Protocol for Self-Fitting Hearing Aid Wear-Time Trial for Listeners With Mild to Moderate Hearing Loss
Phase: NA
Conditions: Hearing Loss, Sensorineural
Sponsor: GN Hearing A/S

Admin. Note:  This document describes the Study Protocol and Statistical Analysis Plan 
for the study “Wear-Time Trial for Self-Fitting Hearing Aid” (NCT04823494, ID: X-Men) 
 
Laboratory Study and Wear-Time Trial for Self-Fitting Hearing Aid 
CLINICAL INVESTIGATION PLAN 
 
 
TITLE 
Laboratory Study and Wear-Time Trial for Self-Fitting Hearing Aid 
PROTOCOL/STUDY NO. 
0001 
VERSION  
1 
DATE 
03AUG2021 
INVESTIGATIONAL DEVICE 
Jabra Enhance Plus 
SPONSOR 
GN Hearing A/S 
Lautrupbjerg 7 
DK-2750 Ballerup 
Denmark 
Registration number: 3005650109 
Contact person: Lars Hagander 
Tel: +45 4575 1111 
Fax: +45 4575 1119 
E-mail: lhagander@gnresound.com 
CONDUCTED BY 
IQVIA 
INVESTIGATIONAL SITE 
United States, Illinois 
Northwestern University 
Evanston, Illinois, United States, 60209 
Contact (PI): Sumitrajit Dhar, PhD (s-dhar@northwestern.edu)     
United States, Tennessee 
Vanderbilt University 
Nashville, Tennessee, United States, 37235 
Contact (PI): Todd Ricketts, PhD (todd.a.ricketts@vumc.org) 
United States, Illinois 
Sertoma Speech and Hearing Center 
10409 S Roberts Road, Palos Hills, IL 60465 
Contact (PI): Tom Wardzala, AuD 
(twardzala@sertomacenter.org) 
AUTHORS AND EXPERTS 
Larry E. Humes, Ph.D.; Marie Schroeder, M.S. 
COMPLIANCE 
The Protocol and clinical investigation are performed in 
accordance with International Standard (ISO) 14155, the 
Declaration of Helsinki, and local and national law. 
CONFIDENTIAL and PROPRIETARY 
This document contains confidential information and is solely the property of GN Hearing A/S. Acceptance of this document constitutes an agreement 
by the recipient that no unpublished information contained herein will be published or disclosed without the prior written approval of GN Hearing A/S. 

This document may be disclosed to the appropriate Institutional Review Board (IRB)/Ethics Committee (EC)/Research Ethics Board (REB) with the 
stipulation that the IRB/EC/REB treats the information contained herein as the confidential property of N Hearing A/S. 

      GN Hearing A/S 
Jabra Enhance Plus 
  
Final dated August 3, 2021 
Protocol/Study No.: 0001 
 
 
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CIP PURPOSE Study Title: Laboratory Study and Wear-Time Trial for Self-Fitting Hearing 
Aid; Protocol version 1.3b; Final dated 03-AUG-2021. 
 
This CIP will serve to further clarify and specify details related to the existing contracts and 
statements of work between Vanderbilt and GN Hearing, Northwestern and GN Hearing, and 
Sertoma Speech and Hearing Center and GN Hearing. Specifically, it will help ensure that the 
IRBs, and research protocols across Vanderbilt and Northwestern are consistent with each other 
and the general protocol developed in collaboration with GN Hearing.  
 
Copies of this protocol will be disseminated to all site-specific research personnel and the IRB 
protocols will be completely consistent with the detailed protocol described herein.  
 
Since the information in this protocol is confidential, it will not be disclosed to any third parties, 
other than those involved in approval, supervision, or conduct of the study.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

TABLE OF CONTENTS 
TABLE OF CONTENTS ............................................................................................................. 4 
DOCUMENTATION AND VERSION CONTROL ........................................................................ 7 
STUDY SYNOPSIS ................................................................................................................... 8 
Figure 1. Study Flow.......................................................................................................11 
1.0 
PRELIMINARY INVESTIGATION AND JUSTIFICATION ..............................................12 
1.1 
Introduction .........................................................................................................12 
1.2 
Background .........................................................................................................12 
1.3 
Non-Clinical Testing ............................................................................................12 
1.4 
Previous Clinical Experience ...............................................................................12 
1.5 
Device Risk Analysis ...........................................................................................12 
1.5.1 Anticipated Clinical Benefits ........................................................................12 
1.5.2 Anticipated Adverse Effects ........................................................................12 
1.5.3 Risk/Benefit Rationale ................................................................................13 
2.0 
INVESTIGATIONAL DEVICE DESCRIPTION ...............................................................14 
2.1 
Identification and Description of the Investigational Device .................................14 
2.1.1 Device Instructions .....................................................................................14 
2.1.2 Device Treatment Description .....................................................................17 
2.1.3 Device Manufacturing .................................................................................18 
2.2 
Additional Device(s) and Comparator(s) ..............................................................18 
2.3 
Regulatory Status ................................................................................................19 
2.3.1 Intended Use/Indications for Use ................................................................19 
2.4 
Risk Category/Rationale ......................................................................................19 
2.5 
Device Classification and Rationale.....................................................................19 
2.6 
Device Insurance and Replacement ....................................................................19 
2.7 
Disposition of the Device .....................................................................................20 
3.0 
OBJECTIVES OF RESEARCH STUDY .........................................................................20 
3.1 
Hypotheses .........................................................................................................20 
3.2 
Study Endpoints ..................................................................................................21 
3.2.1 Primary Effectiveness Endpoint(s) ..............................................................21 
3.2.2 Primary Safety Endpoint .............................................................................21 
3.2.3 Secondary Effectiveness Endpoints ............................................................21 
4.0 
DESIGN OF RESEARCH STUDY .................................................................................22 
4.1 
Type of Research Study ......................................................................................22 

      GN Hearing A/S 
Jabra Enhance Plus 
  
Final dated August 3, 2021 
Protocol/Study No.: 0001 
 
 
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4.2 
Controls and Minimization of Bias .......................................................................22 
5.0 
STUDY SUBJECTS .......................................................................................................22 
5.1 
Sample Size Determination .................................................................................22 
5.2 
Subject Population ..............................................................................................23 
5.3 
Protection of Vulnerable Subjects ........................................................................23 
5.4 
Inclusion Criteria..................................................................................................23 
5.5 
Exclusion Criteria ................................................................................................23 
5.6 
Concomitant Treatments .....................................................................................23 
5.7 
Enrollment Screening ..........................................................................................24 
6.0 
RESEARCH STUDY PROCEDURES............................................................................24 
6.1 
Study Assessments .............................................................................................24 
6.2 
Study Procedures ................................................................................................24 
6.2.9 Telephone Communication and Music Listening ...................................29 
6.3 
Study Duration and Sites .....................................................................................29 
6.4 
Monitoring and Treatment of Subjects with Worsening Clinical Condition ............29 
6.5 
Withdrawal and Discontinuation Criteria ..............................................................29 
6.6 
Prohibited Medications ........................................................................................30 
7.0 
TRAINING PLAN ...........................................................................................................30 
7.1 
Training Plan for Research Device ......................................................................30 
7.2 
Training Plan for Protocol ....................................................................................30 
8.0 
DATA ANALYSIS AND STATISTICS ............................................................................31 
8.1 
Statistical Analysis Methods ................................................................................31 
8.2 
Interim Analysis ...................................................................................................32 
8.3 
Missing Data Management ..................................................................................32 
8.4 
Pass/Fail Criteria of the Study .............................................................................32 
9.0 
DEVIATIONS .................................................................................................................32 
9.1 
Management of Protocol Deviations ....................................................................32 
10.0 
COMPLAINT HANDLING AND ADVERSE EVENT REPORTING .................................33 
10.1 Foreseeable Adverse Events and Device Effects ................................................33 
10.2 Adverse Event Definitions ...................................................................................34 
10.3 Monitoring ...........................................................................................................35 
10.4 Assessment of Severity .......................................................................................36 
10.5 Relationship to Investigation Treatment ...............................................................36 

10.6 Action Taken for Adverse Events ........................................................................36 
10.7 Follow-up of Adverse Events ...............................................................................37 
10.8 Reporting.............................................................................................................37 
10.8.1 Device Issue or Deficiency .......................................................................37 
10.8.2 Adverse Events ........................................................................................37 
10.8.3 Anticipated/Unanticipated Adverse Device Effect .....................................38 
11.0 
EARLY TERMINATION OR SUSPENSION ...................................................................38 
11.1 Study Closure, Early Termination or Suspension Criteria ....................................38 
11.2 Withdrawal of IRB Approval .................................................................................39 
12.0 
INSTITUTIONAL REVIEW BOARD (IRB) AND REGULATORY REQUIREMENTS .......39 
12.1 Regulatory Requirements ....................................................................................39 
12.2 IRB Approval Requirements ................................................................................39 
12.3 Subject Compensation ........................................................................................40 
12.4 CIP Revision/Amendment Management ..............................................................40 
12.5 Informed Consent and Privacy Requirements .....................................................41 
12.5.1 Informed Consent ....................................................................................41 
12.5.2 Privacy Requirements ..............................................................................42 
13.0 
DATA AND QUALITY MANAGEMENT ..........................................................................43 
13.1 Management of Data ...........................................................................................43 
13.2 Subject De-Identification ......................................................................................44 
13.3 Site Record Retention .........................................................................................44 
14.0 
MONITORING PLAN .....................................................................................................44 
14.1 Brief Description ..................................................................................................44 
14.2 Reference to Approved Monitoring Plan ..............................................................44 
15.0 
PUBLICATION POLICY ................................................................................................45 
16.0 
ADDITIONAL STUDY MATERIALS ...............................................................................46 
17.0 
REFERENCES ..............................................................................................................48 
18.0 
APPENDICES ...............................................................................................................49 
Appendix A: List of Abbreviations ................................................................................49 
Appendix B: Investigational Sites ................................................................................50 
 

      GN Hearing A/S 
Jabra Enhance Plus 
  
Final dated August 3, 2021 
Protocol/Study No.: 0001 
 
 
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DOCUMENTATION AND VERSION CONTROL 
Pursuant to U.S. 21 CFR 812.140 and ISO 14155 GCP requirements, this section records all 
changes made to the protocol for a specific study. In the table below, relevant changes to 
controlled versions of the protocol are recorded. 
Revision Date (DDMMMYYYY) Revision Author, Organization 
Comments/Changes 
1.0 
04JUL2021 
Larry Humes, Consultant 
Initial Release 
1.1 
06JUL2021 
Larry Humes, Consultant 
Inclusion Criteria revised 
1.2 
09JUL2021 
Larry Humes, Consultant; and 
site Investigators Ricketts & Dhar 
Reconciliation of CIP with 
protocol and contracts 
1.2d 
18JUL2021 
Larry Humes 
Added scales for phone 
use and music listening 
1.2e 
21JUL2021 
Larry Humes, Carol Sammeth 
Adopted Carol’s edits and 
updated device name 
1.2f 
23JUL2021 
Larry Humes, Carol Sammeth, 
Marie Schroeder 
Edits re: addition and use 
of User's Manual in study; 
edits of company info 
1.3 
24JUL2021 
Larry Humes, Carol Sammeth, 
Marie Schroeder 
Incorporated edits from CS 
and MS 
1.3a 
27JUL2021 
Larry Humes 
Added minor edits from TV 
and TR 
1.3b 
03AUG2021 
Larry Humes 
Changed from 2 to 3 sites 
 
 

