Web App Fitting Strategy Validation NSR Device Study
Phase: NA
Conditions: Hearing Loss, Sensorineural
Sponsor: WSAUD A/S

  
This document may not be shown to any unauthorized person without the express permission of Sponsor.                                                               Page i of 70 
 
 
Self-Fitting (SF) Strategy Validation 
NSR Device Study Protocol: SF Study  
Protocol Number: D00232675 
National Clinical Trial (NCT) Identified Number:  04972162 
Principal Investigator: Lindsey Jorgensen, Ph.D., Au.D. 
NSR Device Sponsor: WSAUD A/S 
Funded by: NSR Device Sponsor 
FINAL Version Number: v. 1.1 
08 September 2021 
 
Summary of Changes from Previous Version 1.0 dated 25 May 2021: 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
Title Page 
Updated NCT Identified Number to: 04972162 
Received it after IRB approval of the study 
Title Page 
Updated FINAL Version Number and Date to: v. 
1.1 and 08 September 2021 
Updated due to minor protocol amendment 
All Headers 
Updated Version Number and Date to: 1.1 and 
08 September 2021 
Updated due to minor protocol amendment 
9.4.2.1 
Corrected (i.e., yellow highlighted parts) 
weighted harmonic mean (WHM) formula to 
show the WHM of a set of p-values is the 
reciprocal of the WHM of the reciprocals of 
these p-values. 
pWHM = ∑ wi / ∑ (wi / pi)        i=1….L 
While typing the formula, typing errors 
occurred 
9.4.2.1 
Corrected to L=3 
Typing error occurred 
9.4.2.1 
Added: The weights (wi ) are set equal to 
0.3333…  We weight them equally because the 
scores are calculated with each component 
weighted equally. 
Specify how the three p-values will be 
weighted. 
This confidential document is the property of SPONSOR. The protocol must be kept in a confidential manner and 
only be used in connection with the investigation. No unpublished information contained herein may be disclosed 
without prior written approval of SPONSOR. 

  
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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 5 
1 
PROTOCOL SUMMARY ............................................................................................................................... 5 
1.1 
Synopsis ................................................................................................................................................ 5 
1.2 
Schema ................................................................................................................................................. 9 
2 
INTRODUCTION .......................................................................................................................................... 12 
2.1 
Study Rationale .................................................................................................................................. 12 
2.2 
Background......................................................................................................................................... 12 
2.3 
Risk/Benefit Assessment .................................................................................................................. 12 
2.3.1 
Known Potential Risks ................................................................................................... 12 
2.3.2 
Known Potential Benefits .............................................................................................. 14 
2.3.3 
Assessment of Potential Risks and Benefits .............................................................. 15 
3 
OBJECTIVES AND ENDPOINTS .............................................................................................................. 15 
4 
STUDY DESIGN ........................................................................................................................................... 19 
4.1 
Overall Design .................................................................................................................................... 19 
4.2 
Scientific Rationale for Study Design.............................................................................................. 20 
4.3 
End of Study Definition ..................................................................................................................... 21 
5 
STUDY POPULATION ................................................................................................................................ 21 
5.1 
Inclusion Criteria ................................................................................................................................ 21 
5.2 
Exclusion Criteria ............................................................................................................................... 22 
5.3 
Screen Failures .................................................................................................................................. 22 
5.4 
Strategies for Recruitment and Retention ...................................................................................... 23 
6 
STUDY INTERVENTION ............................................................................................................................ 24 
6.1 
Study Intervention(s) Administration ............................................................................................... 24 
6.1.1 
Study Intervention Description ..................................................................................... 24 
6.1.2 
Nonsignificant risk determination ................................................................................. 26 
6.1.3 
inventory and dispensing .............................................................................................. 27 
6.2 
Preparation/Handling/Storage/Accountability ................................................................................ 27 
6.2.1 
Acquisition and accountability ...................................................................................... 27 
6.2.2 
Formulation, Appearance, Packaging, and Labeling ................................................ 27 
6.2.3 
Product Storage and Stability ....................................................................................... 29 
6.2.4 
Preparation ...................................................................................................................... 29 
6.3 
Measures to Minimize Bias: RANDOMIZED TREATMENT ORDER and Blinding .................. 29 
6.4 
Study Intervention Compliance ........................................................................................................ 30 
7 
STUDY INTERVENTION DISCONTINUATION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL .................................................................................................................... 30 
7.1 
Discontinuation of Study Intervention ............................................................................................. 30 
7.2 
Subject Discontinuation/Withdrawal from the Study ..................................................................... 30 
7.3 
Lost to Follow-Up ............................................................................................................................... 31 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 31 
8.1 
Effectiveness Assessments ............................................................................................................. 31 
8.1.1 
Screening ........................................................................................................................ 34 
8.1.2 
Visit 1 
34 
8.1.3 
Field Test 1 ..................................................................................................................... 35 
8.1.4 
Visit 2 
36 

  
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8.1.5 
Washout Period (only for CRoss-Over Design) ......................................................... 37 
8.1.6 
Field Test 2 (only For Cross-Over Design) ................................................................ 37 
8.1.7 
Visit 3 (only For Cross-Over Design) .......................................................................... 37 
8.2 
Safety and Other Assessments ....................................................................................................... 37 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 38 
8.3.1 
Definition of Adverse Events (AE) ............................................................................... 38 
8.3.2 
Definition of Serious Adverse Events (SAE) .............................................................. 38 
8.3.3 
Classification of an Adverse Event .............................................................................. 39 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 39 
8.3.5 
Adverse Event Reporting .............................................................................................. 40 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 40 
8.4 
Unanticipated Problems .................................................................................................................... 40 
8.4.1 
Definition of Unanticipated Problems (UP) ................................................................. 41 
8.4.2 
Unanticipated Problem Reporting ................................................................................ 41 
8.4.3 
Reporting Unanticipated Problems to Subjects ......................................................... 41 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 41 
9.1 
Statistical Hypotheses ....................................................................................................................... 41 
9.1.1 
PRIMARY ........................................................................................................................ 41 
9.1.2 
secondary ........................................................................................................................ 42 
9.2 
Sample Size Determination .............................................................................................................. 43 
9.3 
Populations for Analyses .................................................................................................................. 45 
9.4 
Statistical Analyses............................................................................................................................ 45 
9.4.1 
General Approach .......................................................................................................... 45 
9.4.2 
Analysis of the primary Effectiveness Endpoint ........................................................ 47 
9.4.3 
Analysis of the Secondary Endpoints ......................................................................... 50 
9.4.4 
Safety Analyses .............................................................................................................. 51 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 51 
9.4.6 
Planned Interim Analyses ............................................................................................. 51 
9.4.7 
Sub-Group Analyses ..................................................................................................... 51 
9.4.8 
Tabulation of Individual subject Data .......................................................................... 51 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 51 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 51 
10.1.1 
Informed Consent Process ........................................................................................... 51 
10.1.2 
Study Discontinuation and Closure ............................................................................. 53 
10.1.3 
Confidentiality and Privacy ........................................................................................... 53 
10.1.4 
Key Roles and Study Governance .............................................................................. 54 
10.1.5 
Safety Oversight ............................................................................................................. 54 
10.1.6 
Clinical Monitoring .......................................................................................................... 54 
10.1.7 
Quality Assurance and Quality Control ....................................................................... 55 
10.1.8 
Data Handling and Record Keeping ............................................................................ 57 
10.1.9 
Protocol Deviations ........................................................................................................ 59 
10.1.10 
Conflict of Interest Policy .............................................................................................. 59 
10.2 
Additional Considerations ................................................................................................................. 59 
10.3 
Abbreviations ...................................................................................................................................... 61 
10.4 
Protocol Amendment History ........................................................................................................... 61 
11 
References .................................................................................................................................................... 63 

  
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12 
APPENDIX I Nonsignificant Risk Determination...................................................................................... 65 
13 
APPENDIX II Device Labeling .................................................................................................................... 70 

SF Study  
 
FINAL Version 1.1 
Protocol #: D00232675 
 
08 September 2021 
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STATEMENT OF COMPLIANCE 
 
This non-significant risk (NSR) device study will be carried out in accordance with Clinical Investigation of 
Medical Devices for Human Subjects – Good Clinical Practice (ISO 14155 Third edition 2020-07) and the 
following: 
• 
United States (US) Code of Federal Regulations (CFR) applicable to NSR device studies (21 CFR Part 50, 
21 CFR Part 56, 21 CFR Part 812.2(b)) 
 
The protocol, informed consent form (ICF), recruitment materials, and all subject materials will be 
submitted to the Institutional Review Board (IRB) for review and approval.  Approval of both the protocol 
and the consent form must be obtained before any subject is enrolled.  Any amendment to the protocol 
will require review and approval by the IRB before the changes are implemented to the study.  In addition, 
all changes to the consent form will be IRB-approved; a determination will be made regarding whether a 
new consent needs to be obtained from subjects who provided consent using a previously approved 
consent form. 
 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
Self-Fitting (SF) Strategy Validation NSR Device Study Protocol: SF Study 
 
Study Description: 
A prospective, randomized controlled, adaptive design, non-inferiority, 
pre-market and NSR device study. To be conducted in a minimum of 28 
adult subjects with mild-to-moderate hearing loss to validate the 
effectiveness of the Vibe SF strategy. Validation measures subject´s 
perceived hearing aid benefit when using the Vibe SF self-fit hearing aids 
and when using Silk 1X Hearing Care Professional (HCP) fit hearing aids.  
 
The study begins with a cross-over design. At the interim analysis, the 
possibility of an interaction effect is evaluated through a nuisance 
parameter. If it is determined to be likely, the design is switched to a 
parallel-group design with a larger sample size. Only data from the first 
period will be included from those subjects who early on participated in 
the cross-over design.  
 
The Silk 1X HCP fit hearing aids are fitted to National Acoustic Laboratories 
Nonlinear Version 2 (NAL-NL2) prescriptive targets, verified by probe-mic 
real-ear measures (REM). The null hypothesis (H0) is that subject´s 
perceived hearing aids benefit using Vibe SF hearing aids is inferior to Silk 
1X HCP fit hearing aids, and the alternative hypothesis (Ha) is that subject´s 
perceived hearing aids benefit using Vibe SF hearing aids is non-inferior to 
that using Silk 1X HCP fit hearing aids. 

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Description of Study 
Intervention: 
The mechanism for validating the Vibe SF strategy will be to compare 
subject´s perceived hearing aid benefit after two 14 days series of using 
Vibe SF/Silk 1X HCP fit hearing aids.          
 
 
Objectives: 
 
Primary Effectiveness Objective:   
To demonstrate that the Vibe SF strategy is non-inferior to the HCP fit 
strategy in subject´s perceived hearing aid benefit after using the Vibe SF 
and Silk 1X HCP fit hearing aids in real-life conditions. 
 
 
Secondary Hearing Aid Benefit Objectives: 
To score each of the following hearing aid benefit performance measures 
when the subject is using the Vibe SF and Silk 1X HCP fit hearing aids: 
1. 
Sound quality, speech understanding and hearing aid 
satisfaction real-time assessment, 
2. 
Speech-in-noise recognition performance, and 
3. 
Hearing disability in communication situations. 
 
Secondary Gain Selection Objective: 
Individual frequency-specific real-ear gain comparison of the two different 
fitting strategies (Vibe SF and HCP fit).  
 
Secondary Preference Objective: 
Fitting strategy (Vibe SF or HCP fit) preference reported by the subject.  
 
Secondary Safety Objective: 
To estimate the rate of adverse device effects (ADEs) when the subject is 
using the Vibe SF hearing aids.  
 
Endpoints: 
Primary Effectiveness Endpoint:   
Differences in the benefit scores on each of the three communication 
subscales as captured by the Abbreviated Profile of Hearing Aid Benefit 
(APHAB) after wearing each Vibe SF/ Silk 1X HCP fit hearing aids for 14 
days. For each subject, the endpoints are the individual 3 communication 
subscale differences between the HCP fit subscale (benefit) score and SF 
subscale (benefit) score:  
• 
∆EC(benefit)HCP fit - ∆EC(benefit)SF  
• 
∆BN(benefit)HCP fit - ∆BN(benefit)SF  
• 
∆RV(benefit)HCP fit - ∆RV(benefit)SF 
 
Secondary Hearing Aid Benefit Endpoints: 

SF Study  
 
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1. 
The subject´s sound quality, speech understanding and 
hearing aid satisfaction Ecological Momentary Assessment 
(EMA) ratings measured repeatedly under real-life conditions, 
2. 
Speech-in-noise recognition performance as measured by the 
Quick Speech-In-Noise test (QuickSIN),  
3. 
Hearing disability resulting from hearing loss quantified by the 
short form of the Speech, Spatial, and Qualities of Hearing 
Scale for clinical use:  the SSQ-12 questionnaire.  
 
Secondary Gain Selection Endpoint: 
Individual frequency-specific gain comparison for the two different fitting 
strategies (Vibe SF and HCP fit) for each ear as measured with probe-mic 
real-ear measures (REM).  
 
Secondary Preference Endpoint: 
Fitting preference Vibe SF or HCP fit strategy. Subjects are asked which of 
the hearing aids they would prefer to keep using a 5-point Likert scale. 
 
Secondary Safety Endpoint: 
The number of adverse device effects (ADEs) in the time period when the 
subject is using the Vibe SF hearing aids. 
 
Population: 
A minimum of 28 US subjects, within the age of 18 years and older, 
inexperienced or experienced hearing aid users with perceived mild-to-
moderate hearing impairment.  Potential subjects will be screened to 
confirm their bilateral sensorineural hearing loss. 
 
Description of 
Sites/Facilities Enrolling 
Subjects: 
A single US University hearing aid research clinic. Potential subjects will be 
recruited locally by outreach at the investigator sites, local 
advertisements, social media advertisements and if needed professional 
recruiting service. 
 
Study Duration: 
Adaptive Design: IF no significant Interaction Effect 
28 Subjects: Cross-over design 
Enrollment (Visit 1) 
30 days 
4 weeks 
Field Tests 
28 days (+6 days) 
4 weeks 
     2 weeks Field Test 1 +3 days, 2 weeks Field Test 2 + 3 days 
Follow-up (Visit 2) 
1 day (+7 days) 
 
Washout Period 
5 days (+2 days) 
1 week 
Follow-up Visit (Visit 3) 1 day (+7 days) 
 
Interim analysis of 
nuisance parameter 
(interaction effect) 
0 (done in parallel 
during Field Test 1) 
0 
Completion of data 
analysis 
90 days  
12 weeks 

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TOTAL Duration 
155 days (+22 days) 
25 weeks/6 months 
 
 
Adaptive Design: IF significant Interaction Effect 
12 Subjects: Cross-over design 
Enrollment (Visit 1) 
30 days 
4 weeks 
Field Tests 
28 days (+6 days) 
4 weeks 
     2 weeks Field Test 1 +3 days, 2 weeks Field Test 2 + 3 days 
Follow-up (Visit 2) 
1 day (+7 days) 
 
Washout Period 
5 days (+2 days) 
1 week 
Follow-up Visit (Visit 3) 1 day (+7 days) 
 
Interim analysis of 
nuisance parameter 
(interaction effect) 
0 (done in parallel 
during Field Test 1) 
0 
Subtotal Duration 
65 days (+22 days) 
13 weeks/3 months 
 
38 Subjects: Parallel-arm design 
Enrollment (Visit 1) 
30 days 
4 weeks 
Field Test 1 
14 days (+3 days) 
2 weeks 
Follow-up (Visit 2) 
1 day (+7 days) 
 
Completion of data 
analysis 
90 days  
12 weeks 
Subtotal Duration 
135 days (+10 days) 
18 weeks/4.5 months 
 
 
 
Grand TOTAL 
Duration 
200 days (+32 days) 
31 weeks/7.5 months 
 
Subject Duration: 
Adaptive Design: IF no Significant Interaction Effect 
28 subjects 
Each subject receives both treatments (cross-over design) 
7 weeks total study duration on-study per subject 
 
Adaptive Design: IF significant Interaction Effect 
50 subjects: 
• 
Before the interim analysis, 12 subjects get both treatments 
(cross-over design) 
• 
After the interim analysis, 38 subjects get one treatment (parallel-
arm design) 
 
12 subjects get both treatments = 7 weeks total study duration on-study 
per subject 
38 subjects get one treatment = 3 weeks total study duration on-study per 
subject 
 
 
 

SF Study  
 
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1.2 
SCHEMA  
ADAPTIVE DESIGN: NO INTERACTION EFFECT (Cross-over Design) 
Prior to  
Enrollment 
-3 months 
 
 
 
 
Fitting  
Strategy 
 
Visit 1 
Enrollment 
Baseline 
Week 0 
 
 
Field Test 1 
Week 0-2 
(+3 days) 
 
Visit 2 
Week 3 
(+7 days) 
 
 
 
 
Cross Over 
Fitting  
Strategy 
 
Field Test 2 
Week 5-7 
(+3 days) 
 
