
Directive (MDD) 93/42/EEC, Regulation (EU) 2017/745 (MDR) and 
applicable regional or national regulatory requirements.
Date of report
30/6-2021
Author of report
Christina Wassard Maas, Clinical Trial Manager & Clinical Specialist, 
Oticon Medical, Kongebakken 9, 2765 Smørum, Denmark
REVISION HISTORY
Rev
Date
Description 
1
30/6-2021
First version issued
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Table of contents
COVER PAGE..........................................................................................................................................1
REVISION HISTORY.................................................................................................................................1
INTERNAL REFERENCES...........................................................................................................................3
LIST OF ABBREVIATIONS.........................................................................................................................4
1
SUMMARY.....................................................................................................................................5
2
INTRODUCTION..............................................................................................................................6
3
INVESTIGATIONAL DEVICE AND METHODS......................................................................................6
3.1
INVESTIGATIONAL DEVICE DESCRIPTION .................................................................................................... 6
3.2
DEVICES AND ACCESSORIES USED IN THE INVESTIGATION ............................................................................. 6
4
CLINICAL INVESTIGATION PLAN (CIP) ..............................................................................................7
4.1
CLINICAL INVESTIGATION OBJECTIVES....................................................................................................... 7
4.1.1
Primary objective......................................................................................................................... 7
4.1.2
Primary hypothesis ...................................................................................................................... 7
4.1.3
Secondary Objectives................................................................................................................... 8
4.1.4
Secondary Hypothesis.................................................................................................................. 9
4.1.5
Tertiary Objectives....................................................................................................................... 9
4.2
CLINICAL INVESTIGATION DESIGN ............................................................................................................ 9
4.2.1
Method description...................................................................................................................... 9
4.2.1.1
Pure tone audiometry.............................................................................................................. 9
4.2.1.2
Sound field audiometry ........................................................................................................... 9
4.2.1.3
Speech recognition in quiet ................................................................................................... 10
4.2.1.4
Patient reported outcome ..................................................................................................... 10
4.2.1.5
Self-reported usage hours with Ponto 4................................................................................ 11
4.2.1.6
Assessment of connectivity devices....................................................................................... 11
4.3
SUBJECT POPULATION.......................................................................................................................... 11
4.3.1
Inclusion Criteria ........................................................................................................................ 11
4.3.2
Exclusion criteria........................................................................................................................ 11
4.3.3
Early termination ....................................................................................................................... 11
4.3.4
Sample size................................................................................................................................. 12
4.4
VISIT SCHEDULE.................................................................................................................................. 12
4.5
CONCOMITANT MEDICATIONS/TREATMENTS ........................................................................................... 12
4.6
DURATION OF FOLLOW-UP................................................................................................................... 13
4.7
ETHICAL CONSIDERATIONS.................................................................................................................... 13
4.8
DATA QUALITY ASSURANCE................................................................................................................... 13
4.9
STATISTICAL METHODS........................................................................................................................ 13
4.9.1
Sample size calculation.............................................................................................................. 14
5
RESULTS....................................................................................................................................... 15
5.1
INITIATION AND COMPLETION DATES...................................................................................................... 15
5.2
PATIENT DEMOGRAPHICS ..................................................................................................................... 15
5.3
CIP COMPLIANCE................................................................................................................................ 16
5.3.1
Protocol deviations .................................................................................................................... 17
5.3.2
Analysis Populations .................................................................................................................. 17
5.4
PRIMARY OBJECTIVE RESULTS................................................................................................................ 17
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5.4.1
Functional gain for PTA4 (objective A1)..................................................................................... 17
5.5
SECONDARY OBJECTIVE RESULTS............................................................................................................ 18
5.5.1
Functional gain for all frequencies (objective B1)...................................................................... 18
5.5.2
Speech recognition (objective C1).............................................................................................. 20
5.5.3
SSQ (objective D1)...................................................................................................................... 21
5.5.4
GHSI (objective E1)..................................................................................................................... 23
5.5.4
USAGE TIME ACROSS ALL SUBJECTS AND GROUPED BY HEARING LOSS (OBJECTIVE F1 AND F2).......................... 24
5.5.5
Effective gain (objective G1 and G2).......................................................................................... 24
5.5.6
Evaluation on individual levels (objective H1) ........................................................................... 26
5.5.7
Hearing loss degradation (objective I1)..................................................................................... 26
5.5.8
Assessment of intended fitting range (objective J1).................................................................. 27
5.5.9
Assessment of air to bone gap (objective K1)............................................................................ 28
5.6
TERTIARY OBJECTIVE RESULTS................................................................................................................ 29
5.7
ADVERSE EVENTS AND DEVICE DEFICIENCIES ........................................................................................... 29
5.7.1
Serious Adverse Events .............................................................................................................. 30
5.8
MISSING DATA HANDLING .................................................................................................................... 30
6
DISCUSSION................................................................................................................................. 31
6.1
FUNCTIONAL GAIN .............................................................................................................................. 31
6.2
AIDED THRESHOLDS AND EFFECTIVE GAIN................................................................................................ 31
6.3
SPEECH RECOGNITION ......................................................................................................................... 31
6.4
PATIENT-RELATED OUTCOMES............................................................................................................... 31
6.5
OTHER ASPECTS.................................................................................................................................. 32
7
OVERALL CONCLUSIONS............................................................................................................... 32
8
ETHICS......................................................................................................................................... 33
9
INVESTIGATORS AND ADMINISTRATIVE STRUCTURE OF CLINICAL INVESTIGATION......................... 34
10
SIGNATURES ................................................................................................................................ 35
11
REFERENCES................................................................................................................................. 36
INTERNAL REFERENCES
Ref #
Document #
Document title
[1]
Doc-00071998
BC110 Clinical Investigation Plan
[2]
Doc-00072460
BC110 Non-substantial amendment to CIP
[3]
Doc-00072448
BC110 Data Management Plan
[4]
GOT server1
BC110_Database_LOCKED_20210423
[5]
Doc-00073450
BC110 Statistical Analysis Plan
[6]
Doc-00072545
BC110 Monitoring Plan
[7]
Doc-00073443
BC110 End-of-study Database Lock MOM
[8]
Doc-00115197
BC110: Clinical Data Report
[9]
Doc-00063691
C68 CIR
[10]
Doc-00065737
Clinical Data Report – percutaneous BAHS
[11]
Doc-00069593
CIR_C71
[12]
Doc-00067091
State of the Art - BAHS
                                                