STUDY SYNOPSIS 
Full Study Title: 
Laboratory Study and Wear-Time Trial for Self-Fitting Hearing Aid 
Classification: 
Pre-market clinical investigation  
Type of Study: 
There are two components to this study.  For the first, an in-lab session, a 
repeated-measures design is used to assess the reliability and validity of the 
self-fitting method.  For the second, a wear-time trial, a cross-over design is 
used with 10-14 days of wear time for each segment of the field trial. 
Device Regulatory 
Status: 
Jabra Enhance Plus is an investigational device 
Significant / 
Nonsignificant 
Classification: 
Non-Significant Risk Study (Abbreviated IDE regulations apply, 21 Code of 
Federal Regulations Part 812) 
Number of Patients: 
N=36 
Duration of Patient 
Participation: 
20-24 weeks (3-5 weeks per patient) 
Patient Population 
Adults, 18-75 years, with mild-to-moderate sensorineural hearing loss 
Number of Sites: 
3 
Duration of Study: 
Approximately 90 days 
Background and 
Rationale: 
Self-fitting hearing aids represent an FDA device classification that was 
recently created while implementation of the Over the Counter Hearing Aid 
Act by the FDA is in progress.  These devices are designed for adults with 
perceived mild-to-moderate hearing loss and the fitting is largely driven by 
the wearer.  This trial seeks to establish the reliability and validity of GN 
Hearing's self-fitting process, as well as the safety and efficacy of the device, 
for the company's first self-fitting hearing aid, Jabra Enhance Plus. 
Purpose: 
To establish the reliability, safety and effectiveness of GN Hearing's fitting 
process and self-fitting hearing aid, Jabra Enhance Plus. 
Primary Effectiveness 
Objectives/Endpoints: 
- 
For the effectiveness component of the immediate in-lab session 
comparisons, Real-Ear Aided Gain (REAG) will be measured using 
both an audiology-best-practices hearing aid fitting (PRO-FIT) and a 
self-fitting method (SELF-FIT).  
o Success criterion is defined as SELF-FIT REAG is equivalent to 
PRO-FIT NAL-NL2 prescription REAG targets based on the 
average real-ear aided gain at 500, 1000, 2000 and 4000 Hz.  
- 
For the reliability component of the immediate in-lab session 
comparisons, Real-Ear Aided Gain (REAG) will be measured twice (A, 
B) using the SELF-FIT method.  
o Success criterion is four-frequency average REAG for SELF-FIT 
B is equivalent to the REAG for SELF-FIT A  
- 
For the effectiveness of the wear-time crossover field trial, the 
Abbreviated Profile of Hearing Aid Benefit (APHAB) will be measured 

      GN Hearing A/S 
Jabra Enhance Plus 
  
Final dated August 3, 2021 
Protocol/Study No.: 0001 
 
 
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following both an audiology best-practices hearing aid fitting (PRO-FIT) 
and a self-fitting method (SELF-FIT). 
o Success criterion is defined as SELF-FIT APHAB global score is 
non-inferior to PRO-FIT APHAB global scores following completion 
of the wear-time field trial. 
 
Secondary 
Effectiveness 
Objectives/Endpoints: 
 
- 
For the effectiveness component of the immediate in-lab session 
comparison, aided Quick Speech-in-Noise test (QuickSIN) performance 
will be compared between SELF-FIT and PRO-FIT. 
o Success criterion is the SELF-FIT QuickSIN speech-recognition 
threshold in noise (signal-to-noise ratio, SNR) is equivalent to that 
of PRO-FIT.  
- 
For the reliability component of the immediate in-lab session comparison, 
QuickSIN performance will be measured twice (A, B) using the SELF-FIT 
method to assess test-retest reliability. 
o Success criterion is QuickSIN thresholds are equivalent for SELF-FIT 
A and B. 
- 
For the effectiveness of the wear-time crossover field trial, QuickSIN 
performance will be compared between SELF-FIT and PRO-FIT. 
o Success criterion is defined as SELF-FIT QuickSIN SNR is 
equivalent to PRO-FIT QuickSIN SNR following completion of the 
wear-time field trial. 
Primary Safety 
Objectives/Endpoints: 
Tabulations of Adverse Events (AEs) and Serious Adverse Events (SAEs). 
o Success criterion is no recorded device-related AEs or SAEs. 
Inclusion Criteria: 
An initial telephone or internet screening of interested persons will take 
place.  
• 
During this remote screening, prospective subjects will provide 
their age (subject to verification at Visit 1) and answer a Yes/No 
question as to whether they have trouble hearing in noise.  Those 
answering "No" will not be considered further for enrollment. 
• 
Those answering "Yes" will then be asked to describe their 
perceived hearing loss on a 4-point scale (no trouble, a little 
trouble, a lot of trouble, and cannot hear).  Prospects answering 
at the two extremes will not be considered further for this study. 
• 
Those answering "a little trouble" or "a lot of trouble" will be invited 
to the in-person Screen that immediately precedes hearing aid 
fittings in Visit 1. To be eligible to participate in this study, an 
individual must meet all of the following criteria: 

• 
Mild-to-moderate bilateral sensorineural hearing loss 
(thresholds from 250 – 8000 Hz with at least one threshold 
greater than 20 dB HL and thresholds at 500, 1000, 2000 and 
4000 Hz less than or equal to 55, 65, 70, and 80 dB HL, 
respectively) 
• 
Mix of male and female subjects (aiming for a 
representative balance) 
• 
Mix of prior hearing-aid use (aiming for 70-80% 
persons with no prior hearing aid use) 
• 
18-75 years old (aiming for primarily 50-70 years old, 
with avg. age ~65 years) 
• 
Able to read and comprehend English 
• 
Patient willing to provide informed consent  
Exclusion Criteria: 
An individual who meets any of the following criteria will be excluded from 
participation in this study: 
• 
Hearing outside of limits noted above 
• 
Self-reported ear-related pathology (including chronic severe 
dizziness or chronic severe tinnitus) 
 
Sampling Frame: 
The proposed sample size of n=36 subjects will be sufficient to rule out a null 
hypothesis of non-equivalence of SELF-FITSs A and B (reliability) or SELF-
FIT A and PRO-FIT (validity) with about 80% power with 0.05 significance 
level.  In addition, distributions of deviations from the standard-of-care 
measures will be generated for the primary and secondary measure and for 
the reliability and validity components of the study. 
Statistical 
Considerations: 
A statistical test of hypothesis of whether the primary effectiveness endpoint 
is equivalent to the standards observed in professional fits for both the 
reliability and validity components of the study.  The mean absolute values 
of the differences between test-retest for the SELF-FITs and between the 
SELF-FIT and PRO-FIT will be reported by visit. 
 
 

 
 
 
Figure 1. Study Flow  
 
 

1.0 PRELIMINARY INVESTIGATION AND JUSTIFICATION 
1.1 
Introduction  
The objective of this pivotal study is to establish the reliability and validity of the fitting process to 
be used for GN Hearing's Jabra Enhance Plus device.  The Jabra Enhance Plus is a prototype 
self-fitting hearing aid. The study will also evaluate safety and effectiveness of the Jabra Enhance 
Plus device using acoustical measures of gain and output, behavioral measures of benefit, and 
other measures of device safety which are standard in the hearing-aid industry. 
1.2 
Background 
Self-fitting hearing aids are designed for adults with perceived mild-to-moderate hearing loss and 
the fitting is largely driven by the wearer.  This trial seeks to establish the reliability and validity of 
GN Hearing's fitting process for the company's first self-fitting hearing aid, Jabra Enhance Plus, 
and the safety and efficacy of the device. 
1.3 
Non-Clinical Testing   
Non-clinical software verification and validation testing was conducted for the Jabra Enhance Plus 
device, which evaluated the device software elements. All elements passed the verification and 
validation testing regarding the test method, expected result, and actual result. No bugs were 
detected that were associated with either safety or effectiveness of the system. 
1.4 
Previous Clinical Experience  
No prior clinical studies were performed for the Jabra Enhance Plus device.  GN Hearing, 
however, has extensive experience conducting clinical investigations of the effectiveness and 
safety of conventional hearing aids and other ear-worn audio devices. 
1.5 
Device Risk Analysis 
1.5.1 
Anticipated Clinical Benefits 
The Jabra Enhance Plus device will provide measurable acoustic gain and, therefore, is expected 
to improve the auditory function of the wearer as measured behaviorally using a combination of 
speech-in-noise measures and self-report benefit measures.  The individual participant will 
experience these benefits personally, but there is also a greater general benefit to all adults with 
mild-to-moderate hearing loss by establishing the effectiveness and safety of the Jabra Enhance 
Plus device.  The purchase price and access to the device are envisioned to be much less 
burdensome than conventional hearing aids currently available to adults with mild-to-moderate 
hearing loss. 
1.5.2 
Anticipated Adverse Effects 
1.5.2.1 
Potential risks related to using Jabra Enhance Plus as a treatment vs. standard of care 
Compared to the standard-of-care fitting, the only anticipated risks involve the improper self-
selection of device settings such that either too little or too much gain will be selected.  The 
maximum possible gain, however, has been limited to minimize the risk to hearing from device 
use. 

      GN Hearing A/S 
Jabra Enhance Plus 
  
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1.5.2.2 
Potential risks associated with patient population 
Because the app used to fit and control the device requires some familiarity with such apps, the 
user may experience some frustration when initially learning how to fit and control the device. 
1.5.2.3 
Possible interactions and concomitant treatments 
Because both new and experienced hearing aid users are to be included, experienced user may 
be frustrated with the differences between the Jabra Enhance Plus device and their own hearing 
aids, including differences in sound quality and adjustment. 
1.5.3 
Risk/Benefit Rationale  
The risks of the Jabra Enhance Plus device are based on data collected in an early feasibility 
clinical study conducted by GN and are considered minimal. During that  feasibility study, no 
device-related adverse events were observed.  
The potential benefits of the Jabra Enhance Plus device far outweigh the possible risks.  Hearing 
aids are the treatment of choice for adults with mild to moderate hearing loss, yet most estimates 
indicate that only 20-30% of those who could benefit from hearing aids actually purchase them.  
The primary limitations to purchase pertain to the high cost and low accessibility of conventional 
hearing aids.  Self-fitting hearing aids provide a more affordable and accessible path to good 
hearing healthcare for millions of adults with mild to moderate hearing loss. These claims are also 
based on data collected in the early feasibility studies using a previous device version. The 
benefits of the device include: i) lower device cost to the end user; ii) greater sense of self-control 
of treatment options through the self-fitting process; iii) no cost of changes to hearing aid settings 
or fitting. 
1.5.3.1 
Clinical Relevance of Endpoints 
For the in-lab session, the primary effectiveness endpoint will be assessed by the differences in 
acoustical real-ear aided gain (REAG), a gold-standard measure for the acoustical function of 
hearing devices for the study population. This endpoint will be used to assess mean absolute-
value differences between two replications of the SELF-FIT method (reliability) and between the 
SELF-FIT and PRO-FIT methods (validity or effectiveness). 
For the wear-time trial, the primary outcome measure is a widely used clinical self-report measure 
of benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB). The APHAB is also a gold-
standard, validated assessment of hearing aid benefit relevant for the study population.  
Secondary effectiveness endpoints for both the laboratory and field-trial components will be 
assessed by a standardized measure of speech communication in noise, the QuickSIN.  This is 
a widely used clinical measure of an adult’s ability to understand speech in noise and is closely 
tied to the wearer’s primary complaint of difficulty communicating in noise. 
Overall study success will be defined by meeting all primary endpoints for the reliability, 
effectiveness, and safety of the devices and the self-fitting process in the laboratory and field-trial 
components of this study.  Effectiveness outcomes from the SELF-FIT process should be 

equivalent to those of the PRO-FIT method in the in-lab session and non-inferior to PRO-FIT in 
the wear-time trial for the study to be considered successful. 
2.0 INVESTIGATIONAL DEVICE DESCRIPTION 
2.1 
Identification and Description of the Investigational Device 
The Jabra Enhance Plus (also called simply the “Earbuds”) is designed to compensate users 
perceived mild to moderate hearing loss without the aid of a hearing care professional in the fitting 
of the device. The Earbuds are provided with a dedicated smartphone application, also named 
Jabra Enhance, and dedicated Charger.  
 
Using the dedicated smartphone application, the Earbud settings are customized based on an 
initial self-fitting workflow and user preferences. The user can monitor and control the Earbuds, 
amplify environmental sounds through the Earbuds, and wirelessly stream audio to the Earbuds. 
The Earbuds are used with mobile devices through the dedicated smartphone application and a 
standardized Bluetooth Low Energy (BLE) connection. 
 
