Pediatric Performance and Satisfaction of Oticon Medical Ponto on Softband.
Conditions: Hearing Loss
Sponsor: Oticon Medical

Title
Pediatric Performance and Satisfaction of Oticon 
Medical Ponto on Softband, BC117
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CONFIDENTIAL
Clinical Investigation Title
Pediatric Performance and Satisfaction of Oticon Medical Ponto 
on Softband
Investigation Code
BC117
Investigational Device (s)
Ponto on Softband
Sponsor
Oticon Medical AB
Datavägen 37 B
436 32 Askim
Sweden
Date
11 May 2023
Revision history:
Revision no
Date
Description
0.0
11 May 2023
First version - NITC
1.0
26 June 2023
After EC review, EC has requested that the inclusion 
criteria of 18 years of age be changed to “age of majority
(AOM)” as the AOM is not 18 in all states. 
STATEMENT OF COMPLIANCE
This clinical investigation is a survey study and therefore, as applicable, will be 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 as 
well as any additional requirements imposed by the Ethical Committee’s.
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SYNOPSIS
Clinical Investigation Title
Pediatric Performance and Satisfaction of Oticon Medical Ponto 
on Softband
Investigation Code
BC117
Investigational Device (s)
Oticon Medical Ponto sound processor on Ponto Softband
solution
Principal investigator(s):
N/A – online survey, Oticon Medical, LLC
Sponsor:
Oticon Medical AB
Datavägen 37 B
436 32 Askim
Sweden
Objective(s):
Primary Objective

Evaluate subjectively hearing performance of Oticon Medical 
Ponto sound processors on Ponto Softband 

Evaluate subjectively overall satisfaction of Oticon Medical 
Ponto sound processors on Ponto Softband 
Methodology:
Observational survey study
Inclusion/exclusion criteria:
1.
Consent provided
2.
Parent or primary caregiver of child (< 18 years) currently 
using a Ponto Softband for Ponto Sound Processor
Endpoints
Primary Endpoints