Visit 3 
Week 8 
(+7days) 
Exit 
 
 
Final Assessments 
- 
APHAB aided: Field Test 2 hearing aids 
- 
SSQ-12 aided: Field Test 2 hearing aids 
- 
QuickSIN unaided, aided (randomized, double-blinded) 
- 
REM aided (randomized, double blinded) 
- 
Fitting Preference Likert scale question 
Total N = 28:  Obtain informed consent. Screen potential participants by inclusion and 
exclusion criteria; obtain history, document. 
- 
APHAB unaided 
- 
SSQ-12 unaided 
- 
Fitting of Hearing Aids for Field Test 1: Vibe SF or Silk 1X HCP fit 
- 
Silk 1X: HCP fit to NAL-NL2 prescriptive target verified by REM 
HCP fit  
N = 6 + 8 (cross-over design*) 
Vibe SF  
N = 6 + 8 (cross-over design*) 
Randomize 
HCP fit 
N = 6 + 8* 
Vibe SF 
N = 6 + 8* 
Sound Quality, Speech Understanding & Satisfaction EMA Ratings 
ADEs: Vibe  SF Strategy 
- 
APHAB aided: Field Test 1 hearing aids 
- 
SSQ-12 aided: Field Test 1 hearing aids  
- 
Cross Over Fitting of Hearing Aids for Field Test 2: Vibe SF or Silk 1X HCP fit 
- 
Silk 1X: HCP fitted to NAL-NL2 prescriptive target verified by REM 
Sound Quality, Speech Understanding & Satisfaction EMA Ratings 
ADEs: Vibe SF Strategy 
5 days 
Washout 
Interim Analysis after 12 participants, continue cross-over design                                        

SF Study  
 
FINAL Version 1.1 
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ADAPTIVE DESIGN: INTERACTION EFFECT DETECTED (Parallel-arm Design) 
Prior to  
Enrollment 
-3 months 
 
 
 
 
Fitting  
Strategy 
 
Visit 1 
Enrollment 
Baseline 
Week 0 
 
 
Field Test 1 
Week 0-2 
(+3 days) 
 
Visit 2 
Week 3 
(+7 days) 
 
 
 
 
Cross Over 
Fitting  
Strategy 
 
Field Test 2 
Week 5-7 
(+3 days) 
 
Visit 3 
Week 8 
(+7days) 
Exit 
 
Final Assessments (completed by 12 participants) 
- 
APHAB aided: Field Test 2 hearing aids 
- 
SSQ-12 aided: Field Test 2 hearing aids 
- 
QuickSIN unaided, aided (randomized, double-blinde
- 
REM aided (randomized, double blinded) 
- 
Fitting Preference Likert scale question 
Total N = 50:  Obtain informed consent. Screen potential participants by inclusion and exclusion 
criteria; obtain history, document. 
- 
APHAB unaided 
- 
SSQ-12 unaided 
- 
Fitting of Hearing Aids for Field Test 1: Vibe SF or Silk 1X HCP fit 
- 
Silk 1X: HCP fit to NAL-NL2 prescriptive target verified by REM 
HCP fit  
N = 6 + 19 (parallel-arm design) 
Vibe SF  
N = 6 + 19 (parallel-arm design) 
Randomize 
HCP fit 
N = 6 
Vibe SF 
N = 6 
Sound Quality, Speech Understanding & Satisfaction EMA Ratings 
ADEs: Vibe  SF Strategy 
- 
APHAB aided: Field Test 1 hearing aids 
- 
SSQ-12 aided: Field Test 1 hearing aids  
- 
Cross Over Fitting of Hearing Aids for Field Test 2: Vibe SF or Silk 1X HCP fit 
- 
Silk 1X: HCP fitted to NAL-NL2 prescriptive target verified by REM 
- 
FINAL VISIT for parallel arm design: 38 participants 
- 
QuickSIN & REM aided: Field Test 1 hearing aids (only for 38 participants parallel-arm design) 
Sound Quality, Speech Understanding & Satisfaction EMA Ratings 
ADEs: Vibe SF Strategy 
Interim Analysis after 12 participants,  additional 38 participants enrolled & complete up to Visit 2 
5 days 
Washout 

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Schedule of Activities (SoA) 
 
Procedures 
Screening 
- 3 months 
Enrollment/Baseline 
Visit 1, Week 0 
Field Test 1 
Week 1-2 +3 days 
Study Visit 2  
Week 3 +7 days 
Washout Period             5 days 
+ 2 days post Visit 2 
 
Field Test 2 
Week 4-5 + 3 days 
12 subjects completed Visit 3 
 Study Visit 3 
Day 30 + 7 day  
Inclusion/Exlusion Criteria 
X 
 
 
 
 
 
 
 
Demographic (e.g., gender) 
X 
 
 
 
 
 
 
 
Medical history (e.g., Length of hearing loss, 
length of hearing aid use) 
X 
 
 
 
 
 
 
 
Self-perceived hearing loss rating 
X 
 
 
 
 
 
 
 
Hearing Test 
X 
 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
APHAB unaided 
 
X 
 
 
 
 
 
 
SSQ-12 unaided 
 
X 
 
 
 
 
 
 
Bilateral Hearing Aid fitting: 
 
 
 
 
 
 
 
 
Silk 1X Issued, HCP fit strategy: NAL NL2 REM  
 
(X) 
 
(X) 
 
 
 
 
Vibe SF Hearing Aids Issued,   SF strategy 
 
(X) 
 
(X) 
 
 
 
 
Shipment and Delivery of Field Test 2 Hearing Aids 
at 5 days + 2 days post Visit 2 
 
 
 
 
X 
 
 
 
APHAB aided 
 
 
 
X 
 
 
 
X 
SSQ-12 aided 
 
 
 
X 
 
 
 
X 
Sound quality, speech understanding and hearing 
aid satisfication EMA 
 
 
X 
 
 
X 
 
 
Follow-up Call: EMA data collection  
(+3 days Field Test 1 & 2) 
 
 
X 
 
 
X 
 
 
QuickSIN, unaided  
 
 
 
 
 
 
 
X 
QuickSIN, aided, hearing aid order randomized, 
double-blinded 
 
 
 
 
 
 
 
X 
QuickSIN, Field Test 1 device (parallel-arm design) 
 
 
 
X* 
 
 
 
 
REM, hearing aid order randomized, double-
blinded (cross-over design) 
 
 
 
 
 
 
 
X 
REM, Field Test 1 device (parallel-arm design) 
 
 
 
X* 
 
 
 
 
Fitting Preference Likert question 
 
 
 
 
 
 
 
X 
Adverse device effect (ADE) review and evaluation 
 
X 
X 
X 
 
X 
 
X 
Complete electronic Case Report Forms (eCRFs) 
X 
X 
X 
X 
 
X 
 
X 
Final Study Visit at Visit 3 for 28 subjects (cross-
over design) 
 
 
 
 
 
 
 
X* 
Final Study Visit at Visit 2 for 38 subjects (parallel-
arm design) 
 
 
 
X* 
 
 
 
 
Final Study Visit at Visit 3 for 12 subjects 
(parallel-arm design) 
 
 
 
 
 
 
 
X* 
Interim Analysis: Interaction Effect Detection on 
12 subjects 
 
 
 
 
 
 
X 
 

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(X): Visit 1: Device Fitting Strategy order randomly issued to subject. Visit 2: Cross Over to other Device Fitting Strategy 
X*: Adaptive design: detection analysis of significant interaction effect impacting sample size and study design (cross-over vs 
parallel-arm design) 
 
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
 
Having reliable access to hearing health care services in the United States does not equate that individuals 
with hearing impairment will purchase and use hearing aids. Today, an estimated 3.4 million people in the 
US experience hearingstudy  difficulties, have an objectively measurable hearing loss, but still do not use 
any device to mitigate their hearing loss problem. There are many reasons that an individual does not 
pursue adopting a hearing healthcare solution. Accessibility and affordability are two of the main reasons 
reported in the latest MarkeTrak 10 survey (Edwards, 2020). The stigma associated with hearing aids, lack 
of awareness or lack of confidence that hearing aids would help are other reasons.  
 
Self-fitting (SF) hearing aids address primarily the accessibility and affordability issues. These SF hearing 
aids may expand the reach of hearing health care by meeting the unmet needs of a segment of people with 
hearing loss who, until now, have rejected traditional hearing aids.  
 
The Sponsor is conducting this NSR device study to fulfill one of the special controls, 21 CFR § 
874.3325(b)(1) Clinical data must evaluate the effectiveness of the self-fitting strategy…for self-fitting air 
conduction hearing aids. The primary purpose of the SF Study is to validate the effectiveness of the Vibe SF 
strategy based on the device’s intended use and technological characteristics. The SF Study final clinical 
study report will be part of the 510(k) submission for the Vibe SF hearing aid.  
 
2.2 
BACKGROUND  
The Original Hearing Aid Act in 1977 led the FDA to designate hearing aids as medical devices. Hearing Aids 
were listed under the Food and Drug Administration Modernization Act of 1997 (FDAMA) or the 21st 
Century Cures Act of 2016 as exempt from premarket notification requirements. In October 2018, the FDA 
established the new Class II device type, self-fitting air conduction hearing aid (21 CFR § 874.3325) with 
special controls.  
SF strategy clinical data are described by Sabin et al. (2020) who conducted a similar validation 
investigation on the predicate device, the self-fitting and direct-to-consumer (DTC) BOSE® Hearing Aid 
(DEN180026, 2018).  
The Sponsor believes that a 510(k) clearance of this SF device supports its positioning to fulfill the 
upcoming FDA proposed rule on Over-the-Counter (OTC) hearing aids as required in the 2017 Over-the-
Counter (OTC) Hearing Aid Act.  
2.3 
RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  

SF Study  
 
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The risk management process for the self-fitting hearing aid system is performed in accordance with the 
requirements stated in ISO 14971:2007, and the risk analysis results are used to identify and implement 
appropriate product development activities.  The risk analysis in the Risk Management File for the self-
fitting hearing aid system conducted by SPONSOR includes the identified risks in 21 C.F.R. § 874.3325 and in 
the validation investigation on the predicate device, the self-fitting and direct-to-consumer (DTC) BOSE® 
Hearing Aid (see Appendix 1). 
Table 1 below lists the identified risks related to the self-fitting system of the Vibe SF hearing aid and EasyFit 
web application (EasyFit).  
Mitigations to prevent over-amplifications include a safety output limiter which is a hardware measure for 
limiting the output sound pressure level (OSPL) in failure mode. Hence, for the implemented cluster, the 
safety limiter is 6 dB above maximum OSPL of the specific cluster. Other mitigation measures include 
performance testing as electroacoustics and software verification and validation.  Critical use-related 
scenarios (critical tasks) and essential functions have been identified and will be tested and validated in 
Human Factors testing. 
Table 1. Overview of identified risks related to self-fitting system clinical study 
Identified Risk  
Mitigation Measures  
Support 
Diminished hearing due to over-
amplification caused by:  
• 
Excessively high sound output levels 
in the ear canal  
 
• 
Software verification and validation 
(performance testing) 
• 
Electroacoustic (performance testing) 
• 
Safety Limiter implemented in design 
• 
Maximum possible output 114 dB 
• 
Screening of subjects to confirm mild-to-
moderate hearing loss  
• 
ANSI S3.22 
electroacoustic 
testing 
Diminished hearing due to over-
amplification caused by:  
• 
Confusing and switching left and right 
hearing aid  
• 
Safety Limiter implemented in design  
 
Labeling 
• 
IFU and Workflow show Left/Right Hearing 
Aid (Labeling) 
• 
L/R mark on the device to distinguish 
between left and right hearing aid 
• 
Software 
verification and 
validation 
(performance 
testing)  
• 
Design 
verification 
 
Listening fatigue or failure to provide 
sound awareness due to over- or 
under-amplification caused by:  
• 
Poor fitting  
• 
Use error  
• 
Confusion L/R  
 
• 
Software verification and validation 
(performance testing) 
• 
Electroacoustic (performance testing) 
• 
Safety Limiter implemented in design  
 
Labeling 
• 
IFU and Workflow show Left/Right hearing 
aid (Labeling) 
• 
L/R mark on the device to distinguish 
between left and right hearing aid  
• 
Software 
verification and 
validation 
(performance 
testing)  
• 
Human factors 
validation 
• 
Pilot Study  
 

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Identified Risk  
Mitigation Measures  
Support 
Diminished hearing due to unintended use 
as hearing protection in loud 
environments. 
Labeling 
• 
Do not use this device as hearing 
protection in loud environments. 
• 
Frequent exposure to loud sounds may 
harm your hearing. Keep the loudness at 
comfortable listening levels. Wear hearing 
protection 
when 
exposed 
to 
loud 
environmental noise. 
• 
Human factors 
validation 
• 
Wrongly treated hearing loss 
• 
Unintended user (severe hearing 
loss) selects the SF hearing aid 
despite having a severe hearing loss.  
Severe hearing loss remains 
untreated and worsens. 
• 
Labeling 
• 
Web application has built in measures if 
the response is outside the fitting range. 
• 
Screening confirms that subjects have mild-
to-moderate hearing loss 
• 
Human factors 
validation 
• 
Software 
verification and 
validation 
(performance 
testing) 
Diminished hearing due to over-
amplification caused by: 
• 
Hearing ability profiling: Intended user 
does not count how many tones he / 
she hears leading to wrong clusters 
selected. 
• 
Built-in measures in the web application 
to check consistency in the answers of the 
users on how many tones heard.   
• 
Comfort loudness adjustable by the user 
after the hearing ability profiling. 
Labeling  
• 
Perform the hearing ability profiling in a 
quiet environment without interruptions 
for the best result. 
• 
Human factors 
validation 
• 
Software 
verification and 
validation 
(performance 
testing) 
 
 
Acoustic Smartphone App can provide a 
high sound pressure level (SPL) / output 
to the patient's ear causing discomfort in 
the ear. 
The tones are extremely short and not 
perceived by most people 
These types of remote controls have been 
marketed for many years and proven to be 
reliable and safe 
Labeling 
• 
The smartphone generates short tone 
sequences to control the hearing aids. Do 
not hold the smartphone close to the ear 
while using the app. 
• 
Human factors 
validation 
 
 
 
2.3.2 KNOWN POTENTIAL BENEFITS  
Hearing aids relieve the strain of hearing, i.e., less strain and more clear hearing. It is anticipated that 
inexperienced wearers will experience improved ease and better speech understanding in various listening 
environments, e.g., watching television, conversations.  
 
Subjects get the chance to try out state-of-the-art modern hearing aids. Inexperienced hearing aid subjects 
gain experience with hearing aids which will help them to make an informed choice if they decide to 

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purchase hearing aids upon conclusion of the study. Subjects already fitted with hearing aids will gain 
experience with SF hearing aids as well as the instant-fit completely-in-canal (CIC) form factor. 
 
During screening the hearing of the subjects is checked by HCP thus the subjects gain current information 
about the status of their hearing.  
 
Having to fill out the EMA surveys daily may have the benefit that subjects pay more attention to their 
hearing which might lead to increased perceptiveness of sound being an incentive to become more socially 
active. Overall, this could contribute to their emotional well-being. 
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
Overall, all risks identified are mitigated as low as possible / below the risk acceptability threshold.  The 
risks associated with the use of the Vibe SF hearing aid system are acceptable when weighted against the 
expected benefits to the study subjects. The benefit outweighs the overall residual risk. 
 
In conclusion, the overall residual risk and the overall risk/benefit profile is acceptable for the clinical study 
using the self-fitting system EasyFit web application and Vibe SF hearing aid. 
 
3 
OBJECTIVES AND ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary  
 
 
Primary Effectiveness 
 
 
To demonstrate that the Vibe SF 
strategy is non-inferior to the HCP fit 
strategy in subject´s perceived 
hearing aid benefit after wearing the 
Vibe SF and Silk 1X HCP fit hearing 
aids in real-life conditions. 
 
 
        
Differences in the benefit scores on 
each of the three communication 
subscales as captured by the 
Abbreviated Profile of Hearing Aid 
Benefit (APHAB) after wearing each 
Vibe SF/ Silk 1X HCP fit hearing aids 
for 14 days.  
 
The three communication subscales on 
the APHAB are: ease of communication 
(EC), background noise (BN) and 
reverberant room (RV). There is one 
benefit score (i.e., = unaided - aided) 
for each communication subscale (EC, 
BN and RV) scored after each fitting 
strategy field testing (SF or HCP fit): 
∆EC(benefit)SF, ∆BN(benefit)SF, 
∆RV(benefit)SF for the Vibe SF hearing 
aids, and ∆EC(benefit)HCP fit, 
∆BN(benefit)HCP fit, ∆RV(benefit)HCP fit for 
the Silk 1X HCP fit hearing aids.  
 
Self-reporting questionnaires 
have been commonly used to 
measure subjective hearing 
impairment.  
The APHAB is selected because 
of its known psychometric 
properties. The APHAB was 
specifically designed to 
quantify auditory disability so 
that the success of the hearing 
aid fitting in reducing disability 
and comparison between 
hearing aid fitting strategies 
may be examined (Cox & 
Alexander, 1995) .  
 