1 \\gotinfil01\Common\Clinical\Clinical study\Studies\BC110 Ponto 4\Trial Master File\17. Data Management\BC110 
Database Lock_20210423
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LIST OF ABBREVIATIONS
AC
Air Conduction
BC
Bone Conduction
BAHS
Bone Anchored Hearing System
CHL
Conductive Hearing Loss
CI
Confidence Interval
eCRF’s
Electronic Case Report Forms
FPFV
First Patient First Visit
GHSI
Glasgow Health Status Inventory questionnaire
ITT
Intention To Treat
LPLV
Last Patient Last Visit
MHL
Mixed Hearing Loss
PMCF
Post Market Clinical Follow-up
PPS
Per Protocol Set
PTA4
Pure Tone Average (consists of 500, 1000, 2000 and 4000Hz)
SAP
Statistical Analysis Plan
SD
Standard Deviation
SSD
Single Sided Deafness
SSQ
Speech Spatial and Qualities of Hearing Scale
SD
Standard Deviation
TMF
Trial Master File
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1
SUMMARY
Title of the clinical Investigation: Investigating hearing with Ponto 4, a bone anchored hearing solution.
Short introduction: Oticon Medical first developed a percutaneous bone anchored hearing system (BAHS) in 
2009. The latest generation BAHS manufactured by Oticon Medical AB, Askim, Sweden, the Ponto 4, was 
placed on the market in June 2019. This study was a post market clinical follow up (PMCF) study with the 
purpose of gathering knowledge on the use and performance of the Ponto 4 device and its’ accessories on 
existing Ponto 4 users.
Subject population: In total, 20 subjects were included and completed the study. 15 subjects hearing losses 
were CHL/MHL and five had SSD; their average age was 56.1 years (min 18; max 81 years old). Thirteen 
subjects were tested at Aalborg University Hospital, and seven subjects were tested at Oticon Medical.
Objective: The purpose of this study was to investigate hearing with the Ponto 4 in already implanted BAHS 
users in terms of improvement of hearing (thresholds) and speech intelligibility. Additionally, the aim was to 
investigate the subjective experience of the Ponto 4(s) via patients reported outcomes (SSQ12 and GHSI
questionnaires). 
Study design: The study design was a prospective, multi-centre, single arm study consisting of one visit. At 
the study visit were sound field threshold, speech recognition, pure tone audiometry and patient related 
outcome measured. BC In-situ and audiometric data from the time of the fitting of Ponto 4 were collected 
retrospectively. The retrospectively collected was used for the calculation of effective gain, degradation of 
hearing loss and calculation of air to bone gap.  
Results: The functional gain (PTA4) was 31.5 dB (SD 9.5) for all subjects, 29.6 dB (SD 9.6) for the CHL/MHL 
group and 36.3 dB (SD 7.9) for the SSD group, it was all significantly improvements. The effective gain also 
called the remaining air-to-bone gap for the CHL/MHL group was 7.05 dB (SD 6.10). Speech recognition in 
quiet was significant improved with 55.9 % (SD 31.7) comparing the aided to the unaided condition. Patient-
related outcomes obtained via SSQ12 (total score 6.28 (SD 1.91) and GHSI (total score 65.4 (SD 11.7) showed 
a positive subjective experience of the Ponto 4(s) with mean scores slightly higher than reference data.
Conclusion: The study showed that the Ponto 4 subjects within intended use had improved hearing as 
measured with functional gain, speech recognition and subjective outcomes.
Date of initiation (FPFV): 2021-01-21
Date of completion (LPLV): 2021-02-24
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2
INTRODUCTION
Bone conduction hearing systems use the body’s natural ability to transfer sound through bone conduction
(BC). The bone anchored hearing solution picks up sound and converts it into vibrations that are transferred 
via the skull bone to the inner ear (cochlea). Subjects with conductive or mixed hearing losses and subjects 
with lasting hearing loss following a middle ear disease or malformations, utilize that the vibrations are 
bypassing the conductive problem in the ear canal or middle ear, hence stimulating the cochlea directly. 
Subjects with single-sided deafness (SSD) utilize that the vibrations are transmitted to the cochlea on the 
contralateral side.
Oticon Medical first developed a bone anchored hearing system (BAHS) in 2009. The latest generation BAHS,
the Ponto 4 (manufactured by Oticon Medical AB, Askim, Sweden), was placed on the market in June 2019.
This study was a post market clinical follow up (PMCF) study with the purpose of gathering knowledge on the 
use and performance of the Ponto 4 device and its’ accessories on existing Ponto 4 users.
3
INVESTIGATIONAL DEVICE AND METHODS
3.1
Investigational device description
The investigational device, the Ponto 4, used in the study is CE marked and FDA cleared since June 2019. The 
subject’s own Ponto 4(s) were used in this study; hence no specific test device(s) were used. This was due to 
the nature of the study which intended to follow-up and investigate existing Ponto 4 user’s outcomes for 
patients with conductive (CHL) or mixed hearing losses (MHL) or patients with single sided deafness (SSD). 
The Ponto 4 sound processors have prior to the study been fitted via Genie Medical 2019.1, and during the 
study visit the sound processors were also connected to Genie Medical BAHS 2019.1 (see specifications in
Table 1).  
The investigational device is intended to improve hearing for subjects with CHL/MHL by unilateral or bilateral 
fitting, as well as for subjects with SSD. The Ponto 4 is intended to be used either with the Ponto implant 
system or with specific compatible abutments and implants. The investigational device can also be used on 
a softband, headband or a testband (this study only collected data from the Ponto 4 used on compatible 
abutments and implants).
3.2
Devices and Accessories used in the investigation
The subject’s own Ponto 4(s) were used in this study. The Ponto 4 and fitting software article numbers are 
listed in Table 1. The colors of the Ponto 4 devices used in the study were not recorded. All devices were 
fitted prior to any study related activities during a standard clinical fitting session at their regular audiologist.
Table 1 Overview of investigational devices and fitting software utilized in the study.
Name
Denomination
Article #
Initial CE
FDA 
clearance
Ponto 4
Chroma Beige (CBE) CO90
186777
2019
2019
Terracotta (TC) CO94
186778
2019
2019
Silver (SIL) CO44
186779
2019
2019
Steel Grey (STG) CO92
186780
2019
2019
Chestnut Brown (CNB) CO93
186781
2019
2019
Diamond Black (DBL) CO63
186782
2019
2019
Fitting software
Genie Medical BAHS sales pack 2019.1
197603
2019
2019
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The subjects’ own accessories (connectivity device(s)) were included in this study for the exploratory 
objective where the subjects had to report usage and give satisfaction ratings for these – if they were using 
a connectivity device. Again, no specific connectivity device(s) can be listed, but an overview of the 
potential connectivity devices can be found in Table 2.
Table 2 Overview of potential connectivity devices.
LEGAL MANUFACTURER
DENOMINATION
SBO HEARING A/S
Oticon ON app 2.4.0
SBO HEARING A/S
Remote Control
SBO HEARING A/S
ConnectClip
SBO HEARING A/S
TV Adapter 3.0
OTICON A/S
EduMic
4
CLINICAL INVESTIGATION PLAN (CIP)
The revision history of the CIP is listed in
Table 3:
Table 3 Revision history of the CIP.
Revision #
Date
Document #
Amendment #
Description
1
02-12-2020
Doc-00071998 [1]
N/A
CIP first version (1.0)
1
25-01-2021
Doc-00072460 [2]
1.0  
Non-substantial amendment due to 
withdrawal of participation from Site 1. 
A new site, Site 3, has been added.
4.1
Clinical Investigation Objectives
4.1.1
Primary objective
Primary objective
Corresponding endpoint/outcome variable(s)
A. To investigate the improvement 
in hearing with the Ponto 4(s) on 
the implanted ear for patients 
within the intended use.
1.
Functional gain with Ponto 4, i.e. the difference between 
average unaided and aided sound field thresholds. The 
functional gain (PTA4) is calculated as the average of 
frequencies 500, 1000, 2000 and 4000 Hz.
4.1.2
Primary hypothesis
N/A
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4.1.3
Secondary Objectives
Secondary objective(s)
Corresponding endpoint/outcome variable(s)
B. To assess the improvement of 
hearing with the Ponto 4 on the 
implanted ear(s).
1.
Functional gain with Ponto 4, i.e. the difference 
between unaided and aided sound field thresholds,
for frequencies 250, 500, 1000, 2000, 3000, 4000, 
6000 and 8000 Hz.
C.
To assess the improvement of 
speech recognition with Ponto 4 
on the implanted ear(s).
1.
Difference in speech recognition score in percent 
between unaided and aided, assessed in quiet.
D. To assess the subjective 
experience of the Ponto 4.
1.
SSQ12 scores across all subjects.
E.
To assess the quality of life of the 
Ponto 4.
1.
GHSI scores across all subjects.
F.
To assess the usage time with 
Ponto 4.
1.
Self-reported usage hours per day during the month 
prior to the study visit across all subjects.
2.
Self-reported usage hours per day analyzed 
separately for subjects with conductive/mixed 
hearing loss and single sided deafness (SSD).
G. To assess the degree to which the 
Ponto 4 compensates for the BC 
hearing loss in the implanted 
ear(s).
1.
Effective gain defined as the difference in dB 
between aided sound field thresholds with Ponto 4, 
and BC In-situ thresholds on the aided ear(s) 
measured at the time of the fitting of Ponto 4(s). The 
effective gain is calculated for frequencies 250, 500, 
1000, 2000, 3000, 4000, 6000 and 8000 Hz.
2.
Effective gain with Ponto 4, see definition above, 
calculated in average for PTA4.
H. To evaluate the above objectives 
on individual levels.
1.
Endpoints A1, B1, C1 analyzed as the proportion of 
subjects whose performance is better or equal in the 
unaided to aided comparisons, i.e. have a difference 
≥0.
I.
To assess the degree of inner ear 
hearing loss degradation on the 
implanted ear(s) (for SSD, the 
stimulated ear).
1.
Hearing loss degradation is the difference in dB   
between masked (if not available unmasked) BC 
thresholds obtained at the study visit, and at the visit 
when Ponto 4(s) was fitted.
J.
To assess if patients with 
CHL/MHL hearing loss has 
degraded to being outside fitting 
range on the implanted ear(s).
1.
BC hearing loss (PTA4), measured at the study visit,
being outside intended fitting range (PTA4>45 dB HL) 
compared to being inside fitting range (PTA≤45 dB HL) 
at the time of the fitting visit2.
K.
To assess if patients with 
CHL/MHL’s air to bone gap (PTA4) 
has increased/decreased on the 
1.
The difference between masked (if not available 
unmasked) BC and AC thresholds, denoted ‘air to bone 
gap’, calculated for PTA4 from audiogram measured at 
                                                
