Quality Control of CE-Certified Phonak Hearing Aids - 2020_43
Phase: NA
Conditions: Hearing Loss
Sponsor: Sonova AG

 
 
 
 
 
 
Study Protocol & Statistical Analysis Plan 
 
 
Quality Control of CE-Certified Phonak Hearing Aids - 2020_43 
 
 
NCT04723173 
 
 
 
 
 

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<< QUALITY CONTROL OF  
CE-LABELLED PHONAK HEARING SYSTEMS >> 
 
Clinical Study Protocol 
QUALITY CONTROL OF CE-LABELLED PHONAK HEARING SYSTEMS. 
(AGEK 1; SPIRIT #1) 
[A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on 
hard of hearing participants to grant quality control prior to product launch. The aim of the investigation 
series is to ensure zero-defect overall performance of the new hearing systems as well as maximum 
benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing 
Systems and to equivalent competitor devices. The Phonak Hearing System comprises hearing aids 
of different form factors, acoustic couplings, wireless accessories (e.g. remote control) and fitting 
software. Both objective laboratory measurements will be conducted as well as subjective evaluations 
of the devices in daily life will be undertaken. This will be a controlled, single blinded and randomised 
active comparator clinical evaluation which will be conducted mono centric at Sonova AG 
Headquarters based in Stäfa.] 
 
Study Type: 
Clinical trial with Medical Device (MD)  
Study Categorisation: 
Risk category according to LHR A 
Study Registration: 
Intended registry after approval: clinicaltrials.gov and Swiss 
Federal Complementary Database 
Study Identifier: 
CH-PH-Marketing-Validation 
Sponsor: 
                                            
 
 
 
 
 
Principal Investigator: 
Sonova AG 
Contact person: Katrin Manella 
Laubisrütistrasse 28 
CH-8712 Stäfa 
Email: katrin.manella@phonak.com (preferred contact) 
Phone: 058 928 45 10 
  
Bernhard Buschle , 
Laubisrütistrasse 28,  
CH-8712 Stäfa,  
Phone: 058 928  4421 
Email: bernhard.buschle@phonak.com 
Investigational Product: 
MD risk class IIA: Phonak Hearing Systems (comprising hearing 
aids, 
acoustic 
couplings 
and 
fitting 
software), 
Wireless 
Accessories (Receiver) 
MD risk class I: Wireless Accessories (transmitters). 
Protocol Version and Date: 
V1.3,  17.12.2019 
 
 
CONFIDENTIAL 
The information contained in this document is confidential and the property of the sponsor. The 
information may not - in full or in part - be transmitted, reproduced, published, or disclosed to others 

CH-PH-Marketing-Validation, V1.3_ 17.12.2019  
 
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than the applicable Competent Ethics Committee(s) and Regulatory Authority(ies) without prior written 
authorisation from the sponsor except to the extent necessary to obtain informed consent from those 
who will participate in the study. 
Signature Page(s)  
(AGEK 1.1; ICH E6 6.1) 
ICH E6: Have signature pages with name and title of the person(s) authorised to sign the protocol and the 
protocol amendment(s) for the sponsor or of the medical expert (if applicable), the investigator 
responsible for conducting the trial, the statistician (if applicable) 
 
Study number 
www.clinicaltrials.gov as soon as approved by Competent Ethics Committee (CEC) 
Study Title 
Quality Control of CE-Labelled Phonak Hearing Systems 
 
 
 
 
 
 
Local Principal Investigator at study site*: 
I have read and understood this trial protocol and agree to conduct the trial as set out in this study 
protocol, the current version of the World Medical Association Declaration of Helsinki, ICH-GCP 
guidelines or ISO 14155 norm and the local legally applicable requirements. 
 
Site: 
                         Sonova AG, Laubisrütistrasse 28, 8712 Stäfa 
Principal Investigator: 
                          Bernhard Buschle 
 
*Note: In multicentre studies, this page must be individually signed by all participating Local Principal 
Investigators. 
 

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Table of Contents 
STUDY SYNOPSIS ................................................................................................................................. 6 
STUDY SUMMARY IN LOCAL LANGUAGE ......................................................................................... 8 
ABBREVIATIONS ................................................................................................................................... 9 
STUDY SCHEDULE .............................................................................................................................. 11 
1. 
STUDY ADMINISTRATIVE STRUCTURE .................................................................................... 12 
1.1 
Sponsor, Sponsor-Investigator .....................................................................................................12 
1.2 
Principal Investigator(s) ................................................................................................................13 
1.3 
Statistician ("Biostatistician") ........................................................................................................13 
1.4 
Laboratory ....................................................................................................................................13 
1.5 
Monitoring institution ....................................................................................................................13 
1.6 
Data Safety Monitoring Committee ..............................................................................................14 
1.7 
Any other relevant Committee, Person, Organisation, Institution ................................................14 
2. 
ETHICAL AND REGULATORY ASPECTS .................................................................................. 14 
2.1 
Study registration .........................................................................................................................14 
2.2 
Categorisation of study.................................................................................................................14 
2.3 
Competent Ethics Committee (CEC) ...........................................................................................14 
2.4 
Competent Authorities (CA) .........................................................................................................15 
2.5 
Declaration of interest ..................................................................................................................15 
2.6 
Patient Information and Informed Consent ..................................................................................15 
2.7 
Participant privacy and confidentiality ..........................................................................................15 
2.8 
Early termination of the study .......................................................................................................16 
2.9 
Protocol amendments ..................................................................................................................16 
3. 
BACKGROUND AND RATIONALE .............................................................................................. 16 
3.1 
Background and Rationale ...........................................................................................................16 
3.2 
Investigational Product (treatment, device) and Indication ..........................................................18 
3.3 
Preclinical Evidence .....................................................................................................................20 
3.4 
Clinical Evidence to Date .............................................................................................................20 
3.5 
Dose Rationale / Medical Device: Rationale for the intended purpose in study (pre-market MD)20 
3.6 
Explanation for choice of comparator (or placebo) ......................................................................20 
3.7 
Risks / Benefits .............................................................................................................................20 
3.8 
Justification of choice of study population ....................................................................................21 
4. 
STUDY OBJECTIVES ................................................................................................................... 21 
4.1 
Overall Objective ..........................................................................................................................21 
4.2 
Primary Objective .........................................................................................................................21 
4.3 
Secondary Objectives ..................................................................................................................21 
4.4 
Safety Objectives .........................................................................................................................21 
5. 
STUDY OUTCOMES ..................................................................................................................... 21 
5.1 
Primary Outcome .........................................................................................................................21 
5.2 
Secondary Outcomes ...................................................................................................................23 
5.3 
Other Outcomes of Interest ..........................................................................................................23 
5.4 
Safety Outcomes ..........................................................................................................................23 
6. 
STUDY DESIGN ............................................................................................................................ 23 
6.1 
General study design and justification of design ..........................................................................23 
6.2 
Methods of minimising bias ..........................................................................................................24 
6.2.1 Randomisation .....................................................................................................................25 

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6.2.2 Blinding procedures .............................................................................................................25 
6.2.3 Other methods of minimising bias ........................................................................................25 
6.3 
Unblinding Procedures (Code break) ...........................................................................................25 
7. 
STUDY POPULATION .................................................................................................................. 25 
7.1 
Eligibility criteria ............................................................................................................................25 
7.2 
Recruitment and screening ..........................................................................................................26 
7.3 
Assignment to study groups .........................................................................................................27 
7.4 
Criteria for withdrawal / discontinuation of participants ................................................................27 
8. 
STUDY INTERVENTION ............................................................................................................... 27 
8.1 
Identity of Investigational Products (treatment / medical device) .................................................27 
8.1.1 Experimental Intervention (treatment / medical device) .......................................................27 
8.1.2 Control Intervention (standard/routine/comparator treatment / medical device) .................27 
8.1.3 Packaging, Labelling and Supply (re-supply) ......................................................................27 
8.1.4 Storage Conditions...............................................................................................................27 
8.2 
Administration of experimental and control interventions ............................................................28 
8.2.1 Experimental Intervention ....................................................................................................28 
8.2.2 Control Intervention ..............................................................................................................28 
8.3 
Dose / Device modifications .........................................................................................................28 
8.4 
Compliance with study intervention ..............................................................................................28 
8.5 
Data Collection and Follow-up for withdrawn participants ...........................................................28 
8.6 
Trial specific preventive measures ...............................................................................................28 
8.7 
Concomitant Interventions (treatments) .......................................................................................29 
8.8 
Study Drug / Medical Device Accountability ................................................................................29 
8.9 
Return or Destruction of Study Drug / Medical Device ................................................................29 
9. 
STUDY ASSESSMENTS ............................................................................................................... 29 
9.1 
Study flow chart(s) / table of study procedures and assessments ...............................................29 
9.2 
Assessments of outcomes ...........................................................................................................31 
9.2.1 Assessment of primary outcome ..........................................................................................31 
9.2.2 Assessment of secondary outcomes ...................................................................................34 
9.2.3 Assessment of other outcomes of interest ...........................................................................34 
9.2.4 Assessment of safety outcomes ..........................................................................................34 
9.2.5 Assessments in participants who prematurely stop the study .............................................35 
9.3 
Procedures at each visit ...............................................................................................................35 
9.3.1 Screening appointment ........................................................................................................35 
9.3.2 Pre-study appointment .........................................................................................................35 
9.3.3 Main study appointments .....................................................................................................35 
9.3.4   Final appointment .................................................................................................................35 
10. SAFETY ......................................................................................................................................... 36 
10.1 Drug studies .................................................................................................................................36 
10.2 Medical Device Category C studies .............................................................................................36 
10.3 Medical Device Category A studies .............................................................................................36 
10.3.1 Definition and Assessment of safety related events ............................................................36 
10.3.2 Reporting of Safety related events.......................................................................................36 
11. STATISTICAL METHODS ............................................................................................................. 37 
11.1 Hypothesis ....................................................................................................................................37 
11.2 Determination of Sample Size ......................................................................................................37 

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11.3 Statistical criteria of termination of trial ........................................................................................37 
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 Interim analyses ...................................................................................................................38 
11.4.5 Safety analysis .....................................................................................................................38 
11.4.6 Deviation(s) from the original statistical plan .......................................................................38 
11.5 Handling of missing data and drop-outs.......................................................................................38 
12. QUALITY ASSURANCE AND CONTROL .................................................................................... 39 
12.1 Data handling and record keeping / archiving ..............................................................................39 
12.1.1 Case Report Forms ..............................................................................................................39 
12.1.2 Specification of source documents ......................................................................................40 
12.1.3 Record keeping / archiving ..................................................................................................40 
12.2 Data management ........................................................................................................................40 
12.2.1 Data Management System ..................................................................................................40 
12.2.2 Data security, access and back-up ......................................................................................40 
12.2.3 Analysis and archiving .........................................................................................................41 
12.2.4 Electronic and central data validation ..................................................................................41 
12.3 Monitoring .....................................................................................................................................41 
12.4 Audits and Inspections .................................................................................................................41 
12.5 Confidentiality, Data Protection ....................................................................................................41 
12.6 Storage of biological material and related health data .................................................................41 
13. PUBLICATION AND DISSEMINATION POLICY.......................................................................... 41 
14. FUNDING AND SUPPORT ............................................................................................................ 42 
14.1 Funding ........................................................................................................................................42 
14.2 Other Support ...............................................................................................................................42 
15. INSURANCE .................................................................................................................................. 42 
16. REFERENCES ............................................................................................................................... 43 
17. APPENDICES ................................................................................................................................ 45 
 
 
 

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STUDY SYNOPSIS 
(ClinO, Appendix 3, 1.1, 2.1, 3.1, 4.1; Appendix 5, 2b; AGEK Summary)  
 
Sponsor  
                             
Principle Investigator 
Sonova 
AG 
(contact 
person: 
katrin.manella@phonak.com), 
Laubisrütistrasse 28, 8712 Stäfa, 058 928 45 10                                              
Bernhard Buschle ( bernhard.buschle@phonak.com), Laubisrütistrasse 
28, 8712 Stäfa, 058 928 43 12 
Study Title: 
Quality Control of CE-Labelled Phonak Hearing Systems 
Study ID: 
CH-PH-Marketing-Validation 
Protocol Version and 
Date: 
Version  1.3, 17.12.2019    
Trial registration: 
After approval by CEC in:                                                             
• 
clinicaltrials.gov     
• 
Swiss Federal Complementary Database                                            
Study category and 
Rationale 
MD risk class IIA: Phonak Hearing Systems (comprising hearing aids, 
acoustic couplings and fitting software), Wireless Accessories (receiver), 
Smartphone Applications 
MD risk class I: Wireless Accessories (transmitters). 
All investigational devices are CE-labelled and their application is done 
according to the specialised information. 
Clinical Phase: 
“Phase of final inspection” (directly prior to launch) 
Background and 
Rationale: 
Phonak Hearing Systems pass through different development and study 
stages. At an early stage, feasibility studies are conducted to investigate 
new algorithms, features and functions in an isolated manner. If the benefit 
is 
proven, 
their 
performance 
is 
then 
investigated 
regarding 
interdependency between all available algorithms, features and functions 
running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a 
result, they get optimized. Afterwards, and prior to product launch, the 
Phonak Hearing Systems undergo a final quality control in terms of clinical 
trials in the way as planned for this study (“phase of final inspection”). 
Primary Objective(s): 
 
 
 
 
 
 
 
Secondary Objective: 
Zero-defect overall performance of the new Phonak Hearing Systems:  
• 
Technical: 
Sound 
quality, 
system 
stability 
and 
no 
distortions/artefacts/interruptions/feedback/system noise or other 
malfunctions occur. 
• 
Audiological: 
In 
the 
lab 
(objective: 
Standardised 
speech 
intelligibility measures in quiet/noise, threshold measures, cognitive 
measures, simulations of various listening situations, interviews) 
and in the users’ everyday life (subjective: questionnaires). 
• 
Handling: Rate of applicability, size, robustness, look-and-feel. 
 