The reason to examine each 
subscale independently is to 
investigate whether the fitting 
strategies provide different 
benefit in varying kinds of 
environments in the real world. 
 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
For each subject, the endpoints are 
the 3 communication subscale 
differences between the HCP fit 
subscale (benefit) score and 
corresponding SF subscale (benefit) 
score:  
• ∆EC(benefit)HCP fit - ∆EC(benefit)SF  
• ∆BN(benefit)HCP fit - ∆BN(benefit)SF  
• ∆RV(benefit)HCP fit - ∆RV(benefit)SF 
 
Time point data collected:  
Cross-over Design: 
Visit 1, 2, 3  
 
Parallel-arm Design: 
12 subjects: Visit 1, 2, 3 
38 subjects: Visit 1 and 2  
 
 
Secondary 
 
 
Secondary Hearing Aid Benefit: 
 
 
To score each of the following 
performance measures when the 
subject is using the Vibe SF and Silk 
1X HCP fit hearing aids: 
 
 
1. Sound quality, speech 
understanding and hearing aid 
satisfaction real-time 
assessment  
 
The subject´s sound quality, speech 
understanding and hearing aid 
satisfaction Ecological Momentary 
Assessment (EMA)  scores measured 
repeatedly under real-life conditions. 
 
Time point data collected:  
Cross-over Design: 
Field Test 1 and Field Test 2 
 
Parallel-arm Design: 
12 subjects = Field Test 1 and 2 
38 subjects = Field Test 1 
Assessment of perceived 
hearing aid benefit should 
include the dimension 
perceived sound quality, 
speech understanding and 
hearing aid satisfaction. 
 
Only a couple of studies have 
allowed users to make multiple 
adjustments or sound quality 
judgments under real-life 
conditions. We want to further 
the research on standardizing 
the sound quality and speech 
understanding satisfaction 
assessment questions asked in 
real-life conditions. 
 
The use of EMA ratings in 
audiology research is growing. 
Apps allow researchers to 
implement the EMA 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
methodology using 
smartphones in hearing aid 
outcome research (Wu, Stangl, 
Zhang, & Bentler, 2015). 
The EMA approach overcomes 
several long-standing problems 
in assessment.  
First, EMA minimizes the 
problem of retrospective 
memory biases in reporting long 
after specific behaviors or 
emotional reactions are emitted 
because respondents can be 
prompted during real-life 
situations (Schiffman, Stone, & 
Hufford, 2008). Users may 
remember recent events or very 
emotional events more than 
others. For hearing aid trials, this
also means users may not 
remember the acoustical 
background of the situation.  
 
Secondly, EMA is 
representative of real life - 
surveys are not filled out in an 
artificial situation during an 
investigational site visit but 
rather are possible in many 
different situations in the life 
of the subjects. With random 
sampling (random triggers) it is 
possible to deduct how often 
each situation occurs in 
everyday life, but subjects can 
also trigger a survey in very 
important or difficult 
situations.  
 
Thirdly, EMA is context 
sensitive – subjects may have 
different needs and 
preferences in different 
situations. This can be 
measured with EMA as the user 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
can be asked what situation 
he/she is in right now. Subjects 
can for example pay attention 
to acoustical features, if the 
questionnaire asks for it. 
2. Speech-in-noise recognition 
performance  
Speech-in-noise recognition 
performance as measured by the 
Quick Speech-In-Noise test (QuickSIN) 
 
Time point data collected:  
Cross-over Design: 
28 subjects Visit 3 
 
Parallel-arm Design: 
12 subjects Visit 3 
38 subjects Visit 2 
This is an objective measure of 
Hearing aid benefit with known 
psychometric properties to be 
comparable to related SF 
strategy research. 
3. Hearing disability in 
communication situations 
Hearing disability resulting from 
hearing loss quantified by the short 
form of the Speech, Spatial, and 
Qualities of Hearing Scale for clinical 
use:  the SSQ-12 questionnaire 
 
Time point data collected:  
Cross-over Design: 
Visit 1, 2, 3 
 
Parallel-arm Design: 
12 subjects Visit 1, 2, 3 
38 subjects Visit 1 and 2 
This is a subjective measure of 
Hearing aid benefit with known 
psychometric properties to be 
comparable to related SF 
strategy research. The SSQ-12 
(Noble, Jensen, Naylor, Bhullar, 
& Akeroyd, 2013) is selected as 
a verified tool to provide 
insights into other components 
of hearing function. 
Secondary Gain Selection  
 
 
Individual frequency-specific real-ear 
gain comparison of the two different 
fittings (Vibe SF/HCP fit). 
Individual frequency-specific real-ear 
gain comparison for the two different 
fitting strategies (Vibe SF/HCP fit) for 
each ear as measured with probe-mic 
measures (REM).  
 
Time point data collected:  
Cross-over Design: 
Visit 3 
 
Parallel-arm Design: 
12 subjects Visit 3 
38 subjects Visit 2 
Objective comparison of real-
ear gain (Vibe SF vs. HCP fit) to 
characterize performance and 
establish the comparability of 
the Vibe SF and HCP fit 
parameters 
Secondary Preference 
 
 

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Fitting (Vibe SF/HCP fit) preference 
reported by the subject. 
Fitting preference between the Vibe 
SF or HCP fit strategy.  
Subjects will be asked to give their 
response on a 5-point Likert scale to 
the following question: Based on your 
listening experiences regarding speech 
understanding, sound quality and 
naturalness for both products, if you 
could keep one pair of these hearing 
aids, which would you choose? 
 
Time point data collected:  
Cross-over Design: 
Visit 3 
 
Parallel-arm Design: 
12 Subjects: Visit 3 
Assessment of perceived 
hearing aid benefit should 
include the dimension of fitting 
preference of the subject.  
Secondary Safety Objective 
 
 
To estimate the rate of safety when 
the subject is using the Vibe SF 
hearing aids. 
The number of adverse device effects 
(ADEs) in the time period when the 
subject is using the Vibe SF strategy 
hearing aids. 
 
Time point data collected:  
Cross-over Design: 
Visit 1-3, Field Tests 1-2 
 
Parallel-arm Design: 
12 Subjects:  
Visit 1-3, Field Test 1-2 
38 Subjects:  
Visit 1 and 2, Field Test 1 
Record, track and report 
device-related events as part of 
the risk management process 
for the SF strategy validation. 
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
 
The null hypothesis of the SF Study is that subject´s perceived hearing aid benefit using Vibe SF hearing aids 
is inferior to Silk 1X HCP fit hearing aids, and the alternative hypothesis is that subject´s hearing aids benefit 
using Vibe SF hearing aids is non-inferior to that using Silk 1X HCP fit hearing aids. 
 
A prospective, randomized controlled, adaptive design, non-inferiority, pre-market and NSR device study. 
The first 12 subjects will participate in the cross-over design, after which an interim analysis of a nuisance 
parameter will be conducted to evaluate whether there is an interaction effect.  If there is, the design will 
be changed to parallel-arm, the sample size will be increased to 50, and the remaining 38 subjects will 

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receive just one fitting (to which they are randomized).  If there is no significant interaction effect, the 28 
subjects originally planned will complete the cross-over design. 
 
Cross-over design: 28 subjects 
At the final Visit 3 the order of evaluating hearing aids (Vibe SF /Silk 1X HCP fit) will be randomized to 
ensure double-blinding to minimize subject and HCP bias while conducting the QuickSIN and REM 
laboratory assessments.  
 
Parallel-arm design: 50 subjects 
For 38 subjects, the final visit will be at Visit 2 and the REM and QuickSin will be tested with the Field Test 1 
device. 12 subjects will complete the final visit where the order of evaluating hearing aids (Vibe SF /Silk 1X 
HCP fit) will be randomized to ensure double-blinding to minimize subject and HCP bias while conducting 
the QuickSIN and REM laboratory assessments. 
 
This study has two fitting strategy groups, Vibe SF and HCP fit.  In subjects who participate in the cross-over 
design, each subject is in each fitting strategy group for 14 days, 5-day washout period after cross over and 
total subject study intervention duration is 7 weeks. In subjects who participate in the parallel-arm design, 
each subject is in just one fitting strategy for 14 days.  There is no washout period, and no cross-over to the 
other fitting. 
 
A single US University hearing aid research clinic will be the clinical site in this study. The investigational site 
serves 15% Native American, 5% African American and other diverse American population.  
 
The name of the self-fitting air conduction hearing aid is Vibe SF. The EasyFit web application is intended to 
support the SF strategy of the Vibe SF.  The Vibe SF strategy is being evaluated in this study.  
To address a possible significant interaction effect, a sample size re-estimation based on the nuisance 
parameter: interaction term will be conducted after 12 subjects have completed Visit 3.  
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
Research of self-fitting hearing aids is limited, there is only one current published SF validation study done 
by the predicate device from Bose. Today the landscape of the hearing industry is changing quickly due to 
the rapid advancement of amplification technology as well as changes in federal regulations of the hearing 
aid market.  
 
The sponsor does not know, before initiating the study, whether the interaction between treatment and 
order is significant. It is the company’s belief that an interaction effect is unlikely because many studies in 
the hearing aid literature use cross-over designs, and none mention a significant interaction effect. 
Therefore, the company prefers not to start with the assumption that it is necessary to conduct a parallel-
arm trial. To address concerns about a possible interaction effect, the sponsor proposes to address this 
potential problem by using an adaptive design:  changing to a parallel-arm design based on a nuisance 
parameter.  The nuisance parameter is the interaction term.   
 

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It is important to differentiate between traditional hearing aids and SF hearing devices, not only in terms of 
device characteristics but also in terms of expected subject outcomes. Also, it is important to differentiate 
the devices that produce the best patient outcomes across various listening situations. Therefore, there is a 
scientific need to develop an evidence base with well-controlled studies in relation to SF hearing aids.   
 
Assessing the non-inferiority of the SF hearing to HCP fit hearing was the chosen study design because HCP 
counseling on hearing loss has been established in research as being best practice.  In the rapidly changing 
distribution of model of hearing healthcare, it may become more likely a person with perceived hearing loss 
will utilize a self-fitting method as an introduction to hearing care.  In the absence of a best practices model 
involving the HCP, it is necessary to verify that a hearing aid user’s first experience with amplification is 
such that core expected benefits are met with a self-fitting approach.  This does not prevent future 
intervention with a HCP.  Rather, a self-fitting approach to amplification should provide noticeable benefit 
comparable to that of best practices to overcome key challenges of hearing loss directly related to reduced 
audibility.  In this way, the new hearing aid wearer can begin experiencing benefits of amplification and 
develop a positive acceptance of hearing healthcare. 
 
It cannot be expected for a SF hearing aid to be superior as the advantages of the SF lie in accessibility and 
ownership not the fitting-process itself. However, in the best interest of the subjects it has to be ensured 
that the hearing aid fitting is not inferior to that what they would get from the standard alternative, i.e., 
being fitted by a HCP. 
 
 
4.3 
END OF STUDY DEFINITION 
 
28 subjects are considered to have completed the study when they have completed all phases of the study 
including the last visit shown in the SoA, Section 1.3. 
 
In the event an additional 22 subjects are enrolled due to detection of significant interaction effect, these 
are considered to have completed the study when they have completed Visit 2. Refer to SoA, Section 1.3. 
 
The end of the study is defined as the last subject’s (minimum 24th subject, maximum 50th subject) 
completion of the last visit shown in the SoA in the study. 
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
• 
Adults 18 years of age or older, 
• 
Self-perceived mild to moderate hearing impairment,  
• 
Signed informed consent form (ICF), 
• 
Fluent in English listening and reading comprehension, 

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• 
With or without prior experience with hearing aids. At least four subjects and maximum 30% of the 
total number of subjects enrolled in this study will have prior hearing aid experience.  
• 
Measured audiogram with at least four of the test frequencies 500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 
and 4000 Hz within fitting range of Vibe SF hearing aid (See Figure 1 below). 
 
Figure 1. The colored area shows the fitting range of Vibe SF Hearing aids with the use of vented click sleeves; the 
hearing loss of the subjects should fall within that area. 
 
5.2 
EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this study: 
 
• 
Silk 1X (HCP fit)/ Vibe SF hearing aids do not fit into the person’s ears with any of the offered 
silicone ‘Click Sleeves’ instant ear tips. 
• 
Abnormal conditions: 
o Severe hearing loss or deafness in at least one ear. 
o A steep decline in hearing ability within the last 90 days in one or both ears. 
o Active discharge within the last 90 days. 
o Dizziness. 
o A visible deformity of the ear. 
o Pain, or discomfort in the ear, or significant ear wax accumulation.   
o Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz Hz, 1,000 Hz, 
and 2,000 Hz.  
5.3 
SCREEN FAILURES 
 
Screen failures are defined as subjects who consent to participate in the study but are not subsequently 
entered in the study. A minimal set of screen failure information is required to ensure transparent 
reporting of screen failure subjects, to meet the Consolidated Standards of Reporting Trials (CONSORT) 
publishing requirements and to respond to queries from regulatory authorities. Minimal information 
includes demography, screen failure details, eligibility criteria, and any serious adverse event (SAE). 
 

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5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
The study will enroll a minimum of 28 US subjects and a maximum of 50 US subjects, 18 years of age and 
older, inexperienced or experienced (minimum 4, maximum 30% in total) hearing aid users with perceived 
mild-to-moderate hearing impairment that will be screened to confirm that s/he has bilateral sensorineural 
hearing loss. 
 
Potential subjects will be recruited locally by outreach at the investigator site (i.e., a single US University 
hearing aid research clinic), local advertisements, social media advertisements and professional recruiting 
service. Advertisements will be reviewed and approved by the IRB to assure that they are not unduly 
coercive and does not promise a certainty of cure beyond what is outlined in the consent and the protocol. 
No claims will be made, either explicitly or implicitly, that the device is safe or effective for the purposes 
under investigation, or that the test article is known to be equivalent or superior to any other device. FDA 
considers direct advertising for study subjects to be the start of the informed consent and subject selection 
process. 
 
Study subjects will be reimbursed for travel expenses for each clinic visit not to exceed $50/visit. 
In case a subject withdraws from the clinical investigation the subject will receive transport compensation 
covering the number of times he/she has visited the investigation site during the clinical investigation.  
As reimbursement for their time in filling out the EMA surveys and wearing the hearing aids during Field 
Test 1 & 2, and their testing time during Visit 1, 2, and 3, a total of US$175 will be paid out to 28 subjects as 
outlined below:  
Table 2. 28 Subjects: cross-over design 
SCHEMA 
Time 
Amount 
Payment 
Screening 
15 minutes 
0 
 
Visit 1 
60 minutes 
15 
 
Field Test 1 
14 days 
40 
55 
Visit 2 
60 minutes 
15 
 
Field Test 2 
14 days 
40 
55 
Visit 3 
120 minutes 
65 
65 
TOTAL 
 
US$175 
US$175 
 
Table 3. 50 Subjects: parallel-arm design 
12 Subjects 
SCHEMA 
Time 
Amount 
Payment 
Screening 
15 minutes 
0 
 
Visit 1 
60 minutes 
15 
 
Field Test 1 
14 days 
40 
55 
Visit 2 
60 minutes 
15 
 
Field Test 2 
14 days 
40 
55 
Visit 3 
120 minutes 
65 
65 
TOTAL 
 
US$175 
US$175 
 

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38 Subjects 
SCHEMA 
Time 
Amount 
Payment 
Screening 
15 minutes 
0 
 
Visit 1 
60 minutes 
15 
 
Field Test 1 
14 days 
40 
55 
Visit 2 
60 minutes 
15 
 
TOTAL 
 
US$70 
US$70 
 
 
6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION(S) ADMINISTRATION 
 
6.1.1 STUDY INTERVENTION DESCRIPTION 
 
The investigational device Vibe SF hearing aid is a NSR medical device that does not pose a significant risk to 
human subjects based on its intended use. The Vibe SF is intended to amplify sound for individuals 18 years 
of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the 
user’s hearing needs through software tools. The device is intended for direct-to-consumer (DTC) sale and 
use without the assistance of a hearing care professional (HCP). Vibe SF is intended to be sold as a binaural 
set and the Vibe SF strategy is intended to be binaural. The investigational device immediate package shall 
bear a label with the following statement: “CAUTION—Investigational device. Limited by Federal (or United 
States) law to investigational use.” 
The instant fit in-the-ear (ITE) style Vibe SF hearing aid uses silicone ‘Click Sleeves’ which are instant ear tips 
in four different sizes to provide comfort and secure device placement within the ear canal. The click 
sleeves are also used on the global market together with the Signia Silk Xperience devices (e.g., Silk 1X HCP 
fit control device) and other Signia products.  
All hearing aids in the study are provided in black housing and marked with ‘R’ and ‘L’, for right and left side 
respectively, as displayed in Figure 2.  
 
 
 
a) 
b) 
c) 

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Figure 2. Drawings of the Vibe Air SF hearing aid: a) left side housing marked `L’, b) right side housing marked `R’, c) click sleeve, 
microphone, battery door, removal cord and side/orientation indicator.  
The EasyFit web application is used to guide the user through the Vibe SF procedure and to set audiological 
gain parameters and preferred settings on the Vibe SF. EasyFit web application is designed to function in 
standard browsers of a user’s compatible smartphone or tablet device. Access to the internet is required 
when using EasyFit web application during the SF procedure, fine-tuning and use of volume control. 
Through the Vibe SF hearing aid, the EasyFit web application will present several sets of 2 or 3 tones to the 
subject for hearing ability profiling. Within such a test-tone-set all tones have the same frequency, but they 
differ in intensity level. Depending on the extent of hearing loss, the user will hear all, some or none of the 
presented tones. EasyFit web application will ask the user to enter the number of tones s/he hears. A 
selection of screen shots of the fitting process with the EasyFit web application are shown in Figure 3. 
EasyFit web application can activate 4 different “clusters” in the hearing aid. “Clusters” in this context 
means different hearing aid settings. Those settings are the same with respect to hearing aid features, e.g., 
noise reduction etc., but they differ in frequency dependent gain, compression and MPO (maximum power 
output). EasyFit uses the result of the profiling procedure to select and activate the cluster and master gain 
setting that is most suitable for the user. In case of an asymmetrical hearing loss the cluster can differ 
across sides. A short additional test ensures the overall gain is comfortable and balanced between the left 
and right ears. After the fitting is completed, the user may further use EasyFit to fine-tune the hearing aid 
settings during daily use.  