2 In CIP [1] this has been formulated as study visit. The formulation has been corrected here.
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implanted ear(s).
the study visit and the fitting visit.
4.1.4
Secondary Hypothesis 
N/A
4.1.5
Tertiary Objectives
Tertiary objective(s)
Corresponding endpoint/outcome variable(s)
L.
To assess the usage and 
performance of connectivity 
device(s)
1.
Self-reported usage, usage hours and satisfaction 
ratings for connectivity device(s) previously given to the 
test subject.
4.2
Clinical Investigation Design
The study design was a prospective, multi-centre, single arm study consisting of one visit of approximately 3 
hours (split into 2 visits if needed for subjects below 18 years old according to the investigators discretion). 
At the study visit were the following measured: sound field threshold, speech recognition, pure tone 
audiometry and patient related outcome. BC In-situ and audiometric data for Ponto 4 were collected 
retrospectively from the fitting visit. The retrospectively collected was used for the calculation of effective 
gain, degradation of hearing loss and calculation of air to bone gap.  
4.2.1
Method description
The purpose of this study was to investigate hearing with the Ponto 4 in already implanted BAHS users in 
terms of improvement of hearing (thresholds) and speech intelligibility. Additionally, the aim was to 
investigate the subjective experience of the Ponto 4(s) via two questionnaires (SSQ12 and GHSI). 
The next paragraphs describe the methods for each test. Further details are given in the CIP [1].
4.2.1.1 Pure tone audiometry
Pure tone audiometry was measured according to standard clinical audiometry procedure at the study visit. 
This implied that masking should be applied if needed during AC and BC measurements. Unmasked AC and 
BC thresholds were always to be obtained for all frequencies. AC thresholds were obtained at 250 Hz, 500Hz, 
1kHz, 2 kHz, 3kHz, 4kHz, 6kHz and 8kHz; BC thresholds were measured at 250 Hz, 500Hz, 1kHz, 2kHz, 3kHz 
and 4kHz. 
4.2.1.2 Sound field audiometry
Detection of sound field thresholds presented in sound field from a loudspeaker placed at 1 meter’s distance, 
0 degrees azimuth from the subject. Warble tones at 250 Hz, 500Hz, 1kHz, 2kHz, 3kHz, 4kHz, 6kHz, 8kHz were 
presented according to clinical practice at the site. Thresholds were obtained both unaided and aided, and 
the test order was balanced between subjects. Bilaterally Ponto 4 fitted subjects were tested bilaterally. For 
subjects fitted unilaterally with Ponto 4, the contralateral ear was blocked with both an earplug and a 
headphone (but not masked).
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During these measurements, the Ponto 4 was programmed in omni-directional mode, with noise reduction 
and feedback management system turned off.
4.2.1.3 Speech recognition in quiet
Speech recognition was measured in free field using the Matrix sentences test. The test has been validated 
for Danish (Wagener, Josvassen, and Ardenkjær 2003) and optimized to allow for comparability across 
languages (Kollmeier et al. 2015). 
The Matrix test includes five-word sentences with a fixed syntactical structure and limited contextual cues. 
A formula selects a word from a category (name, verb, number, adjective and noun) and creates a five-word 
sentence. A word from each category is chosen at random to create the sentence. A list of 20 sentences is 
compiled from these words, ensuring that no sentence is repeated twice.  
Speech was presented from a loudspeaker 1 meter in front of the subject (0 degree azimuth). The speech 
signal was fixed at 65 dB SPL (C-weighted). The subject had to repeat as many words as possible after each 
sentence. For the aided condition, Ponto 4 was tested in the subject’s user settings. The test order of aided 
and unaided condition was balanced across subjects.
Prior to first condition, a training was conducted in the aided condition at a fixed speech level of 65 dB SPL 
(C-weighted). In total, four list were used, i.e. two list for training purposes and two test conditions.
Bilaterally Ponto 4 fitted subjects were tested bilaterally. For unilaterally Ponto 4 fitted subjects, the 
contralateral ear was blocked with both an earplug and a headphone (but not masked). 
4.2.1.4 Patient reported outcome
Two subjective outcome questionnaires were used; the SSQ12 (Noble et al. 2013), which measures the real-
world performance with Ponto 4, and the GHSI (Robinson, Gatehouse, and Browning 1996), which evaluates 
the quality of life. The subjects were to fill in the questionnaires at the clinic during the visit. 
The validated questionnaire SSQ12 uses 12 questions to cover ratings of speech intelligibility, spatial aspects 
as well as quality of hearing. Subjects are to rate the different questions from 0 (not at all” to 10 (Perfectly).
The GHSI is validated and contains 18 health status questions that goes specifically to how the health 
problem, in this study the hearing loss, has affected subjects’ quality of life at the time the GHSI was 
completed. Subjects were to respond to each question in a five-point scale ranging from high health status
(a score of 5) through to low health status (a score of 1). The questionnaire is either to be filled in by the 
subject or to be completed through interview by the investigator. For this study, the latter method was 
chosen as is leads to more complete and comparable datasets (Hendry et al. 2016). 
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4.2.1.5 Self-reported usage hours with Ponto 4
Usage hours was assessed subjectively via the investigator asking the subject to assess what the average 
hours used per day has been during the last month. 
4.2.1.6 Assessment of connectivity devices
Test subjects might have received connectivity devices when Ponto 4 was fitted, prior to the study. It has 
been be assessed whether and what device subjects are using as well as their benefit from these through a 
self-developed questionnaire (i.e. how satisfied are you with the connectivity device on 0-10 scale where 0 
is very dissatisfied, 2.5 dissatisfied, 5 in between, 7.5 satisfied and 10 very satisfied).
4.3
Subject population
According to the CIP, it was planned to include 20 test subjects. The test subjects were enrolled from Aalborg 
Universitetshospital (Site 2) and from Oticon Medical via a data base with potential candidates interested in 
participating in clinical investigations (Site 3).
4.3.1
Inclusion Criteria

Signed informed consent form

12 years and above

Subjects with hearing loss fitted unilaterally or bilaterally with the Ponto 4(s) on abutment at least 
1.5 months prior to being enrolled in the study

Fluent in local language, as judged by the investigator
4.3.2
Exclusion criteria

Participation in another clinical investigation which might cause interference with study 
participation.

Subjects who do not have the ability or are un-willing to follow investigational 
procedures/requirements, e.g., to complete patient related outcome (PRO’s) according to 
investigators discretion. 
Only subjects that complied to all inclusion criteria and none of the exclusion criteria were found eligible for 
the study.
4.3.3
Early termination

Inability to complete sound field audiometry.

If the investigator assesses that the subject is not fit for participation in the study visit at any stage.
Subjects were free to discontinue participation at any time while the medical care of the subjects would not 
be affected.
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4.3.4
Sample size
The sample size was based on achieving a 95% confidence interval of 11 dB for the functional gain. The sample 
size in the investigation was not hypothesis-driven, but rather based on 1) the typical size of studies on 
audiological outcomes within the bone-anchored hearing system field and 2) the precision of the primary 
endpoint. The precision can be expressed as the width of the two-sided 95% confidence interval (CI). Based 
on this, it was chosen to include a minimum of 20 subjects. See CIP [1] (section 11.2 and 11.2.1) for specifics 
on sample size calculation.
4.4
Visit schedule
The study consisted of one laboratory visit and for minors (teens between 12 and 18 years old) the single 
visit activities could be split into two according to investigators discretion.
Table 4 Overview of protocol activities performed at the study visit(s).
4.5
Concomitant medications/treatments
Concomitant medications were not collected as not relevant for this study.
                                                
3 Masked and unmasked
4 Unaided and aided
5 Can be performed at a Visit 2 for minors
6 Can be completed at a Visit 2 or at home between Visit 1 and Visit 2 for minors
Protocol activity
Collected 
retrospectively 
from the fitting 
visit 
Visit 1
(All 
adults  ≥ 
18 years)
Visit 2
(Optional 
for minors -
<18 years)
Week
≥ 6 weeks
0
+ 2 weeks
(+/- 1 week)
1.
Informed consent procedure
x
2.
Inclusion/exclusion criteria
x
3.
Eligibility
x
4.
Subject characteristics  
x
5.
BC In-situ thresholds
x
6.
Audiometry thresholds (AC and BC thresholds)3
x
x
7.
Speech recognition (Matrix Test) in quiet4 5
x
(x)
8.
Sound field audiometry 4 5
x
(x)
9.
Completion of Patient Reported Outcomes (SSQ and GHSI) 6
x
(x)
10. Self-reported usage hours with Ponto 4 
x
(x)
11. Assessment of Connectivity devices 6
x
(x)
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4.6
Duration of follow-up
N/A
4.7
Ethical considerations
Due to the nature of this study with the possibility of enrolling subjects between ages 12 and 18, it was 
decided to design the study with the option of splitting the study visit into two visits, if deemed necessary by 
the investigator.
This study included subjects who were already implanted and using a BAHS and therefore no interactions 
related to medical and audiological treatments were expected to occur. 
4.8
Data quality assurance
Data management [3] and monitoring [6] was performed by Oticon Medical representatives as a part of
data quality assurance.
4.9
Statistical Methods
Four populations were defined for the analysis of the study data:
1.
The Per Protocol Set (PPS) included subjects included and measured in the study without any 
significant protocol deviations. 
2.
The Intention To Treat (ITT) included all data from consenting and included subjects in the study.
3.
The main analysis and primary end-point analysis was performed on the Target population, i.e. the 
subset of the PPS population including subjects who were within the intended use for Ponto 4, thus 
excluding the following subject categories:

Subjects where the CHL/MHL hearing loss (PTA4) was outside the intended fitting range (PTA4 >
45 dB HL) at the study visit. 

Subjects with SSD who were using a hearing solution (e.g. hearing aid) on the non-BAHS side.
By defining the main analysis on the Target population, more precise data for patients who were 
fitted with Ponto 4 according to recommendations and who also were within intended fitting range 
(PTA4 ≤45 dB HL) was collected. The PPS, who was different from the Target population, described
the performance of real-life use of the Ponto 4 sound processor.
4.
Furthermore, for best performance the Ponto 4 was programmed to the recent hearing thresholds. 
As Ponto 4 was released in June 2019 there was a possibility that the hearing loss had degraded from 
the time when the patients were fitted until the study visit. Since this study design did not prescribe 
new device nor new fitting, this could influence the outcomes (a new fitting could give better 
performance with the same device). Therefore, a fourth analysis was performed for a subset of the 
Target population excluding subjects where the hearing loss (PTA4) had degraded by 10 dB or more 
between the BC thresholds measurement obtained at the time of the fitting of Ponto 4 compared to 
the BC thresholds measured at the study visit.
The primary objective of the study was to investigate the improvement in hearing with the Ponto 4 sound 
processor on the implanted ear(s) for patients within intended use (Target population). The following primary 
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endpoint was then defined:

Functional gain with Ponto 4, i.e. the difference between average unaided and aided sound 
field thresholds. The functional gain (PTA4) is calculated as the average of frequencies 500, 
1000, 2000 and 4000 Hz.
The primary endpoint has in Section 5 (Results) been described with Mean and 95% confidence interval (CI), 
as well as standard deviation (SD), Minimum, Maximum and Number of subjects. The main outcome is the 
mean and 95% CI. 
Descriptive statistics were performed for all endpoints. The distribution of continuous variables has been
given as Mean, standard deviation, Median, Minimum and Maximum whereas the distribution of categorical 
variables has been presented as number and percentage.
Statistical tests have been performed for endpoints A1, B1 and C1, for A1 and B1, the aided compared to 
unaided (functional gain), have been tested. In the case a normal distribution, a one-sample t-test will be 
used - if not, the Wilcoxon Signed-Rank test will be the choice. The tests have been performed at a 
significance level of 5% (p<0.05). Ordered categorical variables have been tested by the Sign test.
For an easy overview of significant p-values and their significance level, the following significance codes are 
used in the results:
Significance code
p-value
***
[0, 0.001]
**
(0.001, 0.01]
*
(0.01, 0.05]
(0.05, 1] (not significant, no code)
4.9.1
Sample size calculation
The sample size in the investigation was not hypothesis-driven, but rather based on:
1.
The typical size of studies on audiological outcomes within the bone-anchored hearing system field.
2.
The precision of the primary endpoint. The precision can be expressed as the width of the two-sided 
95% confidence interval (CI).
Studies from recent years were identified through literature search as part of the clinical evaluation, and in 
particular the state-of-the-art description for the Ponto system. Twenty-three studies were identified and 
included a median of 19 patients and an average of 21 patients. 
The primary endpoint was presented by a point estimate combined with a two-sided 95% CI, to reflect the 
improvement of hearing on the implanted ear (for intended patients). Assuming 18 patients for evaluation 
(in the Target population), a 95% confidence interval of approximately 11 dB can be expected.  
As described in the Statistical Analysis Plan [5], to achieve a sample size of 18 subjects for the primary 
objective where subjects who are outside intended use will be excluded from the main analysis population 
(Target population), the total sample size of the study was 20 patients. 
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5
RESULTS
The number of subjects within each of the four populations can be found below in Table 5.
Table 5 Overview of populations and number of included subjects.
Population
All subjects
(n=20)
Per Protocol Set (PPS)
n=20
Intention To Treat (ITT)
n=20
Target population
n=19
Target population excluding subjects where the hearing loss (PTA4) has degraded 
by 10 dB
n=13
The two populations Per Protocol Set (PPS) and Intention To Treat (ITT) were identical and will in the following 
only be referred to as ITT.
5.1
Initiation and completion dates
Clinical investigation initiation date:
2021-01-21 (FPFV)
Clinical investigation completion date:
2021-02-24 (LPLV)
5.2
Patient demographics
In total, 20 subjects were included and completed the study. Thirteen subjects (subject IDs 001-013) were 
tested at Aalborg University Hospital, and seven subjects (subject IDs 301-307) were tested at Oticon Medical.
All included subjects were adults above 18 years of age. Demographics for the total of included subjects 
(n=20) as well as for the MHL/CHL (n=15) and SSD (n=5) groups are shown in Table 6 with subject-specific 
characteristics in Table 7. Subjects were fitted with Ponto 4 between May 2019 and September 2020.
Table 6 Demographics and baseline characteristics by hearing loss for ITT (n=20).
Variable
Total
(n=20)
MHL/CHL
(n=15)
SSD
(n=5)
Gender
Male     
11 (55.0%)
7 (46.7%)
4 (80.0%)
Female   
9 (45.0%)
8 (53.3%)
1 (20.0%)
Age
Mean (SD)
Median (Min; Max)
(95% CI for Mean)
Number of subjects
56.1 (17.6)
61.5 (18; 81)
(47.8; 64.3)
n=20
55.3 (18.4)
62 (18; 74)
(45.1; 65.4)
n=15
58.4 (16.6)
56 (43; 81)
(37.8; 79.0)
n=5
Type of hearing loss implanted ear
MHL/CHL       
15 (75.0%)
15 (100.0%)
0 (0.0%)
SSD           
5 (25.0%)
0 (0.0%)
5 (100.0%)
Type of hearing loss non-implanted ear
MHL/CHL       
7 (35.0%)
7 (46.7%)
0 (0.0%)
SNHL          
7 (35.0%)
4 (26.7%)
3 (60.0%)
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Variable
Total
(n=20)
MHL/CHL
(n=15)
SSD
(n=5)
Normal hearing
6 (30.0%)
4 (26.7%)
2 (40.0%)
BAHS Surgery
Unilateral
18 (90.0%)
13 (86.7%)
5 (100.0%)
Bilateral 
2 (10.0%)
2 (13.3%)
0 (0.0%)
Unilateral side
Right
9 (50.0%)
8 (61.5%)
1 (20.0%)
Left 
9 (50.0%)
5 (38.5%)
4 (80.0%)
Unilateral fitted subjects with a hearing loss on the non BAHS ear
Hearing aid        
3 (16.7%)
3 (23.1%)
0 (0.0%)
No hearing solution
15 (83.3%)
10 (76.9%)
5 (100.0%)
Table 7 Subject-specific demographics and baseline characteristics for ITT (n=20) from study visit.
Subject 
ID
Gender Age
Type of 
hearing 
loss 
implanted 
ear
Type of 
hearing 
loss non 
implanted 
ear
BAHS 
side
Bilateral 
BAHS
Hearing 
aid on non 
BAHS ear
BC PTA4
Implanted ear
[dB HL]
AC PTA4
Implanted ear
[dB HL]
BC PTA4
Non implanted
ear
[dB HL]
AC PTA4
Non implanted 
ear
[dB HL]
001
Female
69
MHL/CHL
SNHL
R
27.5
70
27.5*
31.25*
002
Male
69
SSD
SNHL
L
62.5
82.5
22.5*
27.5*
003
Female
62
MHL/CHL
SNHL
R
41.25
78.33**
26.25*
32.5*
004
Male
61
MHL/CHL
SNHL
R
x
45
78.75
33.75*
31.25*
005***
Male
74
MHL/CHL
SNHL
R
60.00**
**
25*
31.25*
006
Female
43
SSD
NH
L
18.75*
83.75*
16.25*
15*
007
Male
27
MHL/CHL
MHL/CHL
L
26.25
78.75
21.25*
33.75*
008
Male
24
MHL/CHL
MHL/CHL
L
1.25*
63.75*
1.25*
67.5*
009
Male
56
SSD
SNHL
R
12.5*
71.25*
10*
15*
010
Male
81
SSD
SNHL
L
35*
88.75*
30’
35*
011
Male
71
MHL/CHL
NH
L
25
83.75
13.75*
13.75*
012
Male
18
MHL/CHL
MHL/CHL
R
x
1.25*
65*
2.5*
38.75*
013
Female
57
MHL/CHL
MHL/CHL
L
25
42.5
11.25*
30*
301
Female
43
MHL/CHL
NH
L
1.25*
73.75*
5*
12.5*
302
Female
72
MHL/CHL
MHL/CHL
L+R
x
9.38*
58.13*
N/A
N/A
303
Male
59
MHL/CHL
NH
R
10*
73.33**
8.75*
15*
304
Male
43
SSD
NH
L
13.75*
85.00**
7.5*
12.5*
305
Female
62
MHL/CHL
MHL/CHL
L+R
x
18.13*
68.13*
N/A
N/A
306
Female
66
MHL/CHL
MHL/CHL
R
x
16.25*
66.25*
18.75*
33.75*
307
Female
64
MHL/CHL
NH
R
15*
85.00**
10*
11.25*
Average all subjects
21.32*
71.67
16.18*
27.08*
* = Contains one or more unmasked frequencies.
** = Missing one or more frequencies to calculate PTA4.
*** = Subject 005 excluded in main analysis (Target Population) due to no measurable thresholds (BC and AC) on implanted ear.
5.3
CIP compliance
The study was conducted in compliance with the CIP and a total number of subjects that completed the study 
without major protocol deviations were 20 subjects (100%).
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5.3.1
Protocol deviations
Major protocol deviations
There was no major protocol deviation deemed to affect the quality of the data of the primary and secondary 
endpoints.
Minor protocol deviations
Subject IDs 001-005: Only masked AC and BC thresholds were obtained for the implanted ear. Hence 
unmasked AC and BC thresholds were not collected as described in the CIP. More information can be found 
in BC110 End-of-study Database Lock MOM [7].
5.3.2
Analysis Populations
Data analysis was performed on three populations (PPS and ITT being the same).
As described in the CIP, the main analysis for this study will be shown and discussed below based on the 
Target Population (n=19). Consequently, the results from the remaining two populations (ITT and Target 
Population with degraded hearing loss ≥10 dB) will not be presented here. Full statistical analysis on all 
populations can be found in the statistical report [8].
For the Target Population, subject ID 005 was excluded from target population analysis due to not having the 
BC thresholds for all 4 frequencies to calculate PTA, hence including 19 subjects in the following analysis. 
5.4
Primary objective results
The primary objective was to investigate the improvement of hearing with the Ponto 4(s) on the implanted 
ear(s) for patients within intended use via functional gain. The functional gain has been calculated as the 
difference between unaided and aided sound field thresholds for PTA4.
5.4.1
Functional gain for PTA4 (objective A1)
Table 8 shows the functional gain (PTA4) as well as the mean unaided and aided thresholds (PTA4). In the 
unaided condition, only 18 subjects had measurable thresholds for all 4 frequencies to be calculated for the 
PTA4 of functional gain. 
The mean functional gain (unaided-aided) in this study was 31.5 dB (SD ± 9.5) with significantly better 
thresholds in the aided condition (26.0 dB HL, SD ± 6.4) compared to the unaided condition (57.1 dB HL, SD 
± 12.5). The significance was found across for all subjects (p<.0001***) as well as on group level (MHL/CHL: 