Overall PEACH scores

Overall GCBI scores

Outcomes of satisfaction questionnaire
Duration of study period:
24 months or when targeted number of participants (40) have 
been enrolled. 
Number of participants 
targeted:
40
Investigation plan prepared 
by:
Nicole Amichetti, PhD, Clinical Project Manager, Oticon 
Medical, LLC
Aren Bezdjian, PhD, Clinical Research Manager, Oticon Medical, 
LLC
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TABLE OF CONTENTS
SYNOPSIS..................................................................................................................................2
TABLE OF CONTENTS...........................................................................................................3
LIST OF ABBREVIATIONS ...................................................................................................4
INTRODUCTION......................................................................................................................5
BACKGROUND.......................................................................................................................5
IDENTIFICATION AND DESCRIPTION OF THE DEVICE ............................................5
DEVICE DESCRIPTION............................................................................................................5
MANUFACTURER...................................................................................................................6
POPULATION AND INDICATIONS ............................................................................................6
JUSTIFICATION FOR THE INVESTIGATION..................................................................6
POTENTIAL RISKS AND BENEFITS OF THE INVESTIGATION.................................6
STUDY OBJECTIVES..............................................................................................................7
PRIMARY OBJECTIVE.............................................................................................................7
SECONDARY OBJECTIVE(S)...................................................................................................7
DESIGN OF THE INVESTIGATION.....................................................................................7
SUBJECT POPULATION ...........................................................................................................7
9.1.1
Inclusion criteria..............................................................................................................7
9.1.2
Exclusion criteria.............................................................................................................8
9.1.3
Number of Subjects ..........................................................................................................8
INVESTIGATION PROCEDURES...............................................................................................8
9.2.1
Survey...............................................................................................................................8
MONITORING..........................................................................................................................9
STATISTICAL DESIGN AND ANALYSIS ...........................................................................9
DATA MANAGEMENT...........................................................................................................9
AMENDMENTS TO THE CIP ................................................................................................9
DEVIATIONS FROM CLINICAL INVESTIGATION PLAN...........................................10
DEVICE ACCOUNTABILITY..............................................................................................10
STATEMENTS OF COMPLIANCE.....................................................................................10
INFORMED CONSENT PROCESS......................................................................................10
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS, & DEVICE DEFICIENCIES...10
SUSPENSION OR EARLY TERMINATION OF THE INVESTIGATION ....................10
PUBLICATION POLICY.......................................................................................................11
SIGNED AGREEMENTS.......................................................................................................11
REFERENCES.........................................................................................................................11
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APPENDICES..........................................................................................................................12
LIST OF ABBREVIATIONS
AOM
Age of Majority
BAHS
Bone Anchored Hearing System
CIP
Clinical Investigation Plan
EC
Ethics Committee
EDC
Electronic Data Capture
GCBI
Glasgow Children’s Benefit Inventory
GDPR
General Data Protection Regulation
ICF
Informed Consent Form
IRB
Institutional Review Board
ISO
International Organization for Standardization
OM
Oticon Medical
PEACH
Parent’s Evaluation of Aural/Oral Performance of Children
SIN
Subject Identification Number
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INTRODUCTION
Background
There are two pathways by which physical sound waves can be transformed into mechanical vibrations that 
stimulate the cochlea in the inner ear:  air conduction and bone conduction. In air conduction, an acoustic 
signal travels through the outer and middle ear and arrives at the cochlea. In bone conduction, an acoustic 
signal bypasses the outer/middle ear and vibrates the bones of the skull to stimulate the cochlea. Both air 
and bone conduction support the same conversion mechanism in the cochlea where mechanical vibrations 
are converted into neural impulses to produce the perception of hearing.
Thus, for patients who are unable to reliably transmit acoustic signals through air conduction, e.g., those with 
conductive hearing losses (CHL) or mixed hearing losses (MHL), hearing loss following a middle ear disease 
(e.g., chronic otitis media, cholesteatoma, otosclerosis or other ossicular diseases), or malformations such as 
aural atresia and/or microtia, bone conduction hearing systems can be sued to bypass conductive 
impairment in the ear canal or middle ear, and stimulating the cochlea directly via skull bone vibrations. For 
single-sided deafness (SSD), one utilizes the vibrations that are transmitted in the same manner via the skull 
bone to the (functioning) cochlea on the contralateral side.
Bone Anchored Hearing Systems (BAHS) have been used since the late 1970s and can be divided into two 
types: 1) direct drive and 2) skin drive. Direct drive denotes systems where the vibrations are transmitted 
directly to the bone (e.g., through an abutment connected to an osseo-integrated implant), while in a skin 
drive solution there is a layer of soft tissue between the transducer and the bone (e.g., when utilizing a 
softband). 
A softband solution, in this investigation, the Ponto Softband solution is suitable for children with 
conductive/mixed hearing loss and single-sided deafness. It can also be used by adults who don’t benefit 
from conventional hearing aids, or those who have temporary ear problems such as blockages or infections. 
Worn around the head, with an attachment for Ponto Sound Processor, the softband comes in assorted
colors, is adjustable for a snug and tailored fit. 
IDENTIFICATION AND DESCRIPTION OF THE DEVICE
Device description
The Ponto Softband device is part of a skin-drive bone conduction, wherein a Ponto sound processor is 
attached to the band which allows for circumlocution of the function of the outer and middle ear. Acoustic 
sound pressure waves are picked up by the microphones in the externally mounted sound processor and this 
signal is converted to mechanical energy (vibrations) by the transducer in the sound processor. This signal is 
then transmitted through the skin to the temporal bone of the skull The mechanical energy vibrates the 
temporal bones of the skull which are picked up by the hair cells within the cochlea in the inner ear where 
the mechanical energy is converted to electrical neural impulses and transmitted to the primary auditory 
cortex in brain via the auditory nerve. 
The survey will focus on Softband 5 but will also allow for feedback from parents whose children previously 
or currently use any of the Softband generation models:

Softband/Softband bilateral (initial CE 2010)
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
Ponto Softband (initial CE 2016)

Ponto Softband bilateral (initial CE 2017)

Softband 5 (initial CE 2022)
Parents whose children have been fitted with a Ponto sound processor on a Ponto Softband will be surveyed. 
The study will focus on devices from the following Ponto families:

Ponto 3, Ponto 3 Power, Ponto 3 SuperPower

Ponto 4

Ponto 5 Mini, Ponto 5 SuperPower
Manufacturer
The Ponto sound processors as well as Oticon Medical Softbands 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.
Population and indications
The study population of interest is children below the age of 18 who are currently wearing a softband coupled 
to a Ponto sound processor. Parents or primary caregivers will be the surveyed population. 
The softband solution is intended for children with conductive/mixed hearing loss and single-sided deafness
who cannot be fitted or are waiting to be fitted with a surgically placed bone anchored hearing implant. It 
can often be recommended for individuals who do not benefit from conventional hearing aids who have ear 
problems such as blockages or infections, who present with a high likelihood of implant extrusions or skin 
care related burdens or who have thin or irregular skull bone (i.e. syndromic children).
JUSTIFICATION FOR THE INVESTIGATION
The study is a non-interventional, observational, study on users of Ponto sound processors who use their 
sound processors on a softband solution. The purpose of this study is to assess subjective benefit by 
evaluating performance and overall satisfaction of the Ponto on a Ponto Softband in pediatric users. 
This study will utilize responses from survey questions of parents or primary caregivers of children fitted with 
a softband solution. The survey will collect responses relating to reported hearing improvements and quality 
of life. 
The study will use the PEACH questionnaire1 to evaluate performance. The PEACH is a measure used by 
hearing health professionals to evaluate the effectiveness of a child’s use of hearing in real-world 
environments. PEACH is validated with norms scale (English). This study will also use the GCBI questionnaire2, 
modified to specifically query a child’s quality of life after receiving their Ponto sound processor on softband.  
Additionally, a specialized questionnaire is constructed to gather feedback on wear and general comfort of 
Oticon Medical Softband. 
RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND CLINICAL INVESTIGATION
Participants will be asked to complete a survey. No additional treatments or procedures will be utilized for 
this study. Therefore, only risks associated to data capture and data privacy have been identified and these 
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are mitigated by strict data management procedures (see Section 12).
Although participants included in this study might not receive any benefit from the study itself, the research 
project will promote a better understanding of satisfaction of the Ponto Softband solution which will be 
shared within the field of BAHS and may lead to improvements in future iterations of the oftband design. 
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 the study is to evaluate subjectively reported hearing performance and overall satisfaction 
of Oticon Medical Ponto sound processors on softband.
Primary objective
Primary objective
Corresponding primary endpoint/outcome 
variable(s)
Section
A.
To investigate hearing 
performance of children wearing 
Oticon Medical Ponto sound 
processors on Softband 
B.
To investigate overall satisfaction 
of Oticon Medical Ponto sound 
processors on Softband
PEACH questionnaire evaluating Aural/Oral 
performance of children in quiet, noise and 
overall.
GCBI questionnaire evaluating health related 
benefit after hearing intervention for children.
By answering specialized questionnaire to 
gather feedback on wear and general comfort
of the Oticon Medical Softband.
9.2.1
DESIGN OF THE CLINICAL INVESTIGATION
Subject population
The population for this study will be children who use a Ponto Sound Processors on a Ponto Softband in the 
United States. Parents or caregivers of users (hereforth referred for as “participants” who are part of Oticon 
Medical’s US user database, who signed up for inclusion in the database when fitted with a Ponto Sound 
Processor will be approached through email out-reach. When signing up for the database participants give 
their consent to be contacted by Oticon Medical. In all cases, study awareness and enrollment in this study 
will occur only after being fitted with Ponto sound processor(s) on a softband solution. 
9.1.1
Inclusion criteria
The following participants will be included in the study:
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
Individuals who are a parent or guardian of a softband user who are at or above the age of majority 
(AOM). AOM is 21 in Mississippi, 19 in Nebraska and Alabama, and 18 in all other US states. 

Participants provided study-specific consent before completing the survey. 

Users fitted with at least one Ponto Sound Processor on a softband at the time of the survey.
9.1.2
Exclusion criteria
The following participants will be excluded from the study:

Participants who did not provide consent or later revoked consent.