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Figure 3 Selection of draft screenshots of hearing ability profiling in the EasyFit web application. 
 
The control hearing aid device, Signia Silk Xperience, has been commercially available in the U.S. as a Class 
II 510(k)-exempt medical device since July 2020 in five models: Silk 7X, Silk 5X, Silk 3X, Silk 2X and Silk 1X. 
The performance levels for each model differ in the embedded software configuration but use identical 
hardware. The Silk 1X model will be fitted to the individual hearing thresholds by an HCP as per standard 
clinical care. The Connexx Fitting Software will be used to fit NAL-NL2 prescriptive target verified by probe-
mic REM. The Connexx programming software allows the HCP access to certain programming parameters 
that are not accessible in the Vibe SF using EasyFit.  Parameters that the HCP can adjust in the Silk 1X fitting 
are 8 adjustable gain and compression handles, Frequency Compression, Feedback cancellation (off, min, 
max).  Silk 1X does support multiple programs, however only one single program (titled: universal program) 
will be used. 
6.1.2 NONSIGNIFICANT RISK DETERMINATION 

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The Sponsor has determined that both the study and device are non-significant risk, based on the risk 
profile of this non-invasive device (see Appendix I), and a review of the Code of Federal Regulations 
definitions and rules regarding significant risk devices.  The following rationale is cited as determination of 
non-significant risk: 
The device does not meet the four elements of the definition for a significant risk device per 21 CFR 
812.3, part (m) in that the device does not pose significant risk to the subject and is not an implant, does 
not support or sustain human life, and is not of substantial importance for diagnosis, curing, mitigating, 
preventing impairment to human health or treatment of ESRD patient.  The risk assessment by the 
Sponsor concludes that the device poses minimal risk to the subject.   
 
In Appendix I is a summary of the test validation studies.  
6.1.3 INVENTORY AND DISPENSING 
Investigator site will store the hearing aids in a locked room and cabinet. Only the designated staff at the 
investigator site will conduct the randomization and blinding coding and store randomized devices 
according to the sites working procedure. Only the designated staff is able to retrieve and directly give/ship 
out to subjects directly the randomized/blinded hearing aids. HCP may not be a designated staff to conduct 
randomization, blinding coding, storage, shipment or direct retrieval from storage of the devices to the 
subjects at Visit 3.   
 
6.2 
PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 
 
6.2.1 ACQUISITION AND ACCOUNTABILITY 
 
Sponsor will deliver the hearing aids to the investigation site before the first subject is enrolled in the study.  
 
If for any reason devices need to be returned to the sponsor, investigator site will be provided with 
handling instructions at the study site initiation visit.  
 
Return of all devices will be picked-up by the sponsor at the close out monitoring visit at the investigation 
site.   
 
6.2.2 FORMULATION, APPEARANCE, PACKAGING, AND LABELING 
 
6.2.2.1 INVESTIGATIONAL DEVICE: VIBE SF 
 
Legal Manufacturer of the Vibe SF hearing aids is WSAUD A/S, Nymoellevej 6, DK-3540 Lynge, Denmark. 
Manufactured for Vibe Hearing, 3033 Campus Dr., Suite W 125, Plymouth, MN 55441 
 

SF Study  
 
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The investigational device will come in a hearing aid case placed in a cardboard box together with a pack of 
batteries, a cleaning brush, cleaning cloth and click sleeves sizes XS, M and L. The hearing aid case will 
contain left and right hearing aid with the click sleeve size S attached. See also Figure 3. 
The investigational device will be handed out together with the Safety and Maintenance Information, a 
Quick start guide and a Quick start card. 
 
Figure 3. Content enclosed in the Vibe SF cardboard box 
The Cardboard box will bear the following information: 
CAUTION Investigational device. Limited by Federal (or United States) law to investigational use. 
Content: Jewel case with 2 hearing aids, silicone click sleeves in 4 sizes (XS, S, M & L), 6 batteries size 10, and 
cleaning tools. 
Warning: For adults 18 years and older with mild to moderate hearing loss. Contact your primary care 
provider before using this product if you currently experience any of these conditions: (1) Severe hearing 
loss or deafness in at least one ear. (2) A steep decline in hearing ability within the last 90 days in one or 
both ears. (3) Active discharge within the last 90 days. (4) Dizziness. (5) A visible deformity of the ear. (6) 
Pain, or discomfort in the ear, or significant ear wax accumulation. 
 
This NSR device study complies with the abbreviated IDE requirements set forth in (§812.2(b)). Therefore, 
the Vibe SF is labeled in accordance with §812.5.  
The labeling of our investigational device does not contain any false or misleading statements nor imply that 
the device is safe or effective for the purposes being investigated. 
Detailed information on device labeling is in Appendix II.  
 
 

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6.2.2.2 CONTROL DEVICE: SILK 1X 
 
Legal Manufacturer of the Silk 1X hearing aids is Signia GmbH, Henri-Dunant-Strasse 100, 91058 Erlangen, 
Germany 
The control device will come in a standard hearing aid jewel case enclosed in a cardboard box with the 
following information: 
Brand: Signia 
 
The investigational Site will be provided with Click Sleeves Size XS, S, M and L and Batteries in standard 
packaging to hand out to the participants during standard-of-care fitting at Visit 1 and Visit 2. 
 
 
6.2.3 PRODUCT STORAGE AND STABILITY 
Devices should be stored in their designated jewel cases or appropriate trays or boxes. Temperature for 
storage should be between 10 to 40 °C (50 to 104 °F). Relative humidity should be 10 to 80% and 
Atmospheric pressure 700 to 1060 hPa. 
 
 
6.2.4 PREPARATION 
 
Randomization coding and blinding coding need to be done in advance by the designated investigational 
site staff. The designated site staff must also set up their inventory so that they are able to track, store, 
deliver and retrieve the properly randomized and blinded devices designated to the subject at the time of 
their study visits and when shipping out devices for Field Test 2.  
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZED TREATMENT ORDER AND BLINDING 

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To avoid order effect of evaluating Vibe SF strategy and Silk 1X HCP fit strategy, a balanced randomization 
list will be generated using approved statistical software. A computer-generated pseudo-random-number 
list will be used for assigning the treatment order.  Assignments will be made either by sealed envelope or 
provided real-time on the sponsor’s electronic database capture (EDC) website on a protected page. New 
hearing-aid users and experienced hearing-aid users will be distributed evenly in the two randomized 
groups. 
 
Cross-Over Design: Minimum 12, Maximum 28 subjects 
At the final visit (Visit 3), the order of testing the experimental and reference devices will be randomized for 
the QuickSIN and REM lab tests. Randomization will be handled by a designated person not otherwise 
involved in the study. 
 
During each of the following performance measures, QuickSIN and REM, at Visit 3 when the subject is using 
the Vibe SF and Silk 1X HCP fit hearing aids, the identity of the Vibe SF and Silk 1X will be double blinded to 
the subject and assessor. An assistant other than the HCP will help secure double blinding during the lab 
assessments by handling the blinding codes, storing, retrieving and presenting the appropriate hearing aids 
for evaluation.  
 
During Field Tests 1 and 2 use, blinding is not possible since the option of self-finetuning or finetuning visits 
to the HCP reveals the device under investigation.  
 
6.4 
STUDY INTERVENTION COMPLIANCE 
 
A follow-up call made by investigation site staff to subjects within the first 3 days of their Field Test 1 and 
Field Test 2 will act as a check that they are wearing their hearing aids and that the EMA data collection is 
being completed and functioning properly.   
 
7 
STUDY INTERVENTION DISCONTINUATION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION 
 
In case subject discontinues study intervention the hearing aids and other study material given are 
returned and the subject is out of the study. Organization of returned materials/hearing aids will be 
handled by the Sponsor in collaboration with site. No further follow up is necessary. 
 
7.2 
SUBJECT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Subjects are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue or withdraw a subject from the study for the following reasons: 
 

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• 
If the subject meets an exclusion criterion (either newly developed or not previously recognized) 
that precludes further study participation 
• 
Subject is unable to do Field Test 1 and/or 2 under real-life conditions due to quarantine or social 
distancing due to COVID-19 pandemic.   
The reason for subject discontinuation or withdrawal from the study will be recorded on the Study 
completion Case Report Form (eCRF). Subjects who signed the ICF and are randomized but do not receive 
the study intervention may be replaced.  Subjects who signed the ICF, and are randomized and receive the 
study intervention, and subsequently withdraw, or are withdrawn or discontinued from the study, will be 
replaced if the minimum number of 24 subjects has yet to be enrolled.  
 All data is collected during use of the investigational device. In case a patient is withdrawn from the study 
there is no further data collection needed, except in the case the patient would report an adverse event 
which would be seen as at least possible related to the treatment with the device. In this case the patient 
will be followed up until the event is resolved.  
Data collected before withdrawal of consent will be kept in the study.  
 
7.3 
LOST TO FOLLOW-UP 
 
A subject will be considered lost to follow-up if he or she fails to return for scheduled visits and is unable to 
be contacted by the study site staff.  
The following actions must be taken if a subject fails to return to the clinic for a required study visit: 
• 
The site will attempt to contact the subject and reschedule the missed visit and counsel the subject 
on the importance of maintaining the assigned visit schedule and ascertain if the subject wishes to 
and/or should continue in the study. 
• 
Before a subject is deemed lost to follow-up, the investigator or designee will make every effort to 
regain contact with the subject (where possible, 3 telephone calls and, if necessary, a certified 
letter to the subject’s last known mailing address or local equivalent methods). These contact 
attempts should be documented in the subject’s medical record or study file.  
 
Should the subject continue to be unreachable, he or she will be considered to have withdrawn from the 
study with a primary reason of lost to follow-up. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
EFFECTIVENESS ASSESSMENTS  
Data are collected via questionnaires, laboratory speech testing and EMA surveys during field use. An 
overview is given below in Table 4. 
Stage 
Intervention 
Method 

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Screening 
Otoscopy 
Tympanometry 
Audiometry 
Otoscope, tympanometer and standard audiometer performed 
by HCP.  
Hearing in Noise Question 
HCP asks subject: Do you have trouble hearing in noise? Y/N 
Self-Perceived Hearing Loss 
questionnaire 
HCP asks subject to describe their hearing loss on a 4-point 
scale: 
1. No Trouble 
2. A little trouble 
3. A lot of trouble 
4. Cannot hear 
Visit 1 
Questionnaires for primary 
and secondary endpoints 
on effectiveness  
 
• APHAB  
The APHAB inventory yields scores for speech communication 
in quiet, reverberant, and noisy environments, and also 
measures aversiveness of loud sounds.  
 
• SSQ-12  
The SSQ-12 includes the factors speech hearing, spatial 
hearing, qualities of hearing, and listening effort. 
 
➔ Both completed for unaided condition (irrespective of 
hearing aid experience)  
Randomized Vibe SF or Silk 
1X HCP fit hearing aids: 
Bilateral Hearing Aid fitting 
EasyFit web application (Vibe SF strategy) performed by 
subject.  Connexx Fitting Software NAL-NL2, verified with 
probe-mic REM (Silk 1X HCP fit strategy) performed by HCP. 
Fine-tuning 
For Vibe SF strategy, with fine-tuning dialog on EasyFit web 
application done independently by subject.  For Silk 1X HCP fit, 
fine-tuning with HCP as is standard clinical practice. 
Field Test 1 
Fine-tuning 
Situation tuning 
For Vibe SF strategy, with fine-tuning dialog and situation 
tuning is performed with the EasyFit web application  by the 
subject.  For Silk 1X HCP fit strategy, fine-tuning appointment 
with HCP if necessary due to persistent need for fine-tuning 
that cannot be resolved with the situation tuning using the 
Signia App. 
Follow-up to ensure EMA 
survey data capture 
Phone call from investigational staff approximately 3+3 days 
after visit to ensure that daily EMA surveys are being 
completed; any questions related to data collection may be 
answered. Questions regarding the hearing aids may NOT be 
answered and subject will be reminded to refer to the study 
information provided to them at Visit 1.  
Sound quality,  speech 
understanding and hearing 
aid satisfaction ratings for 
secondary endpoint on 
effectiveness 
Subjects will be asked via their study smartphones to give short 
ratings of sound quality and speech understanding satisfaction 
in their current listening situation. This EMA is a methodology 
involving repeated surveys to collect data describing subjects’ 
current or very recent experiences in their real-life conditions.  
Visit 2 (only 
cross-over 
design) 
Questionnaires for primary 
and secondary endpoint on 
effectiveness 
• 
APHAB 
• 
SSQ-12 
➔ Both completed Aided (Field Test 1 device) and if 
necessary, assistance given by HCP 

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Field Test 1 Vibe SF Strategy 
or Silk 1X HCP fit hearing 
aids put in storage 
Each subject´s Vibe SF or Silk 1X HCP fit hearing aids of the 
Field Test 1 will be blind coded and stored so that the speech 
test at the final visit (Visit 3) may be done with the exact 
settings used during the Field Test 1 (i.e., including fine-
tuning). 
Cross Over Vibe SF or Silk 
1X HCP fit hearing aids: 
Bilateral Hearing Aid fitting 
EasyFit web application (Vibe SF strategy) performed by 
subject.  Connexx Fitting Software NAL-NL2, verified with 
probe-mic REM (Silk 1X HCP fit strategy) performed by HCP. 
(only cross-over design) 
Fine-tuning 
For Vibe SF strategy, with fine-tuning dialog on EasyFit web 
application done independently by subject.  For Silk 1X HCP fit, 
fine-tuning with HCP as is standard clinical practice. 
(only cross-over design) 
Visit 2 (only 
parallel-arm 
design) 
Questionnaires for primary 
and secondary endpoint on 
effectiveness 
• 
APHAB 
• 
SSQ-12 
➔ Both completed Aided (Field Test 1 device) and if 
necessary, assistance given by HCP 
Speech Test for secondary 
endpoint on effectiveness 
 
• 
QuickSIN 
➔ Unaided 
➔ Aided (Field Test 1 device) 
 
A speech test is included to give objective data on speech 
understanding with the Field Test 1 hearing aids. 
Fitting verification of “final 
fit” 
 
REM of Field Test 1 device for gain comparison 
Washout 
Period 
(only cross-
over design) 
5 day + 2-day period of not 
wearing any study devices 
Upon completing Visit 2, the site will collect the hearing aids 
fitted at Visit 2, store them and send them out upon 
completing the 5-day washout period. 
Field Test 2 
(only cross-
over design) 
See Field Test 1 
See Field Test 1 
Visit 3 
(only cross-
over design) 
Questionnaires for primary 
and secondary endpoint on 
effectiveness 
• 
APHAB 
• 
SSQ12 
➔ Both completed Aided (Field Test 2 device) and if 
necessary, assistance given by HCP 
Speech Test for secondary 
endpoint on effectiveness 
 
• 
QuickSIN 
➔ Unaided 
➔ Aided (device order randomized and double-blinded) 
 
A speech test is included to give objective data on speech 
understanding with the Vibe SF and Silk 1X HCP fit hearing 
aids. 
 
Reasons to do speech testing for all three conditions at the 
end of the study: 
1. Otherwise, not able to do perform double-blinded. 
2. The cross-over design minimizes ordering bias effects. 

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Fitting verification of “final 
fit” 
 
REM of both fitting strategies (Vibe SF/HCP fit) for gain 
comparison, device order randomized and double-blinded. 
 
Fitting Preference 
Subjects will be asked to respond to the following question on 
a 5-point Likert scale: Based on your listening experiences 
regarding speech understanding, sound quality and 
naturalness for both products, if you could keep one pair of 
these hearing aids, which would you choose? 
Table 4. Overview of test tools utilized 
 
8.1.1 SCREENING 
Potential subjects will be recruited locally by outreach at the investigator sites, local advertisements, social 
media advertisements and professional recruiting service. Initial phone/electronic screening will include the 
question of whether he/she has trouble hearing in noise. If no, they will be excluded. Those remaining will 
then be asked to rate on a scale of 1-4 her/his perceived hearing loss (no trouble, a little trouble, a lot of 
trouble, and cannot hear). Listeners at the two extremes will be excluded. 
Listeners with appropriate responses are provided an overview of the study intent (subject information) 
and invited into the clinic to be assessed for eligibility, according to inclusion and exclusion criteria, as 
described in Section 5.1 and 5.2. 
The session begins with otoscopy, tympanometry and a standard audiometric evaluation consisting of air 
and bone conduction thresholds for each ear. If it is determined they have mild-to-moderate hearing 
impairment and fulfil all inclusion criteria they will be given study subject information and asked for their 
voluntary informed consent to participate in the clinical study.  
If at this time a subject is identified with significant asymmetries in hearing, the HCP will refer them to an 
audiologist and/or ENT for follow-up and subject will be excluded from the study (screen failure).  
 