p<.0001***, SSD: p=.0005***). 
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Table 8 Functional gain (PTA4) for all subjects and grouped by hearing loss.
Sound field thresholds (PTA4) [dB HL]
Functional gain [dB]
p-value
Unaided
Aided
Unaided-Aided
Total
57.1 (12.5)
56.3 (33.8; 77.5)
(50.9; 63.3)
n=18
26.0 (6.4)
25 (17.5; 42.5)
(22.9; 29.1)
n=19
31.5 (9.5)
32.5 (15; 48.8)
(26.8; 36.2)
n=18
<.0001***
MHL/CHL
54.6 (11.5)
55 (33.8; 75)
(47.7; 61.6)
n=13
25.5 (6.3)
24.4 (17.5; 42.5)
(21.9; 29.2)
n=14
29.6 (9.6)
32.5 (15; 48.8)
(23.8; 35.4)
n=13
<.0001***
SSD
63.5 (14.1)
68.8 (42.5; 77.5)
(46.0; 81.0)
n=5
27.3 (7.2)
27.5 (17.5; 37.5)
(18.3; 36.2)
n=5
36.3 (7.9)
40 (25; 43.8)
(26.5; 46.0)
n=5
0.0005***
Mean (SD)
Median (min; max)
(CI for mean)
Number of subjects
For comparison over time, the t-test was used for continuous variables.
5.5
Secondary objective results
5.5.1
Functional gain for all frequencies (objective B1)
while
Table 9 gives an overview of the specific mean values, SD and corresponding p-values. 
For the functional gain, a significant improvement of sound field thresholds was found between the unaided 
and aided condition across all frequencies (p<.0001***). See Figure 2 for unaided (subplot A) and aided 
(subplot B) thresholds.
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Figure 1 shows the functional gain for all frequencies (250, 500, 1000, 2000, 3000, 4000, 6000 and 8000Hz)
and the average of PTA4 while 
Table 9 gives an overview of the specific mean values, SD and corresponding p-values. 
For the functional gain, a significant improvement of sound field thresholds was found between the unaided 
and aided condition across all frequencies (p<.0001***). See Figure 2 for unaided (subplot A) and aided 
(subplot B) thresholds.
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Figure 1 Functional gain for all frequencies and PTA4 across all subjects as well as grouped by hearing loss. Bolt
indicates mean.
Table 9 Functional gain and the corresponding p-values for all frequencies. 
250Hz
500Hz
1000Hz
2000Hz
3000Hz
4000Hz
6000Hz
8000Hz
Total
Functional 
gain
14.2 (9.9)
15 (0; 30)
(9.4; 19.0)
n=19
28.7 (12.0)
30 (10; 50)
(22.9; 34.5)
n=19
36.6 (9.9)
35 (15; 55)
(31.8; 41.3)
n=19
28.6 (13.8)
30 (5; 55)
(21.7; 35.5)
n=18
32.9 (11.6)
30 (15; 55)
(27.3; 38.5)
n=19
32.8 (8.6)
35 (15; 45)
(28.5; 37.1)
n=18
22.7 (10.2)
25 (5; 35)
(17.0; 28.3)
n=15
22.1 (12.3)
25 (0; 40)
(14.2; 29.9)
n=12
p-value
<.0001***
<.0001***
<.0001***
<.0001***
<.0001***
<.0001***
<.0001***
<.0001***
Mixed/Conductive
Functional 
gain
13.9 (9.8)
15 (0; 30)
(8.2; 19.6)
n=14
28.2 (11.9)
30 (10; 45)
(21.4; 35.1)
n=14
35.0 (9.4)
35 (15; 50)
(29.6; 40.4)
n=14
26.2 (14.3)
25 (5; 55)
(17.5; 34.8)
n=13
30.4 (11.5)
30 (15; 55)
(23.7; 37.0)
n=14
30.4 (9.0)
30 (15; 45)
(24.9; 35.8)
n=13
20.0 (9.5)
20 (5; 35)
(13.9; 26.1)
n=12
19.4 (13.1)
20 (0; 40)
(9.4; 29.5)
n=9
p-value
0.0001***
<.0001***
<.0001***
<.0001***
<.0001***
<.0001***
<.0001***
0.0021**
SSD
Functional 
gain
15.0 (11.2)
15 (0; 30)
(1.1; 28.9)
n=5
30.0 (13.7)
30 (15; 50)
(13.0; 47.0)
n=5
41.0 (10.8)
45 (30; 55)
(27.5; 54.5)
n=5
35.0 (11.2)
35 (20; 50)
(21.1; 48.9)
n=5
40.0 (9.4)
40 (25; 50)
(28.4; 51.6)
n=5
39.0 (2.2)
40 (35; 40)
(36.2; 41.8)
n=5
33.3 (2.9)
35 (30; 35)
(26.2; 40.5)
n=3
30.0 (5.0)
30 (25; 35)
(17.6; 42.4)
n=3
p-value
0.040*
0.0080**
0.0011**
0.0022**
0.0007***
<.0001***
0.0025**
0.0091**
Functional gain [dB]
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250Hz
500Hz
1000Hz
2000Hz
3000Hz
4000Hz
6000Hz
8000Hz
Mean (SD)
Median (min;max)
(CI for mean)
Number of subjects
For comparison over time, the t-test was used for continuous variables.
Figure 2 Unaided (A) and Aided (B) sound field thresholds. Bolt indicates mean.
5.5.2
Speech recognition (objective C1)
Speech recognition was measured in quiet at a fixed input level (65 dB SPL (C)) using the Danish Matrix test, 
Dantale II. Aided and unaided conditions were measured, and the difference calculated. 
On average, subjects scored 96.8% (SD ± 6.8) correct aided compared to 40.9% (SD ± 33.6) correct in the 
unaided condition (
dB HL
A - Unaided
B - Aided
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Table 10). The improvement of speech recognition from unaided to aided (55.9% point) was significant 
(p<.0001***). The spread of the scores across subjects were also smaller and closer to 100% in the aided 
condition compared to unaided, as can be seen in 
Figure 3.
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Table 10 Speech recognition score by unaided, aided and the difference between the two for total subjects and 
grouped by type of hearing loss.
Speech recognition score in quiet [%]
Difference [%]
p-value
Unaided
Aided
Aided - Unaided
Total
40.9 (33.6)
36 (0; 98)
(24.7; 57.1)
n=19
96.8 (6.8)
99 (72; 100)
(93.5; 100.1)
n=19
55.9 (31.7)
64 (2; 99)
(40.6; 71.2)
n=19
<.0001***
MHL/CHL
45.9 (32.7)
47 (0; 98)
(27.1; 64.8)
n=14
98.1 (3.6)
99 (86; 100)
(96.0; 100.2)
n=14
52.1 (31.6)
51 (2; 99)
(33.9; 70.4)
n=14
<.0001***
SSD
26.8 (35.9)
12 (2.1; 88)
(-17.7; 71.4)
n=5
93.2 (11.9)
99 (72; 99)
(78.4; 108.0)
n=5
66.4 (32.9)
70 (11; 94.9)
(25.5; 107.2)
n=5
0.011*
Mean (SD)
Median (min;max)
(CI for mean)
Number of subjects
For comparison over time, the t-test was used for continuous variables.
Figure 3 Boxplot and mean of speech recognition scores in percent for unaided and aided conditions in quiet.
5.5.3
SSQ (objective D1)
The mean SSQ12 scores are shown in Table 11 and visualized in
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Figure 4 for each subscale (speech, spatial and qualities of hearing) for the total, and by type of hearing loss.
Table 11 SSQ12 questionnaire, subscales and total score, and by type of hearing loss.
Total
(n=19)
MHL/CHL
(n=14)
SSD
(n=5)
SSQ12 score total
6.28 (1.91)
6.17 (1.42; 9.09)
(5.36; 7.20)
n=19
6.31 (2.06)
6.5 (1.42; 9.09)
(5.13; 7.50)
n=14
6.19 (1.64)
6.17 (4.36; 8.25)
(4.16; 8.22)
n=5
SSQ12 score Speech
6.34 (2.30)
6.6 (1.4; 9.52)
(5.23; 7.44)
n=19
6.24 (2.49)
6.5 (1.4; 9.52)
(4.81; 7.68)
n=14
6.60 (1.90)
7.2 (4; 8.8)
(4.24; 8.96)
n=5
SSQ12 score Spatial
5.15 (2.51)
5.17 (1; 10)
(3.90; 6.40)
n=18
5.36 (2.64)
5.33 (1; 10)
(3.77; 6.95)
n=13
4.60 (2.33)
3.67 (2; 7.67)
(1.71; 7.49)
n=5
SSQ12 score Quality
7.01 (1.80)
7 (1.75; 9.5)
(6.14; 7.88)
n=19
7.05 (1.91)
7.38 (1.75; 9.5)
(5.95; 8.16)
n=14
6.90 (1.65)
6.75 (5; 9.5)
(4.86; 8.94)
n=5
Mean (SD)
Median (min; max)
(CI for mean)
Number of subjects
Figure 4 Boxplot and mean of SSQ12 scores in each subscale and total score, and by type of hearing loss.
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5.5.4
GHSI (objective E1)
The mean Quality of life (GHSI) scores are shown in Table 12 and visualized in 
Figure 5 for each subscale (General Subscale, Social Support and Physical Health) for the total, and by type of 
hearing loss.
Table 12 GHSI questionnaire, subscales and total score, and by type of hearing loss.
Total
(n=19)
MHL/CHL
(n=14)
SSD
(n=5)
GHSI Total Score-Sum
65.4 (11.7)
62.5 (45.8; 87.5)
(59.7; 71.0)
n=19
63.4 (11.8)
59.7 (45.8; 87.5)
(56.6; 70.2)
n=14
70.8 (10.5)
70.8 (59.7; 86.1)
(57.8; 83.9)
n=5
GHSI General Subscale Score-
Sum
69.5 (12.5)
66.7 (50; 91.7)
(63.5; 75.5)
n=19
67.1 (12.2)
64.6 (50; 91.7)
(60.1; 74.2)
n=14
76.3 (11.8)
72.9 (64.6; 91.7)
(61.5; 91.0)
n=5
GHSI Social Support Score-Sum
80.5 (21.2)
87.5 (33.3; 100)
(70.2; 90.7)
n=19
78.9 (22.0)
85.4 (33.3; 100)
(66.2; 91.5)
n=14
85.0 (20.7)
100 (58.3; 100)
(59.2; 110.8)
n=5
GHSI Physical Health Score-Sum
52.6 (11.5)
58.3 (33.3; 75)
(47.1; 58.2)
n=19
53.6 (9.6)
58.3 (33.3; 66.7)
(48.0; 59.1)
n=14
50.0 (16.7)
41.7 (33.3; 75)
(29.3; 70.7)
n=5
Mean (SD)
Median (min;max)
(CI for mean)
Number of subjects
Figure 5 Boxplot and mean of GHSI scores in each subscale and total score, and by type of hearing loss.
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5.5.4
Usage time across all subjects and grouped by hearing loss (objective F1 and F2)
Average daily use of the Ponto 4(s) during the last month prior to the study visit for all subjects as well as 
grouped by hearing loss are shown in Table 13. The mean daily usage time of all subjects was 12.6 hours (SD 
± 5.2). For the MHL/CHL group, the daily usage time was higher (14.1, SD ± 3.5) compared to the SSD group
(8.20, SD ± 7.05).
Figure 6 clearly shows that the SSD group has a bigger spread in usage hours as compared to the MHL/CHL 
group. 
Table 13 Average daily usage hours of the Ponto 4(s) during last month.
Total
(n=19)
MHL/CHL
(n=14)
SSD
(n=5)
Average daily usage hours of the Ponto 4(s) during the 
last month
12.6 (5.2)
15 (0; 17)
(10.0; 15.1)
n=19
14.1 (3.5)
15.8 (7; 17)
(12.1; 16.1)
n=14
8.20 (7.05)
9 (0; 15)
(-0.55; 16.95)
n=5
Mean (SD)
Median (min;max)
(CI for mean)
Number of subjects
Figure 6 Boxplot of usage time with Ponto 4(s).
5.5.5
Effective gain (objective G1 and G2)
The effective gain also called the remaining air-to-bone-gap is calculated as the difference between aided 
sound field thresholds obtained at the study visit and the BC in-situ thresholds from the time when the Ponto 