Product benchmark:  
Comparison of new Phonak Hearing Systems to previous outstanding 
Phonak models and to competitor devices according to primary objectives. 
Outcome(s): 
• 
Lab trials: Objective and subjective test results 
• 
Home trials: Subjective test results  
Study design: 
Active comparator study, controlled, single blinded, randomised, cross-over 
or parallel design. 

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Inclusion / Exclusion 
criteria: 
Participants fulfilling all of the following inclusion criteria are eligible for the 
study:  
• 
Adult hearing impaired persons (minimum age: 18 years) with and 
without (experience with) hearing aids 
• 
Good written and spoken (Swiss) German language skills 
• 
Healthy outer ear (without previous surgical procedures)  
• 
Ability to fill in a questionnaire (p/eCRF) conscientiously 
• 
Informed Consent as documented by signature  
 
The presence of any one of the following exclusion criteria will lead to 
exclusion of the participant: 
• 
Contraindications to the MD in this study, e.g. known 
hypersensitivity or allergy to the investigational product 
• 
Limited mobility and not in the position to attend weekly 
appointments  
• 
Limited ability to describe listening impressions/experiences and 
the use of the hearing aid 
• 
Inability to produce a reliable hearing test result  
• 
Massively limited dexterity  
• 
Known psychological problems  
• 
Central hearing disorders  
Measurements and 
procedures: 
Pure tone audiogram, speech intelligibility in quiet and noise, threshold 
measurements, cognitive measurements, rating of sound simulation, 
questionnaires, interviews. 
Study Product / 
Intervention:  
MD risk category I and IIA  
 
Control Intervention 
(if applicable): 
MD risk category I and IIA  
 
Number of 
Participants with 
Rationale: 
In total, a maximum of 210 subjects will participate per year. According to 
experience, 6 clinical trials (main studies) with a maximum of 30 subjects 
per study are conducted for a quality control of the Phonak Hearing 
Systems prior to product launch. Additionally, a pre-study with 5 Sonova 
internal (normal hearing and/or hearing impaired) persons may takes place 
to proof the respective study concept in advance if necessary.  
Study Duration: 
10 years (01.10.2015 – 31.10.2025) 
Study Schedule: 
Month Year of First-Participant-In: October 2015 
Month Year of Last-Participant-Out: October 2025 
Investigator(s): 
 Bernhard Buschle, Marie Lewerenz, Josephine Hollenbach, Claudia Zent, 
Claudia Pfister 
Sonova AG, Laubisrütistrasse 28, 8712 Stäfa, Phone: 058 928 01 01 
Study Centre(s): 
Single-centre (Sonova AG, Stäfa) 
Statistical 
Considerations: 
Sample size according to experience and to established specialized 
literature.  
Descriptive statistics: Frequency distribution, mean and standard deviation, 
median and quartile, boxplot, histogram, scatterplot. 
Inferential 
statistics: 
t-Test, 
Mann-Whitney-U-Test, 
Wilcoxon-Test, 
correlation coefficient (Pearson, Spearman) .  
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.  
 
 
 

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STUDY SUMMARY IN LOCAL LANGUAGE  
In dieser Studienreihe findet eine methodische klinische Evaluation von neuen CE-zertifizierter 
Phonak Hörsystemen zur Qualitätskontrolle vor dem jeweiligen Produktlaunch statt. Das Ziel der 
Untersuchungen ist es, mithilfe von hörgeschädigten Studienteilnehmern, eine fehlerfreie 
Leistungsfähigkeit des gesamten Phonak Hörsystems zu gewährleisten. Das Phonak Hörsystem 
umfasst Hörgeräte unterschiedlicher Formfaktoren, akustische Ankopplung, drahtloses Zubehör (z.B. 
Fernbedienung) sowie die Anpass-Software. Des Weiteren wird die Sicherstellung des maximalen 
Nutzens für den Träger des Hörsystems anhand von objektiven Labormessungen sowie von 
subjektiven Bewertungen beim Tragen im Alltag angestrebt. Im Zuge dieser Untersuchungen werden 
die neu entwickelten Phonak Produkte mit ihren Vorgängermodellen sowie mit Mitbewerberprodukten 
verglichen. Diese klinische einfachblinde Studienserie erfolgt unter kontrollierten, randomisierten 
Bedingungen am Hauptsitz der Sonova AG in Stäfa.    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ABBREVIATIONS 
Provide a list of abbreviations used on the protocol - to be completed 
 
AE 
ANL 
BTE 
Adverse Event  
Acceptable Noise Level  
Behind-The-Ear device 
CA 
Competent Authority (e.g. Swissmedic) 
CEC 
Competent Ethics Committee 
CRF 
CU 
Case Report Form  
Categorial Unit 
ClinO 
 
Ordinance on Clinical Trials in Human Research (in German: KlinV, in French: 
OClin) 
CTCAE 
dB 
DD 
DM 
Common terminology criteria for adverse events 
Decibel 
Device Deficiencies 
Digital Modulation 
DSUR 
eCRF 
pCRF 
FM 
Development safety update report 
Electronic Case Report Form 
Paper Case Report Form  
Frequency Modulation 
GCP 
GöSa 
Good Clinical Practice  
Göttinger Satztest 
IB 
ITE 
Investigator’s Brochure 
In-The-Ear device 
Ho 
Null hypothesis 
H1 
Alternative hypothesis 
HFG 
HIBAN 
Humanforschungsgesetz (Law on human research) 
Hearing Instrument Body Area Network 
HMG 
Heilmittelgesetz  
HRA 
Federal Act on Research involving Human Beings 
IMP 
Investigational Medicinal Product 
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 
MUSHRA 
N/A 
Medical Device 
Multi-Stimulus Test with Hidden Reference and Anchor 
Not Applicable  
OClin 
Ordonnance sur les essais cliniques dans le cadre de la recherche sur l'être humain 
(in German : KlinV, in English : ClinO) 

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OLSA 
Oldenburger Satztest 
PI 
PL 
PM 
PPT 
REM 
RIC 
Principal Investigator  
Project Leader 
Product Manager 
Phoneme Perception Test 
Real-Ear Measurement 
Receiver-In-The-Channel device 
SDV 
SNR 
Source Data Verification  
Signal-to-Noise Ratio 
SOP 
Standard Operating Procedure 
SPC 
SPL 
SRT 
Summary of product characteristics 
Sound Pressure Level 
Speech Reception Threshold 
SUSAR 
TEN test 
Suspected Unexpected Serious Adverse Reaction 
Threshold-Equalizing-Noise test  
TMF 
UAT 
UCL 
WaKo 
Trial Master File  
User Acceptance Test 
UnComfortable Level 
Einsilber-Reimtest nach von Wallenberg und Kollmeier 
 
 
 
 
 

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STUDY SCHEDULE  
(AGEK 4.2; SPIRIT #13; ICH E6 6.4.2) 
 
Studies are organized in, a potential pre-study if needed, and the main study itself. A pre-study would 
be organized as follows:  
Study Period 
 
Screening 
Pre-study 
appointments 
Follow-up 
(final appointment) 
Visit Number 
1 
2 
3 
4 
Time [hrs] 
1.5 
2 
2 
2 
Audiological History  
x 
 
 
 
Physical Examination of Ear 
and Ear Canal  
x 
x 
x 
x 
Audiogram  
x 
 
 
x 
Tinnitus Matching 
x 
 
 
x 
Check In- /Exclusion Criteria 
x 
 
 
 
Decision 
Subject 
Participation 
x 
 
 
 
Subject 
Information 
and 
Informed Consent 
x 
 
 
 
Encoded Subject ID 
x 
 
 
 
eCRF Screening 
x 
 
 
 
eCRF Audiometry 
x 
 
 
x 
Randomisation  
x 
 
 
 
Hearing System Fitting 
x 
x 
x 
 
Objective 
and 
Subjective 
Measurements 
 
x 
x 
(x) 
eCRF 
Objective 
and 
Subjective Measurements 
 
x 
x 
(x) 
Introduction to Handling  
 
x 
x 
 
Scheduling Next Visit  
 
x 
x 
 
eCRF Final Appointment 
 
 
 
x 
Capture of Adverse Events 
and Device Deficiencies 
x 
x 
x 
x 
Table 1a: Pre-study: N = max 5 
 
 

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Study Period 
 
Screen
ing 
Study appointments 
Final 
Appointment 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Time [hrs] 
1.5 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
Audiological History  
x 
 
 
 
 
 
 
 
 
 
 
 
Physical Examination of 
Ear and Ear Canal  
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
Audiogram  
x 
 
 
 
 
 
 
 
 
 
 
x 
Tinnitus Matching 
x 
 
 
 
 
 
 
 
 
 
 
x 
Check 
In- 
/Exclusion 
Criteria 
x 
 
 
 
 
 
 
 
 
 
 
 
Decision 
Subject 
Participation 
x 
 
 
 
 
 
 
 
 
 
 
 
Subject Information and 
Informed Consent 
x 
 
 
 
 
 
 
 
 
 
 
 
Encoded Subject ID 
x 
 
 
 
 
 
 
 
 
 
 
 
eCRF Screening 
x 
 
 
 
 
 
 
 
 
 
 
 
eCRF Audiometry 
x 
 
 
 
 
 
 
 
 
 
 
x 
Randomisation  
x 
 
 
 
 
 
 
 
 
 
 
 
Hearing System Fitting 
x 
 
 
 
 
 
 
 
 
 
 
 
Objective 
and 
Subjective 
Measurements 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
(x) 
eCRF 
Objective 
and 
Subjective 
Measurements 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
(x) 
Introduction to Handling   
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
Scheduling Next Visit  
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
eCRF 
Final 
Appointment 
 
 
 
 
 
 
 
 
 
 
 
x 
Capture 
of 
Adverse 
Events 
and 
Device 
Deficiencies 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Table 1b: Main study: N = max 30 (no pre-study subjects) 
 
1. STUDY ADMINISTRATIVE STRUCTURE  
 (ICH/E6 6.1.2-6.1.7; AGEK 1.1; SPIRIT 5a-d) 
This section contains complete contact details. 
1.1 Sponsor, Sponsor-Investigator  
(ICH/E6 6.1.2; AGEK 1.1; SPIRIT 5b) 
ICH: Name and address of the sponsor ….. 
The Sponsor is the company Sonova AG, represented by Katrin Manella. Sonova AG will provide the 
study budget, the staff, the spatial resources, the measurement equipment and the investigational 
products (hearing systems). 
 

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Company:  Sonova AG, Stäfa 
Contact:     Katrin Manella, M.Sc.  
Address:    Laubisrütistrasse 28, 8712 Stäfa 
Phone:       058 928 45 10  
 
Email:        katrin.manella@phonak.com 
Role:          Financier 
  
1.2 Principal Investigator(s)  
(ICH/E6 6.1.5, 6.1.6; AGEK 1.1; SPIRIT 5a-d) 
ICH: Name and title of the investigator(s) who is (are) responsible for conducting the trial, and the 
address and telephone number(s) of the trial site(s). 
In Sonova AG, the Validation Team undertakes a final quality control of the Phonak Hearing Systems 
in terms of clinical trials (“final inspection stage”). Each Validation Team member is qualified to take on 
the role as an Investigator (except of the administrative assistant, Claudia Pfister). The functions as 
the Principle Investigator is taken on by: 
 
Site:           Sonova AG, Stäfa 
Contact:     Bernhard Buschle, B.Sc. (phone: 058 928  4421) 
                    
Address:    Laubisrütistrasse 28, 8712 Stäfa 
Email:         bernhard.buschle@phonak.com 
Role:     
• 
Study design 
• 
Data collection 
• 
Data analysis 
• 
Report 
 
1.3 Statistician ("Biostatistician")  
(ICH/E6 6.1.7; SPIRIT 5a-d) 
ICH: Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical 
department(s) and/or institutions involved in the trial. 
The role as the Statistician is adopted by the Principle Investigator.  
 