The Earbuds are designed to be discrete, but stylish, and are made from premium materials for 
high wearing comfort for longer periods of time. They are dust and liquid resistant. The Earbuds 
can be personalized with respect to sound settings and have a push button for control. Sound 
setting changes can be made directly from the smartphone application. Connectivity-wise, the 
Earbuds allow for: 
• Communication to and from the smartphone application, for: 
o The self-fitting process. 
o Limited fine-tuning adjustments in the form of spectral tilt options. 
o Controls (including volume control and microphone directionality control). 
o Battery / charging state, which is sent to the smartphone application. 
o Firmware updates, which are downloaded from the Internet Cloud to the 
smartphone and applied to the Earbuds. 
• Ear-to-ear communication between the Earbuds for sending relevant control data. 
• Streaming of audio (e.g., phone calls) from mobile devices. 
• Own voice pickup for phone calls, i.e., traditional hands-free headset functionality. 
• Push to talk. 
• Connection to the Charger for transmission of charging and battery status to the 
smartphone application. 
 
The App allows for several different functions: 
• Self-fitting of the Earbuds. 
• Control of the Earbuds, including volume and spectral tilt options. 
• Status monitoring, such as status of the battery and connection to the Earbuds. 
 
The Charger has a stylish appearance, and functions as a carrying case. The Charger itself is 
rechargeable, such that it can be used without having it plugged into a power source, which can 
be beneficial for instances when an outlet is not available, e.g., during travel. 
2.1.1 
Device Instructions 
The Jabra Enhance Plus 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 

      GN Hearing A/S 
Jabra Enhance Plus 
  
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user’s hearing needs. No pre-programming or hearing test is necessary. The device is intended 
for direct-to-consumer sale and use without the assistance of a hearing care professional. 
2.1.1.1 
Pair Devices 
The flow for pairing of Earbuds for the first time is shown in Figure 2. These instructions will be 
available to the user in written form with illustrative pictures.  
 
 
 
 
 
Figure 2. Pairing flow for the Earbuds.   
 
 
 
 
 
 
Steps for device pairing are as follows: 

o The user is instructed to activate the Earbuds and Charger by powering up the 
charger (with the Earbuds inserted) using the USB cable. This will wake the 
Charger and the Earbuds from shipping mode. 
o The user is instructed to take both Earbuds out of the Charger, keeping them next 
to each other, and then the LEDs will flash blue. 
o The left and the right Earbuds will now enter pairing mode, and they will pair to 
each other, i.e., ear-to-ear pairing. The ear-to-ear pairing can only take place in 
the first two minutes after the Earbuds are taken out of the Charger.  For the field 
trial, the ear-to-ear pairing is already set up. 
o After the ear-to-ear pairing is established, both Earbuds will now be visible for the 
smartphone, i.e., smartphone discovery mode. The smartphone discovery window 
is open for three minutes after the Earbuds are ear-to-ear paired. 
o The user is instructed to leave the App and go to the smartphone (iPhone) settings 
to establish the pairing of the Earbuds to the smartphone. 
o If the pairing to the smartphone is established, the LEDs on both Earbuds will light 
up solid blue for a few seconds to indicate that pairing is done. 
o A pairing melody will be played in both devices to indicate that pairing is 
established. This is the traditional pairing melody already used in GN legacy 
hearing instruments. 
2.1.1.2 
Self-fit devices 
The Earbuds can be fitted by the user directly, using the dedicated fitting feature on the 
smartphone App. Before the self-fitting can be started on the smartphone, several things need to 
be in place: 
o The smartphone App must be installed, a trusted bond must be established, and 
terms, conditions and consent must be acknowledged in the smartphone App. The 
user will then be directed to the self-fitting feature. 
o Earbuds need to be powered on, ear-to-ear paired, and paired with the smartphone 
(per instructions above). 
o During the self-fitting, the broadband level of background environmental noise is 
monitored by the Earbuds. If the noise level is too loud, the user is instructed to 
repeat the self-fitting in a quieter environment. 
 
The user initiates the self-fitting flow via the App. The Earbud presents the user with a series of 
tones and the user marks the App on the smartphone screen to indicate when/if a tone is heard. 
Based on the user’s responses to these tones, initial gain settings are applied according to the 
NAL-NL2 fitting algorithm. This self-assessment of hearing loss does not provide the user with 
feedback about accuracy of their responses, nor does it provide the user with a diagnosis or 
information about their hearing loss. The information obtained during this process is used only 
internally to fit the device to the NAL-NL2 prescribed gain by frequency in each ear. Based on the 
initial prescribed gain, the user will subsequently be given the option to choose between two 
alternative gain settings, i.e., limited adjustments of the spectral tilt based on their preference 
while listening to a streamed sound file. The spectral tilt option that is selected can also be 
changed at any time during device use, from the settings menu. 
 
If the Earbuds are powered on for the first time, i.e., no fitting has been done, the Earbuds will 
start up with basic settings, and with a small amount of linear gain. User controls and streaming 
are prohibited until after the self-fitting process has been done. 

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2.1.1.3 
Fine-tune devices 
An important element with the GN Earbuds is the possibility, after the initial fitting is complete, to 
fine-tune the devices from the smartphone application. Although there are some differences with 
respect to the fine-tuning features, the vehicle which is used (standard features, volume control, 
etc.), will be similar to GN legacy hearing instruments currently in commercial distribution in the 
U.S. 
 
Features that can be set from the home screen of the smartphone application include overall 
volume and three frequency responses. 
2.1.1.4 
Remote firmware update 
The firmware in the Earbuds can be updated, e.g., to strengthen cybersecurity. A message can 
be pushed from the Cloud to the smartphone App that an update is available. The update can 
then be applied. 
2.1.1.5 
Charge devices 
The Earbuds are charged with a dedicated Charger. Charging will not take place wirelessly but 
will take place via a physical connection over Pogo contact pins in the Charger. 
2.1.2 
Device Treatment Description 
Millions of Americans experience communication and listening difficulties resulting from mild-to-
moderate hearing loss.  Hearing aids represent the primary treatment for these individuals. The 
conventional best-practices approach to treatment for such individuals has been to consult with 
one or more healthcare professionals for assistance in determining candidacy and acquiring 
hearing aids.  It has been estimated that only 20-30% of adults with such difficulties seek and 
obtain hearing aids within the existing treatment model.  The Jabra Enhance Plus (also called 
simply the “Earbuds” here) is designed to compensate users perceived mild-to-moderate 
hearing loss without the aid of a hearing care professional in fitting of the device.  
2.1.2.1 
Device Treatment Examples 
This product is designed to help individuals 18 years of age or older with perceived mild to 
moderate hearing impairment and who may: 
o Strain to follow conversations in noisier environments 
o Miss important information during conversations 
o Have trouble hearing at a distance 
o Have trouble understanding the TV or telephone calls 
2.1.2.2 
Additional features 
• 
Enhanced hearing for clearer conversations and music 
• 
Optimized sound for different environments 
• 
Water and dust resistant, 1-year warranty 
• 
Miniaturized design for a comfortable fit 
• 
Up to 10 hours use with a fully charged battery 
• 
Simple setup through the Jabra Enhance App 

2.1.2.3 
Troubleshooting 
The following troubleshooting instructions are listed in the device labeling: 
Issue 
Potential Cause 
Potential Solution 
Feedback or “whistling” 
Are 
the 
earbuds 
inserted 
correctly in your ears? 
Reinsert the earbuds in your 
ears. 
 
Is the volume very loud? 
Reduce the volume. 
 
Are the EarGels broken or 
clogged? 
Replace the EarGels. 
 
Are you holding an object 
(e.g., a hat or a telephone 
mouthpiece) close to the 
earbuds? 
Move your hand away to 
create more space between 
the earbuds and the object. 
 
Is your ear full of wax? 
Visit your physician 
No sound 
Are the earbuds turned on? 
Turn the earbuds on. 
 
Are the earbuds charged? 
Charge the earbuds. 
 
Is the charging case charged? 
Charge the charging case. 
 
Is your ear full of wax? 
Visit your physician. 
Earbuds are not charging 
Are 
the 
earbuds 
sitting 
correctly in the charging case? 
Reinsert the earbuds in the 
charging case. 
 
Is the charging case charged 
or plugged into a power 
source? 
Charge the charging case. 
 
2.1.3 
Device Manufacturing 
Jabra Enhance Plus was developed in accordance with 21 CFR 820.30 FDA’s Design Control 
requirements. The device is currently manufactured/developed at the address below: 
GN Hearing A/S  
Lautrupbjerg 7  
DK-2750 Ballerup 
Denmark 
2.2 
Additional Device(s) and Comparator(s) 
In this clinical study, the investigational device is not compared to another device. Instead, this 
investigation compares outcome between the device fitted by a hearing care professional 
versus the same device self-fitted by the subject. 
 

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If the subject does not have a compatible iPhone running iOS 14, an iPhone 11 (iOS 14) will be 
supplied for use in this study.   
2.3 
Regulatory Status 
Jabra Enhance Plus is not currently marketed as a medical device in the US or any other global 
regions and is considered a non-significant risk investigational device for purposes of this study.  
2.3.1 
Intended Use/Indications for Use 
The Jabra Enhance Plus self-fitting hearing aid 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. No pre-programming or hearing test is necessary. The 
device is intended for direct-to-consumer sale and use without the assistance of a hearing care 
professional. 
2.4 
Risk Category/Rationale 
GN Hearing A/S does not consider the Jabra Enhance Plus device or the result of its use in this 
pivotal study to pose a significant risk to study subjects. Per 21 CFR 812.3, the Jabra Enhance 
Plus device and its use in this pivotal study are considered non-significant risk (NSR) because: 
• 
It is not intended as an implant and thus does not present a potential for serious risk to 
the health, safety, or welfare of a subject; 
• 
It is not purported or represented to be for use in supporting or sustaining human life and 
thus does not present a potential for serious risk to the health, safety, or welfare of a 
subject; 
• 
It is not for a use of substantial importance in diagnosing, curing, mitigating, or treating 
disease, or otherwise preventing impairment of human health and thus does not present 
a potential for serious risk to the health, safety, or welfare of a subject; and 
• 
It does not otherwise present a potential for serious risk to the health, safety, or welfare 
of a subject. 
Because the device and its use in this pivotal study is considered NSR, the abbreviated IDE 
requirements of 21 CFR Part 812 will apply. Submission of an IDE to FDA is not considered 
necessary. 
2.5 
Device Classification and Rationale 
The Jabra Enhance Plus device is expected to be classified as a Class II medical device. The 
results of this pivotal study are intended to support a Traditional 510(k) Premarket Notification for 
submission to the FDA.  
2.6 
Device Insurance and Replacement 
All investigational devices will be issued to the investigational sites by GN Hearing A/S.  Any 
special procedures, such as calibration and maintenance of the devices, will be conducted per 
the device labeling provided to study subjects.   If a device breaks, malfunctions, or is lost, 

replacement devices will be issued to the site by GN Hearing A/S for the patient to continue 
participation in the study.    
2.7 
Disposition of the Device 
Subjects will be required to utilize their Jabra Enhance Plus device to access the Jabra Enhance 
app. To access the Jabra Enhance Plus device, enrolled subjects will receive a link from the 
Sponsor prompting them to download the Jabra Enhance Application (app). Once downloaded, 
the enrolled subjects will be prompted to create their own secure login credentials to utilize during 
the study. When subject involvement in the investigational study is completed, the Jabra Enhance 
Plus app will automatically log the subject out, and their account will no longer be usable. The 
data for the subject’s account will be saved. 
3.0 OBJECTIVES OF RESEARCH STUDY 
3.1 
Hypotheses 
  
3.1.1 In-lab validation component-Primary 
• 
Null hypothesis: Mean |REAGPRO-FIT – REAGSELF-FIT| ≥ 2.5 dB 
• 
Alternative hypothesis: Mean |REAGPRO-FIT – REAGSELF-FIT| < 2.5 dB 
 
