BC112 Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors
Conditions: Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Unilateral
Sponsor: Oticon Medical

Title
BC112 Cross-sectional evaluation of the subjective 
performance and satisfaction with Ponto sound 
processors
Document no
Doc-00115596
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1
Study protocol 
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CONFIDENTIAL
Title
Cross-sectional evaluation of the subjective performance and 
satisfaction with Ponto sound processors
Study Code
BC112
Device (s)
Ponto Sound Processors
Sponsor
Oticon Medical AB
Datavägen 37 B
436 32 Askim
Sweden
Date/Version
15-MAR-2022
Revision history:
Revision no
Date
Description
0
09MAR2022
First version
1
15MAR2022
Updated with clarification of study flow and minor 
corrections throughout the document
STATEMENT OF COMPLIANCE
This study will be performed in consistency with applicable parts of the current versions of the Declaration 
of Helsinki, ISO 14155, Regulation (EU) 2017/745 (MDR) and applicable regional or national regulatory 
requirements as well as any additional requirements imposed by Institutional Review boards and Ethical 
committees. 
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NCT05356221

Title
BC112 Cross-sectional evaluation of the 
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Ponto sound processors
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Referenced documents:
[A]
Doc-00064573
Intended purpose Ponto bone anchored hearing system (BAHS)
[B]
Doc-00069507
PMCF plan for Ponto sound processors and accessories
[C]
Doc-00065550
Medical background Oticon Medical BAHS
Appendix:
1.
Part number for devices included in the study
2.
The International Outcome Inventory of Hearing Aids (IOI-HA)
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SYNOPSIS
Clinical Study Title
Cross-sectional evaluation of the subjective performance and 
satisfaction with Oticon Medical’s Ponto Sound Processors
Study Code
BC112
Device (s)
Ponto Sound Processors
Principal investigator(s):
NA Study carried out by sponsor through online survey
Sponsor:
Oticon Medical AB
Datavägen 37 B
436 32 Askim
Sweden
Methodology:
Observational Cross-sectional online survey
Inclusion/exclusion criteria:
Inclusion:

Online consent form filled out

Has been fitted with a Ponto Sound Processor
Objective(s):
Primary Objective

Evaluate subjectively assessed overall hearing performance 
and satisfaction with the Oticon Medical’s Ponto sound 
processors.
Secondary Objective (s)

Evaluate subjectively assessed hearing performance and 
satisfaction
with the Oticon Medical’s Ponto sound 
processors.

Evaluate non-usage among patients fitted with a Ponto sound 
processor
Endpoints
Primary Endpoint

Overall IOI-HA score
Secondary Endpoint(s)

Factor 1, Factor 2 IOI-HA and per item IOI-HA score (Ponto 
4 and Ponto 5 Mini)