1.4 Laboratory 
(ICH/E6 6.1.7; SPIRIT 5a-d) 
ICH: Name(s) and address(es) of the clinical laboratory(ies) …………. involved in the trial. 
The study will take place in the labs of the Headquarter of Sonova AG, Laubisrütistrasse 28, 8712 
Stäfa (see, 11_QualifikationPrüfort_V1.0_30.06.2015). 
 
1.5 Monitoring institution 
(ICH/E6 6.1.2; SPIRIT 5a-d) 
ICH: Name and address of the …. monitor (if other than the sponsor). 
Site:         Sonova AG, Stäfa.  
    Every Sonova employee who is qualified in the domain of audiology research and who is   
    not part of the study team is capable to take on the role of the Monitor.                                                      
Contact:   Katrin Manella, M.Sc. (phone: 058 928 45 10) 
Address:   Laubisrütistrasse 28 
                 8712 Stäfa 
Email:       katrin.manella@phonak.com 

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1.6 Data Safety Monitoring Committee  
(ICH/E6 6.1.7; SPIRIT 5a-d) 
ICH: Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical 
department(s) and/or institutions involved in the trial. 
N/A 
 
1.7 Any other relevant Committee, Person, Organisation, Institution  
(ICH/E6 6.1.7; SPIRIT 5a-d) 
ICH: Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical 
department(s) and/or institutions involved in the trial. 
N/A 
2. ETHICAL AND REGULATORY ASPECTS  
(ICH/E6 6.12; AGEK 11; SPIRIT #24, 5) 
ICH: Description of ethical considerations relating to the trial. 
The decision of the CEC authority concerning the conduct of the study will be made in writing to the 
Sponsor bevor commencement of this study. The clinical study will only begin once approval from all 
required authorities has been received. Any additional requirements imposed by the authorities will be 
implemented. 
 
2.1 Study registration  
(ClinO, Art. 1d, 64; SPIRIT #2a-b) 
This study will be registered at clincaltrials.gov as a primary register and, additionally, it will be 
registered in the Swiss Federal Complementary Database as soon as the ethics application is 
approved by the CEC.  
 
2.2 Categorisation of study  
(ClinO, Art. 19, 20, App 3, 1.1) 
The study is a clinical trial with MD risk category I (wireless accessories (transmitters and receivers)) 
and risk category IIA (hearing aids, acoustic couplings (receivers, tubes, earpieces) and fitting 
software). All medical devices in this trial are CE-labelled and the application is done according to the 
specialized information.  
 
2.3 Competent Ethics Committee (CEC)  
(ClinO, Art 24-29; SPIRIT #24) 
The responsible investigator ensures that approval from an appropriately constituted CEC is sought 
for the clinical study.                                                                                                    
Reporting duties and allowed time frame have to be abided concerning all changes in 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 are 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 is reported within 15 days. The regular end of the 
study is reported to the CEC within 90 days, the final study report will be submitted within one year 
after study end. Amendments are reported according to chapter 2.10. 
 

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2.4 Competent Authorities (CA)  
(ClinO, Art. 23, 27, 30-39, 42, 43, 46-48, 57; SPIRIT #24) 
There is no need for a CA approval or other local requirements because this study is of risk category 
according to LHR A. 
 
(ClinO, Art. 5; AGEK 11; ICH E6 6.12, 6.2.5) 
ICH: A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable 
regulatory requirement(s). 
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 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.  
 
2.5 Declaration of interest  
(ClinO, Art. 3b; SPIRIT #28) 
In accordance to ISO 14155 and KlinV, Art. 3b scientific integrity will be preserved. Therefore, any 
potential conflicts of interest, including financial, that interfere with the conduct of this clinical 
investigation or interpretation of the according results could be disclosed.  
 
2.6 Patient Information and Informed Consent 
(ClinO, Art. 7-9, Art. 15-17, Appendix 3, 1.4, 2.4, 3.4, 4.3, Appendix 4, 3.6; AGEK submission checklist item 
5; SPIRIT #26, 32) 
The investigators 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 may withdraw 
from the study at any time and that withdrawal of consent will not lead to consequences for the 
participant. The participant must be informed that his medical records may be examined by authorized 
individuals.  
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 be given enough time (minimum time frame 
for this study: 1 week) for their participation decision. 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. 
 
2.7 Participant privacy and confidentiality  
(ClinO, Art. 18; ICH/E6 6.10; AGEK 12.2, SPIRIT #27) 
ICH: The sponsor should ensure that it is specified in the protocol or other written agreement that the 
investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB/IEC review, and regulatory 
inspection(s), providing direct access to source data/documents. 
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 audiological 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 measurement data in the computer files. 
For data verification purposes, authorised representatives of the Sponsor, a competent authority (e.g. 

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Swissmedic), or an ethics committee may require direct access to parts of the measurement records 
relevant to the study, including participants’ audiological history. 
 
2.8 Early termination of the study  
(ClinO Art. 47; ICH/E6 6.4.6; SPIRIT #21b) 
ICH: A description of the "stopping rules" or "discontinuation criteria" for individual participants, parts of 
trial and entire trial. 
The Sponsor or the Principle Investigator 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  
 
2.9 Protocol amendments 
(ClinO, Art. 29, 34, 55; SPIRIT #25) 
Every person who is involved in the study performance is able to draft an amendment. All 
amendments have to be reviewed and signed by the Principle Investigator of the main study site 
before they get forwarded to the responsible approval institution.  
 
Substantial amendments are only implemented after approval of the CEC.  
 
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. Such 
deviations shall be documented and reported to the sponsor and the CEC as soon as possible.  
All non-substantial amendments are communicated if applicable to the CEC within the Annual Safety 
Report (ASR). 
 
3. BACKGROUND AND RATIONALE  
(ICH 6.2; AGEK 3; SPIRIT #6)  
This section includes any statements that rely on existing knowledge or published information 
concerning the study. 
 
3.1 Background and Rationale 
(ICH/E6 6.2; AGEK 3.1; SPIRIT #6)  
Phonak Hearing Systems pass through different development and study stages. At an early stage, 
feasibility studies are conducted to investigate new ideas in the form of algorithms, features and 
functions in an isolated manner. If the benefit of a new idea is proven, its performance is then 
investigated regarding interdependency between all available algorithms, features and functions 
running in parallel in a hearing aid (pivotal/pre-validation studies). Consequently, optimizations are 
undertaken according to the outcomes. Afterwards and prior to product launch, the complete Phonak 
Hearing Systems undergo a final quality control, amongst others, in terms of clinical trials conducted in 
a standardized manner by the Phonak Validation Team (“final inspection stage”). 
For years, the Phonak Validation Team could build extensive knowledge regarding quality control and 
clinical investigations. During the past three years, a series of studies for the final quality control of the 
Phonak Hearing Systems has been conducted based on the approved ethics proposal KEK ZH-
Nr.2013-0144 “Strukturiertes Post Market Clinical Follow-up (PMCF) zur Qualitätsbeurteilung der 
ersten Palio3 Feature-, Funktions- und Produktgeneration.” [37]. The planned study series within this 
proposal builds on the experiences of the previous studies in the same way. Please find a brief 
summary of the study series covered by the past ethics proposal below: 

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No. 
Title 
Status 
Primary Objective 
Secondary Objective 
N 
Methodology 
1 
Baseline 
 
completed 
Loudness, sound quality, 
speech intelligibility with 
individual hearing 
instrument prescription 
Speech intelligibility in 
noise 
22 
 
p/eCRFs, WaKo, 
Freiburger, OLSA, PPT, 
sound simulations, REM 
2 
Palio3 - 
Active 
Occlusion 
Control 
(AOC) 
 
omitted 
x 
x 
x 
x 
3 
 
HABS 
 
completed 
Acceptance of the 
automatic program 
during the individual 
daily life 
Perception of artifacts, 
efforts on fine tuning, 
sound balance 
66 
p/eCRFs, Freiburger, 
OLSA, PPT, sound 
simulations, MUSHRA, 
paired comparison, REM 
4 
Low 
Frequency 
amplification 
in open 
fittings 
 
completed 
Speech intelligibility 
Sound balance 
20 
p/eCRFs, WaKo, OLSA, 
PPT, sound simulations, 
REM 
5 
Sprachverst
ändlichkeit 
in 
schwierigen 
Hörsituation
en 
omitted 
x 
x 
x 
x 
6 
System 
Validation 
Palio3 
CR(M)T 
 
completed 
High user’s satisfaction 
with the loudness and 
sound quality  
Increase of hearing 
instrument acceptance 
after long-term 
experience (4wks), 
efforts on fine tuning, 
additional benefit from 
accessories, objective 
speech intelligibility, 
frequency of hardware  
defects 
60 
p/eCRFs, Freiburger, 
OLSA, PPT, sound 
simulations, REM 
7a  
 
7b 
Palio3 HdO 
Systeme  
Palio3 IdO 
Systeme 
 
running 
Equality of the form 
factors regarding 
loudness and sound 
quality perception with 
individual hearing 
instrument prescription 
Increase of hearing 
instrument acceptance 
after long-term 
experience (4wks), 
efforts on fine tuning, 
additional benefit from 
accessories, objective 
speech intelligibility, 
frequency of hardware  
defects 
53 
p/eCRFs, Freiburger, 
OLSA, PPT, sound 
simulations, REM 
8a  
 
 
8b 
Palio3 
(Bi)CROS 
CRT 
Palio3 
(Bi)CROS 
IdO 
 
running 
Objective speech 
intelligibility in noise  
Increase of hearing 
instrument acceptance 
after long-term 
experience (5wks), 
efforts on fine tuning, 
subjective speech 
intelligibility 
32 
p/eCRFs, Freiburger, 
OLSA, PPT, sound 
simulations, REM 
9 
Palio3 
Power 
To be 
planned 
Equality or improved 
performance of the new 
power devices 
compared to appropriate 
predecessor regarding 
loudness and sound 
quality perception with 
individually calculated 
prescription 
New system works 
reliable and no 
malfunctions occur 
40 
p/eCRFs, Freiburger, 
OLSA, PPT, sound 
simulations, REM 

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10 
Benchmark 
omitted 
x 
x 
x 
x 
Table 2: Overview of study series: KEK ZH-Nr.2013-0144. 
 
3.2 Investigational Product (treatment, device) and Indication  
(ICH/E6 6.2.1; AGEK 2; SPIRIT #6) 
ICH: Name and description of the investigational product(s). 
All hearing systems (Phonak and competitor) are CE-labelled MD of risk category I and IIA. All MDs 
(hearing instruments, earpieces and wireless accessories) are bearing product names and unique 
serial numbers for an unambiguous assignment and retracing of the product to the subject. The 
hearing systems will be set and fine-tuned to the individual hearing loss and needs of the subject by 
using the corresponding fitting software (table 3) in accordance to the specialised information whereof 
the latest version can always be printed out of the Phonak Fitting Software, Target.  
 
Manufacturer 
Fitting Software 
Phonak 
Target 
Oticon 
Genie 
Widex 
Compass 
Siemens 
Connexx 
Starkey 
Inspire 
Audio Service 
Connexx 
Table 3: Overview of hearing instrument companies with their appropriate fitting software. 
 
 
Hearing Instruments: 
In general, the hearing instruments themselves can be separated in different form factors: In-The-Ear 
(ITE), Receiver In Canal (RIC) and Behind-The-Ear (BTE) including different acoustic couplings 
depending on the hearing loss and on the anatomical conditions of the hearing aid user, see figures 1-
4 below (source: http://www.phonak.com/ch/b2c/de/products/hearing_instruments/styles-10.html and  
https://www.phonakpro.com/content/dam/phonak/gc_us/Documents/Product/RIC/RIC%20Acoustic_Co
upling_Guide_028-0555-03.pdf, status: 07.05.2015). 
 
                 
                           
 
Figure 1: In-The-Ear (ITE)     Figure 2: Receiver In Canal (RIC)            Figure 3: Behind-The-Ear (BTE) 
 

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Figure 4: Different acoustic couplings offered by Phonak (receiver and coupling options/earpieces). 
 
Earpieces:  
Together with a BTE or RIC, the earpiece is a system which is also of medical device risk category IIA. 
Without the merge of the earpiece and hearing aid the earpiece has no medical harness.  
 
Wireless Accessories: 
The Phonak Wireless Accessories comprise various solutions to simplify the volume adjustment as 
well as the program switching in a hearing aid but also to enhance speech intelligibility in noisy 
environments, in making phone calls or in bridging distances between a talker and the hearing aid 
user like in class/conferences/lectures. The signal processing is based on frequency modulation (FM) 
technology, digital modulation (DM) technology, bluetooth (direct streaming, e.g. from the cell phone to 
the hearing instrument) and/or a specific signal processing algorithm developed by Phonak itself, the 
HIBAN (hearing instrument body area network), respectively. The subsequent current Phonak 
Wireless Accessory solutions are MD of risk class I: Phonak ComPilot, Phonak PilotOne, 
PhonakCompilot Air, RemoteControl App, Roger Pen, Roger Clip-On Mic, Roger for Education and 
their corresponding receivers. Phonak products which are no MD but which are also investigated are: 
Phonak DECT, Phonak EasyCall, Phonak RemoteMic and Phonak TVLink (figure 5, source: 
http://www.phonak.com/com/b2c/en/products/wireless-accessories.html, status: 18.05.2015). They 
also have a unique serial number for an unambiguous assignment and retracing of the product to the 
subject. The intended purpose is also according to the instruction manual.  
 