Under the the AOM 
9.1.3
Number of Subjects
The aim is to enroll 40 participants within 24 months. 
Investigation Procedures
Out-reach will be made through email to registered participants, parents or primary caregivers of children, 
fitted with a Ponto device on a softband in the US Salesforce database. The participants in the US Salesforce 
database had previously consented to being contacted by Oticon Medical in the future. The email will be sent 
through the Salesforce database and contain general information about the study as well as a link to the 
study landing page, created and hosted in SMART-TRIAL. On the landing page more information about the 
survey is provided and participants are asked to proceed with sign-up by providing their email address. At 
this point the participant is assigned a unique identification number. Following providing consent, the 
participant will be provided with access to the survey in SMART-TRIAL. Periodic reminders, one after one
week, another after four weeks, and after five weeks will be sent from SMART-TRIAL if consent has been 
provided by survey not completed. 
Out-reach efforts will also be made through Oticon Medical’s social media accounts (such as linked-in, 
facebook, etc). Additionally, clinics and providers in the US who have active pediatric populations fitted with 
Ponto sound processors on softband who have expressed interest in assisting recruitment efforts may also 
be included in reach out efforts. Interested clinics will be provided with a one-page informational flyer to 
provide to parents of children who meet the inclusion criteria. The flyer will have the same information as 
the social media postings as well as emails sent to the users in the Salesforce database. 
9.2.1
Surveys
PEACH
The Parent’s Evaluation of Aural/Oral Performance of Children (PEACH) was developed to evaluate the 
effectiveness of amplification for infants and children with hearing impairment by a systematic use of 
parents’ observations. The PEACH questionnaire is composed of 13 questions that examines a child’s auditory 
performance in quiet and noisy listening conditions and has been shown to have good internal consistency 
and high test-retest reliability. The PEACH can be used with infants as young as one month old and with 
school-aged children who have hearing loss ranging from mild to profound degree.
GCBI
The Glasgow Children’s Benefit Inventory (GCBI) was designed to retrospectively assess quality of life benefits 
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after a healthcare intervention. The GCBI is a parent-completed questionnaire comprised of 24 questions 
that query various aspects of a child’s daily life and is worded to apply to children of any age. The GCBI is 
commonly modified to be used in any area of paediatric medicine. For this study, “operation” will be adapted 
to “Ponto sound processor on Softband”, (Appendix B). 
Softband specific questionnaire
The softband-specific questionnaire was developed by Oticon Medical and consists of questions designed to 
be completed by parents or other caregivers of children who are currently fitted with a Ponto sound 
processor on a softband.  
MONITORING
Not applicable. 
STATISTICAL DESIGN AND ANALYSIS
The results of the questionnaires will be analyzed and presented using descriptive statistics including the
mean, standard deviation, median, and range. 
The sample size in the investigation is not hypothesis-driven, but rather based on the number of 
users in the database which fit the inclusion criteria as well as estimations derived from previous survey 
study response rates from social media and other Oticon Medical reach out efforts. 
No imputations or estimations will be made to replace missing data. 
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 a secure, password protected electronic data capture 
(EDC) system. Only relevant study personnel will be given a password to access the EDC. A two-factor 
authentication system will also be in place when logging into the EDC and an automatic logout in place if the 
user in the EDC has been idle for more than ten minutes. 
In the EDC system all subjects enrolled in the study will be assigned a three-digit Subject Identification 
Number (SIN) with a link to their personal identification (email address), which will not be stored in the EDC, 
but on a secure, password protected Oticon Medical Server.
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.
AMENDMENTS TO THE CIP
Substantial amendments will be approved by the IRB/EC, before incorporated. For non-substantial 
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amendments, local regulations regarding notifications to IRB/EC will be followed, if applicable. 
If the study is to be deemed exempt via IRB/EC approval, non-substantial amendments to this protocol and 
accompanying material will be made without notifying the IRB/EC. Only on the occurrence wherein
amendments to the protocol are made that might affect the exemption, the IRB/EC will be notified.
DEVIATIONS FROM CLINICAL INVESTIGATION PLAN
All protocol deviations will be documented stating the reason, date, the action(s) taken, and the impact for 
the participants/users and/or the study. At the end of the study, protocol deviations will be categorized as 
minor or major and their consequence on analysis and study conclusions will be determined.
DEVICE ACCOUNTABILITY
Not applicable. 
STATEMENTS OF COMPLIANCE
The CIP, the Subject Information, the Online Informed Consent Form (ICF) and other required documents will 
be submitted to an IRB/EC Documentation will be reviewed and approved, or deemed exempt, in writing, by 
IRB/EC before enrolment of subjects into the study can be initiated. Any additional requirements imposed by 
IRB/EC shall be followed.
INFORMED CONSENT PROCESS
Participants will be given full and adequate written information about the nature and purpose of the 
investigation, including data handling privacy procedures and possible risks involved. Potential participants 
will also be notified that they are free to decline participation in the investigation, and that they are free to 
discontinue at any time, without any consequences to their future care. Sufficient time will be given for 
consideration to participate and the opportunity to ask questions will be provided. Contact details for
research personnel who are available to answer any questions will be provided to potential participants.
Subject consent will be obtained electronically, documented, and stored in the secure EDC system.
If any new information becomes available during the investigation that possibly could influence the 
participant’s willingness to participate, they will be informed and asked to provide electronic consent for a
revised informed consent document, if applicable. 
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS, AND DEVICE DEFICIENCIES
Adverse events, adverse device effects, and device deficiencies will be covered by normal post-market 
complaints handling, including unexpected findings from primary and secondary objectives, i.e., participant 
reported outcomes on the subjective performance and satisfaction of their softband device. 
SUSPENSION OR EARLY TERMINATION OF THE INVESTIGATION
The sponsor may prematurely terminate the study at any time. If the investigation is suspended or 
terminated prematurely, any applicable regulatory authorities and ECs/IRBs concerned will be informed 
promptly in writing.
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PUBLICATION POLICY
A description of this study will be available, throughout the duration and onwards, on www.ClinicalTrials.gov. 
When the 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
On behalf of Oticon Medical I approve this clinical investigation plan.
Date and signature: 
Name and title
REFERENCES
1.
Ching, T. Y., & Hill, M. (2007). The parents' evaluation of aural/oral performance of children 
(PEACH) scale: Normative data. Journal of the American Academy of Audiology, 18(03), 220-235.
2.
Kubba, H., Swan, I. R., & Gatehouse, S. (2004). The Glasgow Children's Benefit Inventory: a new 
instrument for assessing health-related benefit after an intervention. Annals of Otology, Rhinology 
& Laryngology, 113(12), 980-986.
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APPENDICES
A. PEACH
Question
Ne
ver
0%
Seldom
1 - 25%
Someti
mes
26 - 50%
Often
51 -
75%
Always
75-
100%
1
.
How often has your child worn
his/her hearing aids and/or cochlear 
implant?
0
1
2
3
4
2
.
How often has your child complained
or been upset by loud sounds?
4
3
2
1
0
3
.
When you call, does your child respond 
to his/her name in a quiet situation?
0
1
2
3
4
4
.
When asked, does your child follow 
simple instructions or do a simple task
in a quiet situation?
0
1
2
3
4
5
.
When you call does your child respond to 
his/her name in a noisy situation when 
he/she can’t see your face? (examples of 
responses
include
looks
up,
turns,
answers verbally)
0
1
2
3
4
6
.
When asked, does your child follow 
simple instructions or do a simple task
in a noisy situation?
0
1
2
3
4
7
.
When you are in a quiet place reading 
with your child, how often does he/she
pay close attention to what you are
saying? OR if your child is listening to 
stories/songs on the TV or CD when 
there is no other background noise how
often can he/she follow what is being
said?
0
1
2
3
4
8
.
How often does your child initiate/ 
participate in conversation in a quiet
situation?
0
1
2
3
4
9
.
How often does your child initiate/ 
participate in conversation in a noisy
situation?
0
1
2
3
4
10.
How often does your child understand 
what you say in the car/bus/train?
0
1
2
3
4
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B.
GCBI questionnaire
1. Has your child’s Ponto sound processor on softband made his/her overall life better or 
worse?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
2. Has your child’s Ponto sound processor on softband affected the things he/she 
does?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
3. Has your child’s Ponto sound processor on softband made his/her behaviour better 
or worse?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
4. Has your child’s Ponto sound processor on softband affected his/her progress or 
development?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
5. Has your child’s Ponto sound processor on softband affected how lively he/she is 
during the day?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
6. Has your child’s Ponto sound processor on softband affected how well he/she 
sleeps at night?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
7. Has your child’s Ponto sound processor on softband affected his/her enjoyment of 
food?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
8. Has your child’s Ponto sound processor on softband affected how self-conscious 
11.
How often does your child recognize
peoples’ voices without seeing who was
talking?
0
1
2
3
4
12.
How often does your child successfully 
use a phone?
0
1
2
3
4
13.
How often does your child respond
to sounds other than voices?
0
1
2
3
4
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he/she is with other people? 
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
9. Has your child’s Ponto sound processor on softband affected how well he/she gets 
on with the rest of the family?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
10. Has your child’s Ponto sound processor on softband affected his/her ability to 
spend time and have fun with friends?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
11. Has your child’s Ponto sound processor on softband affected how embarrassed 
he/she is with other people?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
12. Has your child’s Ponto sound processor on softband affected how easily distracted 
he/she has been?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
13. Has your child’s Ponto sound processor on softband affected his/her learning?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
14. Has your child’s Ponto sound processor on softband affected the amount of time 
he/she has had to be off nursery, playgroup or school?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
15. Has your child’s Ponto sound processor on softband affected his/her ability to 
concentrate on a task?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
16. Has your child’s Ponto sound processor on softband affected how frustrated and 
irritable he/she is?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
17. Has your child’s Ponto sound processor on softband affected how he/she feels 
about him/herself?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
18. Has your child’s Ponto sound processor on softband affected how happy and 
content he/she is?
Doc-00121767,Revision 1, Released

