A Comparative, Controlled, Clinical Investigation of a Currently Marketed Hearing Aid When Programmed With Two Different Fitting Methods
Phase: NA
Conditions: Hearing Loss
Sponsor: Bernafon AG

 
BF002-1707, CIP, Version 3.0, 21.12.2017 
Cover Page 
A comparative, controlled, clinical investigation of a currently 
marketed hearing aid programmed with two different fitting methods 
 
Protocol 
 
 
Document dated:  2017.12.21 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 1 of 46 
 
 
 
 
 
A comparative, controlled, clinical investigation of 
a currently marketed hearing aid programmed with 
two different fitting methods. 
 
Clinical Study Protocol 
 
 
Study Type: 
Clinical Investigation with Medical Device (MD) 
Study Categorisation: 
Category C:  Medical Device without CE mark 
Study Registration: 
SNCTP, clinicaltrials.gov 
 
Study Identifier: 
BF002-1707 
Sponsor 
 
 Principal Investigator: 
Bernafon AG 
Morgenstrasse 131, 3018 Bern 
Barbara Simon 
bsim@bernafon.com +41 31 998 16 84 
Investigational Product: 
Fitting software; HearToo Studio 
Protocol Version and Date: 
Version3.0; Final Document 
 
 
CONFIDENTIAL 
 
The information contained in this document is confidential and the property of Bernafon AG. The 
information may not - in full or in part - be transmitted, reproduced, published, or disclosed to others 
than the applicable Competent Ethics Committee(s) and Regulatory Authority(ies) without prior written 
authorization from the sponsor except to the extent necessary to obtain informed consent from those 
who will participate in the study. 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 3 of 46 
Table of Contents 
STUDY SYNOPSIS ................................................................................................................................. 6 
STUDY SUMMARY IN LOCAL LANGUAGE ....................................................................................... 11 
ABBREVIATIONS ................................................................................................................................. 12 
STUDY SCHEDULE .............................................................................................................................. 13 
1. 
STUDY ADMINISTRATIVE STRUCTURE .................................................................................... 13 
1.1 
Sponsor, Sponsor-Investigator .................................................................................................... 13 
1.2 
Principal Investigator(s) ............................................................................................................... 14 
1.3 
Statistician ("Biostatistician") ....................................................................................................... 14 
1.4 
Laboratory ................................................................................................................................... 14 
1.5 
Monitoring institution ................................................................................................................... 14 
1.6 
Data Safety Monitoring Committee ............................................................................................. 14 
1.7 
Any other relevant Committee, Person, Organisation, Institution ............................................... 14 
2. 
ETHICAL AND REGULATORY ASPECTS .................................................................................. 15 
2.1 
Study registration ........................................................................................................................ 15 
2.2 
Categorisation of study................................................................................................................ 15 
2.3 
Competent Ethics Committee (CEC) .......................................................................................... 15 
2.4 
Competent Authorities (CA) ........................................................................................................ 15 
2.5 
Ethical Conduct of the Study ....................................................................................................... 15 
2.6 
Declaration of interest ................................................................................................................. 16 
2.7 
Patient Information and Informed Consent ................................................................................. 16 
2.8 
Participant privacy and confidentiality ......................................................................................... 16 
2.9 
Early termination of the study ...................................................................................................... 17 
2.10 Protocol amendments ................................................................................................................. 17 
3. 
BACKGROUND AND RATIONALE .............................................................................................. 18 
3.1 
Background and Rationale .......................................................................................................... 18 
3.2 
Investigational Product (treatment, device) and Indication ......................................................... 18 
3.3 
Preclinical Evidence .................................................................................................................... 19 
3.4 
Clinical Evidence to Date ............................................................................................................ 19 
3.5 
Medical Device: Rationale for the intended purpose in study (pre-market MD) ......................... 19 
3.6 
Explanation for choice of comparator (or placebo) ..................................................................... 20 
3.7 
Risks / Benefits ............................................................................................................................ 20 
3.8 
Justification of choice of study population ................................................................................... 20 
4. 
STUDY OBJECTIVES ................................................................................................................... 22 
4.1 
Overall Objective ......................................................................................................................... 22 
4.2 
Primary Objective ........................................................................................................................ 22 
4.3 
Secondary Objectives ................................................................................................................. 22 
4.4 
Safety Objectives ........................................................................................................................ 22 
5. 
STUDY OUTCOMES ..................................................................................................................... 23 
5.1 
Primary Outcome ........................................................................................................................ 23 
5.2 
Secondary Outcomes .................................................................................................................. 23 
5.3 
Other Outcomes of Interest ......................................................................................................... 23 
5.4 
Safety Outcomes ......................................................................................................................... 23 
6. 
STUDY DESIGN ............................................................................................................................ 24 
6.1 
General study design and justification of design ......................................................................... 24 
6.2 
Methods of minimising bias ......................................................................................................... 24 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 4 of 46 
6.2.1 Randomisation .................................................................................................................... 24 
6.2.2 Blinding procedures ............................................................................................................ 24 
6.2.3 Other methods of minimising bias ....................................................................................... 24 
6.3 
Unblinding Procedures (Code break) .......................................................................................... 25 
7. 
STUDY POPULATION .................................................................................................................. 25 
7.1 
Eligibility criteria ........................................................................................................................... 25 
7.2 
Recruitment and screening ......................................................................................................... 25 
7.3 
Assignment to study groups ........................................................................................................ 26 
7.4 
Criteria for withdrawal / discontinuation of participants ............................................................... 26 
8. 
STUDY INTERVENTION ............................................................................................................... 27 
8.1 
Identity of Investigational Products (medical device) .................................................................. 27 
8.1.1 Experimental Intervention (treatment / medical device) ...................................................... 27 
8.1.2 Control Intervention (standard/routine/comparator treatment / medical device) ................ 28 
8.1.3 Packaging, Labelling and Supply (re-supply) ..................................................................... 28 
8.1.4 Storage Conditions.............................................................................................................. 29 
8.2 
Administration of experimental and control interventions ........................................................... 29 
8.2.1 Experimental Intervention ................................................................................................... 29 
8.2.2 Control Intervention ............................................................................................................. 29 
8.3 
Dose / Device modifications ........................................................................................................ 29 
8.4 
Compliance with study intervention ............................................................................................. 30 
8.5 
Data Collection and Follow-up for withdrawn participants .......................................................... 30 
8.6 
Trial specific preventive measures .............................................................................................. 30 
8.7 
Concomitant Interventions (treatments) ...................................................................................... 30 
8.8 
Medical Device Accountability ..................................................................................................... 30 
8.9 
Return or Destruction of Study Drug / Medical Device ............................................................... 30 
9. 
STUDY ASSESSMENTS ............................................................................................................... 31 
9.1 
Study flow chart(s) / table of study procedures and assessments .............................................. 31 
9.2 
Assessments of outcomes .......................................................................................................... 31 
9.2.1 Assessment of primary outcome ......................................................................................... 31 
9.2.2 Assessment of secondary outcomes .................................................................................. 32 
9.2.3 Assessment of other outcomes of interest .......................................................................... 32 
9.2.4 Assessment of safety outcomes ......................................................................................... 32 
9.2.5 Assessments in participants who prematurely stop the study ............................................ 32 
9.3 
Procedures at each visit .............................................................................................................. 33 
9.3.1 Screening Visit/First Visit .................................................................................................... 33 
9.3.2 Second Visit ........................................................................................................................ 33 
9.3.3 Third Visit ............................................................................................................................ 33 
10. SAFETY ......................................................................................................................................... 34 
10.1 Medical Device Category C Studies ............................................................................................ 34 
10.1.1 Definition and Assessment of (Serious) Adverse Events and other safety related events . 34 
10.1.2 Reporting of (Serious) Adverse Events and other safety related events ............................ 36 
10.1.3 Follow up of (Serious) Adverse Events ............................................................................... 36 
11. STATISTICAL METHODS ............................................................................................................. 37 
11.1 Hypothesis ................................................................................................................................... 37 
11.2 Determination of Sample Size ..................................................................................................... 37 
11.3 Statistical criteria of termination of trial ....................................................................................... 38 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 5 of 46 
11.4 Planned Analyses ........................................................................................................................ 38 
11.4.1 Datasets to be analysed, analysis populations ................................................................... 38 
11.4.2 Primary Analysis ................................................................................................................. 38 
11.4.3 Secondary Analyses ........................................................................................................... 38 
11.4.4 Explanatory analyses .......................................................................................................... 39 
11.4.5 Interim analyses .................................................................................................................. 39 
11.4.6 Safety analysis .................................................................................................................... 39 
11.4.7 Deviation(s) from the original statistical plan ...................................................................... 39 
11.4.8 Deviation(s) from the original statistical plan ........................ Error! Bookmark no t defined. 
11.5 Handling of missing data and drop-outs...................................................................................... 39 
12. QUALITY ASSURANCE AND CONTROL .................................................................................... 40 
12.1 Data handling and record keeping / archiving ............................................................................. 40 
12.1.1 Case Report Forms ............................................................................................................. 40 
12.1.2 Specification of source documents ..................................................................................... 41 
12.1.3 Record keeping / archiving ................................................................................................. 41 
12.2 Data management ....................................................................................................................... 41 
12.2.1 Data Management System ................................................................................................. 41 
12.2.2 Data security, access and back-up ..................................................................................... 41 
12.2.3 Analysis and archiving ........................................................................................................ 42 
12.2.4 Electronic and central data validation ................................................................................. 42 
12.3 Monitoring .................................................................................................................................... 42 
12.4 Audits and Inspections ................................................................................................................ 42 
12.5 Confidentiality, Data Protection ................................................................................................... 42 
12.6 Storage of biological material and related health data ................................................................ 42 
13. PUBLICATION AND DISSEMINATION POLICY.......................................................................... 43 
14. FUNDING AND SUPPORT ............................................................................................................ 43 
14.1 Funding ....................................................................................................................................... 43 
15. INSURANCE .................................................................................................................................. 43 
16. REFERENCES ............................................................................................................................... 44 
17. APPENDICES ................................................................................................................................ 46 
 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 6 of 46 
STUDY SYNOPSIS  
 
Sponsor  / Sponsor -
Investigat or 
Bernafon AG 
Study Title: 
A comparative, controlled, clinical investigation of a currently marketed 
hearing aid programmed with two different fitting methods. 
Short Title / Study ID: 
BF002-1707 
Protocol Version  and 
Date: 
Version 3.0; 2017.12.21   
Trial regist ratio n: 
SNCTP, clincialtrials.gov 
Study category and 
Ration ale 
Category C: Medical Device without CE mark 
 
Clinical  Phase: 
Pre-market validation study involving human subjects. 
This clinical investigation is designed to evaluate different methods of 
fitting a currently marketed hearing instrument system. As human subjects 
are involved, this validation test falls under the definition of a clinical 
investigation. The validation addresses the subjective benefit of the 
instrument when fit with different approaches.  Does the end user perceive 
a difference between the fittings? Evaluating the overall safety is important 
for pre-market performance and safety validation.  
Back ground 
and 
Ration ale: 
Benefits of amplification and accessories used with it outweigh anticipated 
risks in mild to profound hearing-impaired subjects. The basic benefit of 
amplification should be present with any method that the trained 
professional fitting the instruments uses. The goal of this study is to 
compare two fitting methods and determine whether the end user 
perceives more benefit from one fitting method over the other.  The 
objective benefit is expected to be the same; however, the subjective 
benefit may be different due to a possible psychological effect from more 
effort or time spent by the trained professional.    
Bernafon will conduct this clinical investigation to test current hearing 
instruments fitted with the standard procedure and a self-directed 
procedure. Safety and performance validation of the new self-directed 
fitting software is needed before release to the market.   
The reason for this study is to evaluate a currently marketed, CE certified, 
hearing aid and determine whether different fitting methods provide the 
same perceived benefit.  Additionally, this study will validate the safety of 
the fitting procedure as well as collect post market safety information about 
the devices themselves. The goal is to evaluate the audiological 
performance objectively as well as the subjective benefit.   Furthermore, it 
is important to identify unexpected, unwanted behavior from the fitting 
software and the devices. 
Objective(s): 
The purpose of this research is to determine the potential of a narrative 
influence on the subjective benefit of the hearing instruments with the 
traditional fitting method versus the self-directed method. Furthermore, the 
objective benefit of the hearing instruments should not be affected by 
using a different fitting method. The gain applied by each fitting method 
should be the same and will be controlled by electro-acoustical measures.  

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 7 of 46 
Outcom e(s): 
Primary Endpoint: 
• 
Primary Outcome is the subjective benefit with the standard 
fitting compared to the self-directed fitting (using questionnaires) 
Secondary Endpoints: 
• 
Audiometry will be compared using the standard measurement 
made by the Investigator as a control against the self-directed 
measurement 
• 
Comparison of the objective performance of the devices (using 
speech testing) 
• 
Procedural safety meaning that there are no unwanted noises or 
artefacts heard from the devices (as reported by the subjects) 
• 
Scores from speech tests and questionnaires will be compared 
between the self-directed fitting and the standard fitting method.  
• 
No unexpected, unwanted behavior of the devices or 
unexpected device related AEs or SAEs. 
Study design : 
This is a controlled, randomized, cross-over, open label, comparative 
clinical investigation conducted at two sites within the canton of Bern. 
The study is based on a population of hearing impaired people that have 
hearing loss appropriate for the tested devices. 
The treatment assignment of participants is randomized as well as the test 
condition order during the lab testing. 
The standard fitting method will be used as a control.  The hearing 
instruments will be exactly the same.   
There is no placebo or “fake” device that does not provide amplification.  
A randomized cross-over design is used with half of the test subjects 
wearing the device fit with the traditional fitting method first and the other 
half using the self-directed method and then switching after approximately 
10 +/-5  days. 
A lab test will be used to test speech in a simulated environment.  After 
each field trial period, the participants will be tested unaided and aided 
with speech material.  