 
  
Figure 5: Some examples of Phonak Wireless Accessories. 
 

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3.3 Preclinical Evidence  
(ICH/E6 6.2.2; SPIRIT #6a)  
ICH: A summary of findings from nonclinical studies that potentially have clinical significance ….. 
For MD this entry is only applicable if needed for pre-marketed / marketed devices needing 
Swissmedic notification (Guidance on the biological evaluation of medical devices is given in ISO 
10993). Therefore, this entry is not applicable for this study. 
 
3.4 Clinical Evidence to Date  
(ICH/E6 6.2.2; SPIRIT #6a) 
ICH: A summary of findings from … and from clinical trials that are relevant to the trial. 
There is no available clinical research data to date on the investigational product. 
 
3.5 Dose Rationale / Medical Device: Rationale for the intended purpose in 
study (pre-market MD)  
(ICH/E6 6.2.4; SPIRIT #6a) 
ICH: Description of and justification for the route of administration, dosage, dosage regimen, and 
treatment period(s). 
The hearing instruments will be set and fine-tuned to the individual hearing loss and needs of the 
subject in accordance to established audiological test methods and according to the best knowledge 
and conscience of trained staff. The Sonova Validation Team is experienced in hearing instrument 
fitting for more than 15 years.  
 
3.6 Explanation for choice of comparator (or placebo)  
(AGEK 11.3; SPIRIT #6b) 
In this study, hearing instruments of previous Phonak generations or competitors are compared with 
the latest Phonak hearing aid technology to evaluate the current overall product status.  
 
3.7 Risks / Benefits  
(ClinO, Appendix 4, 3.5; Art 25d2; ICH/E6 6.2.3; AGEK 11.1; SPIRIT #6a; MD: ISO 14155 Annex A & ISO 
14971) 
ICH: Summary of the known and potential risks and benefits, if any, to human subjects. 
There are five known risks:  
 
1. Infections can be caused by injuries of the ear canal which can occur by the placement of the 
acoustic coupling (e. g. receiver, earpiece) to the outer ear canal or by the placement of an ITE 
device. Therefore, the ear canal will be thoroughly checked and assessed during the study.  
 
2. Pressure points can be caused by the hearing aid or the acoustic coupling. In case of pressure 
points, the hearing aid should not be worn until it healed up. The cause of the pressure point would 
then be investigated.  
 
3.  Tinnitus can be cause by wearing of the hearing aids. An existing tinnitus can be temporarily 
amplified. If the tinnitus doesn’t improve after several days of not wearing the hearing aid, an 
assessment with an independent doctor (ENT) is necessary.  
 
4. A headache can occur, especially for new hearing aid users. If a headache appears, the subject is 
instructed to interrupt the hearing aid use until the audiologist applies a new fitting (e.g. reduced gain 
level) to acclimatize the subject to the devices.  
 
5. The hearing aid can reach a high maximum power output (MPO). The MPO will be set accordingly 
to clinical expertise at a level that no injuries can occur.  
 

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3.8 Justification of choice of study population  
(ClinO, Art 25d4, Art. 15-17; ICH/E6 6.2.6; AGEK 11.2) 
ICH: Description of the population to be studied. 
In this study, adult hearing impaired persons with different degrees of hearing loss will participate. The 
sound processing in the inner ear significantly differs between normal hearing and hearing impaired 
persons and, furthermore, is dependent on the degree of the hearing loss. For this reason, the sound 
quality and the benefit of new hearing systems, which can be individually fitted to a hearing loss, can 
only be reliably evaluated by appropriate hearing impaired persons. 
In addition, both persons with hearing aid experience (i.e. owning hearing aids) and without this 
experience can participate. Hearing impaired persons are categorized as a vulnerable population 
since in both cases (with and without hearing aid experience), they might expect a benefit from the 
study participation in the form of, e.g. a cheaper acquisition of the newest hearing system technology 
directly from the Sonova AG which is not possible. 
4. STUDY OBJECTIVES  
(ICH/E6 6.3; AGEK 3; SPIRIT #7) 
ICH: A detailed description of the objectives and the purpose of the trial. 
4.1 Overall Objective 
A successive methodical evaluation of new CE-Labelled Phonak Hearing Systems (hearing 
instruments, acoustic couplings, wireless accessories and fitting software) on hard of hearing 
participants will be conducted to grant quality control prior to product launch. 
4.2 Primary Objective 
The study seeks primarily to grant zero-defect overall performance of the new Phonak Hearing 
Systems. 
4.3 Secondary Objectives 
Secondary objectives are to assess efficacy of the new Phonak Hearing Systems compared to 
previously outstanding Phonak Hearing Systems and to competitor devices. 
4.4 Safety Objectives 
With regard to a continuous improvement of the various algorithms running in parallel in a hearing 
systems, the study aims to assess long-term safety of the Phonak Hearing Systems.  
5. STUDY OUTCOMES  
(ICH/E6 6.4.1; AGEK 4.1; SPIRIT #12) 
ICH: A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured 
during the trial. 
This section includes a description of the overall, primary and secondary objective(s) of the study 
including the specific measurement variable and analysis metric. 
5.1 Primary Outcome 
Zero-defect overall performance of the new Phonak Hearing Systems:  
• 
Technical: Sound quality, system stability, no distortions/artefacts/interruptions/feedback/ 
system noise or other malfunctions occur. 
• 
Audiological: In the lab (objective: standardised speech intelligibility measures in quiet and in 
noise, threshold measures, cognitive measures, simulations of various listening situations,  
interviews) and in the users’ everyday life (subjective: questionnaires (p/eCRF)). 
• 
Handling: Rate of applicability, size, robustness, look-and-feel. 
 
Dependent on the investigational device and the corresponding focused algorithm, feature or function 

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(aim) the appropriate audiological testing method will be chosen (for details, see table 4): 
 
Performance 
Aim 
Method 
Result [unit] 
Technical 
Assessment of sound quality 
Subjective Rating Scale [31, 32] 
Point on a scale 
 
Assessment of system stability 
Quantitative Questionnaires [29] 
Yes/No replies and open-
ended 
 
Survey of audibility of 
distortions, artefacts, 
interruptions, feedback, system 
noise or other malfunctions 
Quantitative Questionnaires [29] 
Yes/No replies and open-
ended 
Audiological 
Determination of hearing 
threshold of pure tones  
Pure Tone Audiometry [30] 
Yes/No replies 
 
Assessment of speech 
intelligibility in quiet 
Freiburger Sprachtest [10, 30] 
Discrimination [%] 
 
Assessment of speech 
intelligibility in noise 
Oldenburger Satztest (OLSA) [11, 12] 
Speech intelligibility 
threshold in noise 
[dB SNR] 
 
Assessment of speech 
intelligibility in quiet or in noise 
Einsilber-Reimtest nach von Wallenberg 
und Kollmeier (WaKo) (quiet/noise) [13] 
Discrimination [%] 
 
Assessment of speech 
intelligibility in quiet or in noise 
Göttinger Satztest (GöSa) (quiet/noise) 
[14] 
SRT in quiet [dB], in noise 
[dB SNR] 
 
Determination of threshold of 
fricatives 
Phoneme Perception Test (PPT) [15-18] 
Detection, Distinction and 
Recognition Threshold [dB 
SPL] 
 
Judgment which of the entities 
in pairs is preferred or has a 
greater amount of some 
quantitative property 
Paired Comparison [19] 
Preference or point on a 
scale 
 
Subjective evaluation of the 
audio quality of a defined sound 
Multi-Stimulus Test with Hidden Reference 
and Anchor (MUSHRA) [20] 
Point on a scale 
 
Determination of acceptable 
noise intensities while listening 
to speech 
Acceptable Noise Level (ANL) Test  
[21, 22] 
Tolerated SNR [dB] 
 
Assessment of the subjectively 
perceived loudness of a test 
signal 
Categorial Loudness Scaling [23] 
Loudness [CU] 
 
Assessment of the real-ear 
performance of hearing aids 
Real-Ear Measurement (REM) [24] 
Frequency Response 
[magnitude and phase of the 
output as a function of 
frequency] 
 
Determination of individual 
information or circumstances 
regarding hearing system 
and/or listening situation 
Interviews: Qualitative and Quantitative 
(ad hoc list of questions, semi-
standardized, standardized or normed), 
Focus Groups [29] 
Narrative, open/closed 
replies, ranking, 
single/multiple choice, or 
point on a rating scale 
 
Quantitative assessment of a 
person’s perception of facts or 
circumstances regarding 
hearing system  
Semantic Differential Analysis/ Polarity 
Profile [25] 
Point on a scale 
 
Determination of a present 
tinnitus 
Tinnitus Pitch and Loudness Matching [26] 
Tinnitus frequency/pitch [Hz] 
and sensation level [dB SL]. 
 
Assessment of a person’s 
perception of a specific listening 
situation through selected 
hearing systems or hearing aid 
programs 
Simulations of Various Listening Situations 
(in Car/Cafeteria/Reverberation) via 
Loudspeakers including Preference Rating 
or Subjective Rating Scale 
Preference or point on a 
scale 
 
Determination of localization 
capabilities with and/or without 
hearing systems 
Localization Test in Quiet, Noise, 
Reverberation. [27] 
Average RMS localization 
error [°], back-front 
confusions [%] 
 
Determination of dead regions 
in the cochlear 
TEN (Threshold-Equalizing-Noise) Test 
[28] 
Detection of pure tones 
presented simultaneously 
with a wide band noise 
(TEN) which produces the 
same level of masking [dB 
NPS] throughout audiogram 
frequencies (250 – 10k Hz) 
 
Assessment of a hearing aid 
user’s affection by objective 
occlusion (closed ear canals) 
Occlusion Measurement and Leakage 
Measurement using REM method [36] 
Frequency Responses 
[magnitude and phase of the 
output as a function of 
frequency] => Level 
differences [dB] and  
Level Loss [dB] 
 
Assessment of real-time 
individual information regarding 
MobEval [33, 34, 35] 
Logging of predefined HI 
parameters, time [h/min/s], 

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hearing system and/or listening 
situation via Phonak App on 
Smartphone in daily life 
open/closed replies or 
single/multiple choice 
Other 
Assessment of third-party 
disability and the role of social 
support in hearing care 
Quantitative Data through Questionnaires 
(e.g., IOI-HA-SO [40], SOS-HEAR [41]) 
Score on Likert Rating 
Scales 
 
Assessment of cognitive 
influences on speech 
perception 
Cognitive Measures, e.g. for Working-
Memory Capacity (e.g., Reading Span 
[38]), Executive Functioning and Attention 
(e.g., Stroop Task), Overall Cognitive 
Ability (e.g., MoCA [39]) 
Performance Level [%-
correct responses or time-
to-complete outcomes] 
 
Subjective Assessment of 
Listening Effort and Hearing 
Fatigue 
Questionnaires about Listening Effort in 
Everyday Life (e.g., CTO [42]), Rating 
Scales of Effort perceived during above 
listed Audiological Tests 
Score on a Continuous 
Rating Scale or on a Likert 
Rating Scale 
 
Objective Assessment of 
Listening Effort and Spare 
Capacity 
Response Delays during above listed 
Speech Intelligibility Tests; Dual-Task 
Paradigms with Speech Intelligibility as 
primary task and a Cognitive Outcome 
Measure as the Secondary Add-On Task 
(e.g., Assessment of Cognitive Capacity 
for tasks of Selective Attention or Working 
Memory during the Primary Task [43, 44, 
45]) 
SRT [%] and Errors [%] or 
Response Times [ms] 
Table 4: Primary outcome table. 
 
5.2 Secondary Outcomes 
Product benchmark: Comparison of new Phonak Hearing Systems to previous models and to 
competitor devices according to primary objectives in accordance to table 4. 
 
5.3 Other Outcomes of Interest 
Other outcomes of interest are side-effects. 
  
5.4 Safety Outcomes 
N/A 
 
6. STUDY DESIGN  
(ICH/E6 6.4; AGEK 4; SPIRIT #8) 
6.1 General study design and justification of design  
(ICH/E6 6.4.2, 6.4.5; AGEK 4.2; SPIRIT #8) 
ICH: The scientific integrity of the trial and the credibility of the data from the trial depend substantially on 
the trial design.  
ICH: A description of the type/design of trial to be conducted (e.g., double-blind, placebo-controlled, 
parallel design) and a schematic diagram of trial design, procedures and stages. 
ICH: The expected duration of subject participation, and a description of the sequence and duration of all 
trial periods, including follow-up, if any. 
 