3.1.2  In-lab validation component-Secondary 
• 
Null hypothesis: Mean |QuickSINPRO-FIT – QuickSINSELF-FIT| ≥ 1.5 dB 
• 
Alternative hypothesis: Mean |QuickSINPRO-FIT – QuickSINSELF-FIT| < 1.5 dB 
 
3.1.3 Wear-Time Field Trial-Primary 
• 
Null hypothesis: Mean difference (APHABPRO-FIT – APHABSELF-FIT) ≥ .084 
• 
Alternative hypothesis: Mean difference (APHABPRO-FIT – APHABSELF-FIT) < .084 
 
3.1.4 Wear-Time Field Trial-Secondary 
• 
Null hypothesis: Mean difference (QuickSINPRO-FIT – QuickSINSELF-FIT) ≥ 1.5 dB 
• 
Alternative hypothesis: Mean difference (QuickSINPRO-FIT – QuickSINSELF-FIT) < 1.5 
dB 
 
3.1.5 In-Lab Session-Reliability Component-Primary 
• 
Null hypothesis: Mean |REAGSELF-FIT A – REAGSELF-FIT B| ≥ 2.5 dB 
• 
Alternative hypothesis: Mean |REAGSELF-FIT A – REAGSELF-FIT B| < 2.5 dB 
 
3.1.6 In-Lab Session-Reliability Component-Secondary 
• 
Null hypothesis: Mean difference |QuickSINSELF-FIT A – QuickSINSELF-FIT B| ≥ 1.5 dB 
• 
Alternative hypothesis: Mean difference |QuickSINSELF-FIT A – QuickSINSELF-FIT B|< 
1.5 dB 

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3.2 
Study Endpoints 
3.2.1 
Primary Effectiveness Endpoint(s)  
For the validation component of the immediate in-lab session comparisons, Real-Ear Aided Gain 
(REAG) will be measured using both an audiology-best-practices (professional) hearing aid fitting 
(PRO-FIT) and a self-fitting method (SELF-FIT).  
• 
Success criterion is defined as SELF-FIT REAG is equivalent to PRO-FIT NAL-
NL2 prescription REAG targets based on the average real-ear aided gain at 500, 
1000, 2000 and 4000 Hz.  
For the reliability component of the immediate in-lab session comparisons, Real-Ear Aided Gain 
(REAG) will be measured twice (A, B) using the SELF-FIT method.  
• 
Success criterion is four-frequency average REAG for SELF-FIT B is equivalent to 
the REAG for SELF-FIT A based on the average real-ear aided gain at 500, 1000, 
2000 and 4000 Hz.  
For the wear-time crossover field trial, the APHAB will be measured following both an audiology 
best-practices hearing aid fitting (PRO-FIT) and a self-fitting method (SELF-FIT). 
• 
Success criterion is defined as SELF-FIT APHAB global score is non-inferior to 
PRO-FIT APHAB global scores following completion of the wear-time field trial. 
3.2.2 
Primary Safety Endpoint 
Tabulations of Adverse Events (AEs) and Serious Adverse Events (SAEs). 
• 
Success criterion is no recorded device-related AEs or SAEs. 
3.2.3 
Secondary Effectiveness Endpoints 
For the validation component of the immediate in-lab session comparison, aided QuickSIN 
performance will be compared between SELF-FIT and PRO-FIT. 
• 
Success criterion is the SELF-FIT QuickSIN speech-recognition threshold in noise 
(signal-to-noise ratio, SNR) is equivalent to that of PRO-FIT.  
For the reliability component of the immediate in-lab session comparison, QuickSIN performance 
will be measured twice (A, B) using the SELF-FIT method to assess test-retest reliability. 
• 
Success criterion is QuickSIN thresholds are equivalent for SELF-FIT A and B. 
For the wear-time crossover field trial, QuickSIN performance will be compared between SELF-
FIT and PRO-FIT. 
• 
Success criterion is defined as SELF-FIT QuickSIN SNR is equivalent to PRO-FIT 
QuickSIN SNR following completion of the wear-time field trial. 

4.0 DESIGN OF RESEARCH STUDY 
4.1 
Type of Research Study 
This study has two components to assess the safety and effectiveness of the Jabra Enhance Plus 
device in adults with mild to moderate sensorineural hearing loss.  The reliability and validity of 
the self-fitting method are examined in an in-lab session with counter-balanced conditions.  A 
second component, a single-blind counter-balanced cross-over wear-time field trial, further 
evaluates the validity of the self-fitting method.  Three sites are involved in data collection. 
4.2 
Controls and Minimization of Bias 
The Sponsor, GN Hearing A/S, should avoid improper influence on any parties participating in, or 
contributing to, the clinical study or the induction thereof.  The selection and treatment of subjects 
and evaluation of study data are potential sources of bias.  Methods that are incorporated within 
the study design to minimize potential bias include, but are not limited to, screening subjects to 
confirm study eligibility with defined inclusion/exclusion criteria prior to enrollment; maintaining a 
log of all subjects screened and enrolled for the study, collecting demographics and medical 
history at baseline to later assess possible characteristics that may influence endpoints;  
standardizing data collection requirements and study procedures; requiring all study investigators 
to meet the requirements of 21CFR Part 54 and a Financial Disclosure by Clinical Investigators; 
using standardized training materials for all study personnel; and conducting regular electronic 
monitoring to verify adherence to the protocol and source data. 
5.0 STUDY SUBJECTS 
5.1 
Sample Size Determination 
The sample size was powered by the primary outcome measure of the wear-time field trial, the 
APHAB, as it is the most variable of the outcome measures across all components of this study. 
When the sample size in each sequence group in the crossover trial is 16 (giving a total sample 
size of 32), a crossover design will have 80% power to reject the null hypothesis that the SELF-
FIT APHAB mean is inferior to the PRO-FIT APHAB mean based on the mean difference, in favor 
of the alternative hypothesis that the SELF-FIT mean is non-inferior to the PRO-FIT mean, 
assuming that the expected difference in means is 0, the non-inferiority difference margin is .084 
(or 8.4%), the Crossover ANOVA √MSE is 0.115 (or 11.5%) (giving a standard deviation of 
differences, σ, of 0.163 or 16.3%) and that the test is made at the 2.5% significance level. 
 
The overall design for the in-lab session is a repeated-measures design comparing outcomes for 
three procedures: SELF-FIT A, SELF-FIT B, PRO-FIT.  Given that SELF-FIT A and B are the 
same procedure repeated two times, this results in three possible procedure sequences: (1) 
SELF-FIT A, SELF-FIT B, PRO-FIT; (2) SELF-FIT A, PRO-FIT, SELF-FIT B; and (3) PRO-FIT, 
SELF-FIT A, SELF-FIT B.  An equal number of subjects will receive each sequence at each site 
to ensure full counterbalancing of order. A total of 36 subjects, 18 per site, will be included which 
meets the minimum of 32 required for sufficient statistical power, achieves the desired 
counterbalancing, and allows for some subject attrition or missing data. 

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5.2 
Subject Population 
Adults, 18-75 years of age, with mild to moderate sensorineural hearing loss. 
5.3 
Protection of Vulnerable Subjects 
No vulnerable patients are planned to be enrolled in this study. 
5.4 
Inclusion Criteria 
An initial telephone or internet screening of interested persons will take place.  
• 
During this remote screening, prospective subjects will provide their age (subject to 
verification at Visit 1) and answer a Yes/No question as to whether they have trouble 
hearing in noise.  Those answering "No" will not be considered further for enrollment. 
• 
Those answering "Yes" will then be asked to describe their perceived hearing loss on 
a 4-point scale (no trouble, a little trouble, a lot of trouble, and cannot hear).  Prospects 
answering at the two extremes will not be considered further for this study. 
• 
Those answering "a little trouble" or "a lot of trouble" will be invited to the in-person 
Screen that immediately precedes hearing aid fittings in Visit 1.  To be eligible to 
participate in this study, an individual must meet all of the following criteria: 
 
(1) 
Mild-to-moderate bilateral sensorineural hearing loss (thresholds from 250 
– 8000 Hz with at least one threshold greater than 20 dB HL and thresholds at 500, 
1000, 2000 and 4000 Hz less than or equal to 55, 65, 70, and 80 dB HL, respectively); 
 
(2) 
Mix of male and female subjects (aiming for a representative balance); 
 
(3) 
Mix of prior hearing-aid use (aiming for 70-80% persons with no prior 
hearing aid use); 
(4)  
18-75 years old (aiming for primarily 50-70 years old, with avg. age ~65 
years); 
 
(5) 
Able to read and comprehend English; and 
 
       
(6)  
Patient willing to provide informed consent. 
5.5 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
 
(1) 
Hearing outside of limits noted above; or 
 
(2) 
Self-reported ear-related pathology (including chronic severe dizziness or chronic 
severe tinnitus). 
5.6 
Concomitant Treatments 
No known concomitant treatments exist for this device. 

5.7 
Enrollment Screening 
Screening for eligibility of this study will be made within 28 days prior to the treatment. If a patient 
who meets the study criteria joins the study, preliminary effectiveness and safety using the Jabra 
Enhance Plus in the study will be measured. 
6.0 RESEARCH STUDY PROCEDURES 
6.1 
Study Assessments 
A description of all assessments being performed are provided within Section 3.0. 
6.2 
Study Procedures 
6.2.1 Pre-Fitting Procedures: After consent, otoscopy, and audiological measurements 
verifying candidacy for the study, the subject completes Pre-Fitting of the devices. If the 
subject does not have a compatible iPhone running iOS 14, one will be supplied for use in this 
study. The investigator will install the app on the subject's smartphone, pair the devices to the 
smartphone, and select the appropriate earbud size for each ear prior to the PRO-FIT and 
SELF-FIT procedures.  (These aspects of the fitting process for the Jabra Enhance Plus will 
be evaluated separately in a usability study.) 
 
i. 
Fitting begins by placing probe-tube microphones in the subject’s ear canals and 
measuring the Real-Ear Unaided Response (REUR) for each ear. 
 
ii. 
The Jabra Enhance Plus, powered off, will be placed in the subject's ear with 
medium-sized earbuds and the Real-Ear Occluded Response (REOR) measured. 
• 
If measurable passive attenuation at frequencies above 500 Hz is not seen, 
a smaller or larger earbud will be selected by the audiologist and REOR 
will be remeasured. 
• 
This process will be repeated as needed until a good seal is obtained as 
verified by the REOR. 
• 
The selected earbud size for each ear will be used by the subject during 
the remainder of the study. 
6.2.2 PRO-FIT: The audiologist will use the air-conduction thresholds measured during the 
initial screening to generate REAR targets for the NAL-NL2 prescriptive procedure. 
   
i. 
Targets will be generated for a speech input level of 65 dB SPL. 
ii. 
Fine-tuning of REAR by the audiologist to match NAL-NL2 targets will be 
accomplished using custom device-programming software (AlgoLabTest) to 
program the gain and compression parameters for NAL-NL2. 
iii. 
The Audioscan Verifit 1 or 2 real-ear measurement system will be used to verify 
and fine-tune the fit to match targets for this initial fit for speech input level of 65-
dB SPL.  