Title
BC117 - Pediatric Performance and 
Satisfaction of Oticon Medical Ponto on 
Softband
Document no
Doc-00121767
Revision
0
Page
15(17)
This document is the confidential property of Demant Group.
Template Doc-32211-4
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
19. Has your child’s Ponto sound processor on softband affected his/her confidence?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
20. Has your child’s Ponto sound processor on softband affected his/her ability to care 
for him/herself as well as you think he/she should, such as washing, dressing, and 
using the toilet?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
21. Has your child’s Ponto sound processor on softband affected his/her ability to 
enjoy leisure activities such as swimming and sports and general play?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
22. Has your child’s Ponto sound processor on softband affected how often he/she 
needs to visit a doctor?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
23. Has your child’s Ponto sound processor on softband affected how prone he/she is 
to catch colds or infections?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
24. Has your child’s Ponto sound processor on softband affected how much 
medication he/she has needed to take?
a) much better
b) a little better
c) no change
d) a little worse
e) much worse
C.
Softband specific questionnaire
1. Is your child currently using a Ponto sound processor on a softband?
Yes
No
2. What is your child’s date of birth? (Please use MM/DD/YYYY format)
________/________/_____________
3. What is your child's gender?
Male
Female
Other
Doc-00121767,Revision 1, Released

