Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear
Conditions: Hearing Loss, Conductive, Hearing Loss Mixed, Hearing Disability, Conductive Hearing Loss, Ear Diseases, Conductive Hearing Loss, Bilateral, Conductive Hearing Loss, Unilateral
Sponsor: Oticon Medical

Title
Investigating hearing with Ponto 3 SuperPower, a 
bone anchored hearing aid
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Doc-00072164 
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Clinical Investigation Plan 
State 
Preliminary 
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CONFIDENTIAL 
Clinical Investigation Title Investigating hearing with Ponto 3 SuperPower, a bone anchored hearing 
aid - Investigating hearing with Ponto 3 SuperPower, a bone anchored 
hearing solution. 
Investigation code 
BC107  
NCT04803279 
Investigational Device 
Ponto 3 SuperPower 
Coordinating 
investigator/Principal 
Investigator(s) 
John FitzGerald 
Head of audiology 
Norfolk and Norwich University Hospital (NNUH) 
Colney Lane Norwich NR4 7UY, UK 
Sponsor 
Oticon Medical AB 
Datavägen 37 B 
436 32 Askim 
Sweden 
Date 
15-12-2020 
Revision history: 
Revision no 
Date 
Description 
00 
First version (1.0) 
1 
17-12-2020 
New revision for EC application. 
2 
02-02-2021 
New revision including minor updates to the document 
according to the REC answer 
3 
30-03-2021 
Modify objective C and endpoint H1 as it was discovered that 
the procedures unaided speech test in noise and quiet for 
CHL/MHL patients were not part of the clinic's normal 
procedure, and therefore data will be missing for these. 
Remove exploratory objective K, as it is not part of the clinic's 
normal procedure to document usage hours read from Genie 
Medical for all patients, so data will be missing for this objective 
as well. 
STATEMENT OF COMPLIANCE 
This clinical investigation 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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2.  Synopsis 
Clinical Investigation Title Investigating hearing with Ponto 3 SuperPower, a bone anchored hearing 
solution 
Investigation Code 
BC107 
Investigational Device 
Ponto 3 SuperPower 
Coodinating Investigator/ 
Principal Investigator 
John FitzGerald 
Head of audiology 
Norfolk and Norwich University Hospital (NNUH) 
Colney Ln, Norwich NR4 7UY, UK 
Sponsor: 
Oticon Medical AB 
Datavägen 37 B 
436 32 Askim 
Sweden 
Objective(s): 
To investigate the improvement in hearing with the Ponto 3 SuperPower(s) 
on the implanted ear(s) for patients within intended use. 
Methodology: 
Retrospective study 
Inclusion/exclusion 
criteria: 
Inclusion criteria 
1. Subjects who have consented to Section 3 of the document: “GDPR 
– what this means to you” (Appendix A) as part of a clinical routine 
visit. 
2. Fitted unilaterally or bilaterally with the Ponto 3 SuperPower(s) on 
abutment(s) 
3. Adult subjects (18 years or older) 
4. Patient has attended a clinical routine visit where fitting of Ponto 3 
SuperPower has been performed and at least one following clinical 
routine visit where audiological measurements has been performed 
Exclusion criteria 
There are no exclusion criteria in this retrospective study 
Primary endpoints 
Functional gain with Ponto 3 SuperPower, i.e. the difference between 
average unaided AC thresholds and aided sound field thresholds as the 
average (PTA4) of frequencies 500, 1000, 2000 and 4000 Hz. 
Duration of study period: Data will be collected during Q1-Q2 2021  
Statistical methods: 
Primary analysis: Descriptive statistics; mean and standard deviation; min 
and max (if the data is normally distributed) or median, 1st and 4th 
quartile; min and max (if the data is not normally distributed).  
Investigation plan 
prepared by: 
Jessica Ågren, Oticon Medical AB 
Liselotte Borup, Oticon Medical AB 
 
 

 
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2. TABLE OF CONTENTS 
2. 
SYNOPSIS .................................................................................................................................... 2 
3. 
LIST OF ABBREVIATIONS ........................................................................................................ 5 
4. 
BACKGROUND ........................................................................................................................... 5 
4.1 Background ........................................................................................................................... 5 
5. 
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE ..... 6 
6. 
JUSTIFICATION OF THE STUDY DESIGN AND OUTCOME MEASURES ................ 7 
6.1. JUSTIFICATION OF THE STUDY DESIGN AND OUTCOME MEASURES .............................................. 7 
6.2 
SUMMARY OF DATA ON COMPARABLE DEVICES .................................................................... 7 
6.3 
JUSTIFICATION OF OUTCOME MEASURES ............................................................................... 8 
7. 
RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND CLINICAL 
INVESTIGATION ............................................................................................................................. 9 
8. 
OBJECTIVES AND ENDPOINTS OF THE CLINICAL INVESTIGATION .................... 9 
8.1 
PRIMARY OBJECTIVES AND CORRESPONDING ENDPOINT/OUTCOME VARIABLE(S) ................ 9 
8.2 
SECONDARY OBJECTIVES AND CORRESPONDING ENDPOINT/OUTCOME VARIABLE(S) ............ 9 
9 
DESIGN OF THE CLINICAL INVESTIGATION .............................................................. 10 
9.1 
GENERAL ............................................................................................................................ 10 
9.1.1 Subject enrolment ........................................................................................................... 11 
9.1.2 Screening according to in- exclusion criteria ................................................................ 12 
9.2 
SUBJECT POPULATION ......................................................................................................... 12 
9.2.1 Inclusion criteria ............................................................................................................ 12 
9.2.2 Exclusion criteria ........................................................................................................... 12 
9.2.3 Procedure for identifying potential candidates ............................................................. 12 
9.2.4 Subject withdrawal ......................................................................................................... 12 
9.3 
CLINICAL INVESTIGATION PROCEDURES ............................................................................. 12 
9.3.1 Subject characteristics ................................................................................................... 12 
9.3.2 Safety assessments.......................................................................................................... 13 
9.3.3 Data Collection .............................................................................................................. 13 
9.3.3.1 
Collection of Pure tone thresholds from audiogram measured prior to fitting of 
Ponto 3 SuperPower .................................................................................................................. 13 
9.3.3.2 
Collection of BC In-situ thresholds from BC In-situ audiogram measured during 
fitting of Ponto 3 SuperPower ................................................................................................... 13 
9.3.3.3 
Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower
 
13 
9.3.3.4 
Functional gain ......................................................................................................... 14 
9.3.3.5 
Effective gain ............................................................................................................. 14 
9.3.3.6 
Collection of speech intelligibility scores .................................................................. 14 
9.3.3.7 
Skin reaction .............................................................................................................. 15 
9.3.3.8 
Collection of Glasgow Benefit Inventory ................................................................... 15 
9.3.3.9  Calculation of air-to-bone gap ..................................................................................... 16 
10. 
MONITORING .................................................................................................................... 16 
10.1 MONITORING PLAN .................................................................................................................. 16 

 
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10.2 INSPECTIONS AND AUDITS ....................................................................................................... 16 
11 STATISTICAL DESIGN AND ANALYSIS ......................................................................... 17 
11.1 
STUDY DESIGN, ANALYSIS POPULATIONS, GROUPS AND METHODS ...................................... 17 
11.2 
SAMPLE SIZE ....................................................................................................................... 18 
11.3 
STATISTICAL METHODS AND ANALYTICAL PROCEDURES ..................................................... 19 
11.4 
MISSING DATA .................................................................................................................... 19 
11.5 
TIMING OF ANALYSIS .......................................................................................................... 20 
12 DATA-MANAGEMENT ............................................................................................................ 20 
12.1 
CASE REPORT FORM RECORDING AND PROCESSING ............................................................ 20 
12.2 
SOURCE DOCUMENTS .......................................................................................................... 20 
12.3              DATA MANAGEMENT PLAN .......................................................................................... 21 
12.4               STORAGE OF DATA ....................................................................................................... 21 
13 AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN ................................... 21 
14 DEVIATIONS FROM CLINICAL INVESTIGATION PLAN........................................... 21 
15 DEVICE ACCOUNTABILITY .............................................................................................. 22 
16 STATEMENTS OF COMPLIANCE ..................................................................................... 22 
17 INFORMED CONSENT PROCEDURE ............................................................................... 22 
18 ADVERSE EVENT, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES 
ADVERSE EVENT (AE)................................................................................................................. 23 
18.1               SERIOUS ADVERSE EVENTS (SAE) ............................................................................... 24 
18.1.1  Adverse Device Effect (ADE) ......................................................................................... 24 
18.1.2 
Serious Adverse Device Effect (SADE) ...................................................................... 24 
18.2 
DEVICE DEFICIENCY (DD) ................................................................................................... 24 
18.3 
REPORTING OF SAFETY EVENTS ........................................................................................... 25 
18.3.1 
Reporting of Adverse Event(s) ................................................................................... 25 
18.4 
DEVICE DEFICIENCY REPORTING ......................................................................................... 25 
18.5 
SAFETY EVENT FOLLOW-UP ................................................................................................. 25 
18.6 
SAFETY RELATED CONTACTS .............................................................................................. 25 
19 SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL 
INVESTIGATION ........................................................................................................................... 26 
20 PUBLICATION POLICY ....................................................................................................... 26 
21 SIGNATURE PAGE ................................................................................................................ 27 
21.1 
SPONSOR ............................................................................................................................. 27 
21.2 
PRINCIPAL INVESTIGATOR................................................................................................... 27 
22 REFERENCES ......................................................................................................................... 28 
23 REFERENCE DOCUMENTS ................................................................................................ 28 
24 APPENDIX A ........................................................................................................................... 29 
 