 
8.1.2 VISIT 1 
Subjects complete two questionnaires concerning unaided hearing1: the APHAB and SSQ-12. The subjects 
can ask questions, and the HCP or assistant reads through the filled-out questionnaires with the subject to 
make sure everything is understood and filled out appropriately. 
 
 
1 Participants that have experience with hearing aids are nonetheless asked to fill out the questionnaires as they would without the 
use of their hearing aids in order to have the same baseline for all participants. 

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Investigational staff complete the randomization process to determine which pair of study hearing aids the 
subject will receive.  
Hearing aid fitting is conducted in a quiet dedicated hearing aid fitting and counselling room.  
The subjects starting with the Vibe SF strategy, independently fit their Vibe SF hearing aids bilaterally 
themselves using the EasyFit web application on the study smartphone provided to them. They are 
provided with Vibe SF Safety and Maintenance Information, Quick-Start Guide and a Quick-Start Card. The 
HCP will not interfere or assist subject in fitting their hearing aids.  
For the subjects starting with the HCP fit strategy, an HCP fits the Silk 1X hearing aids bilaterally using the 
Connexx fitting software to NAL-NL2 validated prescription target, probe-mic REM and conduct fine-tuning 
as is standard clinical practice. 
All subjects are given a user manual for the hearing aids, along with instructions by the HCP or research 
assistant on how to use the EMA app and study smartphone. Subjects starting with the Silk 1X (HCP fit 
strategy) will be provided counselling on the use of the Silk 1X hearing aids and Signia App (remote-control 
smartphone app for situation tuning). 
The EasyFit web application guides the user through the SF procedure as well as the fine-tuning and volume 
control functionality. Subjects who start using the Silk 1X HCP fit strategy hearing aids will receive 
instructional material on how to use the Signia App for situation tuning as per standard of care. 
Subjects in both groups are instructed to listen to as many listening environments as possible and enter 
their sound quality, speech understanding and hearing aid satisfaction ratings when randomly prompted by 
the clinical study smartphone, and subjects may at any time self-enter a rating. The investigational staff will 
practice with the subjects until they have observed that the subject is able to successfully enter their sound 
quality, speech understanding and hearing aid satisfaction EMA ratings without any assistance from the 
investigational staff.  
Subjects are asked to report any ADEs occurring during field use. 
8.1.3 FIELD TEST 1  
All subjects wear their first pair of study hearing aids for two weeks. Since the investigation is designed as a 
cross-over design in order to be able to do within-subject comparisons, a two-week period was chosen to 
allow for acclimatization and fine-tuning but not prolong the field test to an extent where it is likely that 
subjects would drop out of the study or be less motivated in the second field test.  
The EMA rating questions on subject´s sound quality, speech understanding and hearing aid satisfaction is 
filled out in various listening conditions daily. The EMA consists of a short survey that is triggered randomly 
four times during the entire day and may also be entered at any time the subject wants to enter a rating. 
The EMA survey comprises of four single/multiple choice questions (or three, if the situation does not 
involve speech) which are: 
1. Current situation, 
2. Sound quality, 

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3. Speech understanding, 
4. Satisfaction 
If the timing is inconvenient (e.g., driving a car), the subject can delay the response to the survey ( reminder 
is given to not delay the response unduly, e.g., for more than 1 hour). 
Phone calls (approximately after 3 days +3 days field testing) are scheduled with investigational staff. These 
calls are intended to ensure that all EMA data collection tools are functioning and subjects are reminded to 
report any adverse device effects (ADE) occurring during field use. The subject also has the possibility to 
call/e-mail the investigation staff when needed; however, to mitigate the potential for introducing bias 
through counselling of the self-fit group, any questions about the Vibe SF fitting strategy or how to use the 
device will not be answered by the investigational staff.  
For the subjects who start in the HCP fit strategy group, based on complaints the subjects have about 
sound quality, the audiologist/HCP is able to invite the subject for an in-person fine-tuning visit and adjust 
the fitting on their Silk 1X as in a real-life HCP fitting (standard clinical care).  
Subjects are asked to report any ADEs occurring during field use.  
All communication with the HCP and/or investigation staff during the field tests will be documented and 
saved. 
8.1.4 VISIT 2 
Subjects return to the clinic after approximately two weeks Field Test 1 use. Subjects complete two 
questionnaires: the APHAB and the SSQ-12, to reflect their hearing experience aided with the Field Test 1 
hearing aids. An HCP or assistant reads through the filled-out questionnaires with the subject to make sure 
everything is understood and filled out sufficiently. 
Subjects are asked to report any ADEs occurring during field use. 
Cross-over design:  
The Field Test 1 HCP fit strategy subjects now cross over to the Vibe SF strategy group. Subjects 
independently fit their Vibe SF hearing aids bilaterally themselves using the EasyFit web application on the 
study smartphone. They are provided with the Vibe SF Safety and Maintenance Information, Quick-Start 
Guide and Quick-Start Card (see Appendix II). The HCP will not interfere or assist the subject with the self-
fitting.  
The Field Test 1 Vibe SF strategy subjects now cross over to HCP fit strategy group. An HCP fits the Silk 1X 
hearing aids bilaterally using the Connexx fitting software, to NAL-NL2 validated prescription target, probe-
mic REM and conducts fine-tuning as is standard clinical practice. 
The hearing aids of the Field Test 1 are stored without altering the settings to be used in the REM and 
speech tests of the final visit (Visit 3).  
Parallel-arm design:  

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12 subjects: The Field Test 1 Vibe SF strategy subjects now cross over to HCP fit strategy group. An HCP fits 
the Silk 1X hearing aids bilaterally using the Connexx fitting software, to NAL-NL2 validated prescription 
target, probe-mic REM and conducts fine-tuning as is standard clinical practice. 
The hearing aids of the Field Test 1 are stored without altering the settings to be used in the REM and 
speech tests of the final visit (Visit 3). 
38 subjects: This is their final visit. The subjects will not cross over to the other fitting strategy. 
Effectiveness is measured with QuickSIN in an unaided condition and aided with Field Test 1 fit hearing aids 
in a sound attenuated booth. REM will be conducted on Field Test 1 hearing aids.  
8.1.5 WASHOUT PERIOD (ONLY FOR CROSS-OVER DESIGN) 
Upon completing Visit 2, the site will collect the hearing aids fitted at Visit 2, store them and send them out 
to subjects upon completing the 5-day washout period. 
8.1.6 FIELD TEST 2 (ONLY FOR CROSS-OVER DESIGN) 
Field Test 2 will be conducted the same as stated in 8.1.3. Field Test 1. 
8.1.7 VISIT 3 (ONLY FOR CROSS-OVER DESIGN) 
At the final session after approximately 4 weeks of total field use with a 5-day washout period after two 
weeks of field use, each subject returns the hearing aids from their second field use test. 
Subjects are asked to report any ADEs occurring during field use. 
Subjects again complete two questionnaires: the APHAB and the SSQ-12, reflecting their hearing 
experience aided with the Field Test 2 hearing aids. An HCP or assistant reads through the filled-out 
questionnaires with the subject to make sure everything is understood and filled out sufficiently.  
Effectiveness is measured with QuickSIN in an unaided condition and aided with the Vibe SF and Silk 1X HCP 
fit hearing aids in a sound attenuated booth. Aided testing will be conducted double-blinded and subject is 
given their field test 1 and 2 devices (Vibe SF and Silk 1X HCP fit hearing aids) in randomized order.  
REM will be conducted double-blinded, and the subject is given field test 1 and 2 devices (Vibe SF & Silk 1X 
HCP fit hearing aids) in randomized order.  
The subject will be asked to fill out a 5-point Likert scale to respond to the prompt: Based on your listening 
experiences regarding speech understanding, sound quality and naturalness for both products, if you could 
keep one pair of these hearing aids, which pair would you choose: Greatly prefer A, Somewhat Prefer A, No 
Preference, Somewhat Prefer B, Greatly Prefer B. 
 
8.2 
SAFETY AND OTHER ASSESSMENTS 
 

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Stage 
Intervention 
Method 
For the 
duration of the 
study 
Secondary endpoint on 
device safety 
Subjects are asked repeatedly to report any adverse device 
effects they experience:  
• 
Instruction during first Visit (Visit 1). 
• 
At follow-up phone call during first field test. 
• 
At Second Visit (Visit 2). 
• 
At follow-up phone call during second field test. 
• 
At final visit (Visit 3). 
 
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
Adverse event, as defined according to ISO1455, means any untoward medical occurrence, unintended 
disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or 
other persons, whether or not related to the investigational medical device and whether anticipated or 
unanticipated.  
 
Note 1: This definition includes events related to the investigational device or comparator. 
Note 2: This definition includes events related to the procedures involved. 
Note 3: For users or other persons, this definition is restricted to events related to the use of investigational medical 
devices or comparators. 
 
An Adverse event related to the use of an investigational medical device is called an Adverse Device Effect. 
This definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational medical 
device. This definition includes any event resulting from use error or from intentional misuse of the 
investigational medical device. It also includes comparator if comparator is a medical device. 
 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
A Serious Adverse event is an adverse event that led to any of the following: 
a) death,  
b) serious deterioration in the health of the subject, users, or other persons as defined by one or more of 
the following:  
1) a life-threatening illness or injury, or  
2) a permanent impairment of a body structure or body function including chronic disease, or  
3) in-patient or prolonged hospitalization, or  
4) medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function,  
c) fetal distress, fetal death or a congenital abnormality or birth defect including physical or mental 
impairment 
Note: Planned hospitalization for a pre-existing condition, or a procedure required by the study, without serious 
deterioration in health, is not considered a SAE. 

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Unanticipated serious adverse device effect (USADE) is a serious adverse device effect which by its nature, 
incidence, severity or outcome has not been identified in the current risk assessment.  
Note: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity or outcome 
has been identified in the risk assessment.  
 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
For adverse events (AEs) the following guidelines will be used to describe severity.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the subject’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a subject’s usual daily activity and may require systemic drug therapy or 
other treatment. Severe events are usually potentially life-threatening or incapacitating.  Of note, 
the term “severe” does not necessarily equate to “serious”.] 
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION 
All adverse events (AEs) must have their relationship to study intervention assessed by the clinician who 
examines and evaluates the subject based on temporal relationship and his/her clinical judgment. The 
degree of certainty about causality will be graded using the categories below. In a clinical trial, the study 
product must always be suspect.  
 
• 
Related – The AE is known to occur with the study intervention, there is a reasonable possibility 
that the study intervention caused the AE, or there is a temporal relationship between the study 
intervention and event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study intervention and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study intervention 
caused the event, there is no temporal relationship between the study intervention and event 
onset, or an alternate etiology has been established. 
 
8.3.3.3 EXPECTEDNESS  
The Sponsor and the independent Medical Monitor will be responsible for determining whether an adverse 
event (AE) is expected or unexpected.  An AE will be considered unexpected if the nature, severity, or 
frequency of the event is not consistent with the risk information previously described for the study 
intervention. 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of study 
personnel during study visits and interviews of a study subject presenting for medical care, or upon review 
by a study monitor. 
 

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All AEs, including local and systemic reactions not meeting the criteria for SAEs, will be captured on the 
appropriate case report form (CRF). Information to be collected includes event description, time of onset, 
clinician’s assessment of severity, relationship to study product (assessed only by those with the training 
and authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs occurring while 
on study must be documented appropriately regardless of relationship. All AEs will be followed to adequate 
resolution. 
 
Any medical condition that is present at the time that the subject is screened will be considered as baseline 
and not reported as an AE. However, if the study subject’s condition deteriorates at any time during the 
study, it will be recorded as an AE.  
 
Further details can be found in the Study Safety Plan. 
 
8.3.5 ADVERSE EVENT REPORTING  
The investigator must record non-serious adverse events and report them to the Sponsor in a timely 
manner after the investigator first learns of the adverse event.  AEs which are non-serious not related to 
the research procedures does not have to be reported to the IRB but will be reviewed by the Sponsor and 
the Independent Medical Monitor.  
In case however that the event is unexpected AND more likely than not related to the research procedures 
it shall be reported to the IRB within 5 days of Investigator receiving notice of the event, as per IRB local 
guidelines.  
 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
The study investigator shall report an Unanticipated Adverse Device Effect to the study sponsor and to the 
reviewing Institutional Review Board (IRB) as soon as possible, but in no event later than 5 working days (as 
per IRB local guidelines) after the investigator first learns of the effect.  The study sponsor is responsible for 
conducting an evaluation of an unanticipated adverse device effect and shall report the results of such 
evaluation to the Food and Drug Administration (FDA) within 10 working days after the sponsor first 
receives notice of the effect. Thereafter, the sponsor shall submit such additional reports concerning the 
effect as FDA requests. 
 
The sponsor must immediately conduct an evaluation of any unanticipated adverse device effect. 
If the sponsor determines that an unanticipated adverse device effect presents an unreasonable risk to 
subjects, the sponsor must terminate all investigations or parts of the investigations presenting that risk as 
soon as possible. Termination must occur no later than 5 working days after the sponsor makes this 
determination and no later than 15 working days after the sponsor first received notice of the effect. 
Resumption of Terminated Studies:  
For a nonsignificant risk device investigation, a sponsor may not resume a terminated investigation without 
IRB approval. If the nonsignificant risk study was terminated for unanticipated adverse device effects, the 
sponsor must also obtain FDA approval. 
 
 
8.4 
UNANTICIPATED PROBLEMS 
 

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8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
 
Unanticipated problems are defined as problems involving risks to subjects or others to include, in general, 
any incident, experience, or outcome that meets all of the following criteria: 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the clinical investigation plan-related documents, such as the approved research Clinical 
Investigation Plan and informed consent document; and (b) the characteristics of the subject 
population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
 
This definition could include an unanticipated adverse device effect, any serious adverse effect (USADE) on 
health or safety or any life-threatening problem or death caused by, or associated with, a device, if that 
effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or application), or any other unanticipated 
serious problem associated with a device that relates to the rights, safety, or welfare of subjects (21 CFR 
812.3(s)).  
 
8.4.2  UNANTICIPATED PROBLEM REPORTING  
An investigator shall submit to the sponsor and to the reviewing Institutional Review Board (IRB) a report of 
any unanticipated adverse device effect occurring during an investigation as soon as possible, but in no 
event later than 10 working days after the investigator first learns of the effect (21 CFR 812.150(a)(1)), A 
sponsor who conducts an evaluation of an unanticipated adverse device effect under 812.46(b) shall report 
the results of such evaluation to the Food and Drug Administration (FDA) and to all reviewing IRB's and 
participating investigators within 10 working days after the sponsor first receives notice of the effect. 
Thereafter the sponsor shall submit such additional reports concerning the effect as FDA requests (21 CFR 
812.150(b)(1)).    
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO SUBJECTS  
In case an unanticipated problem would concern other study subjects they will be contacted by the study 
investigator. 
 
9 
STATISTICAL CONSIDERATIONS 
 
9.1 
STATISTICAL HYPOTHESES  
 
9.1.1 PRIMARY 
 

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The primary purpose of the SF Study is to validate the effectiveness of the Vibe Air SF strategy based on the 
intended use and technological characteristics. 
 
Please refer to Section 3 for more detail about the hypotheses.  There are 3 APHAB communication 
subscales that contribute to the perceived benefit (response condition), and each subscale benefit (EC, BN, 
RV) must simultaneously demonstrate the non-inferiority of Vibe SF strategy to HCP fit strategy.  Note that 
higher means are worse. 
 
• 
Ho EC(benefit):  ∆EC(benefit)HCP fit - ∆EC(benefit)SF > 26     vs      
Ha EC(benefit):  ∆EC(benefit)HCP fit - ∆EC(benefit)SF < 26 
• 
Ho BN(benefit): ∆BN(benefit)HCP fit - ∆BN(benefit)SF > 27     vs      
Ha BN(benefit): ∆BN(benefit)HCP fit - ∆BN(benefit)SF < 27 
• 
Ho RV(benefit): ∆RV(benefit)HCP fit - ∆RV(benefit)SF > 28     vs      
Ha RV(benefit): ∆RV(benefit)HCP fit - ∆RV(benefit)SF < 28 
These are non-inferiority tests comparing the subject´s perceived hearing aid benefit as measured by the 
difference in each of the three APHAB communication benefit subscales when the hearing aid is HCP fit 
compared to when it is Vibe SF by the subject.  The non-inferiority margin (NIM) depends on the 
communication benefit subscale, according to Cox (1995), and these are the minimum clinically important 
differences on each of the three communication benefit subscales. 
 
9.1.2 SECONDARY 
The secondary objectives do not include any hypothesis tests.  However, they will not be analyzed unless 
the primary effectiveness hypothesis test passes (i.e., rejects all 3 null hypotheses).   
Descriptive statistics will be reported on each endpoint by fitting strategy and overall, according to the list 
in Section 9.4.1.1. In addition, some endpoints require more detailed description.  Additional descriptive 
statistics that will be reported are listed with the endpoints. 
EMA Scores: Descriptive statistics of the scores will be reported by fitting strategy and measurement time 
for each real-life condition. 
 
QuickSIN Scores: Descriptive statistics of the scores will be reported by fitting strategy and measurement 
time. 
 
SSQ-12 Scores: Descriptive statistics of the scores will be reported by fitting strategy and measurement time 
for each subscale. 
 
Gain Selection: Descriptive statistics of the probe-mic REM will be reported by fitting strategy and 
measurement time.  
 