A methodical evaluation of new CE-Labelled Phonak Hearing Systems is intended to be conducted on 
hard of hearing participants to grant quality control prior to product launch in spring or in fall per year. 
The aim of the investigation is to continuously ensure zero-defect overall performance of the new 
hearing systems as well as maximum benefit for the participant with the devices in comparison to 
previously outstanding Phonak Hearing Systems and to equivalent strong competitor devices across 
10 years (October 2015 to 2025). This will be a controlled, single blinded (participants),  randomised 
(testing method), cross-over (investigational product) active comparator study which will be conducted 
mono centric at Sonova AG Headquarters based in Stäfa. 

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In total, a maximum of 210 adult subjects will participate per year.If necessary, there will be a pre-
study with a maximum of five internal (normal hearing or hearing impaired) subjects before the main 
study to prove the actual study design . A pre-study will be considered if there are adjustments away 
the normal audiological standard regarding the methode, setup, subject group etc. If a pre-study is 
necessary will be decided by the principal investigator.   . Then, according to experience, 6 clinical 
trials (main studies) with a maximum of 30 subjects per study each of two months duration, are 
conducted for a quality control of the Phonak Hearing Systems. Typically, each participant gets a 
series of weekly appointments of 1.5 to 2 hours (lab trials), respectively, including the fitting procedure 
of the hearing system as well as the objective tests. Between the weekly appointments, the home 
trials take place so that the subjects can test the devices in their daily life in accordance to some 
questionnaires either pCRF or eCRF. In dependence on the form factor of an investigational product, 
which provide different gain levels, participants with appropriate hearing losses ranging from mild, 
moderate, severe to profound need to be recruited. Testing takes place in one of the three double-
walled sound-attenuating booths (Validation Room 1, 2 and 3, see section 9.2.1).  
Despite of the well-defined study protocol, some limitations of the study design are inherent. For 
example, it is not possible to blind the investigational product during the home trial. Especially the 
housing/naming of competitor devices are revealing their identity. During the lab trials, the participants 
are fully blinded. An additional limitation of the study design are software updates during the study for 
both the fitting software and the hearing systems. As soon as quality problems occur, such as acoustic 
feedback problems or artefacts, for example, a device deficiency form is filled in and the devices get 
revised leading to different firmware versions across the study which need to be considered during the 
data analysis.     
 
6.2 Methods of minimising bias  
(ICH/E6 6.4.3; AGEK 4.3; SPIRIT #16, 17) 
ICH: A description of the measures taken to minimize/avoid bias, including: Randomization, Blinding. 
In order to minimize bias: 
  
1. Strictly defined hearing instruments settings will be taken for:  
A. Lab Trial: All objective lab tests will be performed in a lab setting of the hearing 
instruments. The lab setting for each hearing instrument will be defined in appointment 1 
after performing the first fit to the individual hearing loss of the subject as proposed by the 
Phonak Fitting Software, and, if necessary, a fine tuning only in gain level. 
B. Home Trials: If necessary, for the Home Trials the hearing instruments will be fine-tuned 
based on the individual hearing loss and pre-calculation (lab setting). The fine tuning 
comprises every option offered in the fitting software as it can typically be applied by the 
hearing care professionals in the market. 
2. No investigator change per subject during the study, if possible (exceptions: sickness, 
vacation, advanced training). 
3. Uniform and extensive training of the whole study team and monitor prior to study start. 
4. Use of electronic database eClinicalOS (Merge) for direct data capture by the investigators 
during the lab trial and by the study participants during home trial (reduction of pCRFs to the 
greatest possible extent). 
5. Close meshed monitoring of subject appointments conducted by new investigators. 
6. To avoid learning effects, subjects cannot jump from one study to the next (minimum break of 
six months, at least). 
7. To avoid training effects, standardized test methods are applied according to their instructions.  
8. Sensitizing the investigators to bias (e.g. Halo-Effects).  
9. Orthogonal design of the questionnaires (p/eCRF) to fulfil the criteria for test quality 
(objectivity, validity, reliability).  
10. Reduction of order effects – randomized order of the test procedure of the subjective 
judgments, the objective tests and the hardware comparisons.  
11. Limited information will be given to the subjects regarding the test products and the features.  
12. In order to ensure a high satisfaction of the subject, the physical position in and on the ear 
must be comfortable and it must be ensured that the subject can operate the device well (e. g. 
putting the hearing aids on, changing batteries, switching on/off ). These aspects will be 
observed and checked throughout the study sections so that they are not the form factor to 
cause any bias in results, especially subjective results.  
 

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6.2.1 
Randomisation  
Randomization and concealment of randomization list is generated by the Principle Investigator using 
a script written in the program MatLab. The randomization is applied to all investigational products for 
both the lab trials and the home trials. Furthermore, the order of the test method used per visit is liable 
to a randomization. 
 
6.2.2 
Blinding procedures  
Trial participants will be blinded after assignment to interventions. During the lab trials, the subjects 
will not know which hearing system they are wearing because the investigators will mount the hearing 
instruments covered to the subjects ear. During the home trials, the labelling on the housing will be 
covered by a sticker, if possible. Nevertheless, the brand of the device might be identified by the 
subjects due to the shape of the housing (limited blinding).  
 
6.2.3 
Other methods of minimising bias  
To the greatest possible extent validated questionnaires (p/eCRF) come into operation. However, 
specifically adapted questionnaires are inevitable to validly capture the appropriate information 
needed. 
 
6.3 Unblinding Procedures (Code break)  
(ICH/E6 6.4.8; AGEK 4.2; SPIRIT #17b) 
ICH: Maintenance of trial treatment randomization codes and procedures for breaking codes. 
A subject coding list is safely stored and can be used to break the code, if necessary. Also the 
randomization lists can be used to identify the subject and his specific measurement order, if 
applicable.  
7. STUDY POPULATION  
(ICH/E6 6.2.6, 6.4.6; AGEK 3.2, 5; SPIRIT #9, 10, 15, 16, 21) 
ICH: Description of the population to be studied. 
This section describes the population to be studied. 
 
7.1 Eligibility criteria  
(ClinO, Art 25d5; ICH/E6 6.5.1&6.5.2; AGEK 5.2&5.3; SPIRIT #10) 
ICH: Subject inclusion and exclusion criteria. 
 
Only adult subjects will participate. In the pre-study normal hearing persons as well as hearing 
impaired persons will participate whereas in the main study merely hearing impaired subjects will be 
involved. 
 
Participants fulfilling all of the following inclusion criteria are eligible for the study:  
• 
Adult (minimum age: 18 years) hearing impaired persons both with and without (experience 
with) hearing aids 
• 
Good written and spoken (Swiss) German language skills 
• 
Healthy outer ear (without previous surgical procedures)  
• 
Ability to fill in a questionnaire (p/eCRF) conscientiously 
• 
Informed Consent as documented by signature  
 
The presence of any one of the following exclusion criteria will lead to exclusion of the participant: 
• 
Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the 
investigational product 
• 
Limited mobility and not in the position to attend weekly appointments  
• 
Limited ability to describe listening impressions/experiences and the use of the hearing aid 
• 
Inability to produce a reliable hearing test result  

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• 
Massively limited dexterity  
• 
Known psychological problems  
• 
Central hearing disorders  
 
 
7.2 Recruitment and screening  
(ClinO, Art 25, Appendix 3, 1.4 & 1.6; AGEK 5.1; SPIRIT #15) 
At Sonova AG Headquarters, a subject database is existing which is currently containing approx. 1000 
hearing impaired subjects (various degrees of hearing loss) from circumjacent cantons. Furthermore, 
this database is containing hearing impaired employees from Sonova AG (internal subjects). The 
database is permanently extended (study independently) with new subjects recruited via different 
paths and screened by qualified Audiologists employed at Sonova AG: 
- 
Phonak homepage (status 22.11.2019): https://www.phonak.com/ch/de/hoerverlust/feldstudie-
anmeldung.html  
- 
Flyer Phonak Feldstudien (see attachment: 4b1_Flyer_Phonak_Feldstudien.pdf) 
- 
Campaign “Probanden werben Probanden” (see attachment: 
4b2_Kampagne_Probanden_werben_Probanden.pdf) 
- 
Advertisement in magazine Decibel (see attachment: 4b3_Inserat_Decibel.pdf) 
- 
Links at homepages from organization of hearing impaireds, e.g.: 
o 
 ProAudito (status 19.05.2015): http://www.proaudito-
zuerich.ch/fileadmin/customer/Medien/Home_und_Aktuell/pdf/Inserat_Phonak_sucht_
Probanden.pdf  
o 
Audiopädagogik.ch (status 19.05.2015): http://www.audiopädagogik.ch/phonak-sucht-
probanden-ab-sofort/ 
 
After the study approval by the CEC and after a subsequent successful Initiation Visit undertaken by 
the monitor, the subject recruiting by contacting potential candidates can be started. At this initial 
contact, the time expenditure and the availability period will be discussed in advance. In case of a 
positive reply, the participant information as well as the informed consent form is sent to the potential 
study participant by post or email one week prior to the screening appointment, at least, and the 
subject is invited via telephone or email for an assessment of his hearing at Phonak HQ. The 
audiological history of a subject and a pure tone audiogram as well as a speech audiogram is 
recorded, the inclusion and exclusion criteria are requested and open questions concerning the study 
itself, the participant information and the informed consent form are replied before the decision about a 
study participation is made and the signed document is collected by the investigator. If a participant 
quotes hearing a tinnitus, a Tinnitus Pitch and Loudness Matching is executed to determine its 
frequency and intensity (section 5.1, table 4).  
Internal subjects are personally contacted or via email to request their availability and interest in pre-
study participation. The screening process is the same as for the external participants. The internal 
subjects participate on a voluntary basis during their regular working time and contribute to an 
investigational benefit for the company. In case of any non-attendances of the study, no employment 
consequences will occur. 
All the selected participants will be listed and encoded in a password locked file. Only the study 
personal and the monitor have access to this file. For all study related appointments at Sonova AG, 
the participants receive an expense allowance of 25 CHF/hour during the lab trials, of 12.50 CHF per 
questionnaire (p/eCRF) which is filled in during the home trials (assumed duration of 30 min) and a 
train ticket (2nd class) from their home address to Sonova AG, Laubisrütistrasse 28, 8712 Stäfa, by 
the end of the study.  
 
Please note that from the 6th July 2015 on, the Sonova AG is the family brand as well as the employer 
and the Phonak AG is the main brand of Sonova’s different brands. The Validation Team works for the 
brand Phonak AG and, therefore, evaluates Phonak Hearing Systems. For this reason, both brands 
Sonova AG and Phonak AG have the same address and can both officially be used printed on the 
recruiting material. 
 

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7.3 Assignment to study groups  
(AGEK 5; SPIRIT #16) 
The assignment of the participants is done by chance. The first participants who state their 
participation and fulfil the inclusion criteria are picked. 
 
7.4 Criteria for withdrawal / discontinuation of participants  
(ClinO, Art 9; ICH/E6 6.5.3; SPIRIT #21b) 
Subject withdrawal criteria (i.e., terminating investigational product treatment/trial treatment) and 
procedures specifying: a) When and how to withdraw subjects from the trial/ investigational product 
treatment. c) Whether and how subjects are to be replaced. 
If a subject will be withdrawn (e. g. withdrawal of informed consent, non-compliance, disease 
progression, safety etc. or study or routine procedure must be stopped, e. g. due to safety concerns), 
a final assessment of the ear and ear canal will be carried out and all products as well as all study 
material (e.g. pCRFs) that had been used have to be returned by the participant to the study site. The 
participants participate on a voluntary basis and can abort the participation on the study at any point of 
the study. The withdrawn participant will be replaced by another voluntary employee, if needed. The 
measurement results of the withdrawn participants will be excluded of the evaluation if the results are 
not complete to be included in the analysis. A new participant has to pass each study trial from the 
beginning. 
8. STUDY INTERVENTION  
(SPIRIT #11) 
 
8.1 Identity of Investigational Products (treatment / medical device)  
(ICH/E6 6.2.1, 6.4.2, 6.4.4; AGEK Checklist 2, item 3) 
ICH: A description of the trial treatment(s) and the dosage and dosage regimen of the investigational 
product(s).  
This section describes all trial treatments for each arm of the study. 
 
8.1.1 
Experimental Intervention (treatment / medical device) 
ICH: Name and description of the investigational product(s).  
All investigational devices are CE marked and based on the latest Phonak Hearing System portfolio 
(all 
form 
factors 
and 
performance 
levels, 
see 
http://www.phonak.com/ch/b2c/de/products/hearing_instruments.html, 
status 
20.05.2015). 
This 
includes MD of risk category IIA: Phonak Hearing Systems comprising hearing aids, acoustic coupling 
(receiver and earpiece), fitting software and of risk category I: Wireless accessories (transmitters and 
receivers). The application is done according to the specialised information. 
 
8.1.2 
Control Intervention (standard/routine/comparator treatment / medical device)  
ICH: Name and description of the investigational product(s).  
Previous outstanding Phonak Hearing Systems as well as equivalent strong competitor devices. 
 
8.1.3 
Packaging, Labelling and Supply (re-supply)  
ICH: Also include a description of the dosage form, packaging, and labelling of the investigational 
product(s). 
N/A 
 
8.1.4 
Storage Conditions  
All MD and MD supplies have to be stored according to standard procedures as mentioned in the 

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manufacturer directions. The hearing aids will be stored in their hearing aid cases (dry and dust-free). 
There are no special environmental conditions necessary for storage. 
 