 
 

 
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3.  List of Abbreviations 
AC 
Air Conducted 
BAHS 
Bone Anchored Hearing System 
BC 
Bone Conducted 
 
GBI 
Glasgow Benefit Inventory 
IFU 
Instructions for Use 
ITT 
Intention To Treat 
NAL 
National Acoustic Laboratory 
SI 
Speech Intelligibility 
SQ 
Sound Quality 
SSD 
Single Sided Deafness 
SSQ 
Speech Spatial and Qualities of Hearing Scale 
PTA4 
Pure Tone Average (calculated on 500, 1000, 2000 and 4000 Hz) 
PRO 
Patient Related Outcome 
 
 
 
 
4. Background 
4.1 Background 
Bone conduction hearing systems use the body’s natural ability to transfer sound through bone conduction. 
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). Indication for use for a bone anchored hearing solution is patients 
with conductive, mixed or single sided deafness. Thus, for subjects with conductive or mixed hearing losses, 
subjects 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 problem in the ear canal or middle 
ear, stimulating the cochlea directly. For single-sided deaf  (SSD) subjects, one utilizes that the vibrations 
are transmitted to the cochlea on the contralateral side [1].  
BAHS have been used since the late 1970s and are divided into three types: transcutaneous direct drive, 
percutaneous direct drive and transcutaneous skin drive bone conduction [1]. Direct drive denotes systems 
where the vibrations are transmitted directly to the bone, either by direct bone-transducer contact or by a 
stiff-metal, in contact with the transducer. In a skin drive system, there is a layer of soft tissue between the 
transducer and the bone. Percutaneous direct drive, also referred to as bone anchored hearing systems 
(BAHS) is the most common type with more than 150,000 users world-wide [1].  
Oticon Medical first developed a percutaneous system in 2009. Ponto 3 SuperPower was placed on the 
market in December 2016 and is the most powerful device in the Ponto family with a fitting range up to 65 
dB HL The Ponto 3 SuperPower is 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. 
 

 
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5. IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE 
 
The investigational device Ponto 3 SuperPower used in the study is CE marked and FDA cleared and has been 
commercially available since December 2016. Ponto 3 SuperPower sound processors comes in 6 different 
colors, the article numbers are listed in Table 1. Overview of devices and fitting software and corresponding article 
numbers.  The study intends to follow-up and collect data retrospectively on exciting Ponto 3 SuperPower 
user’s outcomes. The Ponto 3 SuperPower sound processors are fitted with Genie Medical 2016.1. 
 
Sound processor 
Denomination 
Article number 
Initial CE 
FDA 
clearance 
Ponto 3 SuperPower 
Ponto 3 SuperPower, Pure White 
52658 (left) 
52659  (right) 
2016 
2016 
 
Ponto 3 SuperPower,  White Silver 
52654 (left) 
52655  (right) 
2016 
2016 
 
Ponto 3 SuperPower, Chroma Beige 
52652 (left) 
52653  (right) 
2016 
2016 
 
Ponto 3 SuperPower, Mocca Brown 
52650 (left) 
52651  (right) 
2016 
2016 
 
Ponto 3 SuperPower, Steel Grey 
52656 (left) 
52657  (right) 
2016 
2016 
 
Ponto 3 SuperPower, Dimond Black  52648 (left) 
52649  (right) 
2016 
2016 
 
Genie 
Medical 
2016.1 
fitting 
software 
50504 
2016 
2016 
Table 1. Overview of devices and fitting software and corresponding article numbers. 
 
The investigational device is intended to improve hearing for subjects with conductive or mixed hearing 
losses by unilateral or bilateral fitting, as well as for subjects suffering from single-sided deafness. The Ponto 
3 SuperPower 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.  
 
The Ponto 3 SuperPower is non-sterile and consists of a coupling, which enables the Ponto 3 
SuperPower to be placed on the abutment (or softband, headband, testband), microphones, 
battery drawer, push button for changing programs and mute function, volume control, 
safety line attachment, transducer and sound processing electronics. The Ponto 3 
SuperPower picks up sound, processes it according to the users individual hearing loss and 
transmits the signal through the abutment. The investigational device has been fitted and 
adapted to the subject’s needs using the fitting software Genie Medical 2016.1 (CE-marked).  
Optional connectivity accessories can be used with the Ponto 3 SuperPower, such as Oticon 
Medical Streamer which can be used as remote control and for streaming phone calls. The 
Oticon Medical Streamer can be paired with a ConnectLine microphone, ConnectLine TV adapter and 
ConnectLine phone adapter in order to stream speech from a conversation or a lecture, TV or from a 
landline phone, see Table 2. All devices in Table 1 are CE-marked and FDA cleared. 
 
The audiological features that are included in the investigational device can be found in the Product 
Information sheet [B].  The site always fit adult users with National Acoustic Laboratory prescription 
method NAL-NL1. 
 
 
Figure 1. Ponto 3 
SuperPower 

 
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Denomination 
Legal manufacturer 
Oticon Medical Streamer 
Oticon A/S 
ConnectLine TV adapter 
Oticon A/S 
ConnectLine microphone 
Oticon A/S 
ConnectLine phone adapter 
Oticon A/S 
Table 2. Overview of optional connectivity devices. 
 
The CE-marked Ponto 3 SuperPower and eventually accessories are the investigational devices in this study. 
Candidates for this study are existing Ponto 3 SuperPower users. This study only obtain data from subjects 
who have been fitted with CE-marked Ponto 3 SuperPower(s) (available on the market since December 2016). 
 
Note: Additional information on the investigational device and accessories are available in the Audiological 
manual [A], product information sheet [B]and IFU [D, F, G, H].  
 
6. JUSTIFICATION OF THE STUDY DESIGN AND OUTCOME MEASURES 
6.1. Justification of the study design and outcome measures 
This is a post market clinical follow up study (PMCF) with the purpose to gather knowledge on the Ponto 3 
SuperPower device on existing Ponto 3 SuperPower users. The study does not include any study visits, 
treatment or fitting of new devices. Instead the available data reflecting the use of Ponto 3 SuperPower will 
be collected from clinical routine visits. 
The Ponto 3 SuperPower has been commercially available since December 2016  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 A retrospective 
study design where all data will be retrospectively collected, from previous clinical routine visits and 
procedures performed according to the clinic’s normal procedures, is suitable to evaluate the hearing 
outcomes on the population using Ponto 3 SuperPower. 
The data that will support the primary and secondary endpoint are available from the clinical routine visit 
where Ponto 3 SuperPower has been fitted and the first clinical routine visit following the fitting. This is 
typically the procedure for hearing aid rehabilitation and therefore a three-months’ time window for data 
collection from described clinical routine visits, or from the clinical routine visit just prior to the fitting visit 
where audiometry threshold might have been performed, see section 9.3.3.1). 
 