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iv. 
If the subject has immediate sound-quality complaints, the audiologist will fine-tune 
the fitting to accommodate those complaints (as was done for the predicate device 
study; Sabin et al., 2020).  The range of adjustments to the frequency response 
will be constrained to the two alternative responses available on the device via the 
app. This will be the final fit for PRO-FIT to be worn during the wear-time trial.  
v. 
No additional fine-tuning will be made by the audiologist to the PRO-FIT fitting for 
the duration of this study, including the field trial.  Although such adjustments may 
be common practice, there is little evidence available about the benefits of such 
adjustments and they are not included in national best-practice guidelines for 
hearing-aid fitting. The validation study of the Bose Hearing Aid (Sabin et al., 2020) 
allowed additional adjustments by the audiologist to the PRO-FIT condition in that 
study after a brief wear-time period (M=5.3 days).  However, the gain from 500-
4000 Hz was not adjusted in 77% of those subjects and another 14% of their 
subjects required adjustments of only 5 dB at one or more of those frequencies in 
either ear after this brief wear-time period.  In other words, 91% of the time, no or 
very minor adjustments, within the range of adjustments that will be available to 
the user during the wear-time trial in this study, occurred. Further, the user will 
have access to self-adjustment of volume and choice of frequency response tilt as 
desired during the wearing period. 
6.2.3 SELF-FIT A: Once the earbuds have been selected by the audiologist for the subject 
and are placed in the ear, subjects will complete the first self-fitting process (Section 16.0, 
Attachment A).  
i. 
Subjects will open the mobile device screen, launch the app, and select from drop-
down menus to indicate age and gender. (These data facilitate the starting point 
for the fitting process, but the process can still be completed if left blank.) 
ii. 
Subjects will be presented with step-by-step fitting instructions on their smartphone 
describing their task during the self-fitting flow (See Section 16.0, Attachment A.). 
iii. 
Subjects will be presented with the “Heard It” design of the self-fitting procedure, 
meaning that they will tap the smartphone screen to indicate when a tone is 
detected. 
iv. 
The self-fitting flow requires 5 practice tones and 25 test tones per self-fit. This 
procedure results in settings as determined by the Jabra Enhance Plus software 
and is referred to as the "initial fit" and is designed to match NAL-NL2 targets. 
REAG targets and measures will be calculated by subtracting the input signal level 
in the sound field from the REAR targets and measures. Comparison of REAG and 
QuickSIN measures among PRO-FIT, SELF-FIT A, and SELF-FIT B in Visit 1 (in-
lab) will be made using these saved initial-fit settings for SELF-FIT. 
v. 
The SELF-FIT process continues uninterrupted with user-preferred adjustments of 
"filters" or frequency-gain responses.  These user-driven fine-tuning adjustments 
are made while streaming a sound file to the devices and comparing filter settings.  
(See Attachment 4A for details.) When the subject selects the final settings, these 

device settings are saved and become the new default settings for when the device 
is powered on.  These settings are referred to as the "final fit" for the SELF-FIT 
procedure.  Measurements made for SELF-FIT A and PRO-FIT at the end of each 
wear-time crossover field trial will make use of these final-fit settings. 
vi. 
Once the subject has completed the test, the app will indicate that the subject is 
finished with personalization of the devices and will return to the home screen of 
the app. 
6.2.4 SELF-FIT B: To assess test-retest reliability, subjects will complete the self-fitting 
procedure a second time (repeat steps for SELF-FIT A above). 
6.2.5  Overview of Procedures at Visits 1, 2, and 3 
Successive subjects will be assigned to one of these six condition sequences illustrated in 
Figure 1 with a total of two cycles through the full set of six sequences at each of the three 
sites. In the end, two subjects will have been tested in each of the six sequences at each site, 
six per sequence for the entire study, and any effects of order will be equalized across 
conditions following the counterbalancing illustrated in Figure 1. 
The table below summarizes the primary and secondary outcome assessments to be 
completed during each study visit.  For Visits 2 and 3, REAG will also be established but only 
for potential explanatory purposes and not as an outcome measure. 
 
Visit 
Primary Outcome 
Secondary Outcome 
1 
REAG from REAR; initial fit 
QuickSIN; initial fit 
2 
APHAB; final fit 
QuickSIN; final fit 
3 
APHAB; final fit 
QuickSIN; final fit 
 
After the final in-lab measures have been completed during Visit 1, 9 subjects at each site will 
wear the devices with the final-fit SELF-FIT A settings and the other 9 at each site will begin 
the crossover trial with the final-fit PRO-FIT settings.  After the initial 10-to-14-day wear-time 
trial, the subjects will return to the lab for the measurement of REAG, aided APHAB, and aided 
QuickSIN during Visit 2.  Each subject will then embark on a second 10-to-14-day wear-time 
period using the devices with the other fitting settings (SELF-FIT A settings if PRO-FIT settings 
were worn first, and vice versa).  Subjects will return after the second 10-to-14-day wear-time 
period for completion of REAG, aided APHAB and aided QuickSIN measures with this second 
fitting, during Visit 3. 
Subjects will follow the instructions for the “Self-fitting flow” (Section 16.0, Attachment A) to 
complete SELF-FIT A and SELF-FIT B procedures.  After the installation of software on the 
smartphone, the pairing of the devices to the smartphone, and the physical fit of the devices, 
no further assistance will be provided to the subject by the professional or research staff until 
the completion of Visit 1.  When Visit 1 has been completed, the subject will be provided with 
the devices, the charger, the USB-C cable, and a copy of the User's Manual (Attachment A).  
The research audiologist will answer questions raised by the subject as he or she pages 
through the manual.  Prior to leaving for the first phase of the field trial, the subject will 
demonstrate to the audiologist that he or she can insert and remove the devices, adjust the 

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volume with the app, and place the devices in the charger.  The audiologist will log any errors 
made in this verification of basic use and will correct the subject on those errors once, if 
needed, prior to the subject leaving with the devices. 
For the wear-time field trial, subjects will be asked to wear the devices in a variety of listening 
situations during the trial including while listening to music and while using the telephone.  
Subjects will be asked to wear their devices a minimum of two hours per day. 
6.2.6 REAR Measurement and REAG Calculation 
SELF-FIT A & B: Personalization begins with an estimate of hearing acuity obtained through the 
Jabra Enhance Plus. The hearing acuity measurements are used internally by the device and are 
not shared with the wearer. Once this step has been completed, devices will apply NAL-NL2 gain 
prescriptions directly using the estimated hearing acuity to generate the initial fit.  Probe-tube 
microphone measures of the REAR (REAG=REAR-input) will be obtained for a 65-dB speech 
input using the Audioscan Verifit real-ear measurement system. All probe-tube microphone 
measures will make use of the custom dome/probe-tube assembly supplied by GN Hearing. 
(Attachment B for details.) 
PRO-FIT: Audiometric thresholds will be imported and the devices programmed using custom 
device programming software (AlgoLabTest) for NAL-NL2 target gains. Probe-tube microphone 
measures of the REUR and REAR (REAG=REAR-input) will be obtained for a 65-dB speech input 
using the Audioscan Verifit real-ear measurement system. All probe-tube microphone measures 
will make use of the custom dome/probe-tube assembly supplied by GN Hearing. (See 
Attachment B for details.) 
6.2.7 QuickSIN   
The subject will be seated in a sound-attenuated booth facing a single loudspeaker. All QuickSIN 
measures, unaided and aided, will be binaural. The QuickSIN test consists of lists of six sentences 
that will be played from that loudspeaker at a constant level of 65 dB SPL (at location of subject's 
head using the method of substitution). This speech level was chosen as one approximating a 
typical conversational level (60-65 dB SPL) and matching the speech input level used for the 
REAR measures (65 dB SPL). The level of the co-located background four-talker babble 
increases across the six sentences for signal-to-noise ratios (SNRs) ranging from +25 to 0 dB 
SNR (in steps of 5 dB). The subject is asked to repeat each sentence. The audiologist scores 
whether the subject correctly repeated the predetermined key words in each sentence. The 
resulting score is interpreted as an SNR loss where a value near 0 indicates better hearing and 
larger values indicate more difficulty listening in noise. 
There are 18 lists of the QuickSIN, but McArdle and Wilson (2006) found four of these to be non-
equivalent to the others.  The remaining 14 lists will be used as follows.  Before the first QuickSIN 
measure at the end of the initial screening (Visit 1), two lists will be presented as practice lists 
(Lists 4 and 5). For the remaining 12 lists (Lists 1-3, 6, 8-12, 15, 17, 18), two will be assigned to 
each of the following conditions: unaided (during initial screen; to permit measures of relative 
benefit), in-lab initial SELF-FIT A, in-lab initial SELF-FIT B, in-lab initial PRO-FIT (the condition 
order and list pair assigned for each condition will be randomized for each participant), at end of 
first 10-to-14-day wear period (Visit 2; either final SELF-FIT A or final PRO-FIT), and at end of 

final 10-to-14-day wear period (Visit 3; either final PRO-FIT or final SELF-FIT A).  Each QuickSIN 
score will be based on two lists, 60 keywords, and no lists will be repeated for a given subject.   
6.2.7.1 QuickSIN Test Procedure 
Four conditions: Unaided, Self-Fit A, Self-Fit B, Pro-Fit  
i. 
Listener will sit in a chair in the center of a sound-treated booth facing the 
speaker from which the test materials will be elicited (0 degrees azimuth, 1 
meter distance).  
ii. 
Training: To familiarize subjects with the speech task, listeners will be 
presented with two practice lists (Lists 4 and 5) before commencing with 
the experimental protocol (Visit 1, Unaided only).  
iii. 
The test will be presented in a sound field at 65 dB SPL. 
iv. 
There are six sentences in each list of the QuickSIN and 5 keywords that 
are scored per sentence, resulting in a total of 30 keywords scored per list. 
Speech levels are automatically presented at SNRs of +25, +20, +15, +10, 
+5 and 0 dB, one SNR per sentence.  The signal-to-noise ratio (SNR) for 
which 50% of the presented words are intelligible is calculated by 
subtracting the number of words correct (out of 30) for a given list from 25.5 
(Killion et al., 2004).  
v. 
The microphone setting will be set to "Wide" (omni-directional) during these 
measurements. 
6.2.8 APHAB 
The APHAB is a 24-item self-assessment inventory in which the subject reports the amount of 
trouble they are having with communication or noises in various everyday situations. Benefit from 
a hearing aid is calculated by comparing the subject’s unaided score to their aided score.  
Although it is possible to collect unaided and aided scores at the same time by asking the subject 
to reflect back on unaided listening, we will obtain unaided APHAB scores during Visit 1 prior to 
initiation of the cross-over wear-time trial.  
A sample question is as follows: "When I’m at the dinner table with several people, and I am trying 
to have a conversation with one person, understanding speech is difficult."  For each of the 24 
items the subject is asked to select one of the following percentages to indicate how frequently 
this occurs:  Always (99%); Almost Always (87%); Generally (75%); Half-the-time (50%); 
Occasionally (25%); Seldom (12%); or Never (1%).  The APHAB will be administered and scored 
via a tablet PC or iPad. 
The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), 
Background Noise (BN), and Aversiveness (AV). To increase reliability, only an APHAB-global 
score based on all 24 items will be used here. 
Three conditions:  Unaided (Visit 1), Aided (Visit 2), Aided (Visit 3).  These three conditions are: 
1) prior to the onset of the wear-time field trial, 2) after the first 10-14-day wear period with the 
first fitting settings (final-fit SELF-FIT A or final-fit PRO-FIT), and 3) after the second 10-14-day 
wear period with the other fitting settings (final-fit PRO-FIT or final-fit SELF-FIT A). 

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6.2.9 
Telephone Communication and Music Listening 
A custom 2-item survey will be completed during Visits 2 and 3 following the APHAB.  This survey 
assesses the enhancement of telephone communication and music listening by the GN prototype 
devices and makes use of a 7-point response scale (“Strongly Agree” to “Strongly Disagree”) for 
each item.  Prior to the beginning of each phase of the cross-over trial, subjects will be encouraged 
to use their devices in a wide range of listening conditions during the wear-time period, including 
using the telephone and listening to music. 
6.3 
Study Duration and Sites 
Given the number of study subjects required within this population and the recruitment capabilities 
of the sites and sponsor, this investigation is expected to last approximately 90-120 days from 
enrollment of the first subject to completion of the final study subject. This study includes 3 sites: 
(1) Northwestern University, Evanston, IL;  (2) Sertoma Speech and Hearing Center, Palos Hills, 
IL; and (3) Vanderbilt University, Nashville, TN. 
6.4 
Monitoring and Treatment of Subjects with Worsening Clinical 
Condition 
Subjects will be monitored for worsening clinical status, including complaints of decreased hearing 
or increased tinnitus, via self-report at Visits 2 and 3.     
6.5 
Withdrawal and Discontinuation Criteria 
Study subjects may withdraw voluntarily from the research investigation for any reason and at 
any time during the investigation. 
A study subject may also be removed from the investigation for the following medical or 
administrative reasons: 
• 
Withdrawal of informed consent 
• 
Request to withdraw from the investigation 
• 
Non-compliance (less than 85%) with, or inability to complete, CIP procedures 
• 
Lost to follow-up 
• 
Adverse event (if the subject experiences an AE that, in the judgment of the Site 
Investigator, presents an unacceptable consequence or risk to the participant). 
If a subject is withdrawn from treatment, the Sponsor will be notified and the date and reason(s) 
for the withdrawal will be documented. If a subject is withdrawn, efforts will be made to perform 
all follow-up assessments, if possible. Other procedures may be performed at the Investigator’s 
(or designee’s) and/or Sponsor’s discretion. The Investigator (or designee) may also request that 
the subject return for an additional Follow-up visit. All withdrawn subjects will be followed until 

resolution of all their AEs or until the unresolved AEs are judged by the Investigator (or designee) 
to have stabilized. 
Subjects who are withdrawn for reasons not related to the investigational treatment may be 
replaced following discussion between the Investigator and the Sponsor. Subjects withdrawn as 
a result of AEs thought to be related to the investigational treatment will generally not be replaced. 
The following actions must be taken if a subject fails to return to the laboratory for a required study 
visit: 
• 
The site will attempt to contact the subject and reschedule the missed visit within 3 working 
days 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 participant’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the participant’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. 
 