8.2 Administration of experimental and control interventions  
(ICH/E6 6.4.4) 
 
8.2.1 
Experimental Intervention  
ICH: Description of and justification of the treatment(s) to be administered, including the name(s) of all 
the product(s), the dose(s), the dosing schedule(s), the route/mode(s) of administration, and the 
treatment period(s), including the follow-up period(s) for subjects for each investigational product 
treatment/trial treatment group/arm of the trial. 
Please find the description of route, dose, study procedure and the utilization period of the 
investigational medical devices in chapter 3.5, 5, 6.1 and in the section STUDY SCHEDULE.  
 
8.2.2 
Control Intervention 
ICH: Description of and justification of the treatment(s) to be administered, including the name(s) of all 
the product(s), the dose(s), the dosing schedule(s), the route/mode(s) of administration, and the 
treatment period(s), including the follow-up period(s) for subjects for each investigational product 
treatment/trial treatment group/arm of the trial. 
Same as in 8.2.1. 
8.3 Dose / Device modifications  
(SPIRIT #11b) 
N/A 
 
8.4 Compliance with study intervention  
(ICH/E6 6.6.3; AGEK Checklist 2, item 2; SPIRIT #11c) 
ICH: Procedures for monitoring subject compliance.  
N/A 
 
8.5 Data Collection and Follow-up for withdrawn participants  
(ICH/E6 6.5.3; AGEK 9.2; SPIRIT #18b) 
ICH: ………..b) The type and timing of the data to be collected for withdrawn subjects. d) The follow-up for 
subjects withdrawn from investigational product treatment/trial treatment. 
The subjects participate on a voluntary basis and can abort the participation on the study at any point 
of the study. The withdrawn participant will be replaced by another voluntary employee. The 
measurement results of the withdrawn participants will be included to the evaluation if data are 
complete for the appropriate trial. The new participant has to pass each study trial from the beginning. 
 
8.6 Trial specific preventive measures 
(ICH/E6 6.6.2; AGEK 9; SPIRIT #11d) 
ICH: Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or 
during the trial. 
To avoid discomfort through too loud output levels of the hearing aids which could harm the subjects 
ear, the uncomfortable level (UCL) will be measured within the pure tone audiogram during the 
screening appointment. The UCL will be used for the fitting of the hearing aids to ensure a comfortable 
maximum power output.  
After fitting the hearing aids to the individual hearing loss of the subject, the subjective acceptance of 
loud input signals will be tested (tolerance test) to ensure that the individual maximum power output 
(based on the UCL measurement) of the hearing aids is guaranteed and accepted by the subject. 
 

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8.7 Concomitant Interventions (treatments)  
(ICH/E6 6.6.2; AGEK 9; SPIRIT #11d) 
ICH: Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or 
during the trial. 
N/A 
 
8.8 Study Drug / Medical Device Accountability  
(ICH/E6 6.4.7; AGEK Checklist 2, item 1; SPIRIT 11c) 
ICH: Accountability procedures for the investigational product(s), including the placebo(s) and 
comparator(s), if any. 
The accountability for the MD is ascribed to both the according Project Leader (PL) of the Research & 
Development Department and the Product Manager of the Marketing Department in the Sonova AG, 
Stäfa. The PL and the PM are also the persons addressed in case of any device deficiencies 
(receivers of the device deficiency form). 
 
8.9 Return or Destruction of Study Drug / Medical Device  
(AGEK Checklist 2, item 1; SPIRIT 11c) 
At the end of the study during the final appointment, all study devices will be returned to the according 
PI. 
9. STUDY ASSESSMENTS  
(ICH/E6 6.7, 6.8; AGEK 6, 7; SPIRIT #18a) 
This section includes a description of the procedures, measurements, collections and storage of 
samples taken. 
9.1 Study flow chart(s) / table of study procedures and assessments 
A study  maybe a combination of a pre-study, if neccesary,  and a main study where of both include 
objective and subjective measurements. A maximum of 5 subjects will take part in the pre-study and a 
maximum of 30 will take part in the main study which does not include the pre-study participants. 
Please note the following tables repeat those of section STUDY SCHEDULE. 
 
Study Period 
 
Screening 
Pre-study 
appointments 
Follow-up 
(final appointment) 
Visit Number 
1 
2 
3 
4 
Time [hrs] 
1.5 
2 
2 
2 
Audiological History  
x 
 
 
 
Physical Examination of Ear 
and Ear Canal  
x 
x 
x 
x 
Audiogram  
x 
 
 
x 
Tinnitus Matching 
x 
 
 
x 
Check In- /Exclusion Criteria 
x 
 
 
 
Decision 
Subject 
Participation 
x 
 
 
 
Subject 
Information 
and 
Informed Consent 
x 
 
 
 
Encoded Subject ID 
x 
 
 
 
eCRF Screening 
x 
 
 
 
eCRF Audiometry 
x 
 
 
x 

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Randomisation  
x 
 
 
 
Hearing System Fitting 
x 
x 
x 
 
Objective 
and 
Subjective 
Measurements 
 
x 
x 
(x) 
eCRF 
Objective 
and 
Subjective Measurements 
 
x 
x 
(x) 
Introduction to Handling  
 
x 
x 
 
Scheduling Next Visit  
 
x 
x 
 
eCRF Final Appointment 
 
 
 
x 
Capture of Adverse Events 
and Device Deficiencies 
x 
x 
x 
x 
Table 1a: Pre-study: N = max 5 
 
Study Period 
 
Scre
enin
g 
Study appointments 
Final Appointment 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Time [hrs] 
1.5 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
Audiological 
History  
x 
 
 
 
 
 
 
 
 
 
 
 
Physical 
Examination of 
Ear and Ear 
Canal  
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
Audiogram  
x 
 
 
 
 
 
 
 
 
 
 
x 
Tinnitus 
Matching 
x 
 
 
 
 
 
 
 
 
 
 
x 
Check 
In- 
/Exclusion 
Criteria 
x 
 
 
 
 
 
 
 
 
 
 
 
Decision 
Subject 
Participation 
x 
 
 
 
 
 
 
 
 
 
 
 
Subject 
Information 
and 
Informed 
Consent 
x 
 
 
 
 
 
 
 
 
 
 
 
Encoded 
Subject ID 
x 
 
 
 
 
 
 
 
 
 
 
 
eCRF 
Screening 
x 
 
 
 
 
 
 
 
 
 
 
 
eCRF 
Audiometry 
x 
 
 
 
 
 
 
 
 
 
 
x 
Randomisation  x 
 
 
 
 
 
 
 
 
 
 
 
Hearing 
System Fitting 
x 
 
 
 
 
 
 
 
 
 
 
 
Objective and 
Subjective 
Measurements 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
(x) 

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eCRF 
Objective and 
Subjective 
Measurements 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
X 
(x) 
Introduction to 
Handling  
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
Scheduling 
Next Visit  
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
eCRF 
Final 
Appointment 
 
 
 
 
 
 
 
 
 
 
 
x 
Capture 
of 
Adverse 
Events 
and 
Device 
Deficiencies 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Table 1b: Main study: N = max 30 (no pre-study subjects) 
 
9.2 Assessments of outcomes  
ICH: Specification of the efficacy parameters. Specification of safety parameters. 
This section includes a description of each endpoint, what variables will be assessed/observed and 
how it will be done, including any related processes to promote data quality. In general, the standard 
measurement equipment gets calibrated by certified specialists sent out by the appropriate company 
to Sonova AG once per year. Study specific adjustments of the measurement tools get calibrated by 
the responsible study team member. Prior to study start, the PI uniformly trains the study team 
according to the study protocol, which is documented in a training log. Every measurement method 
used in this study is conducted according to its instruction. In this way, potential damages of a 
participants ears caused by unexpected loud sound levels are eliminated. Prior to every measurement, 
the participants absolve a training session to minimize a bias induced by training or learning effects. 
These data are not part of the analysis. 
 
9.2.1 
Assessment of primary outcome  
ICH: Methods and timing for assessing, recording, and analysing of efficacy & safety parameters. 
Procedure: After a successful screening as described in section 7.2, the data serving as primary 
outcomes are collected in a series of appointments lasting 1.5 to 2 hours each for the lab trials and 
one week for the home trials taking place between the lab trial appointments. The subjective and 
objective measurements that are applied to grant zero-defect overall performance of the new Phonak 
Hearing Systems regarding technical stability, audiological performance and handling are listed in 
section section 5.1. The general procedure of a lab trial can be described in a flow chart as follows: 

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Figure 6: Schematic procedure of a lab trial.  
 
Testing takes place in one of the three double-walled sound-attenuating booths (Validation Room 1, 2 
and 3). Participants are tested individually. All of them comfortably sit on a chair in the middle of the 
room and are consistently instructed what their task is both written in terms of standardized 
instructions and verbally to ensure that the task is understood. Then, stimuli (speech: words, numbers 
or sentences in quiet or in a specific background noise, also music or sound simulations, like an in car 
situation, in a cafeteria or in a reverberated room) are presented with a computer and loudspeakers of 
a number and of a defined arrangement according to the test method used, see figures 7 and 8. In 
case of a closed-set speech test, the participant are instructed to choose an answer on a touch screen. 
In case of an open-set task, the participant is asked to verbally repeat the things understood.  
Instead of loudspeaker presentations also headphone presentations simulating hearing aids (single 
features or functions) as well as sound situations by pre-recorded sound files can be presented to the 
participant. The advantage is a highly controlled listening situation and a simple possibility to quickly 
switch between different hearing aids (or settings) in case of a paired comparison or a MUSHRA task 
which use subjective rating on a rating scales to evaluate different dimensions. 
 
Measurement methods: The measurement method that comes into operation depends on the 
particular question that needs to be answered during an appointment. Most important aims for 
ensuring a high quality hearing system are both a maximum speech understanding in every listening 
situation and a good sound quality. 

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Speech understanding can be assessed by standardized speech tests both in quiet and in noise (see 
figure 7, 8 and section 5.1, table 4). To evaluate speech intelligibility in quiet, different normed speech 
tests are available, such as the Freiburger, GöSa and WAKO. These methods are complemented with 
a new methodology, the Phoneme Perception Test (PPT), a language independent test, assessing a 
participant’s detection, distinction and recognition threshold for single fricatives (high frequent sounds 
like /s/, /sh/, /f/) which are mostly affected by a hearing loss. In addition to speech understanding in 
quiet, speech intelligibility in noisy surroundings needs to be evaluated. The OLSA method as well as 
the GöSa in noise, the WAKO in noise and the Acceptable Noise Level (ANL) test provide a basis. 
Another important topic is the localization capability of a hearing aid user to know from which direction 
a sound origins from. The Localization Test delivers appropriate results.  
Sound quality is evaluated by using methods of subjective rating on a rating scale using the Paired 
Comparison method or the MUSHRA. Furthermore, sound quality can be rated using qualitative and 
quantitative questionnaires (p/eCRF) during both the home trials and the lab trials or by conducting 
structured interviews, unstructured interviews or group discussions where the data collected are of 
narrative character. In this way data can be supplemented by some information that could not be 
captured using the standardized test methodologies. 
The Real-Ear Measurement (REM) tool is an objective methodology to measure the hearing 
instrument’s frequency response under real ear conditions. A Real-Ear-Measurement includes the 
established real ear measurements of REUG (real ear unaided gain), REAG (real ear aided gain), 
REIG (real ear insertion gain) and RECD (real ear coupler difference). For the real ear measurement a 
soft silicone probe tube is thread through the custom product vent. The individual length of the probe 
tube is measured via otoscopy. The tip of the probe tube has to be placed in the residual ear canal 
volume of the participants ear. After the insertion of the custom product in the participants ear, the ear 
canal gets stimulated by an acoustic source from an exterior sound source. With the probe tube in the 
residual ear canal the frequency response is recorded. 
Further tests used are the Categorial Loudness Scaling a psychoacoustic method to capture the 
individual subjective loudness perception, the TEN test to evaluate dead regions in the cochlear, 
cognitive measures to assess hearing fatigue and listening effort, occlusion measurements to 
investigate 
occlusion 
effects 
mainly 
occurring 
in 
ITE 
devices.
 
Figure 7: Measurement setup: Freiburger, WAKO and GöSa in quiet, PPT, Categorial Loudness   
Scaling. Both study participant and PI in sound-attenuating booth. 

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Figure 8: Measurement setup: OLSA, WAKO and GöSa in noise, sound simulations (e.g. in 
car/cafeteria/reverberation), localization test. Subject in sound-attenuating booth, PI outside. 
9.2.2 
Assessment of secondary outcomes 
ICH: Methods and timing for assessing, recording, and analysing of efficacy & safety parameters. 
The secondary outcomes are assessed in the same way as the primary outcomes (see section 9.2.1). 
 
9.2.3 
Assessment of other outcomes of interest 
ICH: Methods and timing for assessing, recording, and analysing of efficacy & safety parameters. 
Other outcomes of interest like side-effects will be carefully investigated, evaluated and documented. 
 