6.2 Summary of data on comparable devices 
A literature review has been undertaken with the purpose of summarizing state-of-the-art treatment 
options for subjects with a hearing loss within Oticon Medical BAHS indication of use. In this literature 
review, two percutaneous bone conduction systems were identified; Ponto (Oticon Medical AB) and Baha® 
Connect (Cochlear BAS, Mölnlycke, Sweden) [E]. 
Twenty-three publications with clinical data on the performance of the percutaneous systems (452 
subjects) were included. The most commonly used performance measures include but are not limited to 
functional gain (unaided sound field thresholds or AC hearing thresholds relative to aided sound field 
thresholds), speech reception threshold or speech scores at given speech levels; speech-in-noise 
performance and self-reported outcome questionnaires. 
Data from bone anchored devices consistently showed performance improvement in aided sound field 
threshold measurement, over the unaided condition. However, there is a strong heterogeneity in the 

 
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reported results. All reviewed data report improvements in speech recognition. The reviewed data also 
report significant improved self-reported performance when comparing aided to unaided condition. 
 
6.3 Justification of outcome measures 
The study is a retrospective study where the objectives is determined based on the State of the Art report 
(E) and what data the clinic has collected. The site collects functional gain only for patients with CHL/MHL, 
and speech recognition measurements are conducted differently for CHL/MHL and SSD. Therefore, not all 
objectives cover all patient groups. The primary endpoint is investigating the improvement in hearing with 
the Ponto 3 SuperPower(s) for patients with CHL/MHL. Secondary objectives includes speech recognition 
aided with Ponto 3 SuperPower, Patient Reported Outcome  (GBI) evaluating the subject’s quality of life 
before intervention and at the clinical routine visit, following the fitting and skin reaction (Holger score) at 
the clinical routine fitting visit and the clinical routine follow-up visit, which all are collected on all hearing 
categories (CHL, MHL and SSD).  
The outcomes in the study are related to the data the clinic has collected and reflect the benefit of Ponto 3 
SuperPower that is that it compensates for hearing loss, i.e. improve the hearing for subjects within the 
indicated use manifested by: 
• 
Improved ability to hear sounds 
• 
Improved speech intelligibility 
• 
Improved quality of life  
For a subject with a unilateral hearing loss, the benefit will primarily be manifested for sounds directed to 
the fitted side. In general, with BAHS, if the subject has symmetrical BC hearing loss and is bilaterally fitted, 
binaural benefits, manifested by for example improved ability to localize sounds, can be achieved. 
In addition, the Ponto 3 SuperPower is also expected to provide improved quality of life and reduce the 
disability caused by a hearing loss for subjects already using Ponto 3 SuperPower. 
This study will focus on collecting data on the ability to hear sound and speech intelligibility as well as 
evaluate subjective self-reported outcome on subjects using Ponto 3 SuperPower.  
The study is part of the post-market clinical follow-up of Ponto 3 SuperPower with the purpose of refining 
the knowledge on performance outcomes with Ponto 3 SuperPower from subjects who have been fitted 
with the Ponto 3 SuperPower after it was CE market and available on the market since December 2016. The 
primary objective of the study is to evaluate the performance of the Ponto 3 SuperPower for the indicated 
subjects. The primary endpoint was therefore chosen as the functional gain. Functional gain is the 
difference between unaided AC thresholds obtained with headphones TDH39, and aided sound field 
threshold and reflects the hearing benefit with the treatment and is the most common way to report bone 
anchored hearing aid benefit in the literature [E]. Secondary objectives include speech intelligibility and 
self-reported outcome.  
Not many studies on percutaneous bone conduction systems report longitudinal data on aided sound field 
thresholds. However, studies that report longitudinal performance on bone conduction hearing systems 
(with follow-up times between one and 37 months) show no significant change of aided threshold over 
time [2][3][4][5]. This allows for a primary endpoint analysis on test subjects who have had minimum 1.5 
months experience with Ponto 3 SuperPower(s) (chapter 9.3.3.3). 
In summary, the primary endpoint of the study addresses the expected benefit of the Ponto 3 SuperPower 
and is one of the most commonly used performance measures in the research literature. Timing of the 
measurement is not critical as performance is similar over time, which allows for difference in time of the 
measurement performed since fitting of Ponto 3 SuperPower. Secondary endpoints address the expected 
benefit of the Ponto 3 SuperPower terms of speech intelligibility and reported quality of life.  
 

 
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7. RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND CLINICAL INVESTIGATION 
The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device is the CE-
marked Ponto 3 SuperPower (available on the market since December 2016) already fitted to the subjects, 
and data is collected retrospectively from clinical routine visits.  
 
No study visits for treatment or follow-up are provided in the study therefore there are no risk for the subjects 
in regards to collecting their already provided data for the study.  
8. OBJECTIVES AND ENDPOINTS OF THE CLINICAL INVESTIGATION  
The objectives is determined based on the State of the Art report (E) and what data the clinic has collected. 
 
8.1 Primary Objectives and Corresponding endpoint/outcome variable(s) 
The primary objective and corresponding endpoint/outcome variables for the study are listed in Table 3 
below.  
 
Primary objectives 
Corresponding endpoint/outcome variable(s) 
Sec. 
A. To investigate the 
improvement in hearing with 
the Ponto 3 SuperPower for 
patients with CHL/MHL.  
 
1. Functional gain with Ponto 3 SuperPower, i.e. the 
difference between average unaided AC thresholds 
and aided sound field thresholds as the average (PTA4)  
of frequencies 500, 1000, 2000 and 4000 Hz 
9.3.3.3-
9.3.3.4 
Table 3. Primary objective and corresponding endpoint/outcome variables. 
 
 
 
 
8.2 Secondary Objectives and Corresponding endpoint/outcome variable(s) 
The secondary objectives and corresponding endpoints/outcome variables for the study are listed in table 4 
below. 
 
 
1 The AB Isophonemic Monosyllabic Word test -short has been used for most of the patients. The BKB sentence test  
has been conducted when needed as per the audiologist discretion. 
Secondary objectives 
Corresponding endpoint/outcome variable(s) 
Sec. 
B. To investigate the 
improvement in hearing with the 
Ponto 3 SuperPower for patients 
with CHL/MHL.  
 
C. To assess speech recognition 
in quiet and in noise with Ponto 3 
SuperPower on the implanted 
ear(s) for patients with 
CHL/MHL.1 
1 Functional gain with Ponto 3 SuperPower, i.e. the 
difference between average unaided AC thresholds and 
aided sound field thresholds for frequencies 500, 1000, 
2000, 3000 and 4000 Hz 
1. Aided speech recognition (%) in quiet. 
2. Aided speech recognition (%) in noise. 
 
9.3.3.4 

 
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Table 4 Secondary objectives and corresponding endpoint/outcome variables 
 
9 DESIGN OF THE CLINICAL INVESTIGATION  
9.1  General 
The study is a retrospective study.  Subject inclusion for this clinical investigation (see inclusion and 
exclusion criteria below) will be performed among subjects who has been fitted with the Ponto 3 
SuperPower 
  
 
 
 
 
 
 
 
 
 
 
  
D. To assess the speech recognition 
in noise with Ponto 3 SuperPower 
on for patients with SSD 
 
 
 
 
1. Difference in speech recognition score (%) for speech 
recognition in noise between unaided and aided when 
speech is directed to the aided ear, and noise is 
directed to the non-implanted ear 
 
2. Difference in speech recognition score (%) for speech 
recognition in noise between unaided and aided when 
speech is directed to the non-implanted ear, and noise 
is directed to the aided ear. 
 
9.3.3.6 
E. To assess the degree to 
which the Ponto 3 
SuperPower compensates 
for the BC hearing loss on 
the implanted ear(s) for 
patients with CHL/MHL. 
 