Fitting Preference: Descriptive statistics of the scores will be reported by fitting strategy and measurement 
time.  
 

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Safety Analyses: It is very unlikely that any device-related adverse events will be reported during this NSR 
device study. However, those that are reported will be tabulated by severity (mild-moderate-severe), 
seriousness (serious or non-serious) and relatedness (related, not related). 
 
9.2 
SAMPLE SIZE DETERMINATION 
 
The sample size was estimated for the Primary Effectiveness Objective; that is the only objective with a 
hypothesis test. The sample size of 24 was estimated using Pass 2019 and the following parameters: 
Parameter 
Value 
Difference between HCP fit and Vibe SF 
scores (δ) 
• 
EC(benefit) 
• 
BN(benefit) 
• 
RV(benefit) 
 
• 
δ = ∆EC(benefit)HCP fitit - ∆EC(benefit)SF = 0 
• 
δ = ∆BN(benefit)HCP fitit - ∆BN(benefit)SF = 0 
• 
δ = ∆RV(benefit)HCP fitit - ∆RV(benefit)SF = 0 
SD (σ) of scores within a fitting strategy 
and for the difference between Vibe SF 
and HCP fit, assuming independence 
(√(2σ2))*  
• 
EC(benefit) 
• 
BN(benefit) 
• 
RV(benefit) 
 
 
 
• 
σ = 24.3;     σDIFF = 34.4 
• 
σ = 25.6;     σDIFF = 36.1 
• 
σ = 25.5;     σDIFF = 36.2 
(Leohler & et al, 2017) 
Non-inferiority margins (NIMs) 
• 
EC(benefit) 
• 
BN(benefit) 
• 
RV(benefit) 
 
 
• 
EC(benefit) = 26 
• 
BN(benefit) = 27 
• 
RV(benefit) = 28 
(Cox & Alexander, 1995) 
Power 
90% on all 3 tests simultaneously, or 96.5% on each 
individually (.9653 = .90) 
Alpha  
5% on all 3 tests simultaneously 
Test Type 
Paired t-Tests for Non-Inferiority  
 
* 
The variance of the difference of two means is used, not 4 means, even though this is the difference of differences.  The reason 
is that the baseline value (unaided) from which benefit is measured is the same for the SF period and the HCP fit period.  
Therefore, the difference of differences reduces to the difference between the aided SF score and aided HCP fit score. 
 
 
**     All 3 tests must simultaneously have p<.05 
The sample sizes were estimated for each test at 80% and 90% power, as shown in the table below.  The 
NIMs were chosen because each listening condition will be analyzed independently in order to determine if 
there are significant differences in each specific listening conditions.  The largest sample size required for 
combined 90% power was 23.  We will increase this to 24 so that the cross-over periods are balanced.  A 
sufficient number of subjects will be included to allow for a minimum of 24 subjects (anticipate up to 15% 
drop out rate, 24+4) to successfully complete the study. If the parallel-arm design is used, we will increase 
this to 25 per arm (50 total subjects); for more details on this, please refer to the section on Planned Interim 
Analyses:  9.4.6. 
 

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These sample size tables are applicable to both the parallel-group design and the cross-over (paired or 
repeated-measures) design.  This is because we had no information with which to estimate the correlation 
among pairs of measures, so we used 0 correlation.  This is the same as independent treatment groups, or 
parallel-arm design.  Using the largest sample size of the 3 tests, a cross-over design requires 23 subjects with 
endpoints and a parallel-arm design requires 23 subjects in each arm. Because we prefer that each order in 
a cross-over design have the same number of subjects, we increased it to 24.  (Then the sample sizes were 
inflated for losses to follow-up, withdrawals, etc.) 
 
 

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9.3 
POPULATIONS FOR ANALYSES 
The following populations will be used in the analyses of the Primary and Secondary endpoints in this 
study. 
ITT Population: The intent to treat (ITT) population includes all subjects who received at least one 
hearing aid fitting strategy (Vibe SF or HCP fit) to evaluate. This population will be used for the Primary 
Objective hypothesis test.  Missing values will be handled as described in Section 9.1.2. 
mITT Population: The modified intent to treat (mITT) population includes all subjects in ITT population 
who have an endpoint for the analysis in question.  The mITT population will be used for the analysis of 
the Secondary Objectives. No imputation of missing values will be done for these endpoints. 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
 
Section 9 constitutes the statistical analysis plan (SAP) for this study. 
 
The overall approach to this study is that it is an adaptive design with the adaptation being a change 
from a cross-over design to a parallel-arm design if the latter is necessary to avoid the interaction effects 
possible in a cross-over design.  The high-level design with adaptation is: 
 
1. The study begins with an intended sample size of 24 (28) subjects in a randomized cross-over 
design of SF first or HCP fit first.  There is a washout period of 5 days intended to mitigate the 
order effect of the cross-over. 
2. After 12 subjects have completed both hearing aid fittings and both Field tests, we will test for 
the order effect by looking for a significant interaction term in the analysis.  (The methods of 
analysis are described below.)  
a. If there is no interaction effect, then we continue with the cross-over design. 
b. If there IS an interaction effect, then we will add subjects so that we have a minimum of 
23 per arm (23+2, to account for drop-outs).  (Note that we don’t need 24 to balance 
the groups like we did in the cross-over design.)  The new subjects will be randomized to 
SF or HCP fit for one period only.  They don’t cross over.  Of the 12 existing subjects, we 
use only their Period 1 data; we ignore their data post cross-over. 
 
NOTE:  We will not suspend the trial while we analyze the data from the first 12.  We will continue the 
cross-over study, but if we change to the parallel-arm design, we will ignore the Period 2 data (i.e., Field 
Test 2 data). 
 

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9.4.1.1 DESCRIPTIVE STATISTICS  
This section describes the descriptive statistics that will be provided with each analysis.  The statistics 
depend on the type of variable (endpoint) that is analyzed.  All secondary objectives involve descriptive 
analyses only. 
Descriptive statistics of subject demographics and baseline hearing status will be tabulated.  No 
comparisons will be made because the same subjects serve as Vibe SF strategy and HCP fit strategy 
subjects in this cross-over study.   
The descriptive statistics that will be presented will depend on the data type: 
1) 
Continuous data will be summarized using n, mean, SD, minimum and maximum values. 
2) 
Categorical data will be summarized using frequency and percentage. 
3) 
Time-to-event data will be summarized using percentages at relevant time points, along 
with effective sample size and the 95% confidence interval. 
4) 
Frequency (count) data will be summarized as a categorical variable if there are 5 or 
fewer values (see #2), or as a continuous variable if there are more than 5 distinct values 
(see #1). 
 
9.4.1.2 CONTROL OF TYPE 1 ERROR  
All hypothesis tests (of which there is only one compound test in this study, and that is for the Primary 
Effectiveness Objective) will be conducted at α=0.05.  Non-inferiority tests (the type of test in this study) 
are by nature one-tailed.  The Primary hypothesis test will be conducted in 3 parts, as described in 
Section 9.1.1. To control Type 1 error associated with multiple tests, all 3 tests for the Primary Objective 
must have a p-value of 0.05 or smaller simultaneously. 
Although the Secondary Objectives do not include any hypothesis testing, they will not be analyzed or 
reported unless the primary hypotheses pass (reject all 3 Hos).  
  
9.4.1.3 IMPUTATION OF MISSING DATA AND SENSITIVITY ANALYSES  
All attempts will be made to minimize missing data. However, if any subjects in the ITT population have 
missing primary endpoints, five (5) multiple imputations will be used for the analyses. This consists of 
imputing values for each missing value as a set (generating 5-sets), analyzing the results for each set, 
and then pooling the results.  The Primary Effectiveness Endpoint is continuous, so the imputation 
method will be a multiple linear regression using treatment assignment and baseline characteristics. 

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A sensitivity analysis of the Primary Effectiveness Endpoint will be conducted as a tipping-point analysis, 
to examine the impact of missing data. It will only be conducted if the hypothesis test passes (i.e., 
rejects Ho). We will start by assuming that all missing Primary Effectiveness Endpoints have values 
indicating the inferiority of Vibe SF strategy, and if the Primary Effectiveness Hypothesis is not passed, 
we will change one missing endpoint to a difference of 0 until the hypothesis passes.  This will enable 
determination of the amount of missing data that would alter the final result on the primary 
effectiveness endpoint. 
If the hypothesis test of the Primary Effectiveness Endpoint does not pass, the hypothesis test will be 
repeated using only those subjects without major protocol violations, i.e., the mITT population. This test 
is for SPONSOR´s information only, and will not be used to support the study objective.  
 
9.4.1.4 RANDOMIZATION AND BLINDING 
 
At the time of the visit on which the subject is provided with his/her first hearing aid, he/she will be 
randomized to either:  Vibe SF First/HCP fit Second or to HCP fit First/Vibe SF Second. A computer-
generated pseudo-random-number list will be used for assigning the treatment order.  Assignments will 
be made either by sealed envelope or provided real-time on the sponsor’s EDC website on a protected 
page.  
 
9.4.2 ANALYSIS OF THE PRIMARY EFFECTIVENESS ENDPOINT 
The mechanism for validating the Vibe SF strategy will be the comparison of subject´s hearing aid benefit 
as measured by the change from each of the three APHAB communication subscales (EC, BN, RV) benefit 
score (benefit score = unaided – aided) when the hearing aids are HCP fit compared to when it is Vibe SF 
by the subject.     
There are 3 APHAB communication subscales that contribute to the perceived benefit (response 
condition), and each subscale benefit (EC, BN, RV) must simultaneously demonstrate the non-inferiority 
of Vibe SF strategy to HCP fit strategy.  Note that higher means are worse (i.e., higher differences mean 
that Vibe SF strategy performed worse). 
• 
Ho EC(benefit):  ∆EC(benefit)HCP fit - ∆EC(benefit)SF > 26     vs      
Ha EC(benefit):  ∆EC(benefit)HCP fit - ∆EC(benefit)SF < 26 
• 
Ho BN(benefit): ∆BN(benefit)HCP fit - ∆BN(benefit)SF > 27     vs      
Ha BN(benefit): ∆BN(benefit)HCP fit - ∆BN(benefit)SF < 27 
• 
Ho RV(benefit): ∆RV(benefit)HCP fit - ∆RV(benefit)SF > 28     vs      
Ha RV(benefit): ∆RV(benefit)HCP fit - ∆RV(benefit)SF < 28 

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These are non-inferiority tests comparing the subject´s perceived hearing aid benefit as measured by 
the difference in each of the three APHAB communication benefit subscales when the hearing aid is HCP 
fit compared to when it is Vibe SF by the subject.  The NIM depends on the communication benefit 
subscale, according to Cox (1995), and these are the minimum clinically important differences on each 
of the three communication benefit subscales. 
Note that because of the adaptive design which entails possibly moving from a cross-over design to a 
parallel-arm design, the analysis methods must differ slightly.  Section 9.4.2.1 describes the analysis we 
will use for a cross-over design.  Section 9.4.2.2 describes how we will use the cross-over analysis for the 
interim analysis to determine if we must adapt the design.  Section 9.4.2.3 describes the analysis we will 
use for a parallel-arm design if we change the design. 
9.4.2.1 ANALYSIS OF CROSS-OVER DESIGN DATA 
This is the final analysis that will be used if the cross-over design is maintained throughout the study. 
Each communication benefit subscale will be analyzed using a repeated-measures analysis of variance 
(rm-ANOVA) in which the repeated (within) factors are order (HCP fit first or Vibe SF first) and treatment 
(HCP fit or Vibe SF); there are no between-group factors. The interaction term, order x treatment, will 
not be included because, if we use this design, it is because we have concluded that the interaction term 
is not significant.  See Section 9.4.2.2. 
The hypothesis test for each communication benefit subscale will be conducted as the one-sided upper 
95% confidence bound of the regression coefficient on treatment. If this value is less than the NIM for 
that communication benefit subscale, the null hypothesis will be rejected (at α=0.05, by definition of the 
confidence bound). The p-values for all 3 communication subscales must be 0.05 or smaller in order for 
the global hypothesis test to pass (reject the global null of inferiority). 
Because Sponsor would like to report a global p-value for these tests, the 3 p-values will be combined 
into a single value using the weighted harmonic mean (WHM) (Good, 1958) (Wilson, 2019) (Vovk & 
Wang, 2019): 
pWHM = ∑ wi / ∑ (wi / pi)        i=1….L 
where L=3, the number of order tests being combined into one subscale score.  The weights (wi ) are set 
equal to 0.3333…  They are weighted equally because the scores are calculated with each component 
weighted equally. This method does not require the independence of the tests.  Although this method 
can be anticonservative, it has been shown to be very close to the intended false positive rate when the 
pWHM is close to 0.05.  Since the sample was sized for this p-value, the pWHM should be neither 
conservative nor anti-conservative. 
Descriptive statistics for the treatment groups for each of the three communication benefit subscales, 
EC(benefit), RV(benefit), BN(benefit), at each time point will also be reported. 

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9.4.2.2 INTERIM ANALYSIS OF CROSS-OVER DESIGN FOR DETERMINATION OF DESIGN 
APPLICATION 
An interim analysis will be conducted to determine if the design will be changed from a cross-over to a 
parallel-arm design.  The analysis will be conducted by an independent statistical group so that no 
information about the effects of fitting (SF vs HCP FIT) will be known to Sponsor.  A nuisance parameter 
will be estimated and tested for significance to decide whether to change the design. 
The analysis will be conducted as follows. 
Each communication benefit subscale will be analyzed using a repeated-measures analysis of variance 
(rm-ANOVA) in which the repeated (within) factors are order (HCP fit first or SF first) and treatment (HCP 
fit or SF); there are no between-group factors. The interaction term, order x treatment, will be included 
to determine whether it is necessary to change from a cross-over design to a parallel-arm design.  This is 
the nuisance factor that is the crux of the adaptation. The presence of an interaction term means that 
the difference in benefit (i.e., the treatment effect) differs by order.  In this case, we cannot combine the 
estimate of HCP FIT-first benefit with HCP fit-second, and similarly for SF-first and second.  Here is the 
visual representation of the effects in the following Figures a, b and c: 
a) Treatment (TX) Effect 
     b)    TX, Order Effects                                  c)   TX, Order, Interaction Effects  
     
  
 
HCPF = HCP fit 
 
Figure (a) shows an effect of treatment only.  The score with SF, averaged over SF First and SF Second, is 
different from the average score of HCP fit.  The scores for SF are the same for both orders, and that is 
also true for HCP fit, so there is no order effect.  The difference between SF and HCP fit is the same for 
both orders, so there is no interaction effect. 
 
Figure (b) shows an effect of treatment and of order.  The average SF score is lower than the average 
HCP fit score, and the averages are lower when SF is first than when HCP fit is first.  However, the 
difference between SF and HCP fit is the same regardless of order, which means there is no interaction 
effect. So, in spite of the order effect, it is possible to estimate the difference between treatments and to 
test for the non-inferiority of SF to HCP fit. 
 
Figure (c) shows an effect of treatment and order, and also an interaction effect.  The interaction effect 
occurs because the difference between treatments is not the same with both orders.  Compare this to 
Figure (b), in which the difference is the same.  In this case, the test for non-inferiority of SF to HCP fit 

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must be done on SF First and HCP fit First separately because non-inferiority might be true in one case 
and not in the other. 
It is important to note that it is not the order effect, but the interaction effect, that makes it impossible 
to do a non-inferiority test.  The interaction term will be tested be combining the p-values from the 3 
scales.  The method WHM, show in Section 9.4.2.1, will be used here, but in this case, it will be the 
interaction term p-values that are combined. The combined p-value will be compared to α=0.10; if the 
null hypothesis of no interaction is rejected in favor of the hypothesis of an interaction, we will switch to 
the parallel-arm design.   
If the design is switched to parallel-arm, then subjects who have not crossed over will have only one 
treatment, and subjects who have crossed over will have only their first treatment used in the analysis 
of the parallel-arm data.  See Section 9.4.2.3. 
9.4.2.3 ANALYSIS OF PARALLEL-ARM DESIGN DATA 
Each communication benefit subscale will be analyzed using a t-test of the benefit with SF (as described 
previously, the difference between baseline and SF score) versus the benefit with HCP fit (the difference 
between baseline and HCP fit score). The p-values for all 3 communication subscales must be 0.05 or 
smaller in order for the global hypothesis test to pass (reject the global null of inferiority). 
 
Because Sponsor would like to report a global p-value for these tests, the 3 p-values will be combined 
into a single value using the method of WHM as described as in Section 9.4.2.1.  The p-values cannot be 
assumed to be independent because the data are from the same set of subjects, and it is therefore likely 
that the benefit on the EC score is correlated with the benefit on the RV score, etc. 
Descriptive statistics for the treatment groups for each of the three communication benefit subscales, 
EC(benefit), RV(benefit), BN(benefit), at each time point will also be reported. 
 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINTS 
Descriptive statistics will be reported on each endpoint by fitting strategy and overall, according to the 
list in Section 9.4.1.1. In addition, some endpoints require more detailed description.  Additional 
descriptive statistics that will be reported are listed with the endpoints. 
EMA Scores: Descriptive statistics of the scores will be reported by fitting strategy and measurement 
time for each real-life condition. 
QuickSIN Scores: Descriptive statistics of the scores will be reported by fitting strategy and 
measurement time. 
SSQ-12 Scores: Descriptive statistics of the scores will be reported by fitting strategy and measurement 
time for each subscale. 