9.2.4 
Assessment of safety outcomes 
ICH E6 6.8: Specification of safety parameters. The methods and timing for assessing, recording, and 
analysing safety parameters 
9.2.4.1 
Adverse events  
Basically, all participants will be instructed to immediately report any problems, oddness or difficulties 
which occurred with or through the testing devices by contacting the appropriate investigator. 
Additionally, the investigator will request the same after each home trial at the beginning of the subject 
appointment. Any feedback will be recorded in the appropriate eCRF in the clinical database 
eClinicalOS (see eCRF_AdverseEvent_V1.0_30.06.2015).  
 
9.2.4.2 
Laboratory parameters 
N/A 
 
9.2.4.3 
Vital signs 
N/A 
 

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9.2.5 
Assessments in participants who prematurely stop the study 
Withdraw without Adverse Event: If a subject is withdrawn from the study without having an AE, an 
audiogram will be recorded in a final appointment and the outer ear will be controlled to ensure that 
there are no damages through the study.  
 
Withdraw with Adverse Event: If a subject is withdrawn in case of an AE, a referral to an independent 
doctor will be carried out. In accordance with the subject and the doctor, an additional appointment will 
be arranged to record a status update.  
 
9.3 Procedures at each visit 
Each study part follows the same pattern:  
• 
Screening  
• 
Pre-study or main study 
• 
Final appointment 
 
This pattern ensures the best method to not unnecessarily extend the study and to not perform tests 
with participants, which are not needed. For that reason first a pre-study is conducted with only a few 
participants to proof the study concept and the scientific interrogation behind it. If the results of the 
pre-study are promising, the main study will start.   
9.3.1 
Screening appointment   
• 
Mapping to an encoded and randomized subject ID 
• 
Discussion of the subject information and signing of the informed consent which were sent in 
advance by post or email  
• 
Recording of the subject’s audiological history  
• 
Ear and ear canal assessment (otoscopy) 
• 
Hearing test (pure tone and speech audiometry)  
• 
In case of tinnitus: Tinnitus Pitch and Loudness Matching 
• 
Explanation of in-/exclusion criteria  
• 
Decision if patient can participate in the trial regarding to the in-/exclusion criteria  
• 
eCRF Screening  
• 
eCRF Audiometry  
• 
Scheduling of the next visit 
 
9.3.2 
Pre-study appointment 
• 
Ear canal assessment  
• 
Fitting of hearing instrument (randomized) and documentation in eCRF  
• 
Measurements objective and subjective (randomized), see section 5.1 and 9.2.1 
• 
Fine tuning hearing instrument, if necessary  
• 
Introduction to handling of hearing system (randomized)  
• 
Introduction to CRF  
• 
Signing of the device delivery form  
• 
Schedule next visit  
• 
eCRF Adverse Event, if applicable  
 
9.3.3 
Main study appointments 
A main study appointment will only be executed if the pre-study results were promising. The procedure 
for the main study appointments is the same as for the pre-study appointments (see section 9.2.1).  
 
9.3.4     Final appointment 
• 
Ear canal assessment 

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• 
Hearing test (pure tone)  
• 
In case of tinnitus: Tinnitus Pitch and Loudness Matching and comparison with the outcome of 
the screening. If the intensity is increased, a referral to an independent doctor will be carried 
out. In accordance with the subject and the doctor, an additional appointment will be arranged 
to record a status update  
• 
Calculation and signing of the compensation form  
• 
Signing of the device return form  
• 
Collecting all study material 
• 
Hand out of study feedback form  
• 
eCRF Adverse Event, if applicable 
 
10. SAFETY  
(ClinO Art. 37-43; ICH/E6 6.8; ISO14155 8.2.5, A.14; AGEK 4.1; SPIRIT # 22, 30) 
Description of plans for collecting, documenting, assessing, reporting, and managing solicited and 
spontaneously reported adverse events and other unintended effects of trial interventions or trial 
conduct. 
 
10.1 Drug studies 
N/A 
 
10.2 Medical Device Category C studies 
N/A 
 
10.3 Medical Device Category A studies 
10.3.1 Definition and Assessment of safety related events 
All hearing systems are CE-labelled, i.e. the safety of the user is granted. However, the hearing aid 
can reach a high maximum power output (MPO) which can be louder than the user’s threshold of  
uncomfortable levels is. For this reason, the MPO will always be set accordingly to clinical expertise at 
a level so that no injuries can occur. Consequently, neither during the measurements nor in the daily 
routine the safety of the participants will be compromised.  
In order to ensure that each MD works correctly, every device will be checked before each application 
by the appropriate investigator. Furthermore, the participant is instructed to take note of any 
unexpected incidences (e.g. redness or swelling of the outer ear) and to document these in the 
questionnaires (p/eCRF). Pressure points are also controlled by the investigator at the beginning and 
at the end of an appointment. In the case that wearing the test devices in the time between the 
appointments becomes uncomfortable or even painful, the subjects are instructed not to wear the 
devices anymore and to contact the investigator for information and, if necessary, a doctor.  
Furthermore, the participants are advised not to wear the device if a setting is not acceptable or 
tolerable, but to contact the investigator for an additional appointment. If any unexpected incidences 
occur during the lab trials the participant will be encouraged to immediately report the issue to the 
investigator.  
 
10.3.2 Reporting of Safety related events 
Reporting to Sponsor: Health hazards that require measures are reported to the Sponsor within 24 
hours upon becoming aware of the event. If any unexpected AEs are to occur (e.g. chronic pain in the 
ear canal after MD application), the event has to be documented in the AE eCRF. Depending on the 
event, a decision needs to be made whether the participation in the study has to be interrupted or 

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even cancelled. If required, a referral to an independent doctor is to be carried out. An additional 
appointment will be arranged with the test participant (e.g. after one to two weeks) in order to record 
and document the status update.  
Reporting to authorities: In Category A studies it is the investigator’s responsibility to report health 
hazards requiring measures to the local Ethics Committee within 2 days. 
 
11. STATISTICAL METHODS  
(ICH/E6 6.9; AGEK 8; SPIRIT # 14, 20) 
Statistical considerations 
ICH: A description of the statistical methods to be employed, including timing of any planned interim 
analysis(ses). 
This section describes the statistical considerations done for the study and the level of significance 
that will be used. The traceability of the study data is warranted for both the pre-study and the main 
study at any time. This means that an unauthorized and an accidentally change, deletion or copy of 
the gathered and analysed data is excluded. In case of a pre-study, the data are collected in a paper 
based manner. In case of the main study, the data are gathered both paper based and electronically 
whereat the paper based data are all fed into the clinical database eClinicalOS by the respective 
investigator as soon as possible and the source data verification is undertaken by the monitor (see 
section 12.1 for data handling details).    
 
11.1 Hypothesis 
This is a methodical evaluation in which new hardware and software technologies of Phonak products 
shall be compared with previous outstanding Phonak Hearing Systems and with equivalent competitor 
devices regarding a zero-defect overall performance and a maximum audiological benefit for the user. 
Hence, this study will not test a specific hypothesis. 
 
11.2 Determination of Sample Size  
ICH: The number of subjects planned to be enrolled. In multicentre trials, the numbers of enrolled 
subjects projected for each trial site should be specified. Reason for choice of sample size, including 
reflections on (or calculations of) the power of the trial and clinical justification. 
Based on numerous publications in the field of audiology research using standardized measurement 
methods testing hearing impaired subjects as well as on Sonova AG’s extensive study experience, a 
number of maximum 20 subjects per study is sufficient to obtain statistically significant results on a 
significance level of 5%. 
In the case of the pre-study a maximum of 5 subjects is included, since merely the study concept 
needs to be proved, and no inferential but only descriptive statistics is carried out. Later, during the 
main study, both descriptive and inferential statistics are executed. In the past, typically 20 subjects 
participated per study leading to significant results approaching the primary objective (zero-defect 
overall performance of the new Phonak Hearing Systems). To tackle the secondary objective (product 
benchmark) a number up to 30 subjects have taken part in several previous investigations. This case 
is founded in the fact that a study design of parallel groups, either containing 10 or 15 subjects each, 
is applied as soon as more than one competitor device is compared to the Phonak Hearing System. 
For this reason, an appropriate number of subjects will be included during the planned investigations.  
 
11.3 Statistical criteria of termination of trial  
ICH: A description of the "stopping rules" or "discontinuation criteria" for individual participants, parts of 
trial and entire trial. 
After each pre-study an analysis is performed. The corresponding results are the basis for the further 
progress of the main study which might be adjusted accordingly, if necessary. 
 

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11.4 Planned Analyses  
ICH: A description of the statistical methods to be employed, including timing of any planned interim 
analysis(ses). 
In a first step, the distribution of the collected subjective and objective data is verified. Based on this 
outcome (normally distributed yes/no) and depending on the scale level (nominal, ordinal, interval or 
rational) of the variables, descriptive statistics is executed in the form of determining the mean value 
and standard deviation or the median and quartile, respectively. Furthermore, diagrams for 
visualization are compiled such as boxplots, histograms and scatterplots. Then, after a determination 
of the measurement variables regarding their relationship or their difference, inference statistics is 
executed by applying the appropriate parametric or non-parametric test depending on the data’s 
distribution either using the correlation coefficient (Pearson, Spearman), t-Test, Mann-Whitney-U-Test, 
or the Wilcoxon-Test. Generally, a significance level of 5% is pursued. 
 
11.4.1 Datasets to be analysed, analysis populations 
ICH: The selection of subjects to be included in the analyses (e.g., all randomized subjects, all dosed 
subjects, all eligible subjects, evaluable subjects). 
The data of all participants and measurement methods will be analysed. Subgroups typically 
composed are hearing loss dependent groups (mild, moderate, severe, profound) and groups 
depending on their experience level wearing hearing instruments or using accessories (non-
experienced, short-term, experienced, long-term user).  In case of a subject withdrawal, only complete 
data sets of a measurement method will be used as part of the statistical analysis.  
 
11.4.2 Primary Analysis 
The primary analysis will be done by the statistician continuously during the study to capture any 
unexpected issues soon as possible. As soon as a test has been accomplished by every subject, 
these data will be fully analysed. By the end of the study, the final analysis across the tests and the 
subjects will be executed. 
 
11.4.3 Secondary Analyses 
The secondary analysis is done in the same way as the primary analysis. 
 
11.4.4 Interim analyses 
ICH 6.9.1: ...... including timing of any planned interim analysis(ses). 
Interim analyses are continuously executed. Firstly, after the pre-study. Secondly, during the main 
study as soon as the first participant has been seen. Then, the data are analysed as described in 
section 11.4.2.    
 
11.4.5 Safety analysis 
The safety analysis will be permanently done during the study by the PI. 
11.4.6 Deviation(s) from the original statistical plan  
(ICH/E6 6.9.6) 
ICH: Procedures for reporting any deviation(s) from the original statistical plan (any deviation(s) from the 
original statistical plan should be described and justified in protocol and/or in the final report, as 
appropriate). 
Deviation(s) from the original statistical plan will be described and justified in a protocol and in a final 
report, as appropriate. 
 
11.5 Handling of missing data and drop-outs  
(ICH/E6 6.9.5; AGEK 8.5; SPIRIT 20c) 
ICH: Procedure for accounting for missing, unused, and spurious data. 

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If data records are complete from subjects who dropped out of the study early, these data will also be 
used in the analysis. If the data sets are not complete, they will not be integrated at all.  
 
12. QUALITY ASSURANCE AND CONTROL  
(ICH/E6 6.11, 6.13; AGEK 12; SPIRIT #19, 23, 27) 
ICH: Quality Control and Quality Assurance Procedures 
This section describes how quality is assured and controlled. 
12.1 Data handling and record keeping / archiving  
 
ICH: Data Handling and Record Keeping 
All data and documents recorded during the study are only accessible to the clinical study team and to 
the monitor. The personal data, the source data of measurements, the documents inclusive all notes 
get coded and monitored. The code list for the codification is safely kept within the clinical study team. 
The coded study data are to undergo a continuous comprehensive analysis during the study. A final 
report is to be written after the study is finished and is available to Sonova AG. During the study as 
well as afterwards, different password protected platforms are used to collect, save and archive the 
data and documents as listed below. 
  
A. Computers: 
All computers used to conduct measurements and to electronically capture data are password 
protected. The measurement tools used dispose of an automatic data storage. Furthermore, 
all data permanently get transferred to the study database eClinicalOS, see below.  
 
B. eClinicalOS, Merge: 
The database eClinicalOS is a unified, cloud-based system that offers all the electronic data 
capture and study coordination capabilities needed. Each study team member and the monitor 
own an account. Furthermore, each subject can get an account to fill in eCRFs during the 
home trials if they have internet access at home.  
 
C. Lockable filing cabinet: 
Each study team member owns a lockable filing cabinet to store the subject files with the 
paper based documents. 
  
D. Lockable shelf: 
A lockable shelf is available to store the essential documents and the site documents (ISF, 
TMF) during the study. 
 