1. Effective gain with Ponto 3 SuperPower, i.e. the 
difference between aided sound field thresholds 
and the BC In-situ thresholds on the aided ear(s) 
measured when the Ponto 3 SuperPower(s) was 
fitted. The effective gain is calculated as the average 
(PTA4) of frequencies 500, 1000, 2000 and 4000 Hz. 
9.3.3.5 
F. To assess the degree to 
which the Ponto 3 
SuperPower compensates 
for the BC hearing loss on 
the implanted ear(s) for 
patients with CHL/MHL 
2. Effective gain with Ponto 3 SuperPower, i.e. the 
difference between aided sound field thresholds 
and the BC In-situ thresholds on the aided ear(s) 
measured when the Ponto 3 SuperPower(s) was 
fitted. The effective gain is calculated for 
frequencies 500, 1000, 2000, 3000 & 4000 Hz. 
9.3.3.5 
G. To assess the quality of life 
of the Ponto 3 SuperPower  
 
1. Glasgow Benefit Inventory (GBI) scores. 
9.3.3.8 
H. To evaluate the above 
objectives on individual levels 
 
 
I. 
To assess the air to bone gap 
(PTA4) on the implanted 
ear(s) for patients with 
CHL/MHL 
J. 
To assess the skin condition 
around the abutment 
1. Endpoints A, B, D, analyzed as the proportion of 
subjects whose performance is better or equal in the 
unaided to aided comparisons, i.e. have a difference ≥0 
 
1. The difference between masked (if not available 
unmasked) BC and AC thresholds, denoted ‘air to 
bone gap’, calculated for frequencies 500, 1000 and 
2000 Hz from audiogram measured in connection with 
the fitting of Ponto 3 SuperPower 
 
1. Holgers score (scale 0–4) assigned by investigator at 
fitting and post-fitting follow up. 
 
9.3.3.4-9.3.3.6 
9.3.3.10 
9.3.3.7 

 
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The collection of the patient’s data will be performed like this:  The subjects are included over the last 4 
years where the Ponto 3 SuperPower has been on the market, the aim is to distribute the subjects as equal 
as possible over the years 2017 to 2020. As the COVID-19 pandemic had an impact on the hospitals ability 
to see patients for clinical routine rehabilitation visit, fewer patients have been fitted with Ponto 3 
SuperPower during 2020. Thus, a lower number of subjects will be included from 2020 is expected. 
Dependent on the enrollment of subject from 2020, approximately 20 subjects are collected from each year 
from 2017-2019.  
 
9.1.2 Screening according to in- exclusion criteria  
The investigator will ensure that the patient complies with the inclusion criteria, based on a review of the 
already available information in the patients’ medical file. 
9.2   Subject population 
 
A total number of 55 test subjects will be included in this study. Subject inclusion for this clinical 
investigation will be performed among subjects who has been fitted with the Ponto 3 SuperPower after it 
was CE market and available on the market since December 2016.    
The subjects will not participate in any study related visits, instead investigator will collect relevant data 
retrospectively from already performed clinical routine visits. 
 
9.2.1 Inclusion criteria 
1. Subjects who have consented to Section 3 of the document: “GDPR – what this means to you” 
(Appendix A) as part of a clinical routine visit. 
2. Fitted unilaterally or bilaterally with the Ponto 3 SuperPower(s) on abutment(s) 
3. Adult subjects (18 years or older) 
4. Patient has attended a clinical routine visit where fitting of Ponto 3 SuperPower has been 
performed and at least one following clinical routine visit where audiological measurements has 
been performed 
 
 
9.2.2 Exclusion criteria 
There are no exclusion criteria in this study due to the retrospective nature of the study. 
 
9.2.3 Procedure for identifying potential candidates 
Potential candidates will be identified via the Investigators knowledge of the clinic’s pool of patients with 
Ponto 3 SuperPower.  
The medical records, Genie Medical and Auditbase at Norfolk and Norwich university hospital will be basis 
for identifying relevant data during the period of data collection in order to collect described data, by 
investigator, starting from the date 01-01-2017.  
 
9.2.4 Subject withdrawal  
Not applicable as the study is retrospective study. 
 
9.3  Clinical Investigation Procedures 
9.3.1 Subject characteristics 

 
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 The following subject characteristics will be collected:  
• 
Gender 
• 
Age at fitting visit 
• 
Type of hearing/hearing loss on right and left ear (MHL/CHL; SSD and SNHL, normal hearing) 
• 
Type of hearing solution on right and/or left ear 
• 
BAHS surgery, side(s) and year 
• 
Date of Ponto 3 SuperPower fitting on abutment (mm.year)  
• 
Connectivity devices (device: Oticon Medical streamer, ConnectLine Tv adapter, ConnectLine 
microphone, Connectline phone adapter, usage: ) 
 
9.3.2 Safety assessments 
This study is a retrospective study, only focusing on the performance of the Ponto 3 Superpower, and only 
collecting data during the short interval between the clinical routine visit where the Ponto 3 SuperPower 
has been fitted or just prior to that visit (where audiometry thresholds might have been performed, see 
9.3.3.1)  and the subsequent clinical routine visit(s) following the fitting,  therefore there are no safety risk 
involved. Safety events, see section 18, will be collected to the following extent; if the investigator finds 
documentation in the audiological file regarding mentioning of a safety event, these will be recorded in the 
e-CRF. Only the audiology file will be reviewed and only for the time of the data collection time window. 
Any adverse event (AE) that is judged as related to the device by the investigator will be reconciled against 
the Sponsor’s complaint system, and if not previously reported added as a new complaint. Any device-
related AE will be investigated according to the Sponsor’s procedure for complaint handling.  
  
9.3.3 Data Collection 
Any information on how the data obtained in this retrospective study have been described to reflect the 
Norwich and Norfolk university hospital´s routine.  
 
9.3.3.1 Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 
SuperPower 
Unmasked and if available masked BC thresholds for frequencies 500 Hz, 1kHz and 2 kHz and AC thresholds 
for frequencies 250 Hz, 500Hz, 1kHz, 2 kHz, 3kHz, 4kHz, 6kHz and 8kHz will be collected from audiogram 
obtained prior to Ponto 3 SuperPower were fitted.  
 
9.3.3.2 Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 
SuperPower 
BC In-situ thresholds for frequencies 250 Hz, 500 Hz, 1 kHz, 2 kHz, 3 kHz,4 kHz, 6 kHz and 8 kHz will be 
collected from the BC In-situ audiogram obtained when Ponto 3 SuperPower were fitted.  
 
9.3.3.3 Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower 
Sound field thresholds for frequencies 500Hz, 1kHz, 2 kHz, 3kHz and 4kHz will be collected from sound field 
audiogram obtained as follow-up after Ponto 3 SuperPower fitting, typically this is collected 3 months post 
fitting, alternatively from the fitting visit. Thresholds will be obtained aided for the CHL/MHL patients. 
Sound field thresholds are obtained 1-2 m azimuth. The measurement has been conducted with the 
contralateral ear left open, hence no masking has been applied. The measurement has been conducted in 
the patients user settings, with no disabling of DFC or NR. The directionality has been in user settings, 
which for most patients is an [automatic TriMode] which during this measurement was equivalent to have 
the device in an omni mode, because the measurement is conducted in a quiet room with warble tones 

 
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from the front.   
 
9.3.3.4  Functional gain 
The functional gain is a calculation and uses the masked, if not available unmasked, AC thresholds obtained 
with headphone TDH39 and aided sound field thresholds as described above (9.3.3.1-9.3.3.3). Functional 
gain is defined as the difference between the unaided AC and aided sound field thresholds. Functional gain 
can be calculated for frequencies 500Hz, 1kHz, 2 kHz, 3kHz and 4kHz. The average functional gain will be 
also be calculated for PTA4. 
No blocking or masking of the non-implanted ear has been performed during the sound field measurement. 
Unaided AC for the implanted ear will be used for the calculation of functional gain. In case of a bilateral 
Ponto fitting it is the best ear AC that will be used. 
The aided soundfield has only been conducted on patients with CHL/MHL, and not for SSD.  
 
9.3.3.5 Effective gain 
Effective gain is a calculation and is defined as the difference between aided sound field thresholds 
measurement with Ponto 3 SuperPower(s) and BC In-situ thresholds at the time when the Ponto 3 
SuperPower was fitted as described above (9.3.3.3-9.3.3.2). Effective gain can be calculated for frequencies 
250 Hz, 500Hz, 1 kHz, 2 kHz, 3 kHz and 4 kHz.  The average effective gain will be calculated for PTA4. 
 