Title
BC117 - Pediatric Performance and 
Satisfaction of Oticon Medical Ponto on 
Softband
Document no
Doc-00121767
Revision
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Page
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This document is the confidential property of Demant Group.
Template Doc-32211-4
Do not wish to disclose
4. Approximately how long has your child experienced hearing problems?
Less than a year
1 to 3 years
3 to 6 years
6 to 9 years
more than 9 years
I'm not certain
Since birth
5. How long has your child been using a Ponto sound processor on softband?
Less than a year
1 to 3 years
3 to 6 years
6 to 9 years
more than 9 years
I'm not certain
Since birth
6. Is your child using one or two Ponto sound processor(s)?
1 – One sound processor
2 - Two sound processors (one on the left, one on the right)
7. Is your child currently using a Softband 5 or other softband?
Softband 5
Other softband
I'm not sure
8. Is this your child's first softband?
Yes, this is the first
No, they used a different generation softband in the past
I'm not sure
9. Which Ponto sound processor does your child currently use?
Ponto 3
Ponto 3 Power
Ponto 3 SuperPower
Ponto 4
Ponto 5 Mini
Ponto 5 SuperPower
I don't know / other model
10. Think about how much your child used their sound processor(s) over the past two weeks. On an average 
day, how many hours did they use the sound processor(s)?
Doc-00121767,Revision 1, Released

Title
BC117 - Pediatric Performance and 
Satisfaction of Oticon Medical Ponto on 
Softband
Document no
Doc-00121767
Revision
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Page
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This document is the confidential property of Demant Group.
Template Doc-32211-4
none
less than 1 hour a day
1 to 4 hours a day
4 to 8 hours a day
more than 8 hours a day
11. Think about a situation where your child wanted to hear better, before receiving their sound processor. 
Over the past two weeks, how much has the sound processor(s) helped in that situation?
helped not at all
helped slightly
helped moderately
helped quite a lot
helped very much
12. How satisfied overall are you with your child's Ponto experience?
very much
quite a lot
moderately
slightly
not at all
13. How satisfied overall are you with your child's softband?
very much
quite a lot
moderately
slightly
not at all
Doc-00121767,Revision 1, Released