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.  
6.6 
Prohibited Medications 
No medications are prohibited during this brief trial.  For those wearing hearing aids at the time of 
the trial, they are asked to refrain from use of their personal hearing aids during the course of this 
study and while using the Jabra Enhance Plus devices.  
7.0 TRAINING PLAN 
7.1 
Training Plan for Research Device 
All relevant study site personnel and participating subjects will be trained on the investigational 
device using standardized training materials.  All study site personnel will be trained before 
research begins. 
7.2 
Training Plan for Protocol 
All study site personnel will be trained on the study protocol using standardized training materials.  
All study site personnel will be trained before research begins. 

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8.0 DATA ANALYSIS AND STATISTICS 
8.1 
Statistical Analysis Methods 
8.1.1 
In-Lab – Test-Retest Reliability (initial Self-Fit A vs. initial Self-Fit B) 
i. 
Paired-sample t-tests of equivalence of the four-frequency (500, 1000, 2000 and 
4000 Hz) average REAG and the QuickSIN comparing initial-fit settings from the 
SELF-FIT A procedure and the initial-fit settings from the SELF-FIT B procedure.  
ii. 
Supplementary analyses will include examination of the distribution of differences 
in dB between the four-frequency average REAGs and the QuickSIN threshold 
SNRs for initial-fit settings from the SELF-FIT A and B procedures, as well as 
computation of test-retest correlation coefficients for each measure. 
8.1.2 
In-Lab REAG – Validity (initial Pro-Fit vs initial Self-Fit A) 
i. 
Paired-sample t-test for equivalence of the means of the initial-fit settings of the 
SELF-FIT A procedure to the means of the initial-fit settings of the PRO-FIT 
procedure 
ii. 
Supplementary analyses will include examination of the distribution of differences 
in dB between the four-frequency average REAGs for initial-fit settings of the 
SELF-FIT A procedure and initial-fit settings of the PRO-FIT procedure, as well as 
computation of correlation coefficients between the two measures. 
8.1.3 
In-Lab QuickSIN Test - Validity (initial Pro-Fit vs. initial Self-Fit A) 
i. 
Paired-sample t-test for equivalence of the means of the initial-fit settings of the 
SELF-FIT A procedure to initial-fit settings of the PRO-FIT procedure 
ii. 
Supplementary analyses will include examination of the distribution of differences 
in dB between the QuickSIN threshold SNRs for initial-fit settings of the SELF-FIT 
A procedure and the initial-fit settings of the PRO-FIT procedure, as well as 
computation of correlation coefficients between the threshold SNRs for each 
method. 
8.1.4 
Wear-Time Field Trial - Validity: APHAB (final PRO-FIT vs. final SELF-FIT A) 
i. 
Non-Inferiority t-Test for 2 (wear-time sequences) X 2 (fit conditions) 
ii. 
Supplementary analyses will include examination of the distribution of differences 
between the APHAB-global scores for final-fit settings of the SELF-FIT A 
procedure and final-fit settings of the PRO-FIT procedure, as well as computation 
of correlation coefficients between the two measures. Datalogging will also provide 
details of the subject's adjustment of the devices during each segment of the cross-
over wear-time trial.  
8.1.5 
Wear-Time Field Trial - Validity: QuickSIN (final PRO-FIT vs final SELF-FIT A) 

i. 
Non-Inferiority t-Test for 2 (wear-time sequences) X 2 (fit conditions) 
ii. 
Supplementary analyses will include examination of the distribution of differences 
in dB between the QuickSIN threshold SNRs for final-fit settings of the SELF-FIT 
A procedure and the final-fit settings of the PRO-FIT procedure, as well as 
computation of correlation coefficients between the threshold SNRs for each 
method. 
8.2 
Interim Analysis 
No interim analysis will be performed for this investigation. 
8.3 
Missing Data Management 
All planned data will be collected as complete and as timely as possible.  No imputation of missing 
data is anticipated. 
8.4 
Pass/Fail Criteria of the Study 
For the in-lab session, the primary effectiveness endpoint will be assessed by the differences in 
acoustical real-ear aided gain (REAG), a gold-standard measure for the acoustical function of 
hearing devices for the study population. This endpoint will be used to assess mean absolute-
value differences between two replications of the self-fit method (reliability) and between the self-
fit and professional-fit methods (validity or effectiveness). 
For the wear-time trial, the primary outcome measure is a widely used clinical self-report measure 
of benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB). The APHAB is also a gold-
standard, validated assessment of hearing-aid benefit relevant for the study population.  
Secondary effectiveness endpoints for both the laboratory and field-trial components will be 
assessed by a standardized measure of speech communication in noise, the QuickSIN.  This is 
a widely used clinical measure of an adult’s ability to understand speech in noise and is closely 
tied to the wearer’s primary complaint, difficulty communicating in noise. 
Overall study success will be defined by meeting all primary endpoints for the reliability, 
effectiveness, and safety of the devices and the self-fitting process in the laboratory and field-trial 
components of this study.  Effectiveness outcomes from the SELF-FIT process should be 
equivalent to those of the PRO-FIT method in the in-lab session and non-inferior to PRO-FIT in 
the wear-time trial for the study to be considered successful. 
9.0 DEVIATIONS 
9.1 
Management of Protocol Deviations 
A CIP deviation is any noncompliance with the CIP, ISO 14155 Good Clinical Practice (ISO GCP), 
or Manual of Procedures requirements.  The noncompliance may be either on the part of the 
subject, the site investigator, or the study site staff.  As a result of deviations, corrective actions 
are to be developed by the site and implemented promptly.  These practices are consistent with 
ISO 14155 GCP 9.6 Compliance with the CIP and 8.1 Clinical quality Assurance and Quality 
Control. 

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There are two types of CIP deviations, critical deviations and non-critical deviations. All deviations 
must be documented and reported, the criticality of the deviation will determine the reporting path. 
Critical Deviations: Deviations that significantly affect the safety, effectiveness, integrity or 
conduct of the study. These deviations must be reported to the Sponsor no later than 5 working 
days from awareness of occurrence and reported to the IRB per the deviation reporting policy.  
Note: If an Investigator uses a device without obtaining informed consent, the Investigator shall 
consider this a critical deviation and report the event to the Sponsor and the IRB within 5 working 
days of the occurrence. 
Non-Critical Deviations: CIP deviations that do not significantly affect the safety, effectiveness, 
integrity or conduct of the study are considered non-critical deviations. These deviations must be 
documented and will be reviewed by the study monitor. 
It is the responsibility of the site investigator to use continuous vigilance in order to identify 
deviations. All deviations must be addressed in study source documents with explanations as well 
as reported to GN Hearing A/S as soon as possible. CIP deviations must be sent to the reviewing 
IRB per their policies. The site investigator is responsible for knowing and adhering to the 
reviewing IRB requirements. 
The site investigator is not allowed to deviate from the CIP without prior authorization received 
from the Sponsor, except under emergency situations when necessary to preserve the rights, 
safety, or well-being of investigation subjects. In the event the deviation involves a failure to obtain 
a subject’s consent or is made to protect the life or physical well-being of a subject in an 
emergency, the deviation must be reported to the IRB as well as GN Hearing A/S as soon as 
possible but no later than five (5) working days from the date of the deviation occurrence. 
Larry E. Humes is responsible for analyzing deviations, assessing their significance, and 
identifying any additional corrective and/or preventive actions which may include amending the 
CIP, conducting additional training, terminating the investigation, etc. Repetitive or serious 
investigator compliance issues may represent a need to initiate a corrective action plan with the 
investigator and site, and in some cases, necessitate suspending enrollment at that site until the 
problem is resolved or ultimately terminating the site investigator's participation in the study.  
10.0 COMPLAINT HANDLING AND ADVERSE EVENT 
REPORTING 
10.1 Foreseeable Adverse Events and Device Effects 
Adverse events (AEs) are expected to be extremely rare based on the low risk profile of the 
device. In rare cases, it is foreseeable that study subjects may experience moderate to mild and 
typically spontaneously resolving: 

• 
Psychological distress or exacerbation of existing psychological or anxiety conditions, 
related to the requirements of various features of the device 
• 
Effects related to mechanical interaction with the device, such as eye strain leading to 
headaches or in rare cases blurred vision, strain of the digits, or transient discomfort 
For the purposes of this study, the following will not be considered or reported as AEs: 
• 
Unchanged, chronic, non-worsening of a pre-existing conditions  
• 
A planned hospitalization for pre-existing condition, any outpatient medical or surgical 
procedures, or hospitalization due to an elective surgery planned prior to 
screening/baseline visit 
• 
Stable, intermittent chronic conditions present prior to screening/baseline visit that do not 
worsen during the study  
• 
Outpatient medical or surgical procedures planned prior to screening/baseline visit 
As with any medical device that involves electronic transfer of subject data, use of the device may 
pose risk to study subject privacy. These risks have been mitigated by design to levels considered 
As Low as Possible in compliance with ISO 14971:2019 Medical Devices – Application of risk 
management to medical devices. 
These foreseeable risks are not elevated beyond levels that would have occurred within the study 
subject’s standard care.  The site investigator or designee will be responsible for determining 
whether an adverse event is foreseeable or not foreseeable.  An AE will be considered not 
foreseeable if the nature, severity, or frequency of the event is not consistent with the risk 
information previously described for the study. 
As in any medical device study, defects may be discovered during testing of the medical device. 
All defects will be documented during the course of the study as per ISO 14155 and applicable 
CFR requirements. 
10.2 Adverse Event Definitions  
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject 
receiving investigational treatment, which does not necessarily have a causal relationship with 
this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an 
abnormal laboratory finding), symptom, or disease temporally associated with the use of an 
investigational medical device, whether or not related to the investigational medical device.  
Section 1.5, Device Risk Analysis contains a list of foreseeable AEs and adverse device effects. 
Specific adverse event protocols are defined the by IRBs at Vanderbilt UniversityNorthwestern 
University, and Sertoma Speech and Hearing Center; however, these protocols are consistent 
with the following. In addition, Device Risk Assessments and determinations will be performed by 
the appropriate committees at Vanderbilt and Northwestern Universities as well as Sertoma 
Speech and Hearing Center.  
Treatment-Emergent AEs are AEs that are new-onset, or worsen in severity, and are not 
anticipated due to the nature of this study and device. 
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that either:  

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• 
results in death 
• 
is life threatening 
• 
requires inpatient hospitalization or prolongation of existing hospitalization 
• 
results in persistent or significant disability/incapacity (disability is defined as a substantial 
disruption of a person’s ability to conduct normal life functions) 
• 
results in a congenital anomaly/birth defect 
• 
requires intervention to prevent permanent impairment or damage 
• 
results in an important medical event 
 