9.3.3.6 Collection of speech intelligibility scores 
Speech intelligibility is measured in a sound treated room using sentence tests. The sentence tests used at 
Norwich and Norfolk hospital is the The AB[s] Isophonemic Monosyllabic Word test (7) and/or the BKB 
(Bamford-Kowal-Bench). BKB is never measured with SSD patients. 
The sentence tests are measured in quiet and/or with background speech-weighted noise.  
For patients with CHL/MHL speech intelligibility (percent (%)) was collected in quiet at the level of 60-65 dB 
HL for aided condition. For speech in noise the speech intelligibility percent (%) will be collected at the 
speech level of 60-65 dB HL when speech is presented from the front (0°) and 50-55 dB HL noise is 
presented from behind (180°) for aided condition. 
For patients with SSD speech intelligibility in noise (percent (%)) was collected for unaided and aided 
conditions for two test setups with +10 dB fixed signal to noise ratio (SNR) : 1. Speech signal at 60-65 dB HL 
directed to the implanted ear and noise at 50-55 dB HL directed to the non-implanted ear, and 2. Speech 
signal at 60-65 dB HL directed to the non-implanted ear and noise at 50 -55 dB HL directed to the implanted 
ear. 
All measurements have been conducted in user settings, and with no masking or plugging of the 
contralateral ear in case of unilateral patient. 
 
Population 
Speech test in 
quiet (%) – 
BKB1 
Speech test in 
quiet (%) – 
AB[s] 
Speech test in 
noise (%) at 
fixed SNR (+10 
dB) – BKB1 
Speech test in 
noise (%) at fixed 
SNR (+10 dB)– 
AB[s] 
Loudspeakers 
CHL/MHL 
60-65 dB HL 
60-65 dB HL 
Speech 60-65 dB 
HL 
Noise 50-55 dB 
HL 
Speech 60-65 dB 
HL 
Noise 50-55 dB 
HL 
Speech (0°) 
Noise (180°) 
SSD 
 
 
 
Speech 60-65 dB 
HL 
Noise 50-55 dB 
HL 
 
SimplatedNnon-implanted 

 
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Population 
Speech test in 
quiet (%) – 
BKB1 
Speech test in 
quiet (%) – 
AB[s] 
Speech test in 
noise (%) at 
fixed SNR (+10 
dB) – BKB1 
Speech test in 
noise (%) at fixed 
SNR (+10 dB)– 
AB[s] 
Loudspeakers 
SSD 
 
 
 
Speech 60-65 dB 
HL 
Noise 50-55 dB 
HL 
Snon-implatedNimplanted 
1 Only conducted as per the audiologist discretion.  
9.3.3.6.1 BKB sentence test 
BKB sentence test is an open-set speech perception test developed for use with hearing-impaired children 
(usually >8 years of age). It can also be used with adults. The test can be administered in quiet conditions or 
in the presence of background noise. Each BKB list consists of 16 short sentences and is scored on the 
number of words correctly repeated out of 50 key words.  
BKB sentence test might be measured for CHL/MHL, but never for the SSD patients. 
 
9.3.3.6.2 AB[s] word list 
The AB[s] Isophonemic Monosyllabic Word test (7) is an open-set speech perception test comprising fifteen 
lists with each having 10-word lists. The lists are composed of CVC (consonant, vowel, consonant) words in 
isolation, constructed from the same 10 vowels and 20 consonants. They are used to test adults with mild 
to profound hearing impairment using residual hearing alone or when aided with a hearing aid. The lists are 
phonemically balanced and are usually scored phonemically, which increases the test reliability. The AB[s] 
word lists are spoken by English male speaker. 
AB[s] word list is most often measured for all patient groups. 
 
9.3.3.7 Skin reaction 
Classification of skin reactions around skin penetrating implants will be made using the Holgers score [8].  
The Holgers classification is a scale from 0 to 4 that is used to grade skin reactions. Grade 0 indicates a 
reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant, see table 
Table 6. Overview of grades of reaction on the Holger score. The Holger score is collected at the fitting and 
post-fitting follow up. 
Holgers score 
0 
No reaction 
1 
Erythema with slight swelling around abutment 
2 
Erythema, moistness and moderate swelling  
3 
Erythema, moistness and moderate swelling with granulation around abutment 
4 
Overt signs of infection resulting in removal of implant 
Table 6. Overview of grades of reaction on the Holger score. 
 
 
 
9.3.3.8 Collection of Glasgow Benefit Inventory 
The Glasgow Benefit Inventory (GBI) contains 18 health status questions, which ask specific questions about 
how the health problem, in this study hearing loss, has affected their quality of life at the time the GBI is 

 
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completed. In this study GBI has been collected on patients before intervention and 3 months after fitting of 
Ponto 3 SuperPower on abutment. 
 
9.3.3.9  Calculation of air-to-bone gap 
Air-to-bone gap is a calculation of the difference between unaided masked (unmasked is masked is not 
available) AC thresholds and BC thresholds, measured with TDH-39 and BC-71 respectively, for the 
implanted ear. The air-to-bone gap will be calculated for frequencies 500 Hz, 1 kHz & 2 kHz. 
 
10. 
MONITORING 
During the investigation, authorized representatives from Oticon Medical will have regular contact with the 
investigational sites with the purpose to oversee the investigation. Monitoring activities will be performed 
by appointed monitors according to applicable standards (i.e. ISO14155) and internal guidance documents. 
The overall purposes of the monitoring are to make sure that the rights, safety and wellbeing of the 
subjects are protected, that the reported data are accurate, complete, and verifiable from source 
documents, and the conduct of the clinical investigation complies with the approved CIP, subsequent 
amendments (if any), applicable standards (i.e. ISO14155), and applicable regulatory and Ethics Committee 
requirements.  
 
10.1 Monitoring plan 
As this is a retrospective study, there are no direct risks to the patients, and this will be reflected in the 
study specific Monitoring Plan.  
A Site Initiation Visit will be held online.  
Interim monitoring will be performed via online meetings, and this is also due to the ongoing COVID 19 
pandemic and new challenges when it comes to on-site monitoring. Centralized and/or remote  monitoring 
will be performed on an interim basis by e.g. reviewing the data entered in the e-CRFs. Should the need for 
an increase of monitoring besides the planned monitoring occur, e.g. for quality concerns, this will be 
decided on a case by case basis. 
The Investigator Site File (ISF) will be reviewed, also remote, for accuracy and completeness throughout the 
investigation. 
Further details on the extent and the nature of monitoring activities as well as access to source data and 
the strategy of source data verification, will be outlined in a study specific, risk-based Monitoring Plan. 
 
10.2 Inspections and audits 
 
Audits of the clinical investigation may be conducted by authorized sponsor representatives, third parties 
designated by the sponsor or by competent authorities and notified bodies to evaluate compliance with the 
CIP, agreements, ISO 14155, and the applicable regulatory requirements. These audits may cover all involved 
parties, systems and facilities and are independent of, and separate from, routine monitoring or quality 
control functions. The institution’s quality assurance department (or equivalent) may also visit the 
investigation site to perform an audit.  

 
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11 
STATISTICAL DESIGN AND ANALYSIS  
11.1 
Study design, analysis populations, groups and methods 
This is a retrospective post market clinical follow up (PMCF) study with the purpose to gather knowledge on 
Ponto 3 SuperPower by investigating 55 subjects fitted with this sound processor between December 2016 
(market release) and December 2020.  
Due to the retrospective design, no safety population will be defined for the study. The intention-to-treat 
(ITT) population will include all subjects included in the study. No per-protocol (PP) population will be 
defined as this study collects data retrospectively and thus the expectation is that not all data for the 
described procedures (see section 9.3.3) will be available for all patients. Instead, the ITT population will be 
divided into two separate target groups depending on the type of hearing loss in the subjects.  
The Target populations (TPs) are defined as: 
• 
TP1: Subjects with conductive or mixed hearing losses (within intended use for Ponto 3 
SuperPower): pure tone average (PTA) bone conduction (BC) threshold on the BAHS(s) ear(s) better 
than or equal to 65 dB HL, based on BC threshold when Ponto 3 SuperPower were fitted.  
• 
TP2: Subjects with single sided deafness (SSD) (within intended use for Ponto 3 SuperPower): pure 
tone average air conduction (AC) threshold of the hearing ear being better than or equal to 20 dB 
HL AC (measured at 0.5, 1, 2 and 3 kHz). In case AC is larger than 20 dB HL then the patients must 
not use a hearing aid on the other side.  
 
The primary objective of the study is to investigate the improvement in hearing with the Ponto 3 
SuperPower sound processor for patients with CHL/MHL.The related endpoint is defined as: 
• 
Functional gain with Ponto 3 SuperPower, i.e. the difference between average unaided AC thresholds 
and aided sound field thresholds as the average (PTA4)  of frequencies 500, 1000, 2000 and 4000 Hz 
Unaided AC for the implanted ear will be used for the calculation of functional gain. In case of a bilateral 
Ponto fitting it is the best ear AC that will be used. The aided sound field measurement has only been 
conducted on patients with CHL/MHL, and not for SSD.  
 