4 was fitted. The effective gain has been calculated across all frequencies (250, 500, 1000, 2000, 3000, 4000, 
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6000 and 8000 Hz (Table 14) as well as for the PTA4 (Table 15) for the MHL/CHL group (SSD group has no air 
to bone gap, hence not included in these results). Effective gain is visualized in 
Figure 7.
For MHL/CHL, mean aided sound field thresholds were measured to 25.5 dB HL (SD ± 6.3) while mean BC in-
situ thresholds were 18.5 dB HL (SD ± 9.7). This results in a remaining air-to-bone gap as 6.74 dB.
Table 14 Effective gain (difference between aided sound field and BC In-situ thresholds) for MHL/CHL.
250Hz
500Hz
1000Hz
2000Hz
3000Hz
4000Hz
6000Hz
8000Hz
Mixed/Conductive
Effective
gain
22.0 (7.3)
20 (10; 40)
(17.7; 26.2)
n=14
7.14 (7.84)
5 (-2.5; 20)
(2.62; 11.67)
n=14
3.21 (7.69)
0 (-5; 15)
(-1.22; 7.65)
n=14
2.86 (8.25)
2.5 (-10; 20)
(-1.91; 7.62)
n=14
10.2 (7.0)
10 (0; 25)
(6.2; 14.2)
n=14
13.8 (7.1)
12.5 (5; 25)
(9.6; 17.9)
n=14
17.0 (9.4)
20 (0; 35)
(11.5; 22.4)
n=14
12.3 (9.7)
11.3 (-5; 30)
(6.7; 17.9)
n=14
Mean (SD)
Median (min;max)
(CI for mean)
Number of subjects
For comparison over time, the t-test was used for continuous variables.
Table 15 Effective gain (PTA4) for MHL/CHL.
Figure 7 Effective gain for all frequencies for MHL/CHL. Bolt lines indicate mean.
PTA4 BC thresholds [dB HL]
Effective gain [dB]
p-value
Aided sound field
BC In-Situ
Aided - BC In-Situ
MHL/CHL
25.5 (6.3)
24.4 (17.5; 42.5)
(21.9; 29.2)
n=14
18.8 (9.6)
19.4 (2.5; 36.3)
(13.2; 24.4)
n=14
6.74 (6.33)
4.38 (0; 20)
(3.09; 10.39)
n=14
0.0008***
Mean (SD)
Median (min; max)
(CI for mean)
Number of subjects
For comparison over time, the t-test was used for continuous variables.
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5.5.6
Evaluation on individual levels (objective H1)
For 100% of subjects in this functional gain analysis, an improvement ≥ 0 from unaided to aided condition
was found for both PTA4 and for all individual frequencies (Table 9). 
The same improvement (100%) from unaided to aided was also found for speech recognition (Table 10). 
5.5.7
Hearing loss degradation (objective I1)
Hearing loss degradation for subjects with MHL/CHL is the difference in dB between masked (if not available, 
then unmasked) BC thresholds obtained at the study visit and at the visit when the Ponto 4(s) was fitted. For 
subjects with SSD, AC thresholds on the non-implanted ear were used for this calculation. 
On group level (Table 16), no significant difference was found for PTA4 between thresholds measured at the 
fitting visit compared to those obtained at the study visit for neither the MHL/CHL (p=0.95) group nor the 
SSD group (p=0.25).
When looking into the subject-specific data (Table 17), only one subject (#13) had a hearing loss degradation 
larger than or equal to 10 dB (12.5 dB).
Table 16 Hearing loss degradation for all BC frequencies as well as for PTA4 with corresponding p-value.
PTA4
Difference in threshold
Study visit – Fitting visit
Threshold (fitting)
(n=14)
Threshold (study)
(n=14)
p-value
MHL/CHL
18.1 (11.1)
18.8 (0; 37.5)
(10.6; 25.5)
n=11
18.8 (13.9)
17.2 (1.3; 45)
(10.7; 26.8)
n=14
0.114 (5.761)
0 (-8.75; 12.5)
(-3.757; 3.984)
n=11
0.95
SSD
19.3 (7.1)
15 (13.8; 28.8)
(10.4; 28.1)
n=5
21.0 (9.8)
15 (12.5; 35)
(8.9; 33.1)
n=5
1.75 (2.88)
1.25 (-1.25; 6.25)
(-1.82; 5.32)
n=5
0.25
Mean (SD)
Median (min;max)
(CI for mean)
Number of subjects
_________________________________________________________________________________
For comparison over time, the t-test was used for continuous variables.
Table 17 Subject-specific hearing loss degradation.
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Subject ID
Type of hearing loss 
study side
AC PTA4
Degradation
[dB]
BC PTA4
Degradation
[dB]
001
MHL/CHL
-1.25
002
SSD
2.5
003
MHL/CHL
3.75
004
MHL/CHL
*
006
SSD
1.25
007
MHL/CHL
3.75
008
MHL/CHL
1.25
009
SSD
0.00
010
SSD
6.25
011
MHL/CHL
1.25
012
MHL/CHL
0.00
013
MHL/CHL
12.50
301
MHL/CHL
*
302
MHL/CHL
-3.13
303
MHL/CHL
-8.75
304
SSD
-1.25
305
MHL/CHL
-0.63
306
MHL/CHL
*
307
MHL/CHL
-7.50
* = PTA4 cannot be calculated due to one or more missing frequencies
5.5.8
Assessment of intended fitting range (objective J1)
BC hearing loss (PTA4) has been calculated for the study visit to see whether the subjects with MHL/CHL were
within fitting range (within fitting range: PTA4 ≤45 dB HL).
Table 18 BC PTA4 of fitted ear from study visit for MHL/CHL and assessment of fitting range in dB HL. 
Subject 
ID
N=14
Side
250Hz 
(Imp. 
ear)
500Hz 
(Imp. 
ear)
1kHz 
(Imp. 
ear)
2kHz 
(Imp. 
ear)
3kHz 
(Imp. 
ear)
4kHz 
(Imp. 
ear)
250Hz 
Non 
BAHS
500Hz 
Non 
BAHS
1kHz 
Non 
BAHS
2kHz 
Non 
BAHS
3kHz 
Non 
BAHS
4kHz 
Non 
BAHS
BC PTA4 
fitted ear
Within fitting 
range
MHL/CHL
1
R
5
15
20
45
35
30
5*
15*
25*
40*
35*
30*
27.50
Yes
3
R
5
25
25
50
50
65
5*
25*
15*
30*
30*
35*
41.25
Yes
4
R
5
20
30
70
60
0*
15*
10*
65*
55*
45*
45.00
Yes
7
L
0, 0*
5, 5*
25, 25* 45, 40* 35, 30* 30, 15*
5*
5*
20*
40*
25*
20*
26.25
Yes
8
L
-10*
0*
0*
10*
5*
-5*
-10*
0*
0*
10*
5*
-5*
1.25
Yes
11
L
10, 5*
20, 15* 25, 10* 30, 20* 30, 25* 25, 25*
5*
10*
10*
15*
20*
20*
25.00
Yes
12
R
-5*
0*
5*
0, 0*
5, 5*
0, 0*
5*
0*
5*
5*
10*
0*
1.25
Yes
13
L
0, 0*
25, 0*
20, 0*
25, 20* 35, 30* 30, 20*
-5*
5*
0*
20*
35*
20*
25.00
Yes
301
L
10*
0*
5*
0*
15*
0*
0*
10*
5*
5*
0*
0*
1.25
Yes
302**
L
0*
5*
-5*
10*
25*
20*
7.50
Yes
R
0*
15*
5*
10*
20*
15*
11.25
303
R
0*
5*
5*
20*
25*
10*
0*
10*
5*
10*
15*
10*
10.00
Yes
305**
L
-5*
15*
15*
25*
10*
15*
17.50
Yes
R
5*
15*
20*
20*
10*
20*
18.75
306
R
15*
15*
15*
15*
20*
20*
10*
30*
15*
10*
15*
20*
16.25
Yes
307
R
0*
15*
10*
10*
20*
25*
0
5
10
5
10
20
15.00
Yes
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Subject 
ID
N=14
Side
250Hz 
(Imp. 
ear)
500Hz 
(Imp. 
ear)
1kHz 
(Imp. 
ear)
2kHz 
(Imp. 
ear)
3kHz 
(Imp. 
ear)
4kHz 
(Imp. 
ear)
250Hz 
Non 
BAHS
500Hz 
Non 
BAHS
1kHz 
Non 
BAHS
2kHz 
Non 
BAHS
3kHz 
Non 
BAHS
4kHz 
Non 
BAHS
BC PTA4 
fitted ear
Within fitting 
range
* = Unmasked
** = Bilateral subjects.
5.5.9
Assessment of air to bone gap (objective K1)
The difference between masked (if not available unmasked) BC and AC thresholds, denoted ‘air to bone gap’, 
has been calculated for PTA4 from audiogram measured at the study visit. Subjects with SSD are not included 
in this analysis. 
Calculation of air to bone gap for PTA4 at study visit for subjects with MHL/CHL showed a mean value of 50.2 
dB (Table 19). Individual PTA4 values and air to bone gap can be found in 
Table 20 below.
Table 19 Air to bone gap (PTA4) at fitting and study visit across MHL/CHL subjects.
Target population
(n=14)
Fitting visit
Study visit
AC PTA4
66.3 (14.8)
71.3 (43.1; 87.5)
(57.3; 75.2)
n=13
68.1 (11.4)
68.1 (42.5; 83.8)
(60.4; 75.7)
n=11
BC PTA4
18.1 (11.1)
18.8 (0; 37.5)
(10.6; 25.5)
n=11
18.8 (13.9)
17.2 (1.3; 45)
(10.7; 26.8)
n=14
Air to bone gap for PTA4
45.8 (13.6)
42.5 (28.8; 63.8)
(36.7; 54.9)
n=11
50.2 (15.2)
50 (17.5; 72.5)
(40.0; 60.4)
n=11
Mean (SD)
Median (min; max)
(CI for mean)
Number of subjects
Table 20 Individual air to bone gap (PTA4, both AC, BC, fitting visit, and study visit) for all MHL/CHL subjects based on 
audiogram data.
Implanted ear
Subject
PTA4AC fitting 
visit
PTA4BC fitting 
visit
PTA4AC study 
visit
PTA4BC study 
visit
Air to bone gap 
fitting visit
Air to bone gap 
study visit
MHL/CHL
001
71.25
28.75
70.00
27.50
42.50
42.50
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Implanted ear
Subject
PTA4AC fitting 
visit
PTA4BC fitting 
visit
PTA4AC study 
visit
PTA4BC study 
visit
Air to bone gap 
fitting visit
Air to bone gap 
study visit
003
76.25
37.50
78.33*
41.25
38.75
37.08*
004
77.50
38.33*
78.75
45.00
39.17*
33.75
007
77.50
22.50
78.75
26.25
55.00
52.50
008
58.75
0.00
63.75
1.25
58.75
62.50
011
87.50
23.75
83.75
25.00
63.75
58.75
012
62.50
1.25
65.00
1.25
61.25
63.75
013
43.75
12.50
42.50
25.00
31.25
17.50
301
81.25
30.00*
73.75
1.25
51.25*
72.50
302
43.13
12.50
58.13
9.38
30.63
48.75
303
76.25
18.75
73.33*
10.00
57.50
63.33*
305
54.38
18.75
68.13
18.13
35.63
50.00
306
55.00*
30.00*
66.25
16.25
25.00*
50.00
307
51.25
22.50
85.00*
15.00
28.75
70.00*
Mean
65.45
21.22
70.39
18.75
44.23
51.64
* Has missing values in calculation of PTA4
5.6
Tertiary objective results
5.6.1
Assessment of usage and performance of connectivity device(s) (objective L1)7
Subjects were asked to rate their connectivity device(s) (if they had any) from a scale of 0,0 (very dissatisfied) 
to 10,0 (very satisfied). Mean answers can be found in Table 21.
Table 21 Ratings of connectivity devices.
Total
(n=19)
MHL/CHL
(n=14)
SSD
(n=5)
On App
8.21 (2.10)
9 (4; 10)
(6.87; 9.55)
n=12
8.06 (2.38)
9 (4; 10)
(6.23; 9.88)
n=9
8.67 (1.15)
8 (8; 10)
(5.80; 11.54)
n=3
Connect Clip
6.90 (2.30)
6 (4; 9.5)
(4.04; 9.76)
n=5
7.13 (2.59)
7.5 (4; 9.5)
(3.00; 11.25)
n=4
6.00
n=1
Remote Control
8.00 (2.35)
9 (5; 10)
(5.09; 10.91)
n=5
7.50 (2.38)
7.5 (5; 10)
(3.71; 11.29)
n=4
10.00
n=1
Edu Mic
9.00
n=1
9.00
n=1
                                                