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 8 of 46 
Inclu sion  / Exclusion  
criteria: 
Inclusion Criteria: 
• 
All types of hearing loss (sensorineural, conductive, mixed) 
• 
If the hearing loss is conductive or mixed it must first be 
approved for amplification by a physician 
• 
All shapes of hearing loss (flat, sloping, reverse slope, notch)  
• 
Severity ranging from mild to severe 
• 
First time hearing aid users (never worn hearing aids before) 
• 
German speaking 
• 
Both genders 
• 
Ages 18 and older 
• 
Ability and willingness to sign the consent form 
Exclusion Criteria: 
• 
Current hearing aids users 
• 
Contraindications for amplification 
• 
Active ear disease 
• 
Inability to follow the procedures of the study due to language 
problems, psychological disorders, dementia, or other cognitive 
problems of the participant 
• 
A reduced mobility unable to attend weekly study appointments 
• 
A reduced ability to describe auditory impressions and the usage 
of the hearing aids 
• 
Uncooperative so that it is not possible to record a valid pure 
tone audiogram 
• 
A strongly reduced dexterity 
• 
With psychological problems 
• 
Central hearing disorders 
• 
Bernafon employees 
• 
Family members of Bernafon employees 
Measure ments 
and 
procedures: 
A hearing test will be made using standard audiometry performed by the 
investigator and a hearing screening using the new self-directed software 
which includes an automated screening. Amplification is fitted either using 
the first fit procedure with the standard Oasis software (RMD) or with the 
new self-directed software (IMD) that uses a simplified version of the 
existing Oasis software.  First fit in the context of this trial will mean without 
any additional fine tuning.  During a normal first fit it is possible to make 
changes based on subject comments.  However, to maintain that the 
acoustic fitting of the two sets of hearing aids is the same there will be no 
fine tuning performed. 
The subjects will complete a standardized questionnaire that measures 
their perceived handicap of the hearing loss (Gothenburg).  Two additional 
questionnaires will be used to measure a possible narrative effect on the 
subjective perception of the fitting procedures.  A standardized 
questionnaire, IOI-HA, and a custom product questionnaire will be used 
after each 10-day field test to evaluate the benefit of amplification with the 
RMD and the IMD. Also, a custom packaging questionnaire will be used 
after each fitting to measure the usability of the packaging of the RMD and 
the IMD.  At the last appointment the participants will complete a 
preference questionnaire. 
Speech intelligibility tested in quiet will be measured with both fittings.  The 
speech material will be a multi-syllable word test called the Freiburger 
Wörttest (FST) with the speech presented from a speaker in front of the 
subject.  
Safety is measured by reported unexpected sounds from the hearing aids 
verbally.  Safety is also measured by AEs or SAEs reported at visits. 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 9 of 46 
Study 
Product 
/ 
Intervention :  
HearToo Software 
The new self-directed fitting software is not CE marked.  It is a combination 
of two entities:  a self-directed hearing screening based on a known 
algorithm from Audiology Inc. sold in an automated audiogram by Grason 
Stadler, GSI (Eden Prairie, MN) and a simplified version of the Oasis 
software.  The flow of the new software is driven by the end user, but a 
trained professional should always assist with the fitting.  The new 
software will first perform a hearing screening on the end user and then 
recommend a hearing aid and prescribe amplification to the hearing aid 
based on the hearing screening results.  Please see the IB for a full 
description of the self-directed fitting device. An additional medical device 
used for the trial is the Juna 7 behind-the-ear (BTE) hearing device. It was 
released to the market in 2015.    
Control Intervention  
(if applic able): 
The reference intervention is the standard accepted method of fitting 
hearing instruments. The software version used to program the Juna 7 
devices with the traditional fitting is CE marked and has been used on the 
market since the release of the Juna product in 2015. The performance 
and subjective benefit of a self-directed fitting method will be tested 
against the standard.  For the purposes of this trial the standard fitting 
method will be referred to as the RMD and the new self-directed fitting 
software will be the IMD. 
Number 
of 
Particip ants 
with 
Ration ale: 
There will be an exploratory analysis of data only. The total number of 
participants will be a minimum of 24 (no more than 40), and the 
explanation for this sample size is as follows:   
A literature search about this tested topic does not provide enough strong 
references to build a confirmatory analysis. It seems that results might be 
strongly influenced by the inclusion criteria (first time vs experienced 
hearing aid users) or test design (cross-over, multi-investigator, or 
between group designs). There is no article to our knowledge that includes 
a multi-investigator effect in the test design when looking at the effect of 
different fitting procedures. Adding a treatment interaction term seems to 
be mandatory if this trial wants to determine the effect that different 
investigators may have.  Each investigator shall treat the same amount of 
subjects. 
The 24-40 subjects will participate in 2 field studies, but randomized into 
different fitting/intervention groups with half the number of subjects in each 
group.   
Study Duratio n: 
Approximately 3 months 
The screening of the participants will begin in February of 2018 and the 
final data collection appointments will occur in April 2018. 
Study Sched ule: 
The first participant is expected to begin in February 2018. 
The last participant is expected to finish the testing in April 2018. 
Investigat or(s): 
Barbara Simon, Research Audiologist, Doctor of Audiology 
Morgenstrasse 131 
3018 Bern, CH 
bsim@bernafon.com  +41 31 998 16 46 
Study Centre(s): 
The testing will be performed at two clinical sites in canton Bern, 
Switzerland.  
Statist ical 
Consider atio ns: 
The analysis and documentation will be performed by the statistician using 
the latest validated R version with R Studio as IDE.  Appropriate data 
analysis will be performed with parametric and non-parametric tests on 
questionnaire outcomes, hearing threshold measures, and speech test 
scores.   

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 10 of 46 
GCP Statement : 
This study will be conducted in compliance with the protocol, the current 
version of the Declaration of Helsinki, the ICH-GCP or ISO EN 14155 (as 
far as applicable) as well as all national legal and regulatory requirements.  
 
 
 
 
 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 11 of 46 
STUDY SUMMARY IN LOCAL LANGUAGE  
This study is designed to investigate the benefits of the hearing aid in the laboratory and in daily life 
when fitted with two different methods.  Subjective and objective evaluations will be made.  The aim is 
to show the benefits of the hearing aids with both fitting methods with the help of data obtained, and to 
improve the available fitting methods in order to further increase the benefit for people with hearing 
disorders in situations where the standard method and those trained to perform it are not available. 
 
 
Diese Studie soll untersuchen, ob es einen subjektiv wahrnehmbaren Unterschied gibt zwischen der 
Hörgerate Anpassung durch einen Audiologen oder eine Anpassung durch eine vom Hörbehinderten 
selbst bediente Software. Neben der subjektiven Wahrnehmung werden weiter subjektive und objektive 
Parameter in diese Studie erfasst. Insgesamt ist das Ziel dieser Studie, eine selbstbediente 
Anpassungsmethode zu testen, welche eingesetzt werden kann falls kein Audiologe zur Verfügung steht. 
Die Anpassung soll sich dabei nicht unterscheiden und die Hörqualität für den Hörbehinderten nicht 
leiden. 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 12 of 46 
ABBREVIATIONS 
Provide a list of abbreviations used on the protocol - to be completed 
 
AE 
AMTAS 
Adverse Event  
Automated Method for Testing Auditory Sensitivity 
CA 
Competent Authority (e.g. Swissmedic) 
CEC 
Competent Ethics Committee 
CRF 
Case Report Form  
ClinO 
Ordinance on Clinical Trials in Human Research (in German: KlinV, in French: 
OClin) 
eCRF 
Electronic Case Report Form  
CTCAE 
Common terminology criteria for adverse events 
DSUR 
Development safety update report 
GCP 
Good Clinical Practice  
IB 
Investigator’s Brochure 
Ho 
Null hypothesis 
H1 
HCP 
Alternative hypothesis 
Hearing Care Professional 
HFG 
Humanforschungsgesetz (Law on human research) 
HMG 
Heilmittelgesetz  
HRA 
Federal Act on Research involving Human Beings 
IMD 
Investigational Medical Devic 
IIT 
Investigator-initiated Trial 
ISO 
International Organisation for Standardisation 
ITT 
Intention to treat 
KlinV 
Verordnung über klinische Versuche in der Humanforschung (in English: ClinO, in 
French OClin) 
LPTh 
Loi sur les produits thérapeutiques 
LRH 
Loi fédérale relative à la recherche sur l’être humain 
MD 
Medical Device 
OClin 
Ordonnance sur les essais cliniques dans le cadre de la recherche sur l'être humain 
(in German : KlinV, in English : ClinO) 
PI 
RMD 
Principal Investigator  
Reference Medical Device 
SDV 
Source Data Verification  
SOP 
Standard Operating Procedure 
SPC 
Summary of product characteristics 
SUSAR 
Suspected Unexpected Serious Adverse Reaction  
TMF 
Trial Master File  
 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 13 of 46 
STUDY SCHEDULE  
Study Periods 
Intervention Period 
Visit 
Screening/1 
2 
3 
Day 
0 
10 +/- 5 days 
20 +/- 5 days 
Patient Information and 
Consent 
x 
 
 
Demographics 
x 
 
 
Medical/Hearing History 
x 
 
 
In-/Exclusion Criteria 
x 
 
 
Randomization 
x 
x 
 
Otoscopy 
x 
x 
x 
Audiometry 
x 
 
 
Administer Medical Device 
x* 
x* 
 
Baseline Measure (Gothenburg 
questionnaire) 
x 
 
 
Primary Variable (IOI-HA 
questionnaires) 
x 
x 
 
Secondary Variables 
(audiometry) 
x 
 
 
Other Variables (speech 
testing) 
 
x 
x 
Other Variables (product 
questionnaire) 
x 
x 
 
Other Variables (preference 
questionnaire) 
 
 
x 
Adverse Events 
x 
x 
x 
*Depending on randomization subjects will be fit with IMD at the first or second visit. Everyone will use 
the IMD at the first visit to perform audiometry. 
 
1. STUDY ADMINISTRATIVE STRUCTURE  
 
1.1 Sponsor,  Sponsor -Investigator  
Bernafon AG 
Morgenstrasse 131, 3018 Bern 
Tel. +41 31 998 01 01 
The role of the sponsor is to provide the sites for the testing as well as the equipment used during 
testing.  The sponsor will provide the hearing devices, the IMD, and the RMD used for the study.  The 
results will be used by the sponsor to prove the performance of the IMD.  The sponsor may audit the 
clinics as well as the processes and documentation performed by the investigators at those sites. 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 14 of 46 
 
1.2 Princ ipal Investigator( s)  
 
Barbara Simon, Research Audiologist 
Morgenstrasse 131, 3018 Bern 
Tel. +41 31 998 16 46 
Email: bsim@bernafon.com 
 
1.3 Statis tic ian (" Bios tatis tic ian" )  
 
Statistics will be performed by Christophe Lesimple.  Christophe Lesimple is an employee of Bernafon 
that works within the Product Management Audiology group and specializes in statistical analysis.  He 
is also certified in GCP.    
 
1.4 Labora tory 
 
Not applicable 
 
1.5 Monito ring ins tit ution  
Bernafon is in charge of monitoring in order to verify that the conduct of the clinical investigation complies 
with the approved CIP, subsequent amendment(s), ISO14155, and the applicable regulatory 
requirement(s).  There will be a specific person assigned as the Monitor (sec. 1.7). 
 
1.6 Data Safety Monitori ng Co mmi ttee  
 
There will not be a data safety monitoring committee employed.  The data will be stored using an 
accepted and validated data storage management system.   
 
1.7 Any other relevant Commi ttee, Person, Organis ation, Instit ution  
 
Julie Tantau will monitor the investigation.  She works within the Product Validation group at Bernafon.  
She is certified in GCP, and familiar with ISO 14155.  She has also been certified in Clinical Monitoring 
and has a CAS I in Clinical Trial Practice and Management. 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 15 of 46 
2. ETHICAL AND REGULATORY ASPECTS  
 
Before the study will be conducted, the protocol, the proposed patient information and consent form as 
well as other study-specific documents shall be submitted to a properly constituted Competent Ethics 
Committee (CEC) and Swissmedic. Any amendment to the protocol must as well be approved (if legally 
required) by these institutions. 
The decision of the CEC and Swissmedic concerning the conduct of the study will be made in writing to 
the Sponsor before commencement of this study. The clinical study can only begin once approval from 
all required authorities has been received. Any additional requirements imposed by the authorities shall 
be implemented. 
 
2.1 Study regis tration  
 
The study shall be registered in a registry by the US National Institutes of Health, an International Clinical 
Trials Registry Platform called Clinical Trials.gov (https://clinicaltrials.gov/ct2/home). In addition, the 
study will be registered in German in the Swiss National Clinical Trials Portal (SNCTP).  
 
2.2 Categoris ation of  study  
 
The clinical trial of these medical devices falls under Category C because although the hearing aids 
have the conformity marking and will be used in accordance with the instructions, the new self-fitting 
software does not.  The IMD and focus of the trial is the software device. 
Use of the devices is not prohibited in Switzerland. 
 