Device issue or deficiency is an inadequacy of a medical device related to its identity, quality, 
durability, reliability, safety, or performance, such as malfunction, misuse, or use error and 
inadequate labeling. 
An Adverse Device Effect (ADE) is an AE related to the use of an investigational medical device. 
This definition includes AEs resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational 
medical device. The definition also includes any event resulting from use error or from intentional 
misuse of the investigational medical device. 
Unanticipated Adverse Device Effect (UADE)  means any serious adverse effect 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, according to 21 CFR 812.3. 
10.3 Monitoring 
The condition of each subject will be monitored from the time of signing the ICF to final discharge 
from the investigation. Subjects will be observed for any signs or symptoms and asked about their 
condition by open questioning, such as “How have you been feeling since you were last asked?” 
at least once each day at each investigation visit. Subjects will also be encouraged to 
spontaneously report AEs occurring at any other time during the investigation. 
All nonserious AEs, whether reported by the subject voluntarily or upon questioning, or noted on 
physical examination, will be recorded from initiation of investigation treatment until investigation 
completion. Serious AEs will be recorded from the time the subject signs the ICF until investigation 
completion. The nature, time of onset, duration, and severity will be documented, together with 
an Investigator’s, or designee’s, opinion of the relationship to investigation treatment. 
If an AE occurs, appropriate diagnostic and therapeutic measures are to be taken and the 
investigational treatment must be discontinued if appropriate. Follow-up evaluations of the subject 

are to be performed until the subject recovers or until the clinical Investigator considers the 
situation to be no longer clinically significant. 
If clinically significant laboratory abnormalities appear at the final treatment, appropriate additional 
tests may be performed to clarify the nature of any clinically significant laboratory abnormalities 
that occur. 
10.4 Assessment of Severity 
The site Investigator will be asked to provide an assessment of the severity of the AE using the 
following categories:  
Event Severity  
Severity Definition  
Mild  
Usually transient and may require only minimal treatment or 
therapeutic intervention. The event does not generally interfere with 
usual activities of daily living. The AE does not influence 
performance or functioning. Prescription drugs are not ordinarily 
needed for relief of symptom(s).  
Moderate 
Usually alleviated with additional specific therapeutic intervention. 
The event interferes with usual activities of daily living, causing 
discomfort but poses no significant or permanent risk of harm to the 
participant. Performance of daily activities is influenced. Treatment 
of symptom(s) may be needed. 
Severe 
Interrupts usual activities of daily living, or significantly affects clinical 
status, or may require intensive therapeutic intervention. Treatment 
for symptom(s) may be given. 
10.5 Relationship to Investigation Treatment 
The site Investigator will determine the relationship of the AE to the investigational device 
according to the following guidelines: 
 
Event Relationship  
Relationship Definition  
Unrelated 
The adverse event is reasonably expected to be related to (or 
caused by) a concurrent illness, effect of another device/drug or 
other cause, and is unlikely related to the investigational product. 
Possibly Related 
The adverse event is reasonably expected to be related to the 
investigational product, and an alternative etiology is equally or less 
likely compared to the potential relationship to investigational 
product. 
Probably Related 
There is a strong relationship to investigational product, or recurs on 
re-challenge, and another etiology is unlikely, or there is no other 
reasonable medical explanation for the event. 
10.6 Action Taken for Adverse Events 
The site investigator or designee will record the action taken for the AE in the Case Report Form. 
Actions taken will include: 

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Action 
Action Definition  
Treatment Interrupted 
The treatment was modified by temporarily terminating the 
treatment. 
Treatment Withdrawn 
The treatment was modified through termination of the treatment. 
Not Applicable 
No action is needed. 
Unknown 
The action is unknown or to be determined. 
10.7 Follow-up of Adverse Events 
Every reasonable effort will be made to follow up with subjects who have AEs. Any subject who 
has an ongoing AE that is related to the investigational medical device during visits will be followed 
up with, where possible, until resolution. This will be completed at the site investigator’s (or 
designee’s) discretion. Any subject who has an ongoing AE that is not related to the investigational 
medical device at follow-up visits can be closed out as ongoing at the Investigator’s discretion. 
10.8 Reporting 
10.8.1 
Device Issue or Deficiency 
Any issues regarding the operation of the device or any malfunctions are to be reported to the 
sponsor. All reported issues will be processed per the Manufacturer’s standard operating 
procedures outside of the study. Information about device issues to be provided to manufacturers 
will include a description of the event, dates of onset and resolution, action taken, and the 
outcome.  
Copies of all issues documentation submitted to manufacture(s) will be stored as part of the study 
record. If additional information is needed from sites or investigators, the Sponsor or its delegate 
may contact the investigator for follow-up information necessary to investigate reported device 
issue. 
It is the responsibility of the site investigator to report any issues associated with a medical device 
distributed by the Sponsor, regardless of whether they are related to intended use, misuse, or 
abuse of the product. Reporting must be done as soon as possible (within 48 hours). 
10.8.2 
Adverse Events 
Adverse events are monitored and registered at each visit. In absence of a specific diagnosis, an 
individual AE form must be filled in for each sign or symptom.  Adverse events will be reported to 
the local IRB as required by their policy and monitored by the Sponsor’s delegated monitor. 
Persistent AEs will be recorded once until they are resolved or if a new event must be documented 
due to deterioration. These AEs will be carefully monitored; further details of monitoring of 
persistent AEs will be provided in the monitoring plan. If an AE is still not resolved at the end of 
the investigation, this will be documented as ongoing. 
For recurrent AEs (i.e., AEs of the same nature, but with a different date of onset), an individual 
AE form must be completed for each of them. 

Adverse events occurring after the termination of the investigation individually and/or of the 
investigation in total are to be reported to the Sponsor even after the clinical investigation has 
been finished if, in the judgment of the Investigator, there is an association between the event 
and the previous use of the Device under investigation. 
10.8.3 
Anticipated/Unanticipated Adverse Device Effect  
All relevant observations, including records concerning adverse device effects (whether 
anticipated or unanticipated) will be recorded of each subject's study record, per 21 CFR 812.140 
or relevant national regulation. 
The site investigator will notify the Sponsor or designee and reviewing IRB in writing (e.g., 
facsimile) immediately, but no later than 72 hours of when an UADE, that is potentially FDA 
reportable, is first recognized or reported. 
The sponsor will immediately conduct an evaluation of any UADE reported.  The sponsor will 
report the results of the evaluation to FDA and to all reviewing IRB and participating investigators 
within 10 working days after the sponsor first receives notice of the effect. Thereafter the sponsor 
will continue to submit additional reports to the FDA when requested. 
If the sponsor determines that an UADE presents an unreasonable risk to subjects, the sponsor 
shall terminate all investigations or parts of investigations presenting that risk as soon as possible. 
Termination shall occur not later than 5 working days after the sponsor makes this determination 
and not later than 15 working days after the sponsor first received notice of the effect. 
11.0 EARLY TERMINATION OR SUSPENSION 
11.1 Study Closure, Early Termination or Suspension Criteria 
Study closure is defined as closure of a clinical study that occurs when GN Hearing A/S and/or 
regulatory requirements have been satisfied per the protocol and/or by a decision by GN Hearing 
A/S or regulatory authority, whichever occurs first.  Study Closure is a process initiated by 
distribution of an initial study closure letter. The study closure process is complete upon 
distribution of the Final Report or after final payments, whichever occurs last. 
The study may be terminated early if the Sponsor determines that unanticipated adverse event(s) 
presents an unreasonable risk to subjects or for any other reason as Sponsor determines to be 
appropriate.  Termination shall occur no later than five (5) working days after the sponsor makes 
the determination and no later than fifteen (15) working days after Sponsor first received notice 
of the effect. 
The Sponsor will promptly notify the Investigators of any determination to terminate the study 
outside of the protocol timeframe. The Sponsor will provide each Investigator with written 
guidelines/instructions on termination processes and timelines. The Investigator is responsible for 
reporting the early termination to their local IRB. 
Possible reasons for considering study suspension or termination of the study for all centers 
include but are not limited to AEs and device deficiencies associated with the system or product 
under investigation which might endanger the safety or welfare of subjects; observed/suspected 

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performance different from the product’s design intent; cancelation of device development; and/or 
a decision by GN Hearing A/S or regulatory body. 
Possible reasons for clinical investigator or center termination or suspension include but are not 
limited to a failure to obtain initial IRB approval or annual renewal of the study; consistent non-
compliance to the protocol; lack of enrollment; noncompliance to regulations and the terms of the 
Clinical Study Agreement, such as failure to submit data in a timely manner, failure to follow-up 
on data queries and monitoring findings in a timely manner, etc.; IRB suspension of the center; 
fraud or fraudulent misconduct, as defined by local law and regulations; and/or Investigator 
request. 
11.2 Withdrawal of IRB Approval 
The site investigator is to notify the Sponsor of any withdrawal of IRB approval within 5 working 
days of such occurrence. If the IRB terminates or suspends its approval of the Study, the site 
investigator will promptly notify Sponsor and provide a detailed written explanation of the 
termination or suspension. Upon receipt, the sponsor will provide written guidelines/instructions 
on subject withdrawal/termination processes and timelines. 
12.0 INSTITUTIONAL REVIEW BOARD (IRB) AND 
REGULATORY REQUIREMENTS 
12.1 Regulatory Requirements 
To ensure the quality and integrity of research, this study will be conducted according to 21 CFR 
Part 812 and related regulations, principles of ISO 14155 Good Clinical Practice (GCP), and the 
Declaration of Helsinki and its amendments. 
12.2 IRB Approval Requirements 
To approve the research described in the Clinical Investigation Plan (CIP), the IRB shall determine 
that all the following are satisfied in accordance with 21 CFR 56.111. 
• 
Risks to subjects are reasonable in relation to anticipated benefits 
• 
Selection of subjects is equitable 
• 
Informed consent will be sought and appropriately documented  
• 
Data will be monitored and collected, where appropriate, to ensure the safety of subjects 
• 
Safeguards have been included to protect the rights and welfare of subjects that are likely 
to be vulnerable to coercion or undue influence 
This investigation will be conducted in accordance with the CIP and with the following: 

• 
Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical Sciences 
International Ethical Guidelines 
• 
Applicable International Organization for Standardization (ISO) Good Clinical Practice 
(GCP) Guidelines 
• 
Applicable regulations: 
- 
21 CFR 50, Protection of Human Subjects, provides the requirements and general 
elements of informed consent; 
- 
21 CFR 56, Institutional Review Boards, covers the procedures and responsibilities 
for institutional review boards (IRBs) that approve clinical investigations protocols; 
- 
21 CFR 54, Financial Disclosure by Clinical Investigators, covers the disclosure of 
financial compensation to clinical investigators which is part of FDA’s assessment of 
the reliability of the clinical data. 
- 
21 CFR 820 Subpart C, Design Controls of the Quality System Regulation, provides 
the requirement for procedures to control the design of the device in order to ensure 
that the specified design requirements are met. 
Where applicable and consistent with local regulations and prior to enrolment of subjects, the CIP, 
CIP amendments, Informed Consent Form (ICF), Investigator Brochure, and other relevant 
documents must be submitted to an IRB by the Investigator and reviewed and approved by the 
IRB before the investigation is initiated.  Any additional requirements imposed by the IRB or 
regulatory authority shall be followed, if appropriate. Enrollment will not start before written 
confirmation of approval from the relevant central or local IRB. 
The site investigator will be responsible for the following: 
• 
Providing written summaries of the status of the investigation to the IRB annually or more 
frequently in accordance with the requirements, policies, and procedures established by 
the IRB. 
• 
Notifying the IRB of serious adverse events or other significant safety findings as required 
by IRB procedures. 
• 
Providing oversight of the conduct of the investigation at the site and adherence to 
requirements of 21 Code of Federal Regulations (CFR), ISO 14155 guidelines, the IRB, 
and all other applicable local regulations. 
12.3 Subject Compensation 
Participants who fail the inclusion criteria will be compensated $60. All others will be compensated 
at a rate of $60 for each of the three lab sessions plus $70 for the wear trial (a total of $250). 
Payment will be given at one time at the end of the study. 
12.4 CIP Revision/Amendment Management 
Changes to the CIP will be documented in written CIP amendments.  Major, substantial or 
significant, amendments will usually require submission to the relevant IRB for approval.  In such 
cases, the amendment will be implemented only after approval from the IRB has been obtained, 
except for changes necessary to eliminate an immediate hazard to investigation subjects. Minor, 