Percentage of users fitted with a Ponto sound processor 
that have stopped using the Ponto sound processor and is 
unaided
Duration of study period:
10 months
Number of Participants
1000
Study plan prepared by:
Marianne Philipsson, Clinical Trial Manager, Oticon Medical AB
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TABLE OF CONTENTS
SYNOPSIS..................................................................................................................................3
TABLE OF CONTENTS...........................................................................................................4
LIST OF ABBREVIATIONS ...................................................................................................5
INTRODUCTION......................................................................................................................6
THE PONTO SYSTEM .............................................................................................................6
DESCRIPTION OF THE DEVICE .........................................................................................7
IDENTIFICATION OF THE DEVICE ...........................................................................................7
MANUFACTURER...................................................................................................................7
INTENDED PURPOSE ..............................................................................................................7
POPULATION AND INDICATIONS [A]......................................................................................7
JUSTIFICATION FOR THE DESIGN OF THE STUDY ....................................................8
POTENTIAL BENEFITS AND RISKS OF THE STUDY....................................................8
OBJECTIVES AND HYPOTHESES.......................................................................................9
PRIMARY OBJECTIVE.............................................................................................................9
SECONDARY OBJECTIVE(S)...................................................................................................9
DESIGN OF THE STUDY........................................................................................................9
SUBJECTS............................................................................................................................10
9.1.1
Inclusion criteria............................................................................................................10
9.1.2
Exclusion criteria...........................................................................................................10
9.1.3
Number of subjects.........................................................................................................10
STUDY FLOW.......................................................................................................................10
9.2.1
Survey.............................................................................................................................11
MONITORING........................................................................................................................11
STATISTICAL DESIGN AND ANALYSIS .........................................................................11
SAMPLE SIZE .......................................................................................................................11
SUBGROUPS FOR ANALYSIS .................................................................................................12
MISSING DATA HANDLING...................................................................................................12
TIMING FOR DATA ANALYSIS...............................................................................................12
DATA MANAGEMENT.........................................................................................................12
DATA MANAGEMENT PLAN ................................................................................................13
AMENDMENTS TO THE CIP ..............................................................................................13
DEVIATIONS FROM THE PROTOCOL............................................................................13
DEVICE ACCOUNTABILITY..............................................................................................13
STATEMENTS OF COMPLIANCE.....................................................................................13
INFORMED CONSENT.........................................................................................................13
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES
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13
VULNERABLE POPULATION (IF APPLICABLE)..........................................................14
SUSPENSION OR EARLY TERMINATION OF THE CLINICAL STUDY ..................14
PUBLICATION POLICY.......................................................................................................14
SIGNED AGREEMENTS.......................................................................................................14
SPONSOR.............................................................................................................................14
BIBLIOGRAPHY............................................................................................................................15
APPENDICES..........................................................................................................................16
APPENDIX 1. PART NUMBER FOR DEVICES INCLUDED IN THE STUDY ...............................................16
APPENDIX 2 THE INTERNATIONAL OUTCOME INVENTORY OF HEARING AIDS..................................17
LIST OF ABBREVIATIONS
AE
Adverse Event
BAHS
Bone Anchored Hearing System
BC
Bone conduction
CE
Conformité Européenne
CHL
Conductive Hearing Loss
CIP
Clinical Investigation Plan
dB
Decibel
EDC
Electronic Data Capture
FDA
Food and Drug Administration
GCP
Good Clinical Practice
GDPR
General Data Protection Regulation
HIPAA
Health Insurance Portability and Accountability Act
IRB
Institutional Review Board
IOI-HA
International Outcome Inventory for Hearing Aids
ISO
International Organization for Standardization
MDR
Medical Device Regulation
MHL
Mixed Hearing loss
OM
Oticon Medical
PMCF
Post Market Clinical Follow-up
PTA
Pure Tone Average
No
Number
SAE
Severe Adverse Event
SP
Sound Processor
SSD
Single Sided Deafness
US
United States
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INTRODUCTION
Bone conduction hearing systems use the body’s natural ability to transfer sound through bone conduction. 
The bone conduction system picks up sound and converts it into vibrations that are transferred through the 
skull bone to the inner ear(s) (cochlea). A bone conduction system transmits sound directly to the cochlea 
independently of the function of the ear canal and middle ear. Thus, for patients with conductive hearing
losses (CHL) or mixed hearing losses (MHL), patients with lasting hearing loss following a middle ear disease 
(such as for instance chronic otitis media, cholesteatoma, otosclerosis or other ossicular diseases) or 
malformations (such as aural atresia and/or microtia), one utilizes that the vibrations are bypassing the 
conductive impairment in the ear canal or middle ear, stimulating the cochlea directly. For single-sided deaf 
(SSD) Participants, one utilizes that the vibrations are transmitted in the same manner via the skull bone to 
the (functioning) cochlea on the contralateral side [1].
Bone Anchored Hearing Systems (BAHS) have been used since the late 1970’s and are divided into two types:
direct drive and skin drive, both having two sub-types (see Figure 1). Direct drive denotes systems where the 
vibrations are transmitted directly to the bone (e.g. through an abutment connected to an osseointegrated 
implant), while in skin drive solution there is a layer of soft tissue between the transducer and the bone (e.g. 
when utilizing a Softband). Percutaneous direct drive, also referred to as BAHS, is the most common type 
with more than 150.000 users world-wide [1].
The Ponto System
The Ponto system is an osseointegrated, percutaneous (direct drive) bone conduction system, which replaces 
the function of the outer and middle ear. This replacement happens by providing mechanical energy to the 
cochlea from a transducer in the sound processor and via a percutaneous implant anchored in the temporal 
bone. Sound is picked up by the microphones in the external sound processor and converted to mechanical 
energy (vibrations) by the transducer in the sound processor and is then transmitted to a skin-penetrating 
abutment which is connected to the implant in the temporal bone of the skull (see Figure 2). The vibrations 
are conveyed from the implant by means of bone conduction to the cochlea. In the cochlea, the vibrations 
are converted to signals that are transmitted to the brain through the auditory nerve. 
Bone conduction systems
Direct drive
Skin drive
Percutaneous
Active 
transcutaneous
Passive 
transcutaneous
Non-
implantable
Figure 1 Classification of bone conduction systems
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Figure 2 Ponto sound processor connected to an abutment
DESCRIPTION OF THE DEVICE
The devices investigated in the study will be the Ponto sound processors. Ponto sound processors are non-
sterile devices containing a coupling, an electromagnetic transducer (vibrator), microphones, sound 
processor electronics and signal processing chip. The sound processors are powered by a zinc air hearing 
aid batteries accessible through a battery drawer. The Ponto sound processor are fitted and adapted to the 
patient’s by a hearing care professional using a computer with a fitting software (Genie Medical) developed 
together with the sound processors.
Identification of the Device
The subjects included will have been fitted with a Ponto sound processor and they will evaluate the sound 
processor that they are currently fitted with. The study will focus on devices from the following Ponto 
families:

Ponto

Ponto Pro and Ponto Pro Power

Ponto Plus and Ponto Plus Power

Ponto 3, Ponto 3 Power and Ponto 3 SuperPower

Ponto 4

Ponto 5 Mini and Ponto 5 SuperPower
The Ponto sound processor comes in a range of different colors. Part number for each style and color that 
can be included in the study is listed in Appendix 1. 
Manufacturer
The Ponto sound processors are manufactured by Oticon Medical AB, Askim, Sweden. Oticon Medical AB is 
ISO 13485 certified and has CE-marked and FDA-cleared products for hearing healthcare on the market.
Intended Purpose
The Ponto sound processors are intended for improvement of hearing for patients with conductive or mixed 
hearing losses, whether unilaterally or bilaterally fitted, or for those with single sided deafness[A]. 
Population and indications [A]
The study will include subjects that has been fitted with a Ponto Sound Processor. The Ponto system is
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intended for the following patients and indications:

Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. 
The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the 
indicated ear should be better than or equal to 45 dB HL for use with the Ponto, Ponto Pro, Ponto Plus,
Ponto 3, Ponto 4 and Ponto 5 Mini sound processors, 55 dB HL for use with the Ponto Pro Power, 
Ponto Plus Power and Ponto 3 Power sound processors and 65 dB HL for use with the Ponto 3 
SuperPower and Ponto 5 SuperPower sound processors.

Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. 
The difference between the left and right sides’ BC thresholds should be less than 10 dB on average
measured at 0.5, 1, 2 and 4 kHz, or less than 15 dB at individual frequencies. 

Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the 
opposite ear (i.e. single sided deafness or “SSD”). The pure tone average (PTA) air conduction (AC) 
threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 
and 3 kHz).

Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals 
(AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
JUSTIFICATION FOR THE DESIGN OF THE STUDY
The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors.
The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with 
Oticon Medical’s sound processors fitted with the Genie Medical fitting software.
The overall study purpose aims to study long-term use of Oticon Medical’s sound processor Ponto (fitted 
with the Genie Medical fitting software) and how it impacts patient reported hearing improvements and
quality of life. 
The study is making use of subjective self-reported outcomes to evaluate hearing performance. Subjectively 
self-reported outcomes are commonly used to quantify how the patients subjectively perceive the device in 
their everyday life [C] and is considered to provide representative measurements of hearing improvement
[2] One such subjectively self-reported outcome measure is the IOI-HA [3]. The IOI-HA contains generally 
applicable items for self-assessment of hearing aid fitting outcomes. It covers a minimal set of seven core 
outcome items targeting a different outcome domain. The domains are: daily use, benefit, residual activity 
limitations, satisfaction, residual participation restrictions, impact on others and quality of life. Each item has 
five response choices proceeding from the worst outcome to the best outcome. In terms of construction and 
wording, the items of the IOI-HA have been designed to be easy to read and understand. In addition it is 
designed to be self-explanatory and without any need for formal instructions [3]. The IOI-HA was originally 
designed to be distributed in paper form, but Thorén, Andersson and Lunner [4] found that the questionnaire
can be distributed also in an online format without compromising reliability of the outcome. Based on the 
short self-explanatory design [3] together with data supporting the use of the questionnaire for online use
[4] the IOI-HA has been chosen to be the questionnaire used in this study. 
POTENTIAL BENEFITS AND RISKS OF THE STUDY
No additional treatments or procedures will be utilized for this study, although participants will be asked to 
complete a survey. Therefore, only risks associated to data capture and data privacy have been identified 
and these are mitigated by strict data management procedures (see Section12). 
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Although participants included in this study might not receive any benefit from the study, the study will 
promote a better understanding of satisfaction of the Ponto Sound Processors which will be shared within
the field of BAHS and may lead more efficient BAHS for others. Prior to enrollment into the study the 
participants will receive information about potential benefits and risks. Electronically signed consent based 
on this information will be required from all participants prior to collecting any study specific data.
OBJECTIVES AND HYPOTHESES
The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with 
Oticon Medical’s Ponto sound processors (fitted with the Genie Medical fitting software).
Primary objective
Primary objective
Corresponding primary endpoint/outcome 
variable(s)
Section
A. Evaluate the subjectively 
assessed overall performance
and satisfaction with Oticon 
Medical’s Ponto sound 
processors
1.
Overall IOI-HA score
9.2.1.2
Secondary Objective(s)
Secondary objective(s)
Corresponding primary endpoint/outcome 
variable(s)
Section
A. Evaluate the subjectively 
assessed performance and 
satisfaction with Oticon 
Medical’s Ponto sound 
processors
1.
Factor 1 IOI-HA score
2.
Factor 2 IOI-HA score
3.
Per item IOI-HA score
9.2.1.2
B. Evaluate non-usage among 
patients fitted with a Ponto 
sound processor
1.
Percentage of users fitted with a Ponto sound 
processor that have stopped using the Ponto 
sound processor and is unaided
C.
Evaluate Ponto sound 
processor upgrade rate
1.
Percentage of users who have been refitted 
with a Ponto sound processor
DESIGN OF THE STUDY
This is a non-interventional, observational, cross-sectional, study on subjects fitted with Ponto sound 
processors. Subjects fitted with one or two Ponto sound processors will be invited to participate in an online 
survey. The survey contains questions about the subjectively experienced performance and satisfaction of 
the device. The survey can be filled out on computer, tablet or mobile phone and should take the participants 
about 10 minutes to fill out. 
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Subjects
The population for this study will be users of Ponto Sound Processors in the US. User who are a part of Oticon 
Medical’s US user database where the users are signing up in relation to being fitted with a Ponto Sound 
Processor will be approached through email out-reach. When signing up for the database the users give their 
consent for being contacted by Oticon Medical. In addition, out-reach through social media and Oticon 
Medical US website will be considered to increase numbers of subjects. In all both cases, study awareness 
and enrollment of the participants for this study will occur after being fitted with one or two Ponto sound 
processor. 
9.1.1
Inclusion criteria
Following users will be included in the study:

Online consent form filled out

Has been fitted with at least one Ponto Sound Processor
9.1.2
Exclusion criteria
There are no exclusion criteria for this study.
9.1.3
Number of subjects
The aim is to recruit in total approx. 1000 subject. The subjects will be split into sub-groups based on which 
sound processor they are using. 
Study flow
Primarily out-reach will be made through an email. The email will contain overall information about the 
study and a link to the study landing page. In addition, posts might be made in social media or at Oticon 
Medical US website with information and a link to the same landing page. On the landing page the
participants can get more information about the survey and also provide their informed consent. Following 
consent, the users will get access to the survey that should be completed within one month. To maximize
data collection, e-mail and/or text message reminders to complete the survey will be 7 days after the initial 
email and 5 days prior to the survey completion deadline. In Figure 3 an overview of the study flow is 
visualized.
Figure 3 Scematic overview of the flow of the study
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9.2.1
Survey
The study will consist of an online survey distributed to the subjects The survey consists of two parts:
1.
Overall information about the subject and the device 
2.
A validated questionnaire focusing on subjective performance using a hearing device. For 
adult participants the questionnaire IOI-HA will be used.  
  
9.2.1.1
Part 1 Overall information 
Following overall information will be gathered from the participants:

Gender

Age

Usage of device 

Unilateral or bilateral user

Softband or Abutment fitting

Time of fitting (for how long they have used the device) 
9.2.1.2
Part 2 International Outcome Inventory Hearing Aids (IOI-HA)
The IOI-HA is a short questionnaire with generally applicable items used as self-assessment of hearing aid 
fitting outcomes. The questionnaire consists of seven items: daily use, benefit, residual activity limitation, 
satisfaction, residual participation restrictions, impact on other and quality of life. Each item has five response 
choices proceeding from worst to best. Analysis of the results can be done per item or total score. The items 
can be grouped in two subscales: Factor 1 (daily use, benefit, satisfaction and quality of life) and Factor 2: 
(residual activity limitation, residual participation restrictions and impact on others) [3].
MONITORING
Due to the nature of this study, with users reporting data directly into the electronic system, monitoring is 
not applicable. 
STATISTICAL DESIGN AND ANALYSIS
The results of the IOI-HA (ranging from 1-5, 1=worst and 5= best) will be analyzed and presented using 
descriptive statistics. The values of the Overall, Factor 1, Factor 2 and per item IOI-HA score will be given as 
Mean, standard deviation (SD), Median, Minimum and Maximum.
Sample size 
The user database currently consists of approx. 3000 users and we expect an initial response-rate of 50%, i.e.  
that approximately half of the users will respond to the survey invite. As the database continuously increases 
and outreach through social media and website also is planned additional outreach can be made to fulfill the 
sample size estimated below.  
The IOI-HA have been used for many studies on different number of subjects. The original paper the sample 
size was 172 [3] and the for the online validation [4] the sample size was 53. However, the IOI-HA has also 
been used for bigger populations, in [5] the IOI-HA was used on 1649 subjects.  For the two studies [3] and 
[4] the response rate were high and reported drop-out rates were 20% and 34%, respectively. Drop-out is in 
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this study defined as the participants not finalizing the survey after filling out the digital consent form. Drop-
out rate for this study is expected to be low based on previous reported literature and as the study only 
consist of one assessment (i.e. the subject filling out one survey at a single point of time). The drop-out rate 
is estimated to a 30%, aiming for answers from in total 1000 subjects, with minimum 50 subjects from each 
sub-group 1, 2 and 3.  
Subgroups for analysis
Subgroup primary endpoint analysis will be made based on the type of Ponto sound processor. The following 
subgroups will be analysed: 

Subgroup 1: Ponto, Ponto Pro and Ponto Plus (Ponto, Ponto Pro, Ponto Pro Power, Ponto Plus and 
Ponto Plus Power)

Subgroup 2: Ponto 3 SuperPower 

Subgroup 3: Ponto 3 (Ponto 3, Ponto 3 Power)