2.3 Competent Ethic s Commi ttee (CEC)  
The responsible investigator ensures that approval from an appropriately constituted Competent Ethics 
Committee (CEC) is sought for the clinical study.  
The responsible investigator will report any changes as well at the end of study within the allowed time 
frame (including changes to the research activity and all unanticipated problems involving risks to 
humans; including in case of planned or premature study end and the final report). No changes will be 
made to the protocol without prior Sponsor and CEC approval, except where necessary to eliminate 
apparent immediate hazards to study participants. 
Premature study end or interruption of the study will be reported within 15 days. The regular end of the 
study will be reported to the CEC within 90 days, and the final study report shall be submitted within one 
year after study end. Amendments are reported according to chapter 2.10. 
2.4 Competent Authoritie s (CA)  
 
The Sponsor will obtain approval from Swissmedic before the start of the clinical trial. CA approval is 
necessary for all studies category C (MD). 
The Sponsor will report any changes as well as the end of study within the allowed time frame (including 
changes to the research activity and all unanticipated problems involving risks to humans, including in 
case of planned or premature study end and the final report).  No changes will be made to the protocol 
without prior Swissmedic approval, except where necessary to eliminate apparent immediate hazards 
to study participants. 
 
2.5 Ethical Conduct of  the Study  
The study will be carried out in accordance to the protocol and with principles enunciated in the current 
version of the Declaration of Helsinki, the guidelines of Good Clinical Practice (GCP) issued by ICH, in 
case of medical device: the European Directive on medical devices 93/42/EEC and the ISO Norm 14155 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 16 of 46 
and ISO 14971, the Swiss Law and Swiss regulatory authority’s requirements. The CEC and regulatory 
authorities will receive annual safety and interim reports and be informed about study stop/end in 
agreement with local requirements.  
 
2.6 Declaration of  interest  
It is the policy of Bernafon AG that the conduct of employees and all other persons acting as its 
representatives should be at all times in the best interests of Bernafon AG, its members and the general 
public. In performing their duties, Bernafon AG representatives should not be influenced by desire for 
personal gain. Accordingly, Bernafon AG has adopted rules to guide disclosure of potential conflicts of 
interest and the society's response thereto that shall apply to those who agree to serve Bernafon AG in 
any official capacity.   
 
2.7 Patient Informa tion a nd Info rmed Con sent 
The participants will be informed about the study including what type of testing will be involved, how 
long it will last, and who will do the testing.  Consent is sought from each participant.  They will be 
compensated with  100 CHF cash.   
The investigator will explain to each participant the nature of the study, its purpose, the procedures 
involved, the expected duration, the potential risks and benefits and any discomfort it may entail. Each 
participant will be informed that the participation in the study is voluntary and that he/she may withdraw 
from the study at any time and that withdrawal of consent will not affect his/her subsequent medical 
assistance and treatment.  
The participant must be informed that his/her medical records may be examined by authorized 
individuals other than their treating physician. 
All participants for the study will be provided a participant information sheet and a consent form 
describing the study and providing sufficient information for participant to make an informed decision 
about their participation in the study.  The participants will sign the consent form in the clinic during the 
first visit if they choose to become a participant.  
The patient information sheet and the consent form will be submitted to the CEC to be reviewed and 
approved. The formal consent of a participant, using the approved consent form, must be obtained 
before the participant is submitted to any study procedure.   
The participant should read and consider the statement before signing and dating the informed consent 
form, and should be given a copy of the signed document. The consent form must also be signed and 
dated by the investigator (or his designee) and it will be retained as part of the study records. 
2.8 Partic ipant pri vacy and c onf identiality  
 
The investigator will permit trial-related monitoring, audits, IRB/IEC review, and regulatory inspections 
and will provide direct access to source data and/or documents.   
Additionally the investigator affirms and upholds the principle of the participant's right to privacy and that 
they shall comply with applicable privacy laws. Especially, anonymity of the participants shall be 
guaranteed when presenting the data at scientific meetings or publishing them in scientific journals.  
Individual subject medical information obtained as a result of this study is considered confidential and 
disclosure to third parties is prohibited. Subject confidentiality will be further ensured by utilising subject 
identification code numbers to correspond to treatment data in the computer files. 
The subject identification numbers have no relation to any subject private data (e.g. Birthdate).  The 
numbers are assigned as the subjects join the subject pool.  The number and corresponding subject 
name are written in a document that is stored in a secured document management system. The 
document can be opened with a security access code of 11 characters that is only given to study 
personnel that work with subjects (e.g. investigators/ audiologists). For data verification purposes, 
authorized representatives of the Sponsor (-Investigator), Swissmedic, or an ethics committee may 
require direct access to parts of the medical records relevant to the study, including participants’ medical 
history. 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 17 of 46 
2.9 Early termi nation of  the study  
The Sponsor and/or CEC and/or Swissmedic may terminate the study prematurely according to certain 
circumstances, for example: 
• 
ethical concerns, 
• 
insufficient participant recruitment, 
• 
when the safety of the participants is doubtful or at risk, respectively, 
• 
alterations in accepted clinical practice that make the continuation of a clinical trial unwise,  
• 
early evidence of benefit or harm of the experimental intervention  
 
2.10 Proto col amendm ents 
  
The Principal Investigator is allowed to amend the protocol or to provide suggestions for a protocol 
amendment. Any plans for protocol modifications will first be approved by the relevant parties (including, 
other investigators, CEC, and Swissmedic) before amending the protocol. 
Substantial amendments are only implemented after approval of the CEC and CA respectively. 
Under emergency circumstances, deviations from the protocol to protect the rights, safety and well-
being of human subjects may proceed without prior approval of the sponsor and the CEC/CA. Such 
deviations shall be documented and reported to the sponsor and the CEC/CA as soon as possible. 
All non-substantial amendments are communicated to Swissmedic as soon as possible if applicable and 
to the CEC within the Annual Safety Report (ASR).  
 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 18 of 46 
3. BACKGROUND AND RATIONALE  
 
3.1 Backgroun d and Rati onal e  
 
According the World Health Organization (WHO, 2016) 360 million people worldwide suffer from 
disabling hearing loss.  Hearing aid amplification is the most common treatment for hearing loss.  
Benefits of amplification and accessories used with it outweigh any risks in mild to profound hearing 
impaired subjects. A clinical literature evaluation is maintained and updated by Bernafon for new 
products.  The evaluation concludes that, “Hearing device use is “a non-invasive, comparatively low risk 
option with considerable potential benefits”.  As presented in the general literature evaluation, 
substantial scientific clinical literature shows that amplification of sound provides the claimed benefit for 
hearing impaired persons. The literature shows both significant improvements in speech intelligibility 
and improved life quality (Kochkin, 2011). The benefits are obtainable for both unilateral and bilateral 
fittings and are both short term and durable on long term.  
Bernafon AG sells hearing aids internationally.  They conduct trainings to teach people how to fit the 
hearing aids in multiple countries; however, it is not possible to train every person that fits a hearing aid.     
Different countries have different requirements for those that are allowed to sell and fit hearing aids. For 
example, the WHO has written a guideline for providing hearing aid services for developing countries.  
In that guideline it states that “Persons doing the fitting must have received the necessary training…” 
(WHO, 2004).  The document later describes the necessary training as a 3-week training with follow-up 
supervision and refresher courses.  With this in mind, Bernafon proposes a simplified and self-directed 
combined hearing screening and fitting software application that requires little training in order to 
complete a hearing screening and hearing aid fitting.  The availability of such a system will make hearing 
devices available for more people around the world living in either remote areas or developing countries 
without enough equipment and trained personnel.   
Bernafon AG will carry out studies of the IMD with test participants who have hearing loss in order to 
validate the performance and to qualify the benefit for the user when both the RMD and the IMD are 
used.  Additionally, the results of the trial will be used to identify areas of further optimization of the 
tested products.  The aim is to determine whether there is a narrative effect on the perceived benefit of 
the hearing aids from the RMD.  Audiometry will be compared to ensure that similar results are achieved 
with the IMD as those from a standard audiometry test.  Speech intelligibility will measure the objective 
benefit of the hearing aids.  The trial will also provide safety information.   
All participants are hearing impaired persons that have never used hearing aids before.  They will be fit 
with hearing aids that have been on the market for 2 years, Juna 7 Nano BTEs. They will be fit two times 
during the trial, once with the RMD and once with the IMD.   
The RMD is the standard first fit process of the Oasis software. The hearing thresholds are entered into 
the software and then used by the software to calculate the amount of amplification needed.  The 
software has default settings for features such as noise reduction and directionality.  The HCP saves 
the fitting and all settings are saved in the hearing aid.  The IMD will use the same calculation algorithm 
to determine the amount of amplification; however, the hearing thresholds will be transferred directly to 
the software after the automated hearing screening.  The same default settings will be applied, and the 
HCP will save the fitting.  The hearing aids will be fit exactly the same electro-acoustically.  The main 
difference is that the IMD is more patient driven; therefore, there could be a psychological effect that 
results in a higher rating for one hearing aid or the other.   
In summary, the primary reason for this study is to evaluate the new self-directed hearing aid fitting 
software.  It will not replace the current software but supplement markets that may not have the 
infrastructure or the trained personnel to use the current software.  Or in markets that currently use the 
standard software, it could be used as an optional fitting method for other outlets beside the clinics 
where the standard software is used, such as a pharmacy. The goal is to evaluate the audiological 
performance, possible narrative effect, and safety of the new software before it’s released to the market.  
 
3.2 Investigationa l Product (t reatment, de vice) and Indic ation  
 
The investigational product is a medical device (MD).  The brand name is HearToo Studio, 
manufactured by Bernafon AG. The software component of the combined screening and fitting 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 19 of 46 
software is Oasis 26.  The device is intended for people over 36 months of age.  The software does 
not have CE declaration. The device is a software application that can be downloaded onto a 
computer or a tablet.  It will come with headphones and a soundcard to be used for the hearing 
screening.  The hearing aids that can be fitted by the software are Bernafon Juna 7 hearing aids or 
Saphira 3 hearing aids, both of which are CE marked.  They have been sold on the market for 2 years.  
The hearing aids will be used in accordance with their original intended use description.  Consultants 
that receive a minimal amount of training will be able to use the IMD.  The IMD is self-directed 
meaning that the person getting the hearing aids will drive the flow of the software.  However, it is not 
intended to be used by the end user alone.  A consultant will guide them through the fitting flow and 
help with explanations of the screening results, hearing aids, or other questions that arise.  The 
headphones will be in contact with the outer portion of the ears.  The hearing aids consist of a body 
made of plastic parts and non-toxic paint that touch the outer portion of the ears.  Plastic tubing and a 
silicon dome are the parts that are fitted in the ear canal and come in contact with the skin.  The 
device is non-invasive and requires no surgical procedures. 
 
3.3 Preclinic al Evidence  
 
Bernafon requires evidence of the operational safety and medical effectiveness of the devices before 
testing with them.  This evidence includes the device-related performance data in accordance with IEC 
118-7:  Measurement of the maximum output level and the maximum gain of the hearing aids 
themselves.  The safety of the combined screening and fitting software is demonstrated by a beta 
version that has passed through a complete systematic software test and ensures the functionality of 
the hearing aids in combination with the software.  Please see chapter B3e of the IB.    
 
3.4 Clini cal Evidence to Date  
A clinical literature evaluation is maintained and has been updated in 2016 for the hearing aids.  They 
are designed to amplify sound.  The benefit of hearing aids has been shown in various studies 
(Kochkin, 2011).  The evaluation includes an analysis of adverse events for Bernafon products as well 
as competitor devices. The basic benefit of hearing aids does not change with newly released devices.   
A new literature search was completed in June of 2017 specifically for self-directed hearing test and 
fitting devices.  In 2013 a study was completed by Eikelboom et al. to compare the results of standard 
audiometry to an Automated Method for Testing Auditory Sensitivity (AMTAS) system.  The standard 
deviation between methods across frequencies was 6.4 dB.  Using standard audiometry a 5 dB test 
retest difference is acceptable.  The 6.4 dB difference using an AMTAS system is slightly higher than 
the expected but not significant.  According to a study by Convery et al. (2015), self-directed hearing 
tests show good test-retest reliability. Also, a study was completed by Convery et al. (2017) with a 
combination system similar to the IMD in which subjects completed a self-directed hearing test and 
fitting.  Fifty-five percent were able to complete the process with no errors at all.  The results show the 
importance of good training material.    
A risk assessment is performed for all new devices.  The primary risk identified is the possibility of 
achieving incorrect screening results if there is too much background noise.  For the study purposes the 
test will be completed in a clinic; therefore, this risk is not applicable.  However, in everyday use the 
environment in which the system is used cannot be controlled.  The risk is mitigated by providing training 
material for the consultant that describes the type of environment needed to run the hearing screening. 
Additionally, no adverse events for any currently marketed self-fit hearing instrument systems have been 
reported.   
The current study will provide further data for self-directed hearing tests and fitting systems.  
 
3.5 Medic al Device: Rational e for the intend ed purpo se in study (pre-market 
MD)  
 
The IMD will be used in accordance with current use of self-testing devices and fitting software.  The 
intended purpose of the study is to compare the performance of the IMD with the RMD.  In order to 
make an effective comparison the test participants shall wear the hearing aids fitted with both methods 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 20 of 46 
(IMD and RMD) for a minimum of 10 days per field test period. 
 
3.6 Explanation f or choic e of c ompa rator (or pl acebo)  
The comparator device is the standard Oasis software and fitting procedure that is used by HCPs.  
Additionally a standard audiological test completed by the investigator will be compared to the results 
from the self-directed procedure.  A placebo is not justified because the goal is not to test unaided 
versus aided, but the fitting procedure itself and how it impacts the perceived subjective benefit of the 
participants.  Therefore, the current accepted standard will be compared to a new automated 
procedure.   
 