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non-substantial, CIP amendments, including administrative changes, will be filed by the designee 
at each participating site and will be submitted to the relevant IRB or regulatory authorities where 
required by pertinent regulations. Any amendment that could have an impact on the participant’s 
agreement to participate in the study requires the participant’s informed consent prior to continued 
participation in the study. 
12.5 Informed Consent and Privacy Requirements 
12.5.1 
Informed Consent 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in 
the study and continues throughout the individual’s study participation. Consent forms will be 
IRB/IEC-approved, and the subject will be asked to read and review the document. The 
investigator will explain the research study to the subject and answer any questions that may 
arise. A verbal explanation will be provided in terms suited to the participant’s comprehension of 
the purposes, procedures, and potential risks of the study 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 study with their family or 
surrogates or think about it prior to agreeing to participate. The subject will sign the informed 
consent document prior to any procedures being done specifically for the study. Subjects must 
be informed that participation is voluntary and that they may withdraw from the study 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 provided, before the subject undergoes any study-
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 study. 
The informed consent forms (ICFs) will describe in detail the study intervention, study procedures, 
and risks are given to the participant, and written documentation of informed consent is required 
prior to the study start.   
The site investigator or authorized designee must administer the approved ICF to each 
prospective study patient without coercion or undue improper influence on, or inducement of, the 
patient to participate. During the consent discussion the site investigator (or designee) must fully 
inform the patient of all pertinent aspects of the study, using native non-technical language that 
is understandable to the patient. The subject must be informed about their right to withdraw from 
the study at any time and for any reason without sanction, penalty, or loss of benefits to which the 
subject is otherwise entitled and also informed that withdrawal from the study will not jeopardize 
their future medical care. The subject must also be informed that by participating in the study, 
they are not waiving their legal rights. The patient must have ample time and opportunity to inquire 
about details of the study, and to decide whether or not to participate in the clinical study. All 

questions about the study should be answered to the satisfaction of the participant. All items 
discussed in the ICF must be explained. 
The ICF should be revised whenever there are changes to procedures outlined in the informed 
consent or when new information becomes available that may affect the willingness of the subject 
to participate. For any updated or revised ICFs, the medical file for each subject should document 
the informed consent process and that written informed consent was obtained for the 
updated/revised ICF for continued participation in the study. 
12.5.2 
Privacy Requirements 
Subject confidentiality and privacy is strictly held in trust by the participating investigators, their 
staff, and the sponsor(s). All health data collection is conducted in a manner compliant with 21 
CFR Part 11 and applicable data privacy law and regulation in the US. Therefore, the study 
protocol, documentation, data, and all other information generated will be held in strict confidence. 
No information concerning the study, or the data will be released to any unauthorized third party 
without prior written approval of the sponsor. Additionally, all research activities will be conducted 
in as private a setting as possible. 
Data protection and privacy regulations will be strictly observed in capturing, forwarding, 
processing, and storing subject data. Every effort will be made to protect subject confidentiality. 
To maintain patient confidentiality, each patient will be assigned a unique subject identifier upon 
study enrolment. This subject identifier will be used in place of subject name for data analysis and 
reporting. Medical record number or other local reference identifiers are not collected as part of 
the database. All parties will ensure protection of subject personal data and will not include subject 
names on any study forms, reports, publications, or in any other disclosures, except where 
required by law. In accordance with local regulations in each of the registry countries, subjects 
will be informed about data handling procedures and asked for their consent. Data protection and 
privacy regulations will be observed in capturing, forwarding, processing, and storing patient data.  
The study monitor, other authorized representatives of the sponsor, representatives of the IRB, 
regulatory agencies or Sponsor supplying study product may inspect all documents and records 
required to be maintained by the investigator, including but not limited to, medical records for the 
subjects in this study. The clinical study site will permit access to such records. 
Subjects will be assigned a unique identifier and will not be identified by name in electronic 
databases, investigation-related forms, investigation reports, or any related publications. Subject 
and Investigator personal data will be treated in compliance with all applicable laws and 
regulations. In the event the CIP, investigation report, or investigation data are included in a public 
registry, all identifiable information from individual subjects or Investigators will be redacted 
according to applicable laws and regulations.  
The subject must be informed that her personal investigation-related data will be used by the 
Sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant. The subject must also be informed that her investigation-related data 
may be examined by Sponsor or Contract Research Organization (CRO) auditors or other 

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authorized personnel appointed by the Sponsor, by appropriate IRB members, and by inspectors 
from regulatory authorities. 
13.0 DATA AND QUALITY MANAGEMENT 
This study will be performed by Northwestern University, Sertoma Speech and Hearing Center, 
and Vanderbilt University with guidance, input, review, and approval of GN Hearing A/S, including 
development of materials, recruitment, training and management of the site, electronic data 
capture and data management.  
13.1 Management of Data 
High data quality standards will be maintained, and processes and procedures utilized to 
repeatedly ensure that the data are as clean and accurate as possible when presented for 
analysis. Data quality will be enhanced through a series of programmed data quality checks that 
automatically detect out of range or anomalous data.  
The following practices are adopted to ensure data integrity and participant safety:   
1. Data, including outcomes data, should not be shared with GN Hearing A/S until study 
completion.  There are two components to this study: (1) in-lab session (Visit 1); and wear-
time crossover trial (Visits 2 and 3).  Outcome data can be shared with GN Hearing A/S 
at the completion of each component to this study.  That is, the results from Visit 1 can be 
shared with the sponsor as soon as they are available and prior to the completion of the 
entire study. 
2. The site investigators should be blinded from the raw data and the research staff on site 
should enter the data into an electronic database (REDCap). Weekly reports of completed 
data for each visit will be generated by research staff at each site and will be sent to Larry 
Humes. Progress reports, generated by Larry Humes, will tabulate the number of subjects 
who have complete data for Visit 1, Visit 2, and Visit 3, for each site separately and 
combined. Such progress reports will be provided via email to GN Hearing A/S (Troels 
Vingborg and Todd Fortune) and shared with the site investigators (Ricketts, Dhar) on a 
weekly basis.  
3. Larry Humes will monitor the quality of the data exported from REDCap.  PRO-FIT REAG 
values will be checked to determine that they are reasonable, within 5-7 dB of NAL targets, 
for the measured pure-tone hearing loss for that participant.  The pattern across frequency 
for the REAG differences between test and retest will also be examined to assess data 
validity. Such differences should generally be less than 5 dB at a given frequency and also 
should not decrease with increasing frequency.  Concerns about the quality of data being 
gathered will be shared with each site investigator and GN Hearing A/S as soon as 
possible. 

4. Trained research staff at each site should report any concerns about the quality or validity 
of the raw data being obtained to the local site investigator immediately and this feedback 
should be shared among the two site investigators and Larry Humes immediately to 
determine if protocol amendments are warranted to address these concerns.  
5. At study completion at each site, Larry Humes will be primarily responsible for data 
reduction and analyses with drafts shared with GN Hearing A/S and that site’s PI.  When 
both sites have completed data collection, Larry Humes will complete the data reduction 
and analyses, draft a report, and share this report with both site PIs and GN Hearing A/S.   
7. Any adverse events experienced by the participants should be reported by the site 
investigator to Larry Humes and Carol Sammeth with serious adverse events reported 
immediately to GN Hearing A/S and the FDA as well. See Section 10.0 for additional 
details. 
13.2 Subject De-Identification 
At the end of the study, all study databases will be de-identified and archived at the designated 
data coordinating center. 
Data collected for this study will be analyzed and stored at the data coordinating center. After the 
study is completed, the de-identified, archived data will be transmitted to and stored at the 
designated data repository, for use by other researchers including those outside of the study. 
Permission to transmit data to the data repository will be included in the informed consent.  
When the study is completed, access to study data and/or samples will be provided through the 
data repository. 
13.3 Site Record Retention 
Site Record retention will be defined by the IRB policies at Vanderbilt University, Northwestern 
University, and Sertoma Speech and Hearing Center.  
14.0 MONITORING PLAN 
14.1 Brief Description 
In collaboration with investigational site(s), the Sponsor will ensure proper monitoring of the study 
to confirm that all Sponsor obligations are met and that the study is performed in accordance with 
the CIP. Monitoring calls and emails will ensure adherence to the CIP, completion of informed 
consents, IRB/IEC review of the study, maintenance of records, primary outcomes review and 
source documentation for accuracy and completeness. Further information and details regarding 
monitoring arrangements can be found in the monitoring plan. 
14.2 Reference to Approved Monitoring Plan 
The approved monitoring plan will be maintained by the Sponsor or its delegate throughout the 
study. 

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15.0 PUBLICATION POLICY 
Any publication of the results from this study must be consistent with the Sponsor’s publication 
policy.  The rights of the investigator and of the Sponsor with regards to publication of the results 
of this study/registry are described in the investigator contract.  
The results of this study are intended for use in submission to the FDA in support of a 510k 
submission for the Jabra Enhance Plus device. This study will be registered into the 
clinicaltrials.gov website. 
 
 

16.0 ADDITIONAL STUDY MATERIALS 
ATTACHMENT A:  See attached clinical study user’s manual for Jabra Enhance Plus  
 
ATTACHMENT B:  Real-ear measurement details  
 
A. 
SELF-FIT A & B: Personalization begins with an estimate of hearing acuity obtained through 
the Jabra Enhance Plus. The hearing acuity measurements are used internally by the device and are not 
shared with the hearing aid wearer. Once this step has been completed, devices will apply NAL-NL2 gain 
prescriptions directly using the estimated hearing acuity to generate the initial fit.  For the clinical 
validation study, probe-tube microphone measures of the REUR and REAR (REAG=REAR in input) will 
be obtained on the initial fit for a 65-dB speech input using the Audioscan Verifit real-ear measurement 
system, with instructions as follows: 
 
i. 
Use the Audioscan Verifit (see procedure below) to measure Real Ear Aided Response 
(REAR) using the GN-supplied dome/probe tube assembly. 
ii. 
Without adjusting the gain, determine how close the 65 dB-Input referenced Response 
curve from the output of the device is to the NAL-NL2 65 dB REAR Targets in the 
Verifit 1 or 2. 
iii. 
Audioscan includes a method for saving measurements to a USB drive. Please use this 
method for saving the REAR measurements and Targets for analysis of the output. 
iv. 
The file saved to the USB drive should include a .html or .csv file with frequency-
specific values that can be used for plotting and analyzing the results. 
 
B. 
PRO-FIT: Audiometric thresholds will be imported, and the devices programmed using custom 
device programming software (AlgoLabTest) and configured for NAL-NL2 target gains. Probe-tube 
microphone measures of the REUR and REAR (REAG=REAR-REUR) will be obtained for a 65-dB 
speech input using the Audioscan Verifit real-ear measurement system, with instructions as follows:  
 
i. 
Use the Audioscan Verifit (see procedure below) to measure Real Ear Aided Response 
(REAR) using the GN-supplied dome/probe tube assembly. 
ii. 
Using AlgoLabTest to adjust the gain, attempt to match the 65 dB Gain curve from the 
output of the device to the NAL-NL2 65 dB Gain Targets in Verifit. 
iii. 
Audioscan includes a method for saving measurements to a USB drive. Please use this 
method for saving the REAR measurements and targets for analysis of the output. 
iv. 
The file saved to the USB drive should include a .html or .csv file with frequency-
specific values that can be used for plotting and analyzing the results. 
 

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C. 
Audioscan Verifit; Speechmap Configuration 
(https://docs.audioscan.com/userguides/vf2manual.pdf):  
  
 
i. 
Targets: Select [NAL-NL2] 
ii. 
Age: Select [Adult; age ≥ 18 years] 
iii. 
HL Transducer: Select [the