In this study, all analyses will be performed on the ITT population and the Target populations ( 
 
 
Objectives 
ITT 
Target 
Effect of Ponto 3 SuperPower 
(bilaterally fitted CHL/MHL 
subjects) 
A 
X 
X (TP1)  
X 
B 
X 
X (TP1) 
X 
C 
X 
X (TP1) 
X 
D 
X 
X (TP2) 
 
E 
X 
X (TP1) 
X 
F 
X 
X (TP1) 
X 
G 
X 
X (TP1 + TP2) 
 
H 
X 
X (TP1 + TP2) 
X 
I 
X 
X (TP1) 
 

 
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J 
X 
X (TP1 + TP2) 
 
Table 7. Overview of analyses for objectives A-J.). Additional analyses will be perfomed to assess the 
hering benefit of the Ponto 3 SuperPower alone (i.e. without “interference” from a normal-hearing ear).  
The hearing benefit of Ponto 3 SuperPower will be calculated on a subset of the Target population 1 (TP1), 
including only bilaterally fitted Ponto 3 SuperPower users with conductive or mixed hearing losses. This is 
to avoid any contribution from the non-Ponto 3 SuperPower fitted ear in unilaterally fitted users or 
bimodially users (BAHS on one ear, hearing aid on the other), since all measurements have been performed 
without masking or blocking of the contralateral ear. 
 
 
Objectives 
ITT 
Target 
Effect of Ponto 3 SuperPower 
(bilaterally fitted CHL/MHL 
subjects) 
A 
X 
X (TP1)  
X 
B 
X 
X (TP1) 
X 
C 
X 
X (TP1) 
X 
D 
X 
X (TP2) 
 
E 
X 
X (TP1) 
X 
F 
X 
X (TP1) 
X 
G 
X 
X (TP1 + TP2) 
 
H 
X 
X (TP1 + TP2) 
X 
I 
X 
X (TP1) 
 
J 
X 
X (TP1 + TP2) 
 
Table 7. Overview of analyses for objectives A-J. 
 
11.2 
Sample size 
The sample size in the investigation is based on the typical size of retrospective studies on sound processor 
outcomes within the bone-anchored hearing system field. 
For the primary endpoint there is no hypothesis to test, but a sample size at least as large as similar studies 
within state-of-the-art is considered appropriate. A total of 3 retrospective studies on sound processors 
from recent years that included functional gain as outcome, were identified [E]. The number of included 
subjects with functional gain reported on in the identified studies ranged from 6 to 53. The study with 6 
subjects actually included 46 in total whereof 40 were fitted on softband (9). One study included 20 
subjects for which functional gain where reported whereas the total number of subjects in the study was 49 
(29 subjects only had surgical outcomes reported) (10). The third study included 53 subjects, all of which 
had functional gain reported (11), table 8.   
 
 
Year 
Title  
Author 
Number of subjects 
Number of subjects 
in groups 
2018 
Hearing 
improvement with 
softband and 
implanted bone-
anchored devices 
and modified 
implantation 
surgery in patients 
with bilateral 
microtia-atresia.  
Wang et al. 
46  
6 (percutaneus) 
40 (softband) 

 
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2016 
Bone anchored 
hearing implants 
without skin 
thinning: the 
Gruppo Otologico 
surgical and 
audiological 
experience 
Caruso et al. 
49 
20 (audiological 
outcome) 
29 (surgical 
outcome) 
2016 
Bone Anchored 
Hearin Aid (BAHA) 
in children: 
Experience of 
tertiary referral 
centre in Portugal 
Rosa et al. 
53 
 
Table 8. Overview of retrospective studies including functional gain as outcome measure. 
 
 
Due to the retrospective design, no drop-outs are considered. Based on the typical sample size in similar 
studies within state-of-the-art and achieving a sufficient number of patient represented in the hearing loss 
categories for CHL/MHL population (see section 9.1.1),  55 subjects was concluded as an appropriate 
number to include in the study. 
 
 
11.3 
Statistical methods and analytical procedures 
The general methodology for the analysis of primary and secondary endpoints are described below. The 
descriptive statistics of continuous variables will be given as Mean, standard deviation (SD), Minimum and 
Maximum (Mean (SD) (Min; Max)). The distribution of categorical and dichotomous variables will be given as 
number and percentage (n = (%)).  
In case of one factor involved in the design, data will be tested for normality using the Shapiro-Wilk test. 
Paired t-test will be performed if the data is normally distributed. Wilcoxon signed-rank test will be 
performed if the data is not normally distributed. In case of more than one factor involved in the design, 
mixed-model ANOVAs will be performed with subject as a random factor. The decision of the hypothesis test 
is done at the 5% significance level. Pearson’s correlations (or Spearman’s if the data is not normally 
distributed) will be used to test correlations. 
The analysis of the primary endpoint will be performed with descriptive statistics (mean and standard 
deviation; min and max(if the data is normally distributed) or a median, 1st and 4th quartile; min and max (if 
the data is not normally distributed). The analysis of secondary and exploratory endpoints will follow the 
general methodology described above. 
 
All statistical analyses are to be explained in detail in a statistical analysis plan (SAP). Any deviations from the 
original analysis plan will be described in a CIP amendment, as deemed appropriate. 
No pass/fail criteria will be applied to the results of the investigation. 
 
 
11.4 
Missing Data 
Missing data (e.g., single questions, experimental repetitions) will not be imputed and will be disregarded 
from the analysis. In case of a full variable missing for a subject, case-wise deletion will be performed for 
this variable. 

 
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11.5 
 Timing of analysis 
Results will be compiled and reported when all data for all subjects has been collected. No interim analysis is 
planned for.  
 
 
12 DATA-MANAGEMENT  
All data collected and processed concerning the subjects participating in the investigation is protected 
under the Data Protection Act 2018 (the UK’s implementation of the (EU) Regulation 2016/679 (GDPR) and 
the Health Act and will be handled accordingly. Further, professional secrecy regarding subject information 
and data applies to all involved personnel, including sponsor representatives. 
 
All subjects included in the clinical investigation will be assigned a Subject Identification Number linked to 
their personal identification.  Subject will only be identifiable in a Subject Identification Log, where the 
personal identification information matches the Subject Identification Number. The subject Identification 
Number will be used for all data collected and recorded from the subject. Names and/or personal 
identification information will not be collected or recorded for investigational purposes. It is the 
responsibility of the investigator to make sure that the Subject Identification Log is always kept up to date.  
The Subject Identification Log will only be available as part of the Investigator Site File (ISF) in a secure 
location with restricted access, and not, at any time during the investigation, be available to any 
unauthorized party, nor available in sponsor files.  
 
All subjects included in the investigation will be provided with a Subject Identification Number (i.e. 
pseudonymization), consisting of a three digit code, where the leading digit represents the investigation 
site number, ( 1 for site no. 1, 2 for site no. 2 etc.) and the two following numbers represents the 
consecutive subject number (e.g. 101 for the first included subject at site no. 1, 202 for the second included 
subject at site no. 2 etc.). 
 
 
12.1 
Case Report Form recording and processing 
Data captured will be recorded by the investigator and/or delegated site staff in electronic Case Report 
Forms (eCRF) by means of an Electronic Data Capture (EDC) system (SMART-TRIAL) provided/hosted by an 
external party (MEDEI ApS, Copenhagen, Denmark). The system has built in features that enables users to 
be compliant with applicable regulatory standards and regulations.  All data in relation to SMART-TRIAL is 
stored on secured Microsoft Azure hardware located in the EU, i.e. Dublin, Ireland. 
All users of the EDC system have personal accounts, accessed by two-factor authentication, allowing 
tracking of all data entries and changes in the system (i.e. audit trail).  
 
All data, subject and product related, are to be recorded into the EDC system by the delegated site staff. 
This also includes the already collected subject reported outcomes (PRO).  
 
 
12.2 
Source documents 
 
Source documents will be the original records, including  the existing medical records, Auditbase, NOAH 
and Genie Medical. Where printouts or copies of the source documentation are used for the study, these 
shall be signed and dated (i.e. certified) by a member of the investigation site team. 