3.7 Risks / Benefit s  
 
The audiological and psychoacoustic investigations are conducted using volunteer test participants with 
sound pressure levels that will not endanger their residual hearing.  The test participants will be advised 
of the type, content, extent, and possible risks of the test beforehand.  As psychometric methods are 
involved in the methods used, the risk for the test participants is judged to be extremely minor.  However, 
the following precautions should be taken: 
Risk of hearing loss to residual hearing at too high a level in audiological and psychoacoustic 
experiments:  Due to the test design (use of noise level up to a maximum of 100 dB SPL) on the 
construction of the measuring equipment (maximum output of loud speaker, maximum level control of 
headphones-output-stage) the maximum provided sound level is limited.  During the screening (test of 
hearing loss) a level of more than 100 dB SPL must be provided for test subjects who are profoundly 
hard of hearing.  Only the standard audiometry test controlled by the investigator has the capability of 
such levels.  The automated test is limited to an output of 80 dB SPL.   
A device risk analysis and risk assessment has been conducted for the new device according to EN 
ISO 14971. This describes the anticipated adverse device effects, residual risks associated with the 
investigational device and the procedures involved in its use.  It also describes that the anticipated 
clinical benefit outweighs the potential risks. Please see the Risk Assessment for details. 
Post-trial care is organized in a manner that allows the test participants to return to the clinical sites 
where they were originally recruited and arrange an appointment if they choose to purchase hearing 
aids. 
 
3.8 Justif ication of  choi ce of s tudy popula tion   
The choice of the study population was determined by the goal of the study.  The intended purpose of 
the study is to compare the current standard of fitting to the new self-directed device.  Therefore, only 
participants that are hearing impaired with a hearing loss that is indicated for amplification will be 
included.  Experienced hearing aid users will be excluded because they have experience with the 
standard testing and fitting procedure that will bias their judgement of the two processes used for this 
particular study. 
Test subjects will be chosen as they appear in  either the Bern Audika clinic or the Thun Audika clinic 
for appointments that they have made for an initial hearing test.    No employees of Bernafon or family 
members of employees will be included in the study.  The participants will have the study explained 
and be consented before any trial activities take place.  If they would like to participate, they will sign 
the consent form along with the investigator and trial activities for day 0 can begin.  All trial activities 
including the initial hearing test to determine candidacy will take place at either the Bern or Thun 
Audika clinics. 
If they do not wish to participate in the study they can cancel the appointment or they can continue 
with the normal hearing aid purchasing process.   
Testing normal hearing participants would not contribute information to this study.  It would not be 
ethical to fit normal hearing people with hearing aids.  Test participants must be able to sign and 
understand the consent form otherwise they will not be included. 
Vulnerable participants and those incapable of making their own judgments will not be included. 
For emergency situations, the following applies: 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 21 of 46 
-The standard procedure is to recommend that a subject see the ENT with whom they have an 
established relationship.  If a subject does not have an ENT then it is agreed with Dr. Carvacchio 
(Inselspital, Bern) that, if necessary, subjects from this trial could be referred to him.  
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 22 of 46 
4. STUDY OBJECTIVES  
4.1 Overall Objective 
The purpose of this study is to compare the performance of the IMD to the RMD.  The study aims to 
provide a final validation and quality control of the IMD before it is released for sales. 
4.2 Prim ary Objective 
The study seeks primarily to determine if the subjective benefit of the hearing aids fitted with the IMD is 
as good as the RMD.  Does one fitting method provide a psychological effect that influences the 
participants? As a second primary objective the study seeks to proactively determine if there is any 
unknown and/or unwanted behavior from the IMD.  The study seeks to validate that the performance of 
the IMD is not inferior to the RMD. 
4.3 Secondary  Objectives 
Secondary objectives are to assess the performance of the hearing aids after being programmed by 
both fitting methods.  The hearing aids will be the same electro-acoustically and should provide 
equivalent aided benefit. 
4.4 Safety Objectives 
The study aims to validate the overall implementation of the IMD.  The study will test for unexpected 
behavior from the IMD and new risk factors to ensure safety of the devices before they are released to 
the market.  
 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 23 of 46 
5. STUDY OUTCOMES  
5.1 Prim ary Outcome 
The primary outcome variable will be the subjective benefit of the hearing aids measured with a 
standardized questionnaire:  the International Outcome Inventory for Hearing Aids (IOI-HA) and a 
custom questionnaire based on the questionnaire used in the Naylor et al. (2015) study.  A comparison 
will be made between the subjective benefit measured with the hearing aids fitted with the control (RMD), 
and with the test device (IMD).   
5.2 Secondary  Outcomes 
The secondary outcome variables are the audiometry as measured with the standard test and with the 
automated system.  The data analysis will focus on the hearing threshold differences with both 
procedures in a nested model:  ear-participant-investigator. 
Additionally data logging from the hearing aids will be recorded as an indication of hearing aid use.  The 
data will be averaged from each ear.  The following data will be used:   
1.  Daily usage in hours per day, 
2.  Acoustical environment in percentage for the following listening environments:  quiet, speech in quiet, 
speech in noise, and noise. 
 
5.3 Other  Outcomes of In terest 
Explanatory variables include speech intelligibility testing using a multi-syllable word test called the 
Freiburger Sprachverständnistest (FST).  This test will measure the objective benefit (difference from 
unaided and aided) from the hearing aids as fitted with the RMD and the IMD.  Also the perceived 
handicap associated with hearing impairment may influence the perceived benefit from the hearing 
aids.  The Gothenburg Profile (GP) will be used to quantify perceived handicap and the influence it 
may have on the primary outcome.  A custom packaging questionnaire specific to hearing aids will test 
the usability of the packaging. 
  
5.4 Safety Outcomes 
The test participants will be asked whether anything unexpected that occurs during the field trial periods.  
Unexpected things include feedback or whistling from the device, unexpected sounds or artefacts from 
the device, discomfort, muting or shutting off of the device in mid-use, unexplained warning signals or 
beeping from the device, loud sounds, and occlusion. The information provided from the field trial will 
alert Bernafon to the potential for safety risks that should be addressed before the product is released 
to the market.   
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 24 of 46 
6. STUDY DESIGN  
6.1 General study design a nd j ustif ication of  design  
 
This is a controlled, randomized, open label, cross-over, comparative clinical investigation conducted at 
two sites within Canton Bern, Switzerland.  
The exploratory study is based on a population of hearing impaired people that have hearing loss 
appropriate for the hearing aids. 
As a control, the RMD will be used to fit the hearing aids as well as the IMD.  Additionally, a control 
situation will be implemented by using an unaided test condition in laboratory speech testing. 
There is no placebo or “fake” device that does not provide amplification.  A randomized cross-over 
design will be used with one group using the device programmed with the RMD first and the other using 
the device programmed with the IMD and then switching.  The testing will be unblinded as the subjects 
can clearly see a difference between fitting methods.  Although two hearing tests will be completed 
(standard audiometry and IMD screening), the hearing aids will be programmed only with the IMD 
screening results in order to reduce variability in the analysis of the results. Therefore, the hearing aids 
will be acoustically programmed the same, but this will not be explained to the participants.   
The same randomized test order will be used to test in a simulated environment.  At the end of the field 
test period the participants will return to the clinic.  They will be given a speech test in the unaided 
condition and the aided condition with the hearing aids as they have worn them for the previous 10 days.  
They will then be fit with the other method (whichever they did not have in the first round), and then have 
speech testing again in the aided and unaided condition at the end of the field test period.  
The participants will be expected to participate for approximately 1 month for a combination of field tests 
and lab tests.  For lab tests they will not spend more than 1.5 hours in the clinic for testing.  They will be 
expected to come for 3 visits in total.   Field trial periods will not last more than 10 +/-5 days. 
The sequence will begin with the screening visit which will also be the first intervention visit if they satisfy 
the inclusion criteria and if they choose to join the study.  The entire test procedure will be explained, 
and they will be given a Patient Informed consent form to read which will need to be signed, dated, and 
returned before any trial procedures begin. 
Subjects will be given questionnaires to complete with all field test periods.  After they have completed 
all appointments the subjects will complete a preference questionnaire to determine their preference 
between the IMD and RMD.  They will also be given the option to purchase hearing aids from the clinic.  
If they purchase the hearing aids they will receive all follow-up care at that specific clinic. 
 
6.2 Methods of minimi sing bia s  
6.2.1 
Randomisatio n  
For the cross-over design, the participants will be divided into two groups.  One group will begin the trial 
with hearing aids programmed with the IMD and the other group will begin the trial with hearing aids 
programmed with the RMD.  Each field trial will last for 10 days (+/-5d).  Then they will return to the clinic 
for an appointment.  The allocation to the groups will be randomized using a block randomization method 
in groups of four.  They will be assigned as they appear in the clinics for their appointments.  All 
investigators at the sites should be assigned an equivalent number of participants.   
6.2.2 
Blind ing procedu res  
There will be no blinding as it is impossible to hide the programming method because the differences 
are very distinct.   
 
6.2.3 
Other methods of  min imi sing  bias  
Two of the questionnaires used in the study are validated.  Two are custom questionnaires but based 
on similar questionnaires used in a study that was assessing the same narrative aspect as this study 
aims to measure. 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 25 of 46 
6.3 Unblinding P roc edur es (Code break)  
Not applicable. 
7. STUDY POPULATION  
The study will take place at two sites in canton Bern, Switzerland (Thun and Bern). 
 
7.1 Eligibil ity crite ria  
 
Participants fulfilling all of the following inclusion criteria are eligible for the study: 
• 
All classifications of hearing loss (sensorineural, conductive, combined) 
• 
If the hearing loss is conductive or combined it must be approved for amplification by a physician 
• 
All shapes of hearing loss (flat, sloping, reverse slope, notch)  
• 
Hearing loss severity ranging from mild to severe 
• 
First time hearing aid users 
• 
German speaking 
• 
Both genders 
• 
Ages 18 and older 
• 
Ability and willingness to sign the consent form 
 
The presence of any one of the following exclusion criteria will lead to exclusion of the participant: 
• 
Contraindications for amplification  
• 
Experienced or current hearing aid users 
• 
Active ear disease 
• 
Inability to follow the procedures of the study due to language problems, psychological 
disorders, dementia, or other cognitive problems of the participant, 
• 
A reduced mobility making them unable to attend weekly study appointments 
• 
A reduced ability to describe auditory impressions and the usage of the hearing aids 
• 
Uncooperative so that it is not possible to record a valid pure tone audiogram 
• 
A strongly reduced dexterity 
• 
Central hearing disorders 
• 
Bernafon employees 
• 
Family members of Bernafon employees 
 
7.2 Recruitme nt and screening  
The participants will be recruited by the Audika call center.  The call center has a database of 
prospective clients that have either come in for a hearing test and not purchased hearing aids or have 
never come for an appointment.  The call center will use the following text when phoning prospective 
participants: 
Guten Tag, meine Name ist XXX von Audika.  Wir führen eine klinische Studie über Hörgeräte durch 
und wollten Sie anfragen, ob Sie an der Studie teilnehmen möchten. 
Die Teilnahme an der Studie umfasst das Tragen von Hörgeräten, Sprachtests und das Beantworten 
eines Fragebogens über den Anpassungsprozess von Hörgeräten. 
Für die Studie werden insgesamt 3 Termine in einer Audika Filiale in Bern oder in Thun erforderlich 
sein. Zwischen den Besuchen liegt eine Testphase von ca. 10 Tagen, somit wird die 
Gesamtstudienzeit ungefähr 1 Monat betragen. Im ersten Termin stellen wir fest, ob Sie für die Studie 
geeignet sind oder nicht und erklären Ihnen ausführlich den weiteren Ablauf. 
Am Ende des Versuchzeitsraumes haben Sie die Möglichkeit die Hörgeräte zu erwerben. Als Dank für 
Ihre Teilnahme erhalten Sie 100 CHF.  
Wenn Sie teilnehmen möchten oder mehr Informationen benötigen, können wir einen Termin 
vereinbaren.   

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 26 of 46 
((When they don’t want to make an appointment say:)) 
Gerne senden wir Ihnen alle Details der Studie noch einmal per Post zu und melden uns bei Ihnen in 
einer Woche noch einmal. An welche Adresse dürfen wir Ihnen die Unterlagen senden? 
((When they choose not to participate say:)) 
Ich danke Ihnen für ihre Zeit und wünsche Ihnen einen guten Tag. 
Do not send the person any information about the trial or contact them again about the trial. 
 
At the appointment, the trial will be explained and Patient Information given to them to read if they 
have not already received it by mail.  They will have time to ask questions. 
If it is determined that their hearing loss is appropriate they will be given the opportunity to participate 
in the trial.  If they choose to join the trial, they will be given the consent form to sign.  No trial 
proceedings will begin until the consent form has been signed by the participant and the investigator.  
The visit described as the screening/V1 will then proceed as per the trial schedule.   
 
7.3 Assignme nt to study group s  
The participants are randomized by a block assignment as they appear at the trial sites.  There will be 
24-40 subjects.  The test condition order will be randomized using a 2-factor randomization with a 6 
block design.  The first factor is the investigator with 4 levels, and the second factor is the test order 
with 2 levels.  This will minimize the bias created when one test condition is tested in the first or last 
position all of the time.    
 
7.4 Criter ia for withdra wal / discont inua tion o f partic ipants  
 
Participants are allowed to withdraw from the study at any time and for any reason.  They do not have 
to share the reasons with the investigator.  They will be asked to return the hearing aids.  If the decision 
is made by the investigator then they will inform the participant in person that they are no longer needed 
for the study.  Reasons for withdrawing a participant from the study could be for non-compliance during 
testing, unreliable responses, medical reasons such as an ear infection, or the study may need to be 
stopped or postponed.  Any data gathered from these subjects will be used for the current study.  All 
data will remain encoded because results are only recorded using the identification code of the subject. 
There will be at least 5 “back-up” test participants to replace those that withdraw or are withdrawn.  
These are participants that have already been screened and determined to be appropriate for the testing. 
 