Subgroup 4: Ponto 4

Subgroup 5: Ponto 5 Mini

Subgroup 6: Ponto 5 SuperPower
Missing data handling
No imputations or estimations will be made to replace missing data.
Timing for data analysis
Data analyses will be performed in three steps. First data analysis will focus on subgroup 1-3. Second data 
analysis will focus on subgroup 4-5. Third analysis will focus on Subgroup 6. Out-reach to the users will be 
made according to timing of the analysis, also in three steps. Additional outreaches can be performed to 
increase the number of participants. 
Data cleaning and database lock of the applicable data will be performed before each of the three data 
analysis. 
DATA MANAGEMENT
All data collected and processed concerning the subjects participating in the study are protected under the 
Regulation (EU) 2016/679 (GDPR) and Health Insurance Portability and Accountability Act (HIPAA) and will 
be handled accordingly. Further, professional secrecy regarding subject information and data applies to all 
involved personnel.
The data from the online survey will be recorded into an electronic data capture (EDC) system. In the EDC 
system all subjects enrolled in the study will be assigned a Subject Identification Number with a link to their 
personal identification (email address). The personal identification information will used for sending out 
emails with the surveys. The subject can at any time ask to get their personal identification information 
removed. The access to the EDC system is restricted and will be limited to a couple of users with 
administrational rights. 
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Data Management Plan
Data management-related activities, e.g. data cleaning, will be performed by the data manager.
Once all data has been captured, reviewed and declared clean the database will be locked before any data 
analysis. 
AMENDMENTS TO THE CIP
Substantial amendments should be approved by the IRB as applicable, before incorporated. In addition, 
substantial amendments to the Study Information and Consent Form and/or other applicable documents 
previously approved by the IRB must be approved by the IRB before they will come into effect. For non-
substantial amendments, local regulations regarding notifications to IRB should be followed.
If study deemed exempt IRB approval amendments to this protocol and accompanying material will be 
made without notifying the IRB. Only if amendments to the protocol are made that might affect the 
exemption, IRB will be notified.
DEVIATIONS FROM THE PROTOCOL
A deviation is an intentional or unintentional failure to follow the requirements of the protocol. Every effort 
should be made to comply with the requirements of the protocol. If deviations occur a record should be 
made in a deviation log. The implications of the deviation must be reviewed and discussed as soon as possible 
after detection. All protocol deviations must be documented stating the reason, date, the action(s) taken, 
and the impact for the subjects and/or the study. At the end of the study, protocol deviations will be 
categorized as minor or major and their consequence on analysis populations will be determined.
DEVICE ACCOUNTABILITY
Not applicable. Participants will evaluate their own devices. 
STATEMENTS OF COMPLIANCE
Applicable parts of ISO 14155, Regulation (EU) 2017/745 (MDR) as specified in this CIP will be adhered to. 
The CIP, the Subject Information, the Online Informed Consent Form and other required documents will be 
submitted to an Institutional Reivew Board (IRB). Documentation will be reviewed and approved, or deemed 
exempt, in writing, by IRB before enrollment of subjects into the study can be initiated. Any additional 
requirements imposed by IRB shall be followed.
INFORMED CONSENT
Prior to providing the subjects with the survey they will be provided with written information in an 
electronical form. The information will contain detailed information about the study including the purpose, 
procedures and how the subject’s data will be handled in the study. The information will contain contact 
details to sponsor in case of any questions. Subject consent will be obtained electronically and documented. 
No study-specific data collection will occur prior to subject consent.
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES
As the study has patient reported outcomes with focus on subjective performance and satisfaction, there 
will be no adverse events, adverse device effects, or device deficiencies collected. 
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VULNERABLE POPULATION (IF APPLICABLE)
No vulnerable population to be included in the study. 
SUSPENSION OR EARLY TERMINATION OF THE CLINICAL STUDY
The sponsor may at any time terminate the study. If the study is terminated prematurely the concerned IRB 
will be informed promptly in writing by the sponsor.
PUBLICATION POLICY
A description of this study will be available, throughout the whole duration and onwards, on 
www.ClinicalTrials.gov. 
When the clinical Study is completed, even if prematurely terminated, a final report will be compiled, and 
the results will be made publicly available. The results obtained in the study might be submitted for 
publication in scientific journals by the sponsor. Privacy and confidentiality of information about each subject 
will be preserved in any reports and any publications of the clinical Study data. 
SIGNED AGREEMENTS
Sponsor 
On behalf of Oticon Medical AB I approve this clinical Study plan.
Date and signature: 
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Doc-00115596,Revision 1, Released