 
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12.3              Data Management Plan 
 
Data management-related activities, e.g. data cleaning and query handling, will be performed on interim 
basis within the EDC system by the data manager or monitor assigned by the sponsor. 
Once all data has been captured, reviewed and declared clean the database will be locked before any data 
analysis. Further details on the extent and the nature of data management activities will be outlined in a 
study specific Data Management Plan. 
12.4               Storage of data 
 
It is the responsibility of the investigator to make sure that medical files of the clinical investigation subject 
are stored in accordance with this CIP or according to national regulations whichever is most stringent, 
after the investigation has been completed. The principal investigator must take measures to prevent 
accidental or premature destruction of these documents. 
Readable copies of the eCRF data, either in printed form or in a digital format, as per the site’s preference, 
will be archived in the ISF at the study site after study closure. Oticon Medical will not at any time point be 
in control of the eCRF data archived in the ISF, unless only for the purpose of delivering it to the study site. 
All study data and study related documents will be securely stored at Oticon Medical and respective sites 
with restricted access and retained for at least 15 years, or in accordance to national regulations whichever 
is most stringent, after the study has been completed. 
The principal investigator must take measures to prevent accidental or premature destruction of these 
documents and at the end of the storage period, acquire a confirmation from the sponsor before 
proceeding with the destruction of the documentation. 
 
 
13 AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN 
Changes to an approved CIP can either be classified as non-substantial (administrative/minor changes with 
no significant impact on investigation) or as substantial amendments (changes with impact on scientific value, 
conduct and management, quality and safety of the investigation). 
In general, an EC approval is required when implementing a substantial amendment whereas, in case of a 
non-substantial CIP Amendments, it is generally not required. This needs to be confirmed with the EC and 
relevant authorizing parties on a case by case basis. 
In addition, substantial amendments to the Subject Information and Consent Form and/or other applicable 
documents previously approved by the EC must be approved by the EC, as applicable, before they will come 
into effect.  
 
 
14 DEVIATIONS FROM CLINICAL INVESTIGATION PLAN  
A CIP deviation is an intentional or unintentional failure to follow the requirements of the CIP. Every effort 
should be made to comply with the requirements of the CIP. The Investigator, and other representatives of 
the investigational site team, is not allowed to deviate from the CIP, unless needed to protect the rights, 
safety and well-being of the subjects (i.e. emergencies). However, as there will be no study visits, and all 

 
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data collected for this study are already existing in the patients’ medical files, no major deviations are 
expected. The sponsor is aware that there might be some datapoints missing in the final datafile, due to the 
fact that they might not have been collected originally. These will not be regarded as deviations   
If other deviations occur, the Investigator should inform the monitor/clinical trial manager and make a 
record in the CIP Deviation Log provided in the study site file.  The implications of the deviation must be 
reviewed and discussed between the Sponsor and the Investigator. If deviations are found during 
monitoring visits, they should also be documented in the monitoring report and handled as above. This 
should be done as soon as possible after detection to avoid repetitive deviations. Continuous review of 
protocol deviations during monitoring visits aim to detect systematic errors and to identify retraining needs 
at the site. Frequency of monitoring is described in the monitoring plan and should be increased if 
systematic deviations are identified. All protocol deviations must be documented stating the reason, date, 
the action(s) taken, and the impact for the subjects and/or the study. If serious or repeated deviations 
occur at a site, the Sponsor has the right to initiate early termination of the study. 
At the end of the study, or in connection to a predefined interim analysis, protocol deviations, if any, will be 
categorized as minor or major and their consequence on analysis populations will be determined. 
 
 
15 DEVICE ACCOUNTABILITY   
Due to the nature of the study device accountability is not applicable. 
 
16 STATEMENTS OF COMPLIANCE  
This clinical investigation will be conducted in compliance with this CIP, the current versions of the 
declaration of Helsinki and the ISO 14155 standard, the Medical Device Directive (MDD) 93/42/EEC, The 
Medical Device Regulation (EU) 2017/745 (MDR) as well as applicable regional and/or local regulatory 
requirements.  
The CIP and other required documents must be reviewed and approved in writing by an Ethics Committee 
(EC) before enrollment of subjects into the clinical investigation can be initiated. Since the investigational 
device holds the CE-mark, approval from a National Competent Authority (NCA) is not required. If 
applicable, an approval from a local Institutional review board (or equivalent) will be applied for by the 
sites. 
Oticon Medical has a Public and Product Liability Insurance (Policy number: DKLSCA03184), issued by CHUBB, 
that includes coverage of clinical trials. 
Oticon Medical will have a Clinical Agreement with the investigational site, and details regarding costs, 
payments, publication policy etc. will be specifically outlined in this agreement. 
 
17 INFORMED CONSENT PROCEDURE 
No study specific informed consent will be collected from the patients. As this is an observational (non-
interventional) retrospective investigation the informed consent usually required for human research 
subjects may be waived by an ethics committee.  
The rational for arguing for a waiver from the investigation-related informed consent requirement is mainly 
related to the nature and type of investigation, as indicated above. There are also additional arguments 
which may be considered for this investigation; the additional workload (disproportionate effort) for the 
investigation site team and the potential bias in subject inclusion (e.g. patients that either doesn’t respond 

 
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to the invitation or refuse participation) with corresponding scientific shortcomings. To ensure high quality 
data, partly by including as many applicable subjects into the investigation as possible, there is a need to 
enhance subject recruitment without the corresponding disproportionate effort and population bias an 
informed consent procedure would impose. Should an informed consent be required for this retrospective 
non-interventional investigation there is a potential risk for non-responsiveness and refusals that may 
result in inconclusive and biased data on e.g. non-users, indications, types of hearing losses etc. 
In an effort to comply with applicable subject data protection regulations while developing service 
improvements all patients treated at the investigation site, as part of the daily clinical routine practice, are 
asked to provide their consent to the document: “GDPR – what this means to you” (Appendix A). Section 3 
of this document reads:  
“We may also share information about you which will not identify you as an individual for our Service 
Improvement such as patient experience, patient survey or improvement regarding your treatment if you 
have had any.  Again, you may decide you do not want us to use your information for research and trials, 
but it will help the hospital” 
Even though the sponsor nor the investigation site does not rely on consent as the basis for lawful 
processing of personal data when conducting clinical research, it is decided that only subjects who already 
have consented to the referred document and section will be included in the investigation. The rational for 
this decision is based on the assumption that the potential ‘change of data usage’, in relation to the given 
consent, is justified by the type and purpose of the investigation, i.e. a non-interventional retrospective 
evaluation of hearing improvement when using the prescribed sound processor within its intended use. 
As indicated above, applicable data will only be collected retrospectively and will be pseudonymized when 
recorded in the eCRF. Data collection will be performed by the appointed investigators, who are also 
involved in the daily clinical routine at the investigation site. The collection is limited to data from the 
audiology records, and specifically within the pre-defined time window between the clinical routine visit 
when fitting of the Ponto 3 SuperPower sound processor was performed, and up and until the first clinical 
routine visit following this where audiology measurements were made. In addition, audiometric 
measurements for audiometry thresholds, that might have been performed at a clinical routine visit 
preceding the fitting, data will be collected from there. 
Safety data will, in the case of identification of any safety events, be followed up using standard post-
market surveillance/vigilance reporting, see section 9.3.2.  
All data concerning investigation subjects is protected under the Data Protection Act 2018 and General 
Data Protection Regulation (GDPR) and will be handled accordingly. For the sponsor, the legal basis for 
collecting and processing personal data in this investigation is ‘Legitimate interest’ (GDPR, Art. 6.1(f), in 
combination with Art. 9.2(i)). 
In summary, the research interest and the risk for research bias introduced by an additional informed 
consent procedure for this specific investigation justifies the limited, if any, change in use of data compared 
to what the subjects have already consented to as part of their regular care.    
 
18 ADVERSE EVENT, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES ADVERSE EVENT (AE) 
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury or any 
untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, in the 
context of a clinical investigation, whether or not related to the investigational medical device. 

 
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Note 1. This definition includes events related to the investigational medical device or the comparator. 
Note 2. This definition includes events related to the procedures involved. 
Note 3. For users or other persons, this definition is restricted to events related to the use of investigational medical 
devices. 
 