 
 


%)&,39HUVLRQ

3DJHRI
 678'<,17(59(17,21
 ,GHQWLW\RI,QYHVWLJDWLRQD O3URGXFWV PHGLF DOGHYLFH
7KHWUHDWPHQWZLOOEHDSSUR[LPDWHO\PRQWKRIXVHRYHUDOOZLWKKHDULQJDLGV'XULQJKDOIRIWKLVWLPH
WKHSDUWLFLSDQWVZLOOXVHKHDULQJDLGVSURJUDPPHGZLWKWKH,0'DQGGXULQJWKHRWKHUKDOIWKHKHDULQJ
DLGVZLOOEHSURJUDPPHGZLWKWKH50'
7KHUHDUHILHOGWHVWSHULRGVSODQQHG7KH\ZLOOFRQWLQXHZHDULQJWKHKHDULQJDLGVWKURXJKRXWERWKILHOG
WHVWVDQGRQO\KDYHWKHPUHSURJUDPPHGDW9LVLW7KHUHLVQRQHHGIRUDZDVKRXWSHULRGRUEUHDNV
EHWZHHQWKHILWWLQJVEHFDXVHDPSOLILFDWLRQIURPKHDULQJDLGVGRQRWLQGXFHDFDUU\RYHUHIIHFW
$WWKHHQGRIWKHWULDOWKHSDUWLFLSDQWVZLOOUHWXUQDOOKHDULQJDLGV7KH\ZLOOKDYHWKHRSWLRQWRSXUFKDVH
KHDULQJDLGVEXWWKH\ZLOOEHQHZVHULDOQXPEHUVDQGQRWWKHGHYLFHVXVHGGXULQJWKHWULDO

([SHULPHQ WDO,QWHUYHQWLRQ WUHDWPHQWPHGLFDO GHYLFH
7KHLQYHVWLJDWLRQDOSURGXFW,0'LVDPHGLFDOGHYLFH,WLVDQHZVHOIGLUHFWHGVRIWZDUHWKDWFRPELQHV
DKHDULQJVFUHHQLQJDQGWKHKHDULQJDLGILWWLQJLQWRRQHSURFHGXUH7KHQDPHRIWKHVRIWZDUHLV+HDU7RR
6WXGLR7KHKHDULQJDLGWKDWWKHVRIWZDUHZLOOSURJUDPIRUWKHWULDOLVDOUHDG\&(PDUNHGDQGVROGRQ
WKHPDUNHWIRU\HDUV,WVWLOOKDVWKHVDPHLQWHQGHGXVHDQGWKHEDVLFIXQFWLRQRIDPSOLI\LQJVRXQG
7KH,0'ZLOOSURGXFHDXWRPDWHGWRQHVDWDIUHTXHQF\UDQJHRI+]WR+]ZLWKDQRXWSXWOLPLW
RIG%$VWDQGDUGDXGLRPHWHUKDVDQRXWSXWRIXSWRG%DWFHUWDLQIUHTXHQFLHV7KH,0'RQO\
KDVDQRXWSXWRIG%WRPLWLJDWHWKHULVNRIDSHUVRQDOORZLQJWKHV\VWHPWRSUHVHQWWRRORXGRIWRQHV
E\QRWUHVSRQGLQJ7KHXVHUZLOOUHVSRQGZKHQWKH\KHDUWKHWRQH7KH,0'WUDQVIHUVWKHVFUHHQLQJ
UHVXOWVWRDUHVWULFWHGYHUVLRQRI2DVLVVRIWZDUHWRLPSOHPHQWWKHUHVXOWVLQWRWKHKHDULQJDLGILWWLQJ
7UDGLWLRQDOO\WKHVHUHVXOWVDUHLQSXWPDQXDOO\E\WKH+&3LQWRWKHVRIWZDUH7KHVRIWZDUHZLOOXVHWKH
VFUHHQLQJUHVXOWVWRTXDQWLI\WKHDPRXQWRIDPSOLILFDWLRQQHHGHGLQWKHKHDULQJDLGLQWKHVDPHPDQQHU
WKDWLWGRHVLQWKHFXUUHQW2DVLVVRIWZDUH3HUIRUPDQFHLVH[SHFWHGWREHWKHVDPHZKHQSURJUDPPHG
ZLWKWKH,0'DVLWLVZLWKWKH50'EHFDXVHERWKILWWLQJPHWKRGVZLOOXVHWKH,0'VFUHHQLQJUHVXOWVWR
FDOFXODWH JDLQ  7KH KHDULQJ DLGV ZKHQ SURJUDPPHG ZLWK HLWKHU PHWKRG ZLOO EH WKH VDPH HOHFWUR
DFRXVWLFDOO\
7KHYHUVLRQRI2DVLVVRIWZDUHLVDUHVWULFWHGDQGVLPSOLILHGYHUVLRQ7KHUHZLOORQO\EHVW\OHVRIKHDULQJ
DLGVRIIHUHGDQGRQHW\SHRIDFRXVWLFV7KHUHIRUHGHFLVLRQVWKDW+&3VZRXOGQRUPDOO\KDYHWRPDNH
ZLWKWKHVWDQGDUGVRIWZDUHKDYHEHHQUHPRYHGDQGDUHDXWRPDWLFDOO\FKRVHQLQWKHVRIWZDUH7KH+&3
FDQQRWILWPXOWLSOHSURJUDPVWRWKHKHDULQJDLGZLWKWKH,0'RQO\RQH7KH\DOVRFDQPDNHVLPSOHILQH
WXQLQJDVVHHQLQWKHSLFWXUHEHORZ,QWKHVWDQGDUGYHUVLRQRIWKHVRIWZDUHWKH+&3FDQDGMXVWVSHFLILF
IUHTXHQFLHVDQGLQSXWOHYHOVDVZHOODVDGMXVWIHDWXUHV
7KHQHZVRIWZDUHLVDQRQLQYDVLYHGHYLFH,WXVHVVXSUDDXUDOKHDGSKRQHVWRFRQGXFWWKHKHDULQJ
VFUHHQLQJ7KHKHDULQJDLGLWVHOILVZRUQEHKLQGRYHUWKHHDUZLWKDSDUWWKDWILWVLQWRWKHHDUFDQDO7KH
SDUWWKDWILWVLQWKHHDUFDQDOLVHLWKHUPDGHRIVLOLFRQRUSODVWLFWKDWLVFRYHUHGZLWKDQDFU\OLFFRDWLQJ
IRUFXVWRPPROGVRU,7(V7KHKDUGZDUHRIWKH%7(LVSDLQWHGZLWKDQRQWR[LFSDLQW%HORZLVD
SLFWXUHRIWKHSURFHVVRIWKH,0')LUVWWKHKHDULQJVFUHHQLQJWKHQWKHKHDULQJILWWLQJDQGILQDOO\WKH
VHWWLQJVDUHVDYHGWRWKHKHDULQJDLGV





%)&,39HUVLRQ

3DJHRI









&RQWURO,QW HUYHQWLRQ VWDQ GDUGURXWLQHFRP SDUDWRUWUHDWPHQWPHGLFDOGHYLFH
7KH5HIHUHQFH0HGLFDO'HYLFH50'LVWKHVWDQGDUGKHDULQJDLGILWWLQJVRIWZDUHXVHGE\DQ+&3
1RUPDOO\DIWHUWKH\KDYHFRPSOHWHGDPDQXDOKHDULQJWHVWWKH+&3HQWHUVWKHUHVXOWVLQWRWKHILWWLQJ
VRIWZDUHWRSHUIRUPWKHILWWLQJ7KHLQWHQGHGSXUSRVHLVWKHVDPHKRZHYHUWKH,0'LVDXWRPDWHGDQG
WKH50'LVPDQXDO)RUWKHSXUSRVHVRIWKLVWULDOWKHILWWLQJSURFHVVLVWKHIRFXVDQGQRWWKHKHDULQJDLG
RXWSXW7KHVWDQGDUGDXGLRJUDPUHVXOWVZLOORQO\EHXVHGIRULQFOXVLRQH[FOXVLRQFULWHULDDQGDVDFRQWURO
7KHILWWLQJVZLWKERWKWKH,0'DQGWKH50'ZLOOXVHWKHKHDULQJ VFUHHQLQJUHVXOWVIURPWKH,0'WR
FDOFXODWHWKHILWWLQJWDUJHWV7KHUHVXOWLQJDPSOLILFDWLRQZLOOEHWKHVDPHIURPERWKGHYLFHV7KHKHDULQJ
DLGVZLOOEHSURJUDPPHGRQO\ZLWKWKH,0'VFUHHQLQJUHVXOWVLQRUGHUWRUHGXFHYDULDELOLW\LQWKHDQDO\VLV


3DFNDJLQJ /DEHOOLQJ DQG6XSSO\UHVXS SO\

7KH,0'SURGXFWFRPHVLQD86%GULYHWKDWWKHSURIHVVLRQDOFDQGRZQORDGRQWRDFRPSXWHURUD
WDEOHW7KH86%FRPHVLQDER[ZLWKLQVWUXFWLRQVIRUGRZQORDGLQJSULQWHGLQWKHLQVLGHXSSHUIODSRI
WKHER[7ZR86%VZLOOEHQHHGHGIRUWKHWULDORQHSHUVLWH5HVXSSO\VKRXOGQRWEHQHFHVVDU\
XQOHVVWKHUHLVDGHIHFWZLWKWKH86%
2WKHUPHGLFDOGHYLFHVXVHGIRUWKHWULDODUHWKHKHDULQJDLGV(DFKKHDULQJDLGKDVLWVRZQVHULDO
QXPEHUWKDWFDQEHWUDFNHGEDFNWRSURGXFWLRQ7KHVHZLOOEHVKLSSHGWRWKHWULDOVLWHV7KHVLWHVZLOO
GRFXPHQWZKLFKVHULDOQXPEHUVWKDWWKH\UHFHLYH7KH\ZLOOWUDFNZKLFKVHULDOQXPEHUVDUHJLYHQWR
SDUWLFLSDQWVDQGWKH\ZLOOWUDFNWKDWHDFKRIWKRVHVHULDOQXPEHUVLVUHWXUQHGWRWKHVLWH


 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 29 of 46 
8.1.4 
Storage Condition s  
The IMD is stored on the computer or tablet once downloaded and will stay there for the entire study.   
The hearing aids should be kept in a locked compartment, and only the site investigator should have 
access.  This is to maintain control over the serial numbers handed out and received back at the site.   
The devices are stored in the blister packs which are kept in boxes in a warehouse until shipped.  
They have a shelf life of years.  They should not be exposed to temperatures below -25° and not 
above 60° Celsius during storage or transport.  The storage of these devices is according to standard 
procedures. 
 
8.2 Admini stration of  experim ental and c ont rol i nterventions   
8.2.1 
Experimen tal Intervention   
At the first visit the participants will complete a hearing test using standard audiometry performed by 
the clinician and a screening using the IMD.  The standard audiometry is used as a base test for the 
inclusion/exclusion criteria and as a control measure for the screening results of the IMD. The hearing 
devices will be programmed using both the RMD and the IMD during the course of the trial. The 
screening results from the IMD will be used for both fittings to ensure that the acoustic output of both 
methods is the same.  The difference in the fitting process of the RMD and the IMD is the focus of the 
trial and not the actual output of the hearing aid. 
The IMD will present tones from 250 Hz to 8000 Hz, and the participants will indicate when they’ve 
heard the tone.  The tones are directed into the ears of the participants with supra-aural headphones.  
The test should take no more than 15 minutes.  Depending on the randomization assignment, some 
participants will then start the fitting portion of the IMD.  Hearing instruments will be connected using a 
wireless neck loop that the subjects will wear.  Once the fitting has been programmed into the hearing 
aids the investigator will place the hearing aids in the subject’s ears.  The fitting process should not 
take more than 20 minutes.  They will wear the programmed devices for approximately 10 hours per 
day for an overall time of approximately 20 +/-10 days for the trial.  There are no surgical techniques 
used in the application of this device.  It is a non-invasive device.   
The study procedure will use a cross over design with two groups.  One group will wear the hearing aids 
fitted with the IMD and one will wear the hearing aids fitting with the RMD.  After 10 days they will switch 
to whichever method they did not have previously.  As stated, the device is non-invasive and requires 
no surgical procedure.  The device sound port will be inserted into the ear and the body of the device 
placed behind the ear each morning by the subjects themselves and removed each night by the subjects 
themselves. There is minimal training needed for a first time user to learn how to insert a hearing device.   
The subjects will be given an Instructions for Use booklet that explains how to insert the device and 
provides further instructions concerning cleaning, battery changing, and warnings. 
 
8.2.2 
Control Int ervention  
The hearing screening results achieved from the IMD will be manually entered into the standard Oasis 
software for the fitting with the RMD. The hearing aids will be connected to the software using the 
same wireless neck loop used for the programming with the IMD.  The investigator will fit the hearing 
aids and then place them in the subject’s ears.   
The subject will then wear the hearing aids for 10 days.  The device will be inserted into the ear and 
placed over the ear each morning by the subjects themselves and removed each night by the subjects 
themselves. There is minimal training needed for a first time user to learn how to insert a hearing device.   
The subjects will be given an Instructions for Use booklet that explains how to insert the device and 
provides further instructions concerning cleaning, battery changing, and warnings. 
 