Title
BC112 Cross-sectional evaluation of the 
subjective performance and satisfaction with 
Ponto sound processors
Document no
Doc-00115596
Revision
1
Page
15(17)
This document is the confidential property of Demant Group.
Template Doc-32211-5
BIBLIOGRAPHY
1.
Reinfeldt, S., et al., New developments in bone-conduction hearing implants: a review. Med 
Devices (Auckl), 2015. 8: p. 79-93.
2.
Cox, R.M., Assessment of subjective outcome of hearing aid fitting: getting the client's point 
of view. International Journal of Audiology, 2003. 42: p. 90-96.
3.
Cox, R.M. and G.C. Alexander, The International Outcome Inventory for Hearing Aids 
(IOI-HA): psychometric properties of the Enlish version. Int J Audiol, 2002. 41(1): p. 30-5.
4.
Thoren, E.S., G. Andersson, and T. Lunner, The use of research questionnaires with hearing 
impaired adults: online vs. paper-and-pencil administration. BMC Ear Nose Throat Disord, 
2012. 12: p. 12.
5.
Houmoller, S.S., et al., Prediction of successful hearing aid treatment in first-time and 
experienced hearing aid users: Using the International Outcome Inventory for Hearing 
Aids. Int J Audiol, 2021: p. 1-11.
Doc-00115596,Revision 1, Released

Title
BC112 Cross-sectional evaluation of the 
subjective performance and satisfaction with 
Ponto sound processors
Document no
Doc-00115596
Revision
1
Page
16(17)
This document is the confidential property of Demant Group.
Template Doc-32211-5
APPENDICES
Appendix 1. Part number for devices included in the study
Style/side
Colour    
Ponto
Ponto Pro
Ponto Pro Power
Left
Right
Left
Right
Left
Right
White Silver
130-00-113-00
130-00-123-00
130-00-213-00
130-00-223-00
M50903
M50902
Chroma Beige
130-00-110-00
130-00-120-00
130-00-210-00
130-00-220-00
M50875
M50874
Mocca Brown
130-00-111-00
130-00-121-00
130-00-211-00
130-00-221-00
M50873
M50872
Diamond Black
130-00-112-00
130-00-122-00
130-00-212-00
130-00-222-00
M50677
M50676
Style/side
Colour    
Ponto Plus
Ponto Plus Power
Left
Right
Left
Right
White Silver
M51706
M51707
M51736
M51737
Chroma Beige
M51704
M51705
M51734
M51735
Mocca Brown
M51702
M51703
M51732
M51733
Diamond Black
M51700
M51701
M51730
M51730
Style/side
Colour    
Ponto 3
Ponto 3 Power
Ponto 3 SuperPower
Left
Right
Left
Right
Left
Right
Pure White
M52630
M52631
M52644
M52645
M52658
M52659
White Silver
M52626
M52627
M52640
M52641
M52654
M52655
Chroma Beige
M52624
M52625
M52638
M52639
M52652
M52653
Mocca Brown
M52622
M52623
M52636
M52637
M52650
M52651
Steel Grey
M52628
M52629
M52642
M52643
M52656
M52657
Diamond Black
M52620
M52621
M52634
M52635
M52648
M52648
Style
Colour
Ponto 4
Ponto 5
Ponto 5 SuperPower
CBE Chroma Beige CO90
186777
223156
223162
TC Terracotta CO94
186778
223157
223163
SIL Silver CO44
186779
223155
223161
STG Steel Grey CO92
186780
223159
223165
CNB Chestnut Brown CO93
186781
223158
223164
DBL Diamond Black CO63
867821
223160
223166
Doc-00115596,Revision 1, Released

Title
BC112 Cross-sectional evaluation of the 
subjective performance and satisfaction with 
Ponto sound processors
Document no
Doc-00115596
Revision
1
Page
17(17)
This document is the confidential property of Demant Group.
Template Doc-32211-5
Appendix 2 The International Outcome Inventory of hearing aids
Doc-00115596,Revision 1, Released