 18.1               Serious Adverse Events (SAE)  
 
A serious adverse event (SAE) is an adverse event that led to any of the following: 
a) death, 
b) serious deterioration in the health of the subject, users or other persons as defined by one or more 
of the following: 
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function including chronic diseases, or 
3. in-subject or prolonged hospitalisation, or 
4. medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
c) foetal distress, foetal death or a congenital abnormality or birth defect including physical or mental 
impairment 
 
Note: Planned hospitalisation for a pre-existing condition, or a procedure required by the CIP, without serious 
deterioration in health, is not considered a serious adverse event. 
 
 
18.1.1  Adverse Device Effect (ADE)  
An adverse device effect is an adverse event related to the use of an investigational medical device. 
 
Note 1: This definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. 
Note 2: This definition includes any event resulting from use error or from intentional misuse of the investigational 
medical device. 
 
18.1.2 Serious Adverse Device Effect (SADE) 
A serious adverse device effect is an adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event (see section 18.1). 
 
18.1.2.1 
Unanticipated Serious Adverse Device Effect (USADE) 
An unanticipated serious adverse device effect is a serious adverse device effect which by its nature, 
incidence, severity or outcome has not been identified in the current version of the risk analysis report. 
 
Note: Anticipated Serious Adverse Device Effect (ASADE) is an effect which by its nature, incidence, severity or 
outcome has been identified in the risk analysis. 
 
 
18.2 Device deficiency (DD) 
A device deficiency is defined as any inadequacy of an investigational medical device related to its identity, 
quality, durability, reliability, usability, safety or performance. 

 
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Note 1: Device deficiencies include malfunctions, use errors, and inadequacy in the information supplied by the 
manufacturer including labelling 
Note 2: This definition includes device deficiencies related to the investigational medical device or the comparator. 
Note: To distinguish between a DD and an ADE it may be useful to consider DDs as not directly affecting or 
involving the subject. 
 
 
18.3 Reporting of safety events 
18.3.1  Reporting of Adverse Event(s) 
All health problems, whether judged as related or not, that are assessed as described in section 9.3.2, must 
be recorded by the PI, or authorised designee, in the eCRF accordingly. For events judged as related, will be 
followed up using standard post-market surveillance/vigilance reporting, see section 9.3.2. Due to the 
retrospective approach no specific time limits are required regarding reporting time, but all reporting must 
be completed at the time of the closure of the study. 
 
18.4 Device deficiency reporting 
The Investigator is responsible for recording the following in the eCRF, for all device deficiencies identified 
as described in section 9.3.2: 
• 
Device deficiency details (e. g. date and description of occurrence). 
• 
Device deficiencies that might have led to a SADE if:  
o suitable action had not been taken or 
o intervention had not been made or 
o if circumstances had been less fortunate 
For device deficiencies that fulfil the SADE definition, the Investigator must provide Oticon Medical with 
detailed information. 
 
 
18.5 Safety event follow-up 
See section 9.3.2.  
 
18.6 Safety related contacts 
Should the need for further guidance on safety-related issues  or how to record these be evident, the 
following contact details applies: 
 
Oticon Medical: 
Phone: 
 
+46 31 748 61 70 (vigilance) 
Mail: 
 
QA@oticonmedical.se 
 
Postal address: 
Oticon Medical 
Datavägen 37, 
SE-436 32 Askim, Sweden 
 

 
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Clinical Trial Manager:  
Liselotte Borup 
Phone:  
 
+45 4124 1964 
e-mail: 
 
lsbo@oticonmedical.com 
 
 
 
19 SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL INVESTIGATION  
If the investigation is terminated early or suspended due to any reason, the Sponsor will promptly inform 
the Principal Investigators and the investigation sites of the termination or suspension and the reason(s) 
thereof. The EC will also be informed promptly and provided with the reason(s) for the termination or 
suspension by the Sponsor or by the PI/investigation sites. 
In addition, CIP deviations may result in termination of the Clinical Investigation at a site. 
 
 
20 PUBLICATION POLICY  
This investigation will be registered on ClinicalTrials.gov. 
The results obtained in the investigation will be compiled in a final Clinical Investigation Report and 
submitted for publication by the investigators in cooperation with the Sponsor. The Sponsor reserves the 
right to postpone publication and/or communication of the results for a short period of time to protect 
intellectual property as according to the Clinical Investigation Agreement Privacy and confidentiality of 
information about each subject will be preserved in any publication of the clinical investigation data.  
 
 
 
 
 
 
 

 
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21 SIGNATURE PAGE  
21.1 
Sponsor 
On behalf of Oticon Medical AB I agree to the terms of this investigation plan. 
  
 
Date and signature:  
 
Tove Rosenbom, Senior Director Clinical Research and Audiology 
 
Name and title 
 
 
 
 
 
21.2 
Principal Investigator  
I agree to the terms of this investigation plan. I will conduct the investigation according to the procedures 
specified herein and in consistency with the current version of the declaration of Helsinki and ISO 14155, 
Clinical investigation of medical devices for human subjects - Good Clinical Practice (GCP).  
 
 
Date and signature:  
 
John E FitzGerald ,Consultant Clinical Scientist  
Head of Audiological Services 
 
Name and title 
 
 

 
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22 REFERENCES 
1. Reinfeldt, S., et al., New developments in bone-conduction hearing implants: a review. Med Sound 
processors (Auckl), 2015. 8: p. 79-9 
2. Skarzynski, P.H., et al., The Bonebridge in Adults with Mixed and Conductive Hearing Loss: 
Audiological and Quality of Life Outcomes. Audiol Neurootol, 2019: p. 1-10. 
3. Rader, T., et al., Retrospective Analysis of Hearing-Impaired Adult Subjects Treated With an Active 
Transcutaneous Bone Conduction Implant. Otol Neurotol, 2018. 39(7): p. 874-881. 
4. Bravo-Torres, S., C. Der-Mussa, and E. Fuentes-Lopez, Active transcutaneous bone conduction 
implant: audiological results in paediatric subjects with bilateral microtia associated with external 
auditory canal atresia. Int J Audiol, 2018. 57(1): p. 53-60. 
5. Ratuszniak, A., et al., The Bonebridge implant in older children and adolescents with mixed or 
conductive hearing loss: Audiological outcomes. Int J Pediatr Otorhinolaryngol, 2018. 118: p. 97-
102. 
6. The Glasgow Health Status Questionnaires Manual, 1998 
7. Boothroyd A. (1968). Developments in speech audiometry. British Journal of Audiology , 2, 3–10. 
10.3109/05384916809074343 
8. Holgers, K.M., et al. Soft tissue reactions around percutaneous implants: a clinical study of soft 
tissue conditions around skin-penetrating titanium implants for bone-anchored hearing aids. Am J 
Otol, 1988. 9(1): p. 56-9 
9. Wang, Y., et al. Hearing improvement with softband and implanted bone-anchored hearing devices 
and modified implantation surgery in patients with bilateral microtia-atresia. Int. J. Ped. Otor 104 
(2018) 120-125.  
10. Caruso, A., et al. Bone anchored hearing implants without skin thinning: the Gruppo Otologico 
surgical and audiological experience. Ear Arch Otorhinolaryngol (2016). 
11. Rosa, F., et al. Bone Anchored Heairng Aid (BAHA) in children: Experience of tertiary referral centre 
in Portugal. Acta Otorrinolaringológica Espanola. (2016)  
 
 
 
23  REFERENCE DOCUMENTS 
 
[A] 197424 
 
Audiological Manual Ponto system 
[B] M52682 
 
Product information sheet 
[D] M52611 
 
UK IFU Ponto 3 SuperPower  
[E] EDMS DOC-00067091 
State of the Art – BAHS 
[F] M153631  
UK IFU Oticon Medical Streamer 
 
[I] M164253  
UK IFU Connectline microphone 
[J] M185563  
UK IFU Connectline phone adapter 
 
 
 
 
 
 
 

 
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24 
APPENDIX A 
GDPR - What this means to you. 
Sharing of Information 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The hospital keeps your information such as your 
name address, contact number and information 
relevant to your visits to the hospital. We may share 
this information with other hospitals or other 
organisations if they are involved in your care or to 
your GP practice. 
We may share your information with other agencies 
that can help you in the community settings such as 
Health Visitors, Social services, Housing and 
voluntary organisation who can support you with your 
condition.  You may decide you do not want to share 
your information.  
We may also share information about you which will 
not identify you as an individual for our Service 
Improvement such as patient experience, patient 
survey or improvement regarding your treatment if you 
have had any.  Again, you may decide you do not want 
us to use your information for research and trials but it 
will help the hospital