8.3 Dose / Device modifi cations  
 
The IMD will fit the same amount of amplification to the hearing aids as the RMD; therefore, they 
should not experience any significant negative differences that would make the subjects want to 
discontinue use of the device.  However, if the subject requests to discontinue they can, at any time, 
remove the hearing aids fitted either with the IMD or the RMD.  They will be asked to return the 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 30 of 46 
hearing aids to the site, but their data will still be included in the results for the current study. All data 
will remain encoded because results are only recorded using the identification code of the subject. 
 
 
8.4 Compli ance with s tudy intervention  
  
It is clearly explained to the subjects that during the periods of intervention it is important to the study 
that they wear the hearing aids.  However, it is the responsibility of the subject to place the hearing aids 
in their ears every morning.   
The software monitors the amount of time that the devices are worn.  Therefore, it will be noted if the 
hearing aids from either field trial have not been worn the expected amount of time or if the time worn 
between trial periods is not similar.  If the device has not been worn a sufficient amount of time the data 
will not be used for the study.  The subjects will be asked to return the devices.  
8.5 Data Coll ection and Follo w-up fo r withdr awn partic ipants  
 
Withdrawn subjects’ data will not be used in any final data analysis or report.  Any data that is 
collected prior to withdrawal will be kept in the data management database.  The data will remain 
encoded because results are only recorded using the identification code of the subject.  Withdrawn 
subjects will have the opportunity to return to the clinic that recruited them for their hearing healthcare 
needs whether to purchase hearing aids or routine hearing tests.   
8.6 Trial specifi c preventive measures 
 
The performance of a hearing aid is not impacted by medication.  The subjects will continue to take 
whatever type of medication that they normally take.  There will be no impact on the study objectives.  
 
8.7 Concomitant Inter ventions  (treatments)  
 
Test subjects will continue to receive any concomitant care and medication that they normally receive 
during the use of the IMD.  Use of medication or other therapies will not affect the benefit of the hearing 
aids. There will be no impact on the study objectives. 
 
8.8 Medic al Device Account abili ty  
 
The USB used to download the IMD software into each site’s trial specific computer will be tracked with 
serial numbers.  They will be shipped from Poland. Only IMD that are from a tested batch will be used 
in the study 
The subjects will be assigned hearing aids with serial numbers.  The serial numbers are tracked when 
fitted and tracked that they are received back by the sites on the last visit.  The devices have serial 
numbers by which the individual device can be identified and the production history traced.  They will 
be shipped from the production site in Poland.  The serial numbers will provide the traceability of their 
production and from which batch they came.   
 
8.9 Return or De structio n of Stud y Drug /  Medic al Device  
At the end of the study the software will be uninstalled from the sites’ computers (confirmed by the 
monitor), and the USB containing the software will be shipped back to the sponsor. 
At the end of the study all of the subjects will return the hearing aids to the sites.  The sites will return 
the hearing aids back to the sponsor.  It will be noted in the documentation that the devices were returned. 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 31 of 46 
9. STUDY ASSESSMENTS  
 
9.1 Study flow  chart(s) / table of s tudy proc edure s and assessments 
Study Periods 
Intervention Period 
Visit 
Screening/1 
2 
3 
Day 
0 
10 +/- 5 days 
20 +/- 5 days 
Patient Information and 
Consent 
x 
 
 
Demographics 
x 
 
 
Medical History 
x 
 
 
In-/Exclusion Criteria 
x 
 
 
Randomization 
x 
x 
 
Otoscopy 
x 
x 
x 
Audiometry 
x 
 
 
Administer Medical Device 
x* 
x* 
 
Baseline Measure (Gothenburg 
questionnaire) 
x 
 
 
Primary Variable (IOI-HA 
questionnaires) 
x 
x 
 
Secondary Variables 
(audiometry) 
x 
 
 
Other Variables (speech 
testing) 
 
x 
x 
Other Variables (product 
questionnaire) 
x 
x 
 
Other Variables (preference 
questionnaire) 
 
 
x 
Adverse Events 
x 
x 
x 
*Depending on randomization subjects will be fit with IMD at the first or second visit. Everyone will use 
the IMD at the first visit to perform audiometry. 
9.2 Assessments of out comes  
 
9.2.1 
Assessment of primar y outcom e  
The primary outcome is the subjective assessment of the IMD compared with the RMD.  It will be 
measured two times during the trial.  After each field trial when the subjects have worn the devices 
programmed with either the RMD or the IMD they will answer 2 questionnaires (IOI-HA and product) 
that measure their subjective opinion of the benefit they received from the hearing aids during that period 
of the trial. The results from the two trial periods will directly compare the IMD with the RMD.  At the final 
visit they will answer one preference questionnaire where they will choose between the hearing aids 
fitted with the IMD or the RMD. 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 32 of 46 
9.2.2 
Assessment of secondary ou tcom es 
The secondary outcome is the comparison of the two hearing results.  The IMD combines an 
automated screening into the hearing aid fitting.  The results from this screening will be compared with 
a standard audiometry test performed by the investigator.  This will be measured at the first visit.  
Additionally, the data recording from the hearing aids will be compared including the average amount 
of time in hours per day that the hearing aids are worn and in which listening environments:  quiet, 
speech in quiet, speech in noise, and noise.  This information will be collected at the end of each field 
trial period when the subjects return to the clinic. 
 
9.2.3 
Assessment of other outcom es of int erest 
Other outcomes of interest include speech testing as an objective measure of the hearing aids 
programmed with the IMD and the RMD.  The Freiburger Sprachverständnistest consists of speech 
material that contains groups of 10 multi-syllable words which are numbers.  The words are presented 
every 5 seconds.  The participant must repeat the word immediately after they hear it.  The goal is to 
find the presentation level at which the participant can repeat approximately 50% of the words 
correctly.  This level will be measured for the unaided and aided conditions and recorded as test 
outcomes by the investigator. The differences between unaided and aided (IMD vs. RMD) will be used 
as an explanatory variable for the model. 
Also, the perceived handicap associated with hearing impairment could potentially play a role in the 
perceived benefit from hearing aid. The Gothenburg Profile (GP) is a 20-item questionnaire with a 5 
points scale (how often…? never, rarely, sometimes, often, and always). It will be given to the subjects 
on their first visit. 
 
9.2.4 
Assessment of safety outcom es 
During the use of the IMD the subjects will be asked to alert the investigator to any unexpected or 
uncomfortable sounds heard during the screening or the fitting of the hearing aid. 
Additionally, they will be asked about any adverse events or unexpected events that involve the hearing 
aids.  Unexpected events or effects include feedback or whistling from the device, unexpected sounds 
or artefacts from the device, discomfort, muting or shutting off of the device in mid-use, unexplained 
warning signals or beeping from the device, loud sounds, and occlusion. The information provided from 
the field trial will alert the testers to the potential for safety risks that should be addressed before the 
product is released to the market.  It is not expected that any of these things will occur and have not 
during testing on previous products. 
9.2.4.1 
Adverse events  
For the recording of adverse events the subjects will be asked for a description of the event including 
how long it lasted, how many times it occurred, and if it caused discomfort or pain or a disruption of 
hearing ability.  They will be recorded on the AE forms in the CRF. 
9.2.4.2 
Laboratory parameters 
Not applicable 
 
9.2.4.3 
Vital signs 
Not applicable 
 
9.2.5 
Assessments in p articipa nts who prematu rely sto p the study 
After the study concludes the subjects will return the hearing aids. They will have the choice of 
purchasing hearing aids and continuing a regular follow-up procedure with the clinic that recruited them.  
Those that withdraw prematurely will also have the option to purchase hearing aids and continue with 
normal follow-ups as needed with the clinic that recruited them.   

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 33 of 46 
9.3 Proc edure s at each visit 
 
9.3.1 
Screening  Visi t/First Visi t 
Screening visit, Day 0: The trial will be explained including how many visits are expected as well as the 
type of testing that they will complete.  They will be given the Patient Information sheet and everything 
explained to them by the site investigator.  Subjects are given time during the appointment to decide, 
whether or not to participate in the study.  If they choose to not take part in the trial they will not sign the 
consent form and the appointment will finish.  They can still follow-up with the clinic for a standard 
hearing aid purchase if they choose.  If they choose to join the trial they will sign and date the Patient 
Informed consent form.  No trial activities will be performed before the Patient Informed consent form is 
signed and dated by the subject and investigator.  Subjects will receive a copy of the signed patient 
informed consent form and the patient information. A hearing history is then taken and otoscopy is 
performed.  The initial hearing test is performed to determine hearing loss including air and bone 
audiometry. Inclusion/exclusion criteria will be determined. The subjects will then complete a 
questionnaire to quantify their perceived hearing loss handicap (Gothenburg).  They will complete a 
hearing screening using the IMD.  Based on the randomization plan they will be fitted with hearing aids 
either with the IMD or the RMD.  The investigator will make no fine tuning of the fittings.  Gain and 
features will be set as prescribed by the software.  They will receive an Instructions for Use (IFU) for the 
hearing aid.  They will be given a standardized questionnaire (IOI-HA) and a custom product 
questionnaire to fill out during the first period of the field trial. The HCP will review the questionnaires to 
ensure that the subjects understand their task. They will be scheduled for the Second Visit.  Any AEs 
will be reported in the CRFs. 
9.3.2 
Second Visi t 
Visit 2, Day 10 +/-5:  Otoscopy is performed.  The subjects will hand in the completed questionnaires 
given to them at the previous appointment.  The investigator will review the questionnaires and inquire 
about AEs.  Any AEs will be reported in the CRFs. A lab test will be made to test speech intelligibility 
with the FST.   
Their hearing aids will be fit with either the IMD or RMD (depending on what they had for the first period). 
The investigator will make no fine tuning of the fittings.  Gain and features will be set as prescribed by 
the software. They will be given a standardized questionnaire (IOI-HA) and a custom product 
questionnaire to fill out during the second period of the field trial. The HCP will review the questionnaires 
to ensure that the subjects understand their task.  They will be scheduled for the Third Visit.   
9.3.3 
Third Visi t 
Visit 3, Day 20 +/-5:  Otoscopy is performed.  The subjects will hand in the completed questionnaires 
given to them at the previous appointment.  The investigator will review the questionnaires and inquire 
about AEs.  Any AEs will be reported in the CRFs. A lab test will be made to test speech intelligibility 
with the FST. 
The subjects will return the hearing aids.  The subjects will complete a custom preference questionnaire 
about the experience with both field test periods. They will report which period of the field trial that they 
preferred.     

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 34 of 46 
They will be given the option to purchase hearing aids from the clinic where they were recruited. 
10. SAFETY  
10.1 Medic al Device Categor y C Studies 
All adverse events (AE) including all serious adverse events (SAE) are collected, fully investigated and 
documented in the source document and appropriate case report form (CRF) during the entire study 
period, i.e. from patient’s informed consent until the last protocol-specific procedure, including a safety 
follow-up period. Documentation includes dates of event, treatment, resolution, assessment of 
seriousness and causal relationship to device and/or study procedure. 
The information on AEs is systematically collected by the clinician at each study visit.  They will follow 
the procedures outlined in SOP-Medical Device Incident Reporting.  The subjects are asked to keep a 
diary and write down any unexpected events.  During the regular clinic visits the subjects are then asked 
questions about the event to gather details and to determine the severity of the event.  If a subject 
reports pain that results in the inability to use the device he will be withdrawn from the study in order to 
avoid any pain from using the device and to remove partial data from the study. For reports of pain 
caused by insertion or the dome itself, the problem can be addressed in the clinic.  For example, a 
different style or size of dome can be placed on the hearing aid, and re-training of insertion can be 
performed with the subject to avoid wrong or forceful insertion of the device.  For reported pain they will 
be advised to not wear the device for 24 hours before resuming use.   
Foreseeable adverse events outlined in the risk management file include discomfort caused by the 
domes, domes or filters falling off in the ear, no amplification coming from the device causing alarms or 
traffic to not be heard by the subject, skin reaction if chemical profile of device is changed, maximum 
output of the device exceeding 132 dB SPL, battery exploding or catching fire, and the device affecting 
other medical devices worn by the subject,.  The incidence of all of these risks or adverse events is 
improbable.  To mitigate the risk, the IFU describes how to insert the device, how to change the domes, 
and how to change a battery in case of no amplification.  The IFU describes how to clean the device, 
domes, and filters in order to not introduce cleaning agents that might change the chemical profile of 
the hardware of the device.  The labelling warns of the potential maximum output of the device.  The 
IFU instructs the user to keep the device away from explosive environments, The IFU warns of 
interference with implantable devices. 
 
10.1.1 Definit ion  and Assessment of (Seriou s) Adverse Events and other safety related events 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including 
an abnormal laboratory finding) in participants, users or other persons whether or not related to the 
investigational medical device [ISO 14155: 3.2]. 
This includes events related to the IMD or the RMD and to the procedures involved. For users or other 
persons this is restricted to events related to the IMD.  
 
Adverse Device Effect (ADE) 
Adverse event related to the use of an investigational medical device [ISO 14155: 3.1]. 
This includes any adverse event resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, operation, or any malfunction of the investigational medical 
device. This includes any event that is a result of a use error or intentional misuse.  
 
AEs/ADEs include: 
- Exacerbation of a pre-existing disease or condition. 
- Increase in the frequency or intensity of a pre-existing episodic disease or medical condition. 
- Any disease or medical condition detected or diagnosed after treatment with the study intervention 
device even though it may have been present yet undetected prior to the start of the clinical investigation. 
- Any continuous persistent disease or symptoms present at baseline that worsen following the start of 
the clinical investigation. 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 35 of 46 
- Events considered by the investigator to be related to any of the clinical investigation-mandated 
procedures. 
- Abnormal assessments, e.g. physical examination findings, will be reported as AEs/ADEs if they 
represent a clinically significant finding that was not present at baseline or that has significantly 
worsened during the course of the clinical investigation. 
- Test abnormalities will be reported as AEs/ADEs if they represent a clinically significant finding, 
symptomatic or not, which was not present at baseline or has significantly worsened during the course 
of the clinical investigation. 
 