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Gain Selection: Descriptive statistics of the probe-mic REM will be reported by fitting strategy and 
measurement time.  
Fitting Preference: Descriptive statistics of the scores will be reported by fitting strategy and 
measurement time.  
9.4.4 SAFETY ANALYSES 
It is very unlikely that any device-related adverse events (ADEs) will be reported during this NSR device 
study. However, those that are reported will be tabulated by severity (mild-moderate-severe), 
seriousness (serious or non-serious) and relatedness (related, not related). 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
Descriptive statistics of patient demographics and baseline hearing status will be tabulated.  No 
comparisons will be made because the same subjects serve as Vibe SF and HCP fit strategy groups in this 
cross-over study.  The statistics that will be tabulated for each variable are listed by variable type in 
Section 9.4.1.1. 
 
9.4.6 PLANNED INTERIM ANALYSES  
 
See Section 9.4.2.2.  We will conduct an interim analysis using a nuisance parameter to decide if the 
design of the study will be changed from a cross-over design to a parallel-arm design.   
 
9.4.7 SUB-GROUP ANALYSES 
 
This study does not include any sub-group analyses. 
 
9.4.8 TABULATION OF INDIVIDUAL SUBJECT DATA 
 
Data listings by subject will be provided to regulatory agencies. 
 
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
10.1.1 INFORMED CONSENT PROCESS 
 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO SUBJECTS 

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The responsible investigator at each site ensures that approval of advertisements used to recruit subjects 
and of the Patient Information / Informed consent form, from an appropriately constituted IRB, is sought 
for the clinical investigation. The decision of the IRB concerning the conduct of the clinical investigation 
will be made in writing to the Sponsor and Investigator before commencement of this clinical 
investigation. The clinical investigation can only begin once approval has been received. Any additional 
requirements imposed shall be implemented. 
 
Consent forms, including all items as per ISO1455, describing in detail the study intervention, study 
procedures, and risks are given to the subject and written documentation of informed consent is 
required prior to starting intervention/administering study intervention.  The following consent 
materials are submitted with this protocol: 
• 
Patient Information Sheet 
• 
Informed Consent Form 
 
The above listed documents are provided separately.  
 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
The screening process is described in detail in 8.1.1 Screening.  
If it is determined that mild-to-moderate hearing impairment is present and that all inclusion criteria 
seem to be fulfilled the study subject information will be provided and the subject will be asked for their 
voluntary informed consent to participate in the clinical study.  
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the clinical 
investigation and continues throughout the individual’s clinical investigation participation. Consent forms 
will be IRB-approved and the subject will be asked to read and review the document.  
 
The investigator will obtain informed consent, as per 21 CFR 50, for each subject. The investigator will 
explain the research clinical investigation to the subject and answer any questions that may arise. A verbal 
explanation will be provided in terms suited to the subject’s comprehension of the purposes, procedures, 
and potential risks of the clinical investigation and of their rights as research subjects.  Subjects will have 
the opportunity to carefully review the written consent form and ask questions prior to signing. The 
subjects should have the opportunity to discuss the clinical investigation with their family or surrogates 
or think about it prior to agreeing to participate.  
The subject must also give their permission for representatives of the Sponsor, auditor and regulatory 
authorities to review their hospital records for the purposes of source data verification. 
The subject will sign the informed consent document prior to any procedures being done specifically for 
the clinical investigation. Subjects must be informed that participation is voluntary and that they may 
withdraw from the clinical investigation at any time, without prejudice. A copy of the informed consent 
document will be given to the subjects for their records. The informed consent process will be conducted 
and documented in the source document (including the date), and the form signed, before the subject 

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undergoes any clinical investigation-specific procedures. The rights and welfare of the subjects will be 
protected by emphasizing to them that the quality of their medical care will not be adversely affected if 
they decline to participate in this clinical investigation. 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
This clinical investigation may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause.  Written notification, documenting the reason for clinical investigation suspension or 
termination, will be provided by the suspending or terminating party to the IRB and regulatory authorities. 
If the clinical investigation is prematurely terminated or suspended, the Principal Investigator (PI) will 
promptly inform clinical investigation subjects who will also be informed of changes to clinical 
investigation visit schedule. 
 
 Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Ethical concerns 
• 
Insufficient subject recruitment 
• 
Alterations in accepted clinical practice that make the continuation of a clinical trial unwise.  
• 
Determination of unexpected, significant, or unacceptable risk to subjects 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance to Clinical Investigation Plan requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
Clinical investigation may resume once concerns about safety, Clinical Investigation Plan compliance, and 
data quality are addressed, and satisfy the sponsor, the IRB and the regulatory authorities.  
 
Should termination occur, the procedures will be arranged on an individual basis after review and 
consultation by both parties. In terminating the clinical investigation, the Sponsor and the Principal 
investigator will assure that adequate consideration is given to the protection of the subject’s interests. 
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
Subject confidentiality and privacy is strictly held in trust by the participating investigators, their staff, and 
the sponsor(s) and their interventions. Therefore, the clinical investigation plan, documentation, data, 
and all other information generated will be held in strict confidence. No information concerning the 
clinical investigation or the data will be released to any unauthorized third party without prior written 
approval of the sponsor.  
All research activities will be conducted in as private a setting as possible. 
 

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The clinical investigation monitor, other authorized representatives of the sponsor, representatives of the 
IRB, regulatory agencies or the company supplying the clinical investigation product may inspect all 
documents and records required to be maintained by the investigator, including but not limited to, 
medical records (office, clinic, or hospital) and pharmacy records for the subjects in this clinical 
investigation. The clinical investigation site will permit access to such records. 
 
The clinical investigation subject’s contact information will be securely stored at each clinical site for 
internal use during the clinical investigation. At the end of the clinical investigation, all records will 
continue to be kept in a secure location for as long a period as dictated by the reviewing IRB, or sponsor 
requirements. 
Clinical investigation subject research data, which is for purposes of statistical analysis and scientific 
reporting, will be entered in an Electronic Data Capture (EDC) system database. The data entered will not 
include the subject’s contact or identifying information. Rather, individual subjects and their research data 
will be identified by a unique clinical investigation identification number. The clinical investigation data 
entry and clinical investigation management systems used will be secured and password protected.  
 
10.1.4 KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator 
Independent Medical Monitor 
Name, degree, title 
Name, degree, title 
Institution Name  
Institution Name  
Address 
Address 
Phone Number 
Phone Number 
Email 
Email 
Further information in regards to members of the study team roles and responsibilities can be found in 
the study monitoring plan.  
10.1.5 SAFETY OVERSIGHT 
Safety oversight will be under the direction of the Independent Medical Monitor. All adverse event 
reports will be directed to the Sponsor / the Independent Medical Monitor. The Independent Medical 
Monitor will be responsible for the timely review of all adverse events in order to identify seriousness, 
severity, causality and expectedness (anticipated vs. unanticipated) of the event to the study device 
and/or study procedure.   
The Independent Medical Monitor will review all adverse events throughout the duration of the 
study until study completion.  
10.1.6 CLINICAL MONITORING 

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The Sponsor shall secure compliance with the requirements of § 812.46 with respect to monitoring 
investigations. Clinical site monitoring is conducted to ensure that the rights and well-being of trial 
subjects are protected, that the reported trial data are accurate, complete, and verifiable, and that the 
conduct of the trial is in compliance with the currently approved clinical investigation plan/amendment(s), 
with the ISO 14155 and with any other applicable regulatory requirement(s).  
 
• 
Monitoring for this study will be performed by delegee. 
• 
Monitoring will be performed on-site as well as remote. After the Site initiation visit, up to 5 
monitoring visits are planned during the study. Due to the setup of the study, with an interaction 
effect assessment after 12 subjects to decide on a final sample size, monitoring will be planned 
accordingly to make sure that the data needed has been reviewed before assessment. In case of 
difficulties to perform on-site monitoring, this data can be reviewed centrally / remotely. 
• 
Risk-based monitoring will be used, including targeted data verification of key data variables:  
o Informed consent 
o Adherence to eligibility criteria 
o Device accountability 
o Primary endpoints 
o Safety endpoints 
o In addition to this a random review of certain data will be performed. 
• 
In addition to on-site monitoring, the following alternative monitoring techniques will be used: 
o 
Centralized monitoring by data manager / clinical monitor  
o Communication with study site staff  
• 
Details of clinical site monitoring are documented in a Clinical Monitoring Plan (CMP). The CMP 
describes in detail who will conduct the monitoring, at what frequency monitoring will be done, 
at what level of detail monitoring will be performed, and the distribution of monitoring reports. 
 
10.1.7 QUALITY ASSURANCE AND QUALITY CONTROL 
The clinical site will perform internal quality management of clinical investigation conduct, data 
collection, documentation and completion.   
Quality control (QC) procedures will be implemented beginning with the data entry system and data QC 
checks that will be run on the database will be generated. Any missing data or data anomalies will be 
communicated to the site(s) for clarification/resolution. 
Following written Standard Operating Procedures (SOPs), the monitors will verify that the clinical trial is 
conducted and data are generated and biological specimens are collected, documented (recorded), and 
reported in compliance with the clinical investigation plan, ISO 14155, and any other applicable 
regulatory requirements.  
 
The investigational site will provide direct access to all trial related sites, source data/documents, and 
reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and 
regulatory authorities. 
 

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Quality control procedures shall ensure that participating investigators maintain the records of each 
subject’s case history and exposure to the device under §812.140(a)(3)(i) and ensure that participating 
investigators make the following required reports to the sponsor: 
• 
Unanticipated Adverse Device Effects [§812.150(a)(1)] 
• 
Withdrawal of IRB Approval [§812.150(a)(2)] 
• 
Failure to obtain informed consent [§812.150(a)(5)] 
• 
Other reports requested by a reviewing IRB or FDA [§812.150(a)(7)] 
 
As per 21 CRF §812.45, a sponsor who discovers that an investigator is not complying with the signed 
agreement, the investigational plan, the IDE requirements, any other applicable FDA regulations, or any 
conditions of approval imposed by the reviewing IRB or FDA must promptly either secure compliance, or 
discontinue shipments of the device to the investigator and terminate the investigator's participation in 
the investigation. A sponsor must also require that the investigator dispose of or return the device, 
unless this action would jeopardize the rights, safety, or welfare of a subject. 
The following sponsor records will be maintained in one location and available for FDA inspection 
[§812.140(b)(4)]: 
• 
the name and intended use of the device; 
• 
the objectives of the investigation; 
• 
a brief explanation of why the device is not a significant risk device; 
• 
the name and address of each investigator; 
• 
the name and address of each IRB; 
• 
a statement of the extent to which the good manufacturing practices (21 CFR 820) will be 
followed in manufacturing the device. 
• 
any other information required by FDA 
The sponsor will maintain records concerning complaints and adverse device effects whether 
anticipated or not [§812.140(b)(5)]. 
The sponsor will provide the following reports in a timely manner to FDA, the IRB's, and/or the 
investigators [§812.150(b) (1) through (3) and (5) through (10)]. 
• 
Unanticipated Adverse Device Effects 
• 
Withdrawal of IRB Approval 
• 
Withdrawal of FDA Approval 
• 
Progress Reports 
• 
Recalls and Device Disposition 
• 
Final Report 
• 
Failure to obtain informed consent 
• 
Significant Risk Device Determination 
• 
Other Reports 
 
 

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10.1.8 DATA HANDLING AND RECORD KEEPING  
 
10.1.8.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
investigator. The investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data.   
 
Study visit worksheets / checklists will be provided for use as supporting source document for recording 
data for each subject enrolled in the study.  Data recorded in the electronic case report form (eCRF) 
derived from source documents should be consistent with the data recorded on the source documents.  
 
An Electronic Data Capture system will be used, created as per clinical investigation requirements. The 
database will be tested to verify that the design meets the specification. Data validation checks will be 
designed to be applied consistently across trial data, and all errors that are identified through data 
validation checks should be corrected with a documentation of the discrepancy resolution.   
Clinical data (including adverse events (AEs), and expected adverse reactions data) will be entered into 
SMARTTRIAL, a 21 CFR Part 11-compliant data capture system provided by the Sponsor. The data system 
includes password protection and internal quality checks, such as automatic range checks, to identify 
data that appear inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the 
source documents. 
 
Validation of the system will be performed to ensure that data entered map to the correct variable in 
the system, and that the parameters for the variable correctly store the data.  
Further details can be found in the clinical investigation Data Management Plan. 
10.1.8.1.1 DATA MANAGEMENT SYSTEM  
 
SMART-TRIAL will be used as the primary Electronic Data Capture tool in this study. SMART-TRIAL is 
developed and owned by MEDEI ApS (www.medei.dk). 
Development, validation, and maintenance of SMART-TRIAL is conducted according to medical device 
software and quality standards.  
 
The Sponsor will enter a contractual agreement with MEDEI ApS which clarifies how MEDEI ApS 
complies with regulatory requirements for processing of personal identifiable information according to 
applicable regulations. 
All critical actions performed by users of SMART-TRIAL are logged both in relation to general operations 
(e.g. user creation/edit) and study specific operations. Audit logging ensures that all operations 
performed by users can be traced. 
Validation of the system will be performed before it is being released.  

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10.1.8.2 DATA SECURITY, ACCESS AND BACK-UP  
All data in SMART-TRIAL is collected, transferred, and stored encrypted in databases, which are hosted 
on ISO certified servers that are managed by MEDEI ApS within the European Union (Ireland). Backups 
are performed continuously throughout the day and stored within the same country.  
 
To collect and view data, or access a study in SMART-TRIAL users must create a user account with an 
associated strong password, which shall be used to authenticate with the system. To perform any 
security critical actions within the system, a user must be authenticated. SMART-TRIAL implements two-
step authentication for every log in, i.e. users must log in to the system using their created credentials 
and confirm their authentication with a unique one-time code sent to their mobile phone or e-mail 
address. On successful authentication, SMART-TRIAL creates a unique user-session that is used to 
identify the authenticated user.  
10.1.8.3 ANALYSIS AND ARCHIVING 
 
After a proper quality check and assurance, the final data validation is run. If there are no discrepancies, 
the Statistical datasets are finalized in consultation with the statistician. Once approval for locking is 
obtained from all stakeholders, the database is locked and clean data is extracted for statistical analysis. 
After the database is locked, no modification in the database is possible except in exceptional cases.  
 
An unlocking of the database requires proper documentation and an audit trail has to be maintained 
with sufficient justification for updating the locked database. Data extraction is done from the final 
database after locking. This is followed by its archival. 
10.1.8.3.1 ELECTRONIC AND CENTRAL DATA VALIDATION  
 
Data validation will be completed on a regular basis. Quality control audits of all key performance and 
safety data in the database will be made after the sites complete enrolment. The entire database will be 
re-validated to ensure that there are no outstanding data discrepancies prior to database lock. Any 
changes to the database after that time will require joint written agreement between Clinical Affairs and 
Clinical Data Management. Concomitant Medications and Adverse Events entered into the database will 
be reviewed and assigned the appropriate codes by qualified personnel. 
 
10.1.8.4 STUDY RECORDS RETENTION  
The Investigator will be responsible for data handling and record keeping and retention. Data required 
according to this Clinical Investigation Plan must be recorded on the electronic case report forms (eCRFs) 
as soon as possible.  
If the Investigator relocates, or for any reason withdraws from the clinical investigation, the Sponsor 
should be prospectively notified. Subjects' hospital files will be archived according to local regulations. 
 

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Study documents should be retained for a minimum of 2 years after the date the investigation is 
completed or terminated or the records are no longer required to support a PMA or PDP, whichever 
dates is longer.  These documents should be retained for a longer period, however, if required by local 
regulations. No records will be destroyed without the written consent of the sponsor, if applicable. It is 
the responsibility of the sponsor to inform the investigator when these documents no longer need to be 
retained. 
 
10.1.9 PROTOCOL DEVIATIONS  
 
A protocol deviation is any noncompliance with the clinical trial protocol and the ISO 14155 
requirements. The noncompliance may be either on the part of the subject, the investigator, or the 
study site staff. As a result of deviations, corrective actions are to be developed by the site and 
implemented promptly.  
An investigator shall notify the sponsor and the reviewing IRB of any deviation from the investigational 
plan to protect the life or physical well-being of a subject in an emergency. Such notice shall be given as 
soon as possible, but in no event later than 5 working days after the emergency occurred. Except in such 
an emergency, prior approval by the sponsor is required for changes in or deviations from a plan, and if 
these changes or deviations may affect the scientific soundness of the plan or the rights, safety, or 
welfare of human subjects, FDA and IRB is also required. 
 
It is the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations. All deviations must be addressed in study source documents, and reported to the Sponsor.  
Protocol deviations must be sent to the reviewing Institutional Review Board (IRB) per their policies. The 
site investigator is responsible for knowing and adhering to the reviewing IRB requirements. 
Further details about the handling of protocol deviations will be included in the Clinical Monitoring Plan.  
 
10.1.10 
CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence, such as by the medical device 
industry, is critical.  Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the design and conduct of this trial.  The study 
leadership has established policies and procedures for all study group members to disclose all conflicts 
of interest and will establish a mechanism for the management of all reported dualities of interest. 
 