7 Usage hours were supposed to be obtained as well but unfortunately was not a part of (e)CRF.
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Total
(n=19)
MHL/CHL
(n=14)
SSD
(n=5)
Mean (SD)
Median (min;max)
(CI for mean)
Number of subjects
5.7
Adverse events and Device Deficiencies
No adverse events nor device deficiencies were encountered during the study.
5.7.1
Serious Adverse Events 
No serious adverse events were encountered during the study.
5.8
Missing data handling
Unmasked AC and BC thresholds for subjects 001-005 were not collected as according to the CIP. The missing 
data was deemed as a minor protocol deviation, hence did not influence the data quality. Missing variables 
IDs can be found in [7]. 
No subject was withdrawn or discontinued from the study and no subject was lost to follow-up. 
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6
DISCUSSION
This study design was a prospective, multi-centre, single arm study consisting of one visit of approximately 3 
hours. The hearing with the Ponto 4 was investigated in adult BAHS users (no children were enrolled in this 
study) in terms of sound fields thresholds and speech recognition. Additionally, self-reported performance 
in everyday life as well as health and quality of life was evaluated via the SSQ12 (Noble et al. 2013) and GHSI 
(Hendry et al. 2016). 
6.1
Functional gain
Concerning the primary endpoint, the results of functional gain showed a significant improvement of sound 
field thresholds in the aided condition compared to unaided - not only for the PTA4 (primary endpoint, A1), 
but for all measured frequencies (secondary endpoint, B1) for both the MHL/CHL group and the SSD group.
The mean functional gain for PTA4 was calculated to 31.5 dB, meaning that subjects’ mean sound field 
thresholds improved by 31.5 dB when wearing the Ponto 4 compared to not wearing a device regardless of 
having MHL/CHL or SSD. These results are in line with previous data on BAHS in general (Bosman et al. 2018; 
Rigato et al. 2016) with mean values of 40 dB and 32 dB, respectively and on Ponto 4 in particular [9] with 
mean value of 26.5 dB. In a literature review of functional gain (amongst other outcomes), a mean functional 
gain across 13 publications was 37.5 dB with a minimum and maximum of 20 dB and 48.3 dB, respectively 
[10. 
6.2
Aided thresholds and effective gain
When looking into mean values of the aided thresholds obtained in this study (mean of 26 dB HL), these are 
also in line with results from the above-mentioned literature review where a mean aided threshold of 28.9 
dB HL was found across 13 publications [10]. 
The effective gain (remaining air-to-bone gap) was found to be 6.74 (SD ± 6.33) for subjects with MHL/CHL. 
In a literature review of 8 studies [12], a mean effective gain of 5.1 with a SD of ± 8.7 was found which is in
alignment with results from this current study.
6.3
Speech recognition
Concerning the secondary endpoint on speech recognition (endpoint C1), the overall score was significantly 
better aided (96.8%) compared to unaided (40.9%) (p<.0001). These results show that the subjects’ speech 
recognition in quiet was close to 100% when wearing a Ponto 4 which is in line with previous studies
performed with other Ponto’s or bone-anchored devices in general (Bruschini et al. 2020; Della Volpe et al. 
2020; Fan et al. 2019; Wang et al. 2018). This means that subjects who are wearing a BAHS device can
recognize and repeat close to 100% of speech in quiet when presented at normal speech level.
6.4
Patient-related outcomes
For patient-related outcomes, the SSQ12 and GHSI questionnaires were used. 
SSQ12
Self-reported performance obtained in the SSQ12 questionnaire had a mean value of 6.28 for the total score. 
This result is slightly higher (better) than a previous study utilizing the same shorter version of the SSQ 
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(SSQ12) where the mean value for the total score was 4.46 [11]. In order to evaluate in relation to reference 
data, one can look into results from the full SSQ (49 questions compared to 12) where the mean total score 
was 5.5 (Gatehouse and Noble 2004). The current results differ slightly from both which may be attributed 
to 1) the difference in length of SSQ and 2) the difference in device used and consequently also the signal 
processing utilized.
When looking further into the subscales from the SSQ12, the mean Spatial score was lower compared to the 
remaining subscales, as seen in the literature (Bosman et al. 2018; Bruschini et al. 2020). For SSD subjects, 
the Spatial score was even lower compared to the MHL/CHL group, as expected (Elkins et al. 2020). For spatial 
hearing, both cochlea’s need to receive cues to localize sound. In asymmetrical and SSD cases, BAHS can/will 
possibly only stimulate one cochlea which is known to lead to poor sound localization due to limitations in 
restoring binaural cues (Elkins et al. 2020).
GHSI:
In the quality-of-life measure (GHSI), the subjects scored 65.4 on average (median 62.5) When looking into 
the reference data8 for GHSI, the median (50th percentile) of 62.5 places the quality-of-life ratings between 
the 40th and 50th percentile for hearing aid provision. Not many studies utilize the GHSI questionnaire, but 
the mean values of 63.4 for MHL/CHL and 70.8 for SSD are slightly better compared to one other study where 
mean values of 60.9 and 63.8 was found for MHL/CHL and SSD, respectively (Koro and Werner 2019).
6.5
Other aspects
Average usage hours
The average usage hours for the last month prior to the study visit was 12.6. The average usage hours for the 
MHL/CHL group were higher (14.1 h) as compared to the SSD group (8.20 h); in the SSD group 1 subject did 
not use device at all during the last month because he/she only uses the device when working in the office 
(he/she has been working from home due to COVID-19). Usage hours are seldom reported, but it is known 
that SSD patients are not as dependent on their device as subjects with MHL/CHL, hence utilizing their 
device(s) less (Kompis, Wimmer, and Caversaccio 2017; Han et al. 2020)
Usage and satisfaction with connectivity devices
Twelve out of 18 subjects used the ON app, while respectively 5, 5 and 1 subjects were using the ConnectClip, 
Remote control and EduMic. Generally, the satisfaction was high with the connectivity devices one a scale 
from 0 (very dissatisfied) to 10 (very satisfied) with mean values of 8.21, 6.90, 8.00 and 9.00 with the ON app, 
ConnectClip, Remote control and EduMic, respectively. Ponto 4 is the first sound processor from Oticon 
Medical that uses these connectivity devices and there is yet no other studies that have recorded the usage 
of these connectivity devices. 
7
OVERALL CONCLUSIONS
The study showed that the Ponto 4 subjects within intended use had improved hearing regarding functional 
gain, speech recognition and patient-related outcomes. 
                                                