AEs/ADEs do not include:  
- Pre-planned interventions or occurrences of endpoints specified in the CIP are not considered 
AEs/ADEs, if not defined otherwise. 
- Unrelated medical or surgical procedures, e.g. surgery, endoscopy, tooth extraction, transfusion. 
However, the event leading to the procedure may be considered an AE. If this event is serious, the 
procedure will be described in the SAE/SADE narrative. 
-  Any pre-existing disease or medical condition that remains stable and does not worsen during the 
course of study participation. 
- 
Situations in which an adverse change did not occur, e.g., hospitalizations for unrelated 
cosmetic elective surgery or for social and/or convenience reasons. 
 
Serious Adverse Event (SAE) 
Adverse event that: 
• 
results in death, or 
• 
led to a serious deterioration in health that either: 
- 
results in a life-threatening illness or injury, or 
- 
results in a permanent impairment of a body structure or a body function, or 
- 
required in-patient or prolonged hospitalisation, or 
- 
results in medical or surgical intervention to prevent life threatening illness, or 
• 
led to fetal distress, death or a congenital abnormality or birth defect. [ISO 14155: 3.37]. 
This includes device deficiencies that might have led to a serious adverse event if a) suitable action 
had not been taken or b) intervention had not been made or c) if circumstances had been less 
fortunate. These are handled under the SAE reporting system. A planned hospitalization for pre-
existing condition, or a procedure required by the protocol, without a serious deterioration in health, is 
not considered to be a serious adverse event.  
 
Device deficiency 
Inadequacy of a medical device related to its identity, quality, durability, reliability, safety or performance, 
such as malfunction, misuse or use error and inadequate labelling [ISO 14155: 3.15].  
 
Health hazards that require measures 
Findings in the trial that may affect the safety of study participants and, which require preventive or 
corrective measures intended to protect the health and safety of study participants. 
 
Severity of adverse events/adverse device effects 
The severity of clinical AEs is graded on a three-point scale: mild, moderate and severe, and reported 
in the CRF. If the severity of an AE worsens during medical device administration, only the worst 
intensity should be reported on the CRF. If the AE lessens in intensity, no change in the severity is 
required. 
Mild: Event may be noticeable to subject; does not influence daily activities; the AE resolves 
spontaneously or may require minimal therapeutic intervention;  
Moderate: Event may make subject uncomfortable; performance of daily activities may be influenced; 
intervention may be needed; the AE produces no sequelae. 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 36 of 46 
Severe: Event may cause noticeable discomfort; usually interferes with daily activities; subject may not 
be able to continue in the study; the AE produces sequelae, which require prolonged therapeutic 
intervention. 
 
Causal Relationship of Adverse Events 
A causal relationship towards the medical device or study procedure should be rated as follows: 
• 
Not related: The event is definitely not associated with device application or with study 
procedures; a relationship can be ruled out. 
• 
Possibl y related: The relationship between device application or study procedures and the 
event is possible, but other causes cannot definitely be ruled out. 
• 
Related: The event is definitely associated with device application or study procedures. 
Device deficiencies that might have led to an SAE are always related to the medical device. 
 
10.1.2 Reporting  of (Seriou s) Adverse Events and other safety related  events 
The following events are to be reported to the Sponsor within 24 hours upon becoming aware of the 
event: 
• 
All SAEs  
• 
Health hazards that require measures 
• 
Device deficiencies 
 
The Sponsor will evaluate SAEs with regard to causality and seriousness. Device deficiencies are 
assessed regarding their potential to lead to an SAE. 
 
Reporting  to Authorities: 
In Category C studies it is the local Investigator’s responsibility to report seriou s adverse events in 
Switzerland which are 
• 
related or possibly related to the medical device under investigation 
• 
related or possibly related to study procedures 
within 7 days to the local Ethics Committee. The Sponsor-Investigator reports within the same timeline 
to Swissmedic (incl. events from abroad).  
• 
Health hazards that require measures are reported within 2 days  
 
All in the trial involved other Ethical Committees receive all mentioned reportable SAEs and health 
hazards having occurred in Switzerland via the Sponsor-Investigator within the same timeline. All 
participating investigators are informed regarding the occurrence of a health hazard. 
 
Period ic safety reporting   
In Category C studies a yearly safety update-report is submitted by the Investigator to the Ethics 
Committee and by the Sponsor-Investigator to Swissmedic. 
 
 
10.1.3 Follow  up of (Seriou s) Adverse Events 
The adverse event shall be followed by the PI until its resolution or until the adverse event is recognised 
as permanent or stable condition by the PI. Follow-up investigations may be necessary according to the 
PI’s medical judgement. In this situation, the follow-up does not have to be documented in the CRF but 
must be noted in the source documentation. 
In case of SAE / SADE the sponsor can be contacted following the list below. If the first person in the 
list cannot be timely contacted, the PI should try to contact the next and so on. 
 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 37 of 46 
 
 
 
 
Contact order 
Contact 
order 
Name 
Mobile 
Office 
E-Mail 
1 
Michael Ernst 
+41 31 998 15 
57 
Head of SIV 
mier@bernafon.com 
2 
Bruno Keller 
+41 31 998 15 
92 
Senior Director  
brke@bernafon.com 
Table 1: Contact information of the sponsor-investigator in case of SAE/SADE 
 
11. STATISTICAL METHODS  
The purpose of this study is to compare the performance of the IMD to the RMD.  The study aims to 
provide a final validation and quality control of the IMD before it is released for sales. The hearing aids 
will have the same electro-acoustic characteristics with bot the IMD and the RMD.  For this reason, it is 
not expected to find that the IMD outperforms the standard RMD. 
11.1 Hypot hesis 
Both devices will have the same electro-acoustical performance; however, it is suspected that 
changing the fitting procedure might influence the subjective benefit for the hearing aid user. Research 
suggests that placebo effect might impact hearing aid trials (Dawes et al., 2013) and that clinician 
behavior might also modify the perceived benefit of hearing aids (Naylor et al., 2015). The designed 
test will investigate the potential effect of the IMD compared to the RMD on first time users.  
The test should answer the following research questions: 
1. Narrative effect of fitting procedure: Do different fitting procedures lead to differences in 
perceived benefit with hearing aids despite similar electro-acoustical performance? 
(Questionnaires) 
2. Self-administrated audiometry: Is AMTAS self-administrated screening equivalent to standard 
clinical procedure? (hearing loss thresholds) 
 
11.2 Determi nation of  Sample  Size  
A literature search about this tested topic does not provide enough strong references to build a 
confirmatory analysis. It seems that results might be strongly influenced by the inclusion criteria (first 
time vs experienced hearing aid users) or test design (cross-over, multi-investigator, or between group 
designs). There is no article to our knowledge that includes a multi-investigator effect in the test design 
when looking at the effect of different fitting procedures. Adding a -by investigator- treatment interaction 
term seems to be mandatory if this trial wants to be determine the effect that different investigators have 
on the fitting procedure. 
The sample size cannot be computed on reported effect sizes from previous experiment; however, the 
following summary shall be used as an indication to determine the sample size for participants per 
investigator: 
 
•Naylor et al. (2015) about the narrative effect during the fitting with 24 experienced users and 16 first 
time users, 
•Humes et al. (2017) about the performance with over-the-counter hearing aids compared to audiology 
best practice with 154 participants, 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 38 of 46 
 
•Dawes et al. (2013) about the placebo effect in hearing aid trials with 16 experienced hearing aid users, 
•Dawes et al. (2011) about the placebo effect in hearing aid trials with 20 experienced hearing aid users. 
 
A placebo effect was found with sample sizes of about 20 participants in a single site study design. 
Adding an investigator effect in the design might bring new insights in this domain but requires a 
minimum number of participants per investigator to reduce imbalance between them.  
With an effect size of 0.65 from the literature review, 2 degrees of freedom, 24 participants, and an alpha 
of 0.05, we can achieve a power of 0.82.  Therefore, a minimum of 24 participants will be included in 
the trial overall.  There will be 4 investigators with 6 to 8 participants per investigator.   
11.3 Statis tic al crit eria of t ermi nation of  trial  
A single statistical analysis is planned once all recruited subjects have completed the protocol (per-
protocol). No interim analysis is planned for a test period of 14 days and no “stopping rules” are set from 
a statistical perspective.  PI’s and clinician judgement are considered as reliable enough to stop the trial. 
 
11.4 Planned Analyses  
The analysis and documentation will be done by the statistician using R (latest available and validated 
version) downloaded from the official Comprehensive R Archive Network (https://cran.r-project.org/). R-
Studio IDE will be used to integrate the analysis to the report. R provides adequate packages for 
descriptive statistics (base, stats, and Rmisc), data visualisation (ggplot2), mixed effect models (lmer, 
lmerTest, and nlme), and principal component analysis (FactoMineR). 
 
A linear mixed effect regression will be used on the IOI-HA questionnaire, chi-squared distribution on 
the preference test and a paired t-test on hearing thresholds. The principal component analysis will be 
made on different outcomes and explanatory variables combinations. 
11.4.1 Datasets to be analysed, analysis populatio ns 
Analysis population: a single group that had the same treatment (per protocol set). 
The included subjects are first time hearing aid users with the same hearing aid model across the 
population.  As hearing loss does not normally fluctuate, we assume that their hearing capabilities are 
stable over time and that the performance with a hearing aid can be compared over a longer period 
without any wash out period.  Subjects’ individual auditory capacities (hearing loss degree, noise 
tolerance, speech recognition) vary, however the sample is considered as a homogenous population 
regarding their experience with the RMD. It will be ensured that the acceptance to generic amplification 
via hearing aids is not tested but an actual evaluation of the difference between the RMD and the IMD.  
A single assignment treatment will be considered representative of clinical intervention, i.e. when an 
experienced hearing aid user acquires a new device. 
 
11.4.2 Primary Analysis 
The narrative effect on the subject perception of the end user will be measured using a standardized 
questionnaire, the IOI-HA, and a custom product questionnaire.  The questionnaires will be 
administered twice during the study, once after each field trial period.  The responses for the IMD will 
be compared with those for the RMD. At the last visit the subjects will complete a preference 
questionnaire based on the Naylor et al. (2015). 
 
11.4.3 Secondary Analyses 
The standard audiological hearing test results will be compared to those completed with the 
automated IMD hearing screening.  Data analysis will focus on hearing threshold differences with both 
procedures in a nested model: ear-participant-investigator. 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 39 of 46 
11.4.4 Explan atory analyses 
Speech intelligibility will be measured using the Freiburger Sprachverständnistest. The level at which 
50% of words are correctly repeated will be recorded as test outcomes by the investigator for the 
unaided and aided conditions for each test session.   
The differences between unaided and aided (for IMD and RMD) speech intelligibility will be compared 
and used as an explanatory variable for the model. 
The subjects’ perceived hearing handicap will be measured with a standardized questionnaire.  
Participants that are not often affected in their daily life by their hearing impairment, might report 
smaller benefit from amplification with a hearing aid. Understanding and quantifying their struggles 
with the principal component analysis could be used to improve the modelling of the results.  
The usage of hearing aids will be recorded as another indication of hearing aid use. The data will be 
averaged from each ear. The following data will be used: 
• 
1. Daily usage in hours per day, 
• 
Acoustical environment in percentage for following listening environments: quiet, speech in 
quiet, speech in noise, and noise 
11.4.5 Interim an alyses 
No interim analysis is planned according the test design. 
11.4.6 Safety analysis 
Safety analysis is foreseen to be accomplished with the AEs reported by the participants during the trial. 
Clinical judgement from the PI will be used for the safety evaluation. 
11.4.7 Deviatio n(s) from the ori ginal stat isti cal pl an  
Any deviation from the original protocol has to be justified and reported in the final report.  Post hoc 
analysis can be done on secondary outcomes and reported in the final report. 
11.4.8 Further uses of  data  
Data collected from the study will potentially be used for further research purposes.  The data will remain 
anonymized and stored in a secure document management system.  The participant code list will be 
destroyed so that nobody will be able to connect the data to a specific test participant. 
11.5 Handli ng of  missing data and drop -out s  
For missing data, the PI will contact the involved subject to evaluate the possibility of getting missing 
data from a questionnaire by post.  If a test subject cannot come to the evaluation visit, after exhausting 
all the possibilities to reschedule a new one, the devices will be sent back per post.  If a subject does 
not want to adhere to the protocol, he can easily withdraw from the study and return the devices. 
Data will be immediately removed if the PI has some doubts about the data accuracy (especially about 
the understanding of the questionnaires). 
Dropouts will not be replaced; therefore, extra subjects over the calculated sample amount will be 
included from the beginning to ensure enough completed cases with all data.  
Analysis will be done on the complete case only. 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 40 of 46 
12. QUALITY ASSURANCE AND CONTROL  
The Sponsor is responsible for implementing and maintaining quality assurance and quality control 
systems with written SOPs and working instructions, at all sites. The PI is responsible for proper 
training of all involved study personnel. 
 