E. Safe: 
Keys of the filing cabinets and of the shelf are retained in a safe with a security code 
overnight. Furthermore, the coding list of the subjects is stored there.  
 
F. SharePoint: 
SharePoint is a Microsoft Web Application used by Sonova AG to store documents and export 
files from the Phonak Fitting Software. 
 
G. Archive (minimum of 10 years): 
At the end of the study, all of the collected data, either collected in paper form or 
electronically, are saved in a trial master file (TMF) in a folder and on CD or DVD which are 
stored in a lockable stock in the cellar at Sonova AG, Stäfa.  
 
12.1.1 Case Report Forms  
(ICH/E6 6.4.9) 
ICH: The identification of any data to be recorded directly on the CRFs (i.e., no prior written or electronic 
record of data), and to be considered to be source data. 
Study data is recorded both with paper and with electronic Case Report Forms (p/eCRF). For each 

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enrolled study participant a CRF is maintained. CRFs are kept current to reflect the subject’s status at 
each phase during the course of study. Participants cannot be identified in the CRF by name or initials 
and birth date but an appropriate coded identification is used, e.g. VP10SL15 containing the subject 
number and the study identifier. 
All study team members are authorized for the CRF entries and it is assured that any authorised 
person can be identified both for pCRFs and eCRFs. If pCRFs are used, the investigator’s acronym as 
well as the subject ID is filled in and data are entered into an electronic file for analysis by the 
respective investigator and data get monitored by the assigned monitor. In case of a self-evident 
corrections, either the subject does it by himself or the investigator undertakes the correction by 
crossing out the word/sentence with a single horizontal line and by adding the correction including his 
personal identifier and the date. 
 
12.1.2 Specification of source documents  
(ICH/E6 6.4.9) 
ICH: The identification of any data to be recorded directly on the CRFs (i.e., no prior written or electronic 
record of data), and to be considered to be source data. 
Source data are available at the site to document the existence of the study participants and can be 
found as described in section 12.1. The source data include the original documents relating to the 
study as follows: 
• 
Demographic data / audiological history 
• 
Visit dates 
• 
Informed Consent Forms 
• 
Randomisation number 
• 
AEs/SAEs 
• 
Device Deficiencies (DD) 
• 
Results of relevant measurements 
• 
Directly recorded data in p/eCRFs  
12.1.3 Record keeping / archiving  
(ICH/E6 6.13) 
ICH: Data Handling and Record Keeping 
All study data will be archived for a minimum of 10 years after study termination or premature 
termination of the clinical trial. The location of storage is on SharePoint as well in the archive at 
Sonova AG, Stäfa, as explained in section 12.1, subsections F and G. 
 
12.2 Data management  
(ICH/E2; AGEK 12.2; SPIRIT #19) 
This section describes plans for data entry, coding, security, and storage, including any related 
processes to promote data quality. 
 
12.2.1 Data Management System  
The data management is carried out as described in section 12.1. Data management systems that are 
applied are the database eClinicalOS (Merge), the SharePoint Web Application (Microsoft) and the 
SQL server (Microsoft). The eClinicalOS system gets verified and validated by the study team in the 
form of User Acceptance Tests (UAT) prior to each study start to ensure a proper working of the 
solution for the user. In addition, the study team owns a permanent SharePoint site which is verified as 
well as validated and the filing of the documents follows a predefined scheme. The SQL server 
working in the background is controlled by the IT at Sonova AG, Stäfa. 
 
12.2.2 Data security, access and back-up  
Data security is fully granted, the access is limited to specified persons and both systems eClinicalOS 
and SharePoint undergo a daily backup on appropriate servers.  
 

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12.2.3 Analysis and archiving 
Data are extracted via the Microsoft SQL server and can be converted to an arbitrary format, e.g. xls 
file. For the data analysis, different programs are used such as Microsoft Excel, SPSS, Statistica and 
MatLab. Archiving is done according to section 12.1, subsections F and G, for a minimum of 10 years.   
 
12.2.4 Electronic and central data validation  
The data is validated by the monitor. 
 
12.3 Monitoring  
(AGEK 12.1; SPIRIT #23) 
The extent and nature of monitoring activities based on the objective and design of the study 
is defined in a study specific monitoring plan. Every Sonova employee who is qualified in the 
domain of audiology research and who is not part of the study team can be assigned to the 
role of the Monitor. Typical monitoring activities are: 
• 
Initiation Visit (see 12a_Initiation_Visit.pdf) 
• 
Routine On-Site Monitoring Visit (source data verification, data monitoring in eClinicalOS 
including 
queries, 
random 
attendance 
of 
subject 
appointments) 
(see 
12b_Routine_OnSite_Monitoring_Visit.pdf) 
• 
Close Out Visit (see 12c_Close_Out_Visit.pdf) 
The source data/documents are accessible to the monitor and questions are answered during 
monitoring. Each monitoring visit is documented in the form of a monitoring report. 
 
 
12.4 Audits and Inspections  
(ClinO, Art. 58, 59; AGEK 12.1; SPIRIT #23) 
At Phonak, regular annual audits of the trial conduct take place. This process is strictly independent 
from investigators and the Sponsor. The study documentation and the source data/documents are 
accessible to the auditors/inspectors (also CEC and CA, if applicable) and questions are answered 
during the inspections. All involved parties have to keep the participants’ data strictly confidential. 
 
12.5 Confidentiality, Data Protection  
(ClinO, Art. 18, 58; SPIRIT #27, 29) 
Direct access to source documents will be permitted for purposes of monitoring (12.3), audits and 
inspections (12.4) (ICHE6, 6.10). Confidentiality and data protection is granted since access to the 
original data is only allowed to the study team, the monitor and the auditor. In case of publications by 
Sonova AG, the data is anonymized and no conclusion can be made to the subjects. Single exception 
are subjects serving as testimonals of a specific product. All testimonials agree with publication plans 
revealing their identity (e.g. photo or video) in written form (see 13_Testimonial_Agreement.pdf).  
 
12.6 Storage of biological material and related health data  
(ClinO, Art. 18; HVF Art. 28-32; SPIRIT #33) 
N/A 
13. PUBLICATION AND DISSEMINATION POLICY  
(ICH/E6 6.15) 
ICH: Publication policy, if not addressed in a separate agreement. 
Basically, all subject data are anonymized. The trial results are documented in a final report which is 

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handed out to relevant employees of the Sonova AG. Furthermore, trial outcomes are communicated 
to study participants in the form of presentations during a subject follow-up event taking place twice 
per year after a product launch. In addition, the results can be published in an industry magazine, in a 
peer 
reviewed 
journal 
or 
 
as 
field 
study 
news 
on 
the 
Sonova 
AG 
homepage 
(https://www.phonakpro.com/ch/b2b/de/evidence/publications/field-study-news.html). 
The 
study 
results also can support product claims to be found in brochures for the hearing care professionals 
and the end user. 
14. FUNDING AND SUPPORT  
(ClinO, Art. 25i; ICH/E6 6.14; SPIRIT #4) 
This section provides a brief statement of sources and types of financial, material, and other support 
for the trial.  
14.1 Funding  
(ClinO, Art. 25i) 
ICH: Financing and insurance if not addressed in a separate agreement. 
All sources and types of financial support for the study is provided by the Sponsor, Sonova AG. 
 
14.2 Other Support  
(ClinO, Art. 25i) 
ICH: Financing and insurance if not addressed in a separate agreement. 
All material is provided by the Sponsor, Sonova AG. 
15. INSURANCE  
(ClinO Art 12, 13; ICH/E6 6.14, AGEK 10.3; SPIRIT #30) 
ICH: ….and insurance if not addressed in a separate agreement. 
Category A studies are exempt hence no insurance is required. However, insurance will be provided 
by the Sponsor, Sonova AG: Police (Nr. CHCANA00770) „Versicherung für klinische Versuche in der 
Humanforschung“ beim Versicherungsbroker KESSLER & CO AG Forchstrasse 95, CH-8032 Zürich. 
A copy of the specific certificate for each study part is filed in the ISF and in the TMF.  
 
 

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16. REFERENCES  
(ICH/E6 6.2.7) 
ICH: References to literature and data that are relevant to the trial, and that provide background for the 
trial. 
List of the references cited in the protocol. 
1. Declaration of Helsinki, Version October 2013, 
(http://www.wma.net/en/30publications/10policies/b3/index.html )  
2. 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_R1/Step
4/E6_R1__Guideline.pdf ) 
3. 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) 
4. 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. 
(http://www.bag.admin.ch/themen/medizin/00701/00702/07558/index.html?lang=de) 
5. 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. 
(http://www.bag.admin.ch/themen/medizin/00701/00702/12310/index.html?lang=de) 
6. 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. 
(http://www.admin.ch/ch/d/sr/8/812.21.de.pdf) 
7. ISO 14155:2011 Clinical investigation of medical devices for human subjects -- Good clinical 
practice (www.iso.org) 
8. ISO 10993 Biological evaluation of medical devices (www.iso.org) 
9. WHO, International Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/en/)  
10. Kollmeier, B. (1992), Moderne Verfahren der Sprachaudiometrie, Band 1. Medianverlag von 
Killisch-Horn GmbH 
11. Wagener, K., Kühnel, V. & Kollmeier, B. (1999a). Entwicklung und Evaluation eines 
Satztestes für die deutsche Sprache Teil III: Evaluation des Oldenburger Satztestes. 
Zeitschrift für Audiologie 38, 1999. p: 86-95  
12. Wagener, K., Brand, T. & Kollmeier, B. (1999b). Entwicklung und Evaluation eines Satztestes 
für die deutsche Sprache Teil I: Design des Oldenburger Satztests. Zeitschrift für Audiologie 
38(1), p: 4-14  
13. Wallenberg v., E. & Kollmeier, B. (1989). Sprachverständlichkeitsmessungen für die 
Audiologie mit einem Reimtest in deutscher Sprache: Erstellung und Evaluation von Testlisten. 
Audiologische Akustik, 28(2):50-65. 
14. Sukowski H., Brand T., Wagener K.C., Kollmeier B. (2010). Vergleich des Göttinger Satztests 
und des Einsilber-Reimtests nach Wallenberg und Kollmeier mit dem Freiburger Sprachtest. 
HNO Volume 58 Nr. 6  
15. McDermott, H. (2010). SoundRecover – The importance of wide perceptual bandwidth. 
Background Story. Phonak AG: 2010. Retrieved from 
http://www.phonakpro.com/com/b2b/en/evidence/topics/soundrecover.html 
16. Wolfe, J., John, A., Schafer, E., Nyffeler, M., Boretzki, M., & Caraway, T. (2010). Evaluation of 
nonlinear frequency compression for school-age children with moderate to moderately severe 
hearing loss. Journal of the American Academy of Audiology, 21(10), 618-628. doi: 
10.3766/jaaa.21.10.2. 
17. Wolfe, J., John, A., Schafer, E., Nyffeler, M., Boretzki, M., & Caraway, T., et al. (2011). Long-
term effects of non-linear frequency compression for children with moderate hearing loss. 
International Journal of Audiology, 50(6), 396–404. doi: 10.3109/14992027.2010.551788. 
18. Phoneme Perception Test: URL (status: 04.06.2015) 
https://www.phonakpro.com/com/b2b/de/professional_tools/diagnostic/phoneme-perception-
test/overview.html 

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19. David, H.A. (1988). The Method of Paired Comparisons. New York: Oxford University Press 
20. MUSHRA: ITU-R recommendation BS.1534 
21. Freyaldenhoven, M.C., Nabelek, A.K., Burchfield, S.B., & Thelin, J.W. (2005). Acceptable 
noise level (ANL) as a measure of directional benefit. Journal of the American Academy 
of Audiology 16, 228-236. 
22. Nabelek, A.K., Freyaldenhoven, M.C., Tampas, J.W., Burchfield, S.B., & Muenchen, R.A. 
(2006). Acceptable noise level as a predictor of hearing aid use. Journal of the American 
Academy of Audiology,17, 626-639. 
23. Brand, T. and Hohmann, V. (2002). An adaptive procedure for categorical loudness scaling. J. 
Acoust. Soc. Am., 112(4): 1597-604. 
24. Aazh, H. and Moore, B.C.J (2007). The Value of Routine Real Ear Measurement of the Gain 
of Digital Hearing Aids. J. Acoust. Soc. Am., 18: 653-664(12). 
25. Gustav H. Blanke (1973). Einführung in die semantische Analyse. Hueber, München, 135–137. 
26. Hoare, D.J., Edmonson-Jones, M., Gander, P.E., Hall, D.A. (2014). Agreement and Reliability 
of Tinnitus Loudness Matching and Pitch Likeness Rating. PloS ONE 9(12): e114553. 
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17. APPENDICES 
ICH: (NOTE: Since the protocol and the clinical trial/study report are closely related, further relevant 
information can be found in the ICH Guideline for Structure and Content of Clinical Study Reports.) 
All attached documents are listed in 0b_Checkliste_KlinV_Kat_A_d_V1.0_30.06.2015.pdf.