8 https://studylib.net/doc/8450311/the-health-status-questionnaires-manual
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8
ETHICS
An ethical approval was sought, but the local EC considered this study to be a project of quality assurance 
rather than a health research project, thus they provided a waiver for the study (Ethics Committee Journal 
nr: H-20050735). 
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9
INVESTIGATORS AND ADMINISTRATIVE STRUCTURE OF CLINICAL INVESTIGATION
Table 22 List of Investigators, sponsor representatives and external organizations as applicable. 
Coordinating 
investigator –
Chris L. Jacobsen
Audiologisk Afsnit
Aalborg Universitetshospital
Havrevangen 1, 6. sal
9000 Aalborg
Principal investigator(s):
Site 2:
Chris L. Jacobsen
Audiologisk Afsnit
Aalborg Universitetshospital
Havrevangen 1, 6. sal
9000 Aalborg
Site 3:
Eva Kümmel Christensen
Oticon Medical
Kongebakken 9
2765 Smørum
Sponsor:
Oticon Medical AB
Datavägen 37 B
436 32 Askim
Sweden
Monitor:
Jessica Ågren, Liselotte Borup
Data manager:
Valentina Zapata-Rodriguez
Statistician:
Mattias Molin, Statistika Konsultgruppen
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10 SIGNATURES
Sponsor
On behalf of Oticon Medical AB, I approve the content of this report.
Date and signature: 
Name and title
Coordinating Investigator
I approve the content of this report.
Date and signature: 
Name and title
Principal Investigator
I approve the content of this report.
Date and signature: 
Name and title
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11 REFERENCES
Bosman, A. J., I. J. Kruyt, E. A. Mylanus, M. K. Hol, and A. F. Snik. 2018. 'Evaluation of an Abutment-level 
SuperPower Sound Processor for Bone-Anchored Hearing', Clin Otolaryngol.
Bruschini, L., R. Canelli, A. Morandi, C. Cambi, G. Fiacchini, S. Berrettini, and F. Forli. 2020. 'Bone Anchored 
Hearing Aids for the Treatment of Asymmetric Hearing Loss', J Int Adv Otol, 16: 313-17.
Della Volpe, A., V. Ippolito, D. Roccamatisi, S. Garofalo, A. De Lucia, V. Gambacorta, F. Longari, G. Ricci, and 
A. Di Stadio. 2020. 'Does Unilateral Hearing Loss Impair Working Memory? An Italian Clinical Study 
Comparing Patients With and Without Hearing Aids', Front Neurosci, 14: 905.
Elkins, E., A. Harvey, J. Hillyer, C. Hazlewood, S. Watson, and A. Parbery-Clark. 2020. 'Estimating Real-World 
Performance of Percutaneously Coupled Bone-Conduction Device Users With Severe-to-Profound 
Unilateral Hearing Loss', Am J Audiol, 29: 170-87.
Fan, X., T. Yang, X. Niu, Y. Wang, Y. Fan, and X. Chen. 2019. 'Long-term Outcomes of Bone Conduction 
Hearing Implants in Patients With Bilateral Microtia-atresia', Otol Neurotol, 40: 998-1005.
Gatehouse, S., and W. Noble. 2004. 'The Speech, Spatial and Qualities of Hearing Scale (SSQ)', Int J Audiol, 
43: 85-99.
Han, J. J., H. R. Park, J. J. Song, J. W. Koo, and B. Y. Choi. 2020. 'A comparison study of audiological outcome 
and compliance of bone conduction implantable hearing implants', Eur Arch Otorhinolaryngol.
Hendry, J, A Chin, Iain RC Swan, Michael A Akeroyd, and George G Browning. 2016. 'The G lasgow B enefit I 
nventory: a systematic review of the use and value of an otorhinolaryngological generic patient-
recorded outcome measure', Clinical otolaryngology, 41: 259-75.
Kollmeier, B., A. Warzybok, S. Hochmuth, M. A. Zokoll, V. Uslar, T. Brand, and K. C. Wagener. 2015. 'The 
multilingual matrix test: Principles, applications, and comparison across languages: A review', Int J 
Audiol, 54 Suppl 2: 3-16.
Kompis, M., W. Wimmer, and M. Caversaccio. 2017. 'Long term benefit of bone anchored hearing systems 
in single sided deafness', Acta Otolaryngol, 137: 398-402.
Koro, E., and M. Werner. 2019. 'Outcomes after Application of Active Bone Conducting Implants', Audiol 
Neurootol, 24: 197-205.
Noble, W., N. S. Jensen, G. Naylor, N. Bhullar, and M. A. Akeroyd. 2013. 'A short form of the Speech, Spatial 
and Qualities of Hearing scale suitable for clinical use: the SSQ12', Int J Audiol, 52: 409-12.
Rigato, C., S. Reinfeldt, B. Hakansson, K. J. Jansson, M. K. Hol, and M. Eeg-Olofsson. 2016. 'Audiometric 
Comparison Between the First Patients With the Transcutaneous Bone Conduction Implant and 
Matched Percutaneous Bone Anchored Hearing Device Users', Otol Neurotol, 37: 1381-7.
Robinson, K., S. Gatehouse, and G. G. Browning. 1996. 'Measuring patient benefit from 
otorhinolaryngological surgery and therapy', Ann Otol Rhinol Laryngol, 105: 415-22.
Wagener, Kirsten, Jane Lignel Josvassen, and Regitze Ardenkjær. 2003. 'Design, optimization and evaluation 
of a Danish sentence test in noise: Diseño, optimización y evaluación de la prueba Danesa de frases 
en ruido', Int J Audiol, 42: 10-17.
Wang, Y., X. Fan, P. Wang, Y. Fan, and X. Chen. 2018. 'Hearing improvement with softband and implanted 
bone-anchored hearing devices and modified implantation surgery in patients with bilateral 
microtia-atresia', Int J Pediatr Otorhinolaryngol, 104: 120-25.
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