12.1 Data handling a nd record k eeping /  archiv ing  
Data will be documented on paper and archived with an electronic data management system.  The 
subjects will be given numbers to maintain anonymity.  There are also hard copies of subjects’ charts 
that are kept in a locked file cabinet inside of the clinic rooms.  Only the PI, statistician, Monitor, and 
Auditor will have access to the information. The information will always be archived under the 
identification number with a key to the identification codes stored in another location (described in 
chapter 2.8).    
12.1.1 Case Report Forms  
Participant identities are coded using a participant identification number. 
The PI or the Site Investigator will enter protocol defined data into a web based Electronic Case 
Report Forms using an EDC-software that conforms to 21 CFR Part 11 (FDA guidance) requirements. 
Site staff will be given access to the EDC system after a training. The data are checked automatically 
for plausibility and discrepancies. The generated appropriate error messages, allow the data to be 
confirmed or corrected before being saved in the database. At the end of the study, the PI must certify 
that the data entered into the Electronic Case Report Forms are complete and accurate. After 
database lock, the PI will receive a CD-ROM or paper copies of the patient data for archiving at the 
sites. 
 
The CRF contains the following information: 
Field 
Author 
Date of examination 
PI 
Participant identification number 
PI 
Age 
PI 
Sex 
PI 
Date of Informed Consent 
PI 
Inclusion / Exclusion Criteria 
PI 
Ear disease 
PI 
Control hearing device serial numbers 
PI 
Investigational device serial numbers 
PI 
Results to FST 
PI 
Results from Gothenburg questionnaire 
PI 
Results from IOI-HA questionnaire 
PI 
Results from preference questionnaire 
PI 
Results from product questionnaire 
PI 
Results from packaging questionnaire 
PI 
AEs / SAEs, ADE / SADE 
PI 
Name, date, signature of PI 
PI 
 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 41 of 46 
12.1.2 Specification  of sou rce docum ents  
The Principle Investigator will maintain adequate and accurate records to enable the conduction of the 
study to be fully documented and the study data to be subsequently verified. These documents will be 
classified into two different categories: PI's file, and subject clinical source documents.  There will be a 
PI file or Ivestigator Site File (ISF) for each site (Bern and Thun) as well as corresponding subject files 
with source documents pertaining to each site. 
The PI's file will contain the CIP/amendments, IB/Instructions for use, CRFs, sites’ standard operation 
procedures (SOPs) or reference to it, EC and CA approval with correspondence, informed consent, 
device records, staff curriculum vitae and authorization forms, screening and enrolment logs, site-
specific subject identification code logs, and other appropriate documents/ correspondence as required 
by EN ISO 14155 and local regulations. 
Subject clinical source documents include, but are not limited to subject hospital/clinic records, 
physician’s and nurse’s notes, appointment book, original laboratory reports, CT, X-ray, MRIs, pathology 
and special assessment reports, consultant letters, etc. 
These two categories of documents must be kept on file by the PI for 10 years. If source documents are 
not durable as long as needed they must be preserved as a copy. When source documents are required 
for the continued care of the subject, appropriate copies should be made for storing outside of the site. 
The information will always be archived under the identification number with a key to the identification 
codes stored in another location (described in chapter 2.8).   
For each subject enrolled an encoded electronic CRF must be completed and e-signed by the PI. This 
also applies to those subjects who fail to complete the study. If a subject withdraws from the study, the 
reason must be noted on the CRF. 
Case report forms are to be completed after the visit. 
CRF entries and corrections will only be performed by study site staff, authorized by the PI. All forms 
should be completed using a blue permanent pen and must be legible. Errors should be crossed out but 
not obliterated, the correction inserted, and the change initialled and dated by the PI, co-PI or study 
nurse. 
The entries will be checked by the Monitor and any errors or inconsistencies will be checked immediately. 
The Sponsor-Investigator will collect original completed and signed CRFs at the end of the study. A 
copy of the completed and signed CRFs will remain on site. 
 
12.1.3 Record keepin g / archiv ing   
All study data will be archived for a minimum of 10 years after study termination or premature termination 
of the clinical trial. 
12.2 Data management  
12.2.1 Data Management  System  
The CRFs in this trial are implemented electronically using a dedicated electronic data capturing (EDC) 
system. The EDC system is activated for the trial only after successfully passing a test procedure. 
All data entered in the CRFs are stored on a Windows server in a dedicated database. 
12.2.2 Data securit y, access and back -up  
The server hosting the EDC system and the database is kept in a locked server-room in Biel. Only the 
system administrators have direct access to the server. A role concept with personal passwords (site 
investigator, statistician, monitor, administrator etc.) regulates permission for each user to use the 
system and database as he/she requires. 
All data entered into the CRFs are transferred to the database using Secure Sockets Layer (SSL) 
encryption. Each data point has attributes attached to it identifying the user who entered it with the exact 
time and date. Retrospective alterations of data in the database are recorded in an audit table. Time, 
table, data field, original value and altered value, and the person are recorded (audit trail). 
A multi-level back-up system is implemented. Back-ups of the whole system including the database are 
run several times per day. The back-up-data are stored in a secure place on a different storage-server. 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 42 of 46 
12.2.3 Analysis and archiv ing  
At final analysis, data files will be extracted from the database into statistical packages to be analyzed. 
The database will be locked at this time, recorded in special archiving format and securely stored for at 
least 1 year. In addition, the PI will receive a CD-ROM or paper copies of the patient data for archiving 
at the site. 
12.2.4 Electronic and central data validatio n  
Data can be entered into the database only after a check of completeness and plausibility. Furthermore, 
selected data points are cross-checked for plausibility with previously entered data for that participant. 
 
12.3 Moni toring  
The study sites will be monitored by an employee of the Sponsor. A minimum of five visits will be 
performed; one site initiation visit, 3 routine monitoring visits and one close out visit. The number of 
routine monitoring visits will be increased if needed based on the course of the study. The first routine 
monitoring visit will take place shortly after the first patient has been enrolled.  
Source documents will be made available for the monitor and the principle investigator or a delegated 
and authorized person will be available during the visits to answer questions.  
100% source data verification will be completed for 3 patients at the first interim visit. For another 3 
patients 100% source data verification will be completed at the second interim visit, and an additional 3 
at the third interim visit. 
Subject to SDV for all patients are: 
Patient Informed Consent Form 
Eligibility criteria 
Diagnosis 
Visit dates 
Study intervention details related to: 
 
Procedural success  
 
Procedure date and time 
 
(Serious) Adverse Events 
 
Device deficiencies  
The content of Investigator Site File (ISF) will be checked during each monitoring visit. 
 
12.4 Audits and Ins pectio ns  
CEC as well as CA have the right to execute inspections at the study sites.  
The study documentation and the source data/documents have to be made accessible to 
auditors/inspectors and questions have to be answered during audits/inspections. All involved parties 
must keep the participant data strictly confidential. 
 
12.5 Confidentiality, Data Protection  
Direct access to source documents will be permitted for the purposes of monitoring, audits and 
inspections and only authorized persons involved in those activities are allowed to have direct access 
to source documents and must keep participants data strictly confidential. 
12.6 Storage of biologic al materi al and r elated health da ta  
Not applicable 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 43 of 46 
13. PUBLICATION AND DISSEMINATION POLICY  
Trial results will be communicated to participants at the end of the trial. The trial results primary 
purpose are for internal product validation to ensure safety and performance of the device.  The 
results will be communicated to other relevant groups (e.g., via publication, reporting in results 
databases, and other internal data sharing arrangements) as needed and for the purpose of sharing 
scientific information within the industry.  The only people with authorship eligibility will be those that 
worked on the trial including the PI, statistician, and any other clinicians involved in testing. Any plans 
for writing will not include access to the full protocol but a description of it as well as a description of 
the participants.  Statistics will be described sufficiently so that the reader understands the analysis 
and any conclusions made from it.  Ultimately the decision to submit the report for publication and the 
ultimate authority over any of the activities is held by the Sponsor, Bernafon.   
14. FUNDING AND SUPPORT  
14.1 Fund ing  
The Sponsor will financially support the trial including providing the clinic and all materials needed to 
complete the testing.  This includes the devices themselves as well as equipment. 
15. INSURANCE  
Insurance will be provided by the Sponsor. A copy of the certificate is filed in each investigator site file 
and the trial master file. 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 44 of 46 
16. REFERENCES  
1. Convery, E., Keidser, G., Seeto, M. Yeend, I., Freeston, K.  (2015). Factors affecting reliability 
and validity of self-directed automatic in situ audiometry:  implications for self-fitting hearing 
aids.  Journal of the American Academy of Audiology, 26, 5-18. 
2. Convery, E., Keidser, G., Seeto, M., & McLelland, M.  (2017). Evaluation of the self-fitting 
process with a commercially available hearing aid.  Journal of the American Academy of 
Audiology, 28, 109-118. 
3. Cox, R. M., Stephens, D., & Kramer, S. E. (2002). Translations of the International Outcome 
Inventory for Hearing Aids (IOI-HA). International Journal of Audiology, 41, 3–26. 
4. Dawes, P., Powell, S., & Munro, K. J. (2011). The Placebo Effect and the Influence of 
Participant Expectation on Hearing Aid Trials. Ear and Hearing, 32(6), 767–774. 
5. Dawes, P., Hopkins, R., & Munro, K. J. (2013). Placebo effects in hearing-aid trials are 
reliable. International Journal of Audiology, 52(7), 472–477. 
6. Declaration of Helsinki, Version October 2013, 
(http://www.wma.net/en/30publications/10policies/b3/index.html )  
7. Eikelboom, R. H., Swanepoel, D. W., Motakef, S., & Upson, G. S. (2013). Clinical validation of 
the AMTAS automated audiometer. International Journal of Audiology, 52(5), 342–349. 
8. Feaster, D. J., Mikulich-Gilbertson, S., & Brincks, A. M. (2011). Modeling site effects in the 
design and analysis of multi-site trials. The American Journal of Drug and Alcohol Abuse, 
37(5), 383–91. 
9. International Conference on Harmonization (ICH, 1996) E6 Guideline for Good Clinical 
Practice. 
(http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__
Step_4.pdf) 
10. International Conference on Harmonization (ICH, 1997) E8 Guideline: General Considerations 
for Clinical Trials 
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E8/Step4/E8
_Guideline.pdf) 
11. Humanforschungsgesetz, HFG Bundesgesetz über die Forschung am Menschen 
(Bundesgesetz über die Forschung am Menschen, HFG) vom 30. September 2011/ Loi 
fédérale relative à la recherche sur l’être humain (loi relative à la recherche sur l’être humain, 
LRH) du 30 septembre 2011 / Legge federale concernente la ricerca sull'essere umano 
(Legge sulla ricerca umana, LRUm) del 30 settembre 2011 
(http://www.bag.admin.ch/themen/medizin/00701/00702/07558/index.html?lang=de) 
12. Kochkin S.  (2011). Marke Trak VIII Patients report improved quality of life with hearing aid 
usage.  Hearing Journal, 64(6), 25-26, 28, 30, 32. 
13. Kraemer, H. C., & Robinson, T. N. (2005). Are certain multicenter randomized clinical trial 
structures misleading clinical and policy decisions? Contemporary Clinical Trials, 26(5), 518–
529. 
14. Margolis, R. H., Saly, G. L., Le, C., & Laurence, J. (2007). Qualind: A method for assessing 
the accuracy of automated tests. Journal of the American Academy of Audiology, 18(1), 78–
89. 
15. Naylor, G., Öberg, M., Wänström, G., & Lunner, T. (2015). Exploring the Effects of the 
Narrative Embodied in the Hearing Aid Fitting Process on Treatment Outcomes. Ear and 
Hearing, 36(5), 517–526. 
16. Ringdahl, A., Eriksson-Mangold, M., & Andersson, G. (1998). Psychometric evaluation of the 
Gothenburg Profile for measurement of experienced hearing disability and handicap: 
applications with new hearing aid candidates and experienced hearing aid users. British 
Journal of Audiology, 32(6), 375–385. 
17. Verordnung über klinische Versuche in der Humanforschung (Verordnung über klinische 
Versuche, KlinV) vom 20. September 2013 / Ordonnance sur les essais cliniques dans le 
cadre de la recherche sur l’être humain (Ordonnance sur les essais cliniques, OClin) du 20 
septembre 2013. Ordinanza sulle sperimentazioni cliniche nella ricerca umana 
(Ordinanza sulle sperimentazioni cliniche, OSRUm) del 20 settembre 2013 
(https://www.admin.ch/opc/de/classified-compilation/20121176/201705010000/810.305.pdf) 
18. Heilmittelgesetz, HMG Bundesgesetz über Arzneimittel und Medizinprodukte 
(Heilmittelgesetz, HMG) vom 15. Dezember 2000 / Loi fédérale sur les médicaments et les 
dispositifs médicaux (Loi sur les produits thérapeutiques, LPT) du 15 décembre 2000 / Legge 
federale sui medicamenti e i dispositivi medici (Legge sugli agenti terapeutici, LATer)  

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 45 of 46 
(http://www.admin.ch/ch/d/sr/8/812.21.de.pdf) 
19. ISO 14155:2011 Clinical investigation of medical devices for human subjects -- Good clinical 
practice (www.iso.org) 
20. ISO 10993 Biological evaluation of medical devices (www.iso.org) 
21. WHO, International Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/en/)  
22. WHO (2016). Development of a new Health Assembly resolution and action plan for 
prevention of deafness and hearing loss. 
 
 

 
 BF002-1707, CIP, Version 3.0, 21.12.2017 
 
Page 46 of 46 
17. APPENDICES 
 
1. IMD: IB or SPC  
 
2. Medical Devices: IB (according to ISO 14155) 
 
3. Medical Devices: Assurance of producer 
 
4. Medical Devices: List of norms (vollständig eingehaltene, teilweise eingehaltene) 
 
5. Case Report Form (e.g. CRF) 
 
6. Patient Information and informed consent 
 
7. Instructions for Use 
 
8. Meta-Analysis