10.2 ADDITIONAL CONSIDERATIONS 
 
There is currently an outbreak of respiratory disease caused by a novel coronavirus, which may impact 
the conduct of clinical trials of medical products. Challenges may arise, for example, from quarantines, 

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site closures, travel limitations, interruptions to the supply chain for the investigational product or other 
considerations if site personnel or trial subjects become infected with COVID-19. These challenges may 
lead to difficulties in meeting protocol-specified procedures, including administering or using the 
investigational product or adhering to protocol-mandated visits and testing, leading to unavoidable 
protocol deviations.  
 
Ensuring the safety of trial subjects is paramount. It may be necessary to modify the study conduct due 
to changing circumstances. This may include changes to trial recruitment, continuing use of the 
investigational product for patients already participating in the trial, and the need to change patient 
monitoring during the trial. In all cases, it is critical that trial subjects are kept informed of changes to 
the study and monitoring plans that could impact them.  
 
The Sponsor, in consultation with clinical investigators and Institutional Review Boards (IRBs) may 
determine that the protection of a subject’s safety, welfare, and rights is best served by continuing a 
study subject in the trial as per the protocol or by discontinuing the administration or use of the 
investigational product or even participation in the trial.  
Due to the fact that the device is a non-significant risk device, with no or very limited expected Adverse 
Events, no increased risk to safety is expected in the case that the patient cannot come back for a 
planned follow up visit.  
 
 
 

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10.3 ABBREVIATIONS 
 
Abbreviation 
Word 
AE 
Adverse Event 
APHAB 
Abbreviated Profile of Hearing Aid Benefit 
AV 
APHAB subscale: aversiveness of environmental sounds  
BN 
APHAB communication subscale: communication in settings with background noise 
CFR 
Code of Federal Regulations  
EC 
APHAB communication subscale: ease of communication in favorable conditions 
EasyFit 
EasyFit web application 
EMA 
Ecological Momentary Assessment 
GCP 
Good Clinical Practice 
HCP 
Hearing Care Professional 
HCP fit Strategy 
Silk 1X Hearing Care Professional Hearing Aid Fitting Strategy 
Ha  
Alternative hypothesis 
Ho 
Null hypothesis 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
ITT 
Intent to Treat population 
mITT 
Modified intent to treat population 
n 
Number; sum of subjects 
NAL NL2 
National Acoustic Laboratories Nonlinear Version 2 
NIM 
Non-inferiority margin 
NSR 
Non-Significant Risk 
OSPL 
Output sound pressure level 
QuickSIN 
Quick Speech-in-Noise test 
REM 
Real-ear measures 
rmANOVA 
Repeated-measures analysis of variance 
RV 
APHAB communication subscale: communication in reverberant rooms such as classrooms 
SAE 
Serious Adverse Event 
SAP 
Statistical analysis plan 
SF 
Self-Fitting 
SF Strategy 
Self-Fitting Hearing Aid Fitting Strategy 
SOA 
Schedule of Activities 
SSQ-12 
Speech, Spatial and Qualities of Hearing scale  
 
10.4 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 

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Version 
Date 
Description of Change  
Brief Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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11 REFERENCES 
Benjamini, Y., & Hochberg , Y. (1995). Controlling the False Discovery Rate: A Practical and Powerful 
Approach to Multiple Testing. J.R. Statist. Soc. B, 57(1), 289-300. 
Carr, K. (2020, March 16). 20Q: Consumer Insights on Hearing Aids, PSAPs, OTC Devices, and More from 
MarkeTrak 10. AudiologyOnline. Retrieved from 
https://www.audiologyonline.com/articles/20q-understanding-today-s-consumers-26648 
Cox, R., & Alexander, G. (1995). The abbreviated profile of hearing aid benefit. Ear & Hearing, 16(2), 176-
186. 
Cox, R., & Alexander, G. (1995). The abbreviated profile of hearing aid benefit. Ear & Hearing, 16(2), 176-
186. 
Date Accessed: 2021JAN26. (Verison 2). Data Sheet Vibe Air (EN). Source of product information: 
WSAUD A/S: Document No: D00216771. 
Date Accessed: 2021JAN26. (Version 1). Data Sheet Silk X (EN). Source of product information: WSAUD 
A/S: Document No: D00202451. 
Date Accessed: 2021JAN26. (Version 1). User Guide Quick Start Vibe Air Remote Fit (EN). Source of 
Product Information: WSAUD A/S: Document No: D00220217. 
Date Accessed: 2021JAN26. (Version 1). User Guide Silk X (EN). Source of product information: WSAUD 
A/S: Document No: D00203084. 
Date Accessed: 2021JAN26. (Version 2). User Guide Safety Manual Remote Fit (EN). Source of product 
information: WSAUD A/S: Document No: D00219451. 
Date Accessed: 2021JAN26. (Version 5). User Guide Safety USA. Source of product information: WSAUD 
A/S: Document No: D00168097. 
DEN180026. (2018, May 11). Retrieved from accessdata fda: 
https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180026.pdf 
Edwards, B. (2020, Feb). Emerging Technologies, Market Segments, and MarkeTrak 10 Insights in 
Hearing Health Technology. Semin Hear, 41(1), 37-54. 
Good, I. (1958). Significance tests in parallel and in series. Journal of the American Statistical Association, 
53(284), 799-813. doi:https://doi.org/10.1080%2F01621459.1958.10501480 
Leohler, J., & et al. (2017). Sensitivity and specificity of the abbreviated profile of hearingaid benefit 
(APHAB). Eur Arch Otorhinolaryngol(274), 3593-3598. 

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Noble, W., Jensen, N., Naylor, G., Bhullar, N., & Akeroyd, M. (2013). A short form of the Speech, Spatial 
and Qualities of Hearing scale suitable for clinical use: The SSQ12. International Journal of 
Audiology, 52(6), 409-412. 
Sabin, A., Van Tasell, D., Rabinowitz, B., & Dhar , S. (2020). Validation of a self-fitting method for over-
the-counter hearing aids. Trends in Hearing(24), 1-19. 
Schiffman, S., Stone, A., & Hufford, M. (2008). Ecological momentary assessment. Annual Review of 
Clinical Psychology, 4, 1-32. 
Vovk, V., & Wang, R. (2019, November 3). Combining p-values via averaging. On-line Compression 
Modelling Project (New Series): Working Paper #21. Retrieved from 
http://alrw.net/articles/21.pdf 
Wilson, D. (2019). The harmonic mean p-value for combining dependent tests. Proceedings of the 
National Academy of Sciences USA, 116(4), 1195-1200. 
doi:https://doi.org/10.1073%2Fpnas.1814092116 
WSAudiology. (2020.11.24). Product Risk Assessment. EasyFit system (covering HW and SW 
components). Retrieved Verion: 2.0 Doc. ID: D00212131 
Wu, Y., Stangl, E., Zhang, X., & Bentler, R. (2015). Construct validity of the Ecological Momentary 
Assessment in audiological research. J Am Acad Audiol, 26(10), 872-84. 
Yulia Carroll, J. E. (2017, February 10). Vital Signs: Noise-Induced Hearing Loss Among Adults - United 
States 2011-2012. Morbidity and Mortality Weekly Report (MMWR). 
 
 
 

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12 APPENDIX I NONSIGNIFICANT RISK DETERMINATION 
 
Nonsignificant Risk Device Study Classification 
US FDA Definition 
Non-significant risk devices are devices that do not pose a significant risk to the human subjects. Examples 
include most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, Foley catheters, 
endoscopes, magnetic resonance imaging devices, and low power lasers for treatment of pain. 
A non-significant risk device study requires only IRB approval prior to initiation of a clinical study. Sponsors 
of studies involving non-significant risk devices are not required to submit an IDE application to the FDA 
for approval. Submissions for non-significant risk device investigations are made directly to the IRB of each 
participating institution. Sponsors should present to the reviewing IRB an explanation why the device does 
not pose a significant risk. If the IRB disagrees and determines that the device poses a significant risk, the 
sponsor must report this finding to the FDA within five working days [§812.150(b)(9)]. The FDA considers 
an investigation of a non-significant risk device to have an approved IDE when the IRB concurs with the 
non-significant risk determination and approves the study. 
The sponsor also must comply with the abbreviated IDE requirements under §812.2 (b): 
• 
Labeling - The device must be labeled in accordance with the labeling provisions of the IDE regulations 
(§812.5) and must bear the statement "CAUTION Investigational Device. Limited by Federal (or United 
States) law to investigational use."; 
• 
IRB Approval – The sponsor must obtain and maintain Investigational Review Board (IRB) approval 
throughout the investigation as a non-significant risk device study; 
• 
Informed Consent – The sponsor must assure that investigators obtain and document informed consent 
from each subject according to 21 CFR 50, Protection of Human Subjects, unless documentation is 
waived by an IRB in accordance with §56.109(c); 
• 
Monitoring - All investigations must be properly monitored to protect the human subjects and assure 
compliance with approved protocols (§812.46). Guidance on monitoring investigations can be found in 
Guideline for the Monitoring of Clinical Investigations. 
• 
Records and Reports - Sponsors are required to maintain specific records and make certain reports as 
required by the IDE regulations. 
• 
Investigator Records and Reports – The sponsor must assure that participating investigators maintain 
records and make reports as required (see Responsibilities of Investigators); and 
• 
Prohibitions –Commercialization, promotion, test marketing, misrepresentation of an investigational 
device, and prolongation of the study are prohibited (§812.7). 
 
Background 
The Vibe Air is an investigational self-fitting air conduction hearing aid that is intended to compensate for 
impaired hearing and incorporates technology, including software, that allows users to program 
independently their hearing aids. This technology integrates user input with a self-fitting strategy and 
enables users to independently derive and customize their hearing aid fitting and settings. 

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Risk Assessment 
- Summary of test validation studies 
Document No: D00230228 Version 1, Clinical Study Doc – SF System Verification Activities Overview 
- SF System 
Risk assessment identified risks of over-amplification or misuse of the device, which are mitigated by 
design and labeling and are below risk acceptability threshold.  
Mitigations to prevent over-amplifications include a safety output limiter which is a hardware measure 
for limiting the OSPL in failure mode. Hence, for the implemented cluster, the safety limiter is 6 dB above 
maximum OSPL of the specific cluster. Other mitigation measures include performance testing as 
electroacoustics and software verification and validation.  Critical use-related scenarios (critical tasks) 
and essential functions have been identified and will be tested and validated in Human Factors testing. 
The risks associated with the use of the SF system are acceptable when weighted against the expected 
benefits to the study subjects. The benefit outweighs the overall residual risk.  
- Comparison to Bose Hearing Aid 
 
The principles of operation, performance and repeatability of the self-fitting feature have been a subject 
of research for a number of years. In October 2018, Bose was granted its request for De Novo 
classification of the Bose® Hearing Aid (DEN180026, 2018).  FDA classified this type of device as a Class 
Topic 
Bose Hearing Aid 
(comparator device) 
Vibe SF (investigational 
device) 
Risk comparison 
Energy source 
Li-Ion rechargeable 
battery 
Standard Zinc-Air hearing 
aid battery, non-
rechargeable 
Lower risk due to the 
absence of a charging 
procedure 
Maximum output sound 
pressure level 
115 dB SPL 
114 dB SPL 
No difference 
Frequency bandwidth 
200 Hz to 8000 Hz 
530 Hz to 8400 Hz 
No difference 
Acoustic coupling to ear 
canal 
Closed 
Open 
Lower risk due to larger 
ventilation opening 
Noise reduction 
Active noise cancellation 
(by inverse sound wave) 
Noise reduction based on 
attenuation of the 
microphone signal 
Lower risk due to the 
absence of high-level 
cancellation signals  
Directionality 
Omnidirectional or 
directional hearing aid 
modes 
User cannot control 
directionality 
Lower risk due to 
reduced chance of not 
hearing vehicles, sirens, 
etc. 

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II, self-fitting air-conduction hearing aid.  FDA created a new classification regulation (21 C.F.R. § 
874.3325) identifying this device type as a wearable sound amplifying device that is intended to 
compensate for impaired hearing and incorporates technology, including software, that allows users to 
program their own hearing aids. This technology integrates user input with a self-fitting strategy and 
enables users to independently derive and customize their hearing aid fitting and settings. 
Comparison of Bose Validation Study vs. Vibe SF Validation study depicted in the following table:  

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Topic 
Bose (comparator) 
Vibe SF (investigational 
device) 
Risk 
Study design 
2 arm study 
Cross-over design 
No new risk 
Study design 
1 month field trial 
2x 2 weeks field trial 
No new risk, risk less 
because of scheduled 
visit after 2 weeks 
Experimental device 
Prototype Hearing Aid 
with Earbuds and Neck 
band 
Instant Fit CIC with Click 
Sleeves 
Smaller risk than Bose 
because Vibe SF based on 
a released hearing aid, 
SPONSOR has a lot of 
experience with hearing 
aids 
Fitting device  
Smartphone App 
Smartphone Web App 
For Vibe SF risk of loss of 
internet connection 
Basis of First Fit 
Start Setting at 0 dB real 
ear insertion gain,  
Adjustments with two 
wheels “Loudness” and 
“Fine-Tuning” inducing 
changes in 2 compression 
bands 
Guided Procedure 
resulting to activation of 
one of the built-in 
clusters  
Similar risk than Bose, 
Vibe SF clusters are based 
on audiological expertise, 
all settings after self-fit 
are audiologically valid. 
Loudnesswheel Settings 
of Bose are also based on 
typical hearing aid 
settings 
Initial Setting 
0 dB real ear insertion 
gain 
Most common Cluster 
activated 
Smaller Risk than Bose 
because even in the case 
of failed first-fit, 
audiologically valid 
setting active in hearing 
aid 
Self-Fitting procedure 
Adapting “Loudness” and 
“Fine-Tuning” Wheel on 
Smartphone App 
Web-App guided 
procedure starting with 
hearing loss profiling and 
subsequent cluster and 
master gain selection. 
Overall loudness can be 
adapted before 
completing procedure 
Smaller Risk because 
Hearing profiling gives 
some indication to 
hearing condition, 
warnings are issued of 
hearing loss is too severe 
or asymmetrical 
Time of Self-Fitting 
Over the course of the 
field-trial 
Completed at 1st visit 
Fine-tuning possible 
during field-trial 
Smaller Risk because 
subject leaves clinic with 
the first fit completed, 
benefits from 
amplification straight 
away 
Questionnaires 
APHAB, SSQ 12 
APHAB, SSQ 12 
No difference 
Speech Test 
QuickSin 
QuickSin 
No difference 

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The Bose Validation study reported no adverse events or serious adverse events during its study. 
 
Sources for all Risk information in this study protocol have been derived from the following documents: 
• 
Date Accessed 2021APR26. (Version X). EasyFit system covering hardware and software 
components (EN). Source of product information: WSAUD A/S: Document No.: D00212131 
• 
Date Accessed 2021APR26. (Version X). Risk analysis for Hearing Instruments, Fitting-Software, 
Accessories and Smartphone Apps (EN). Source of product information: WSAUD A/S: Document 
No.: D00013737 
• 
Date Accessed 2021APR26. (Version X). Self-Fitting System Risk Assessment for Clinical Study 
(EN). Source of product information: WSAUD A/S: Document No.: PENDING 
 
Summary Conclusion 
The Vibe Air hearing aid and SF study poses a nonsignificant risk to patients when compared to other US 
FDA approved SF hearing aid (Bose Hearing Aid) and Bose validation study.  
 
 
Surveys 
5 Star Rating and in-the 
moment blinded 
comparisons of self-
selected settings with 
those that had been 
selected by audiologist 
EMA Survey on Sound 
Quality, Speech 
understanding and 
Satisfaction 
EMA Survey most likely 
quicker than having to 
compare two settings 
and giving a rating. Less 
disturbing in every-day 
life 
Energy source 
Li-Ion rechargeable 
battery 
Standard Zinc-Air hearing 
aid battery, non-
rechargeable 
Lower risk due to the 
absence of a charging 
procedure 
Maximum output sound 
pressure level 
115 dB SPL 
114 dB SPL 
No difference 
Frequency bandwidth 
200 Hz to 8000 Hz 
530 Hz to 8400 Hz 
No difference 
Acoustic coupling to ear 
canal 
Closed 
Open 
Lower risk due to larger 
ventilation opening 
Noise reduction 
Active noise cancellation 
(by inverse sound wave) 
Noise reduction based on 
attenuation of the 
microphone signal 
Lower risk due to the 
absence of high-level 
cancellation signals  
Directionality 
Omnidirectional or 
directional hearing aid 
modes 
User cannot control 
directionality 
Lower risk due to 
reduced chance of not 
hearing vehicles, sirens, 
etc. 

SF Study  
 
FINAL Version 1.1 
Protocol #: D00232675 
 
08 September 2021 
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13 APPENDIX II DEVICE LABELING 
• 
Safety and Maintenance Information: Order/Item No.: 10997498 Document No. 00473-99T##-
#### ##, Master Rev 05, 04.2021. (D00219154) 
• 
Quick Start Guide: Order/Item No.: 10997511. Document No. 04477-99T##-#### ##, Master Rev 
02, 04.2021 (D00219293) 
• 
Quick Start Card: Document No. Order/Item No.: 21006310, Master Rev01, 03.2021 
(D00229153) 
• 
Date Accessed 2021APR27. (Version X). SF Study Packaging Image (EN). Source of information: 
WSAUD A/S: Document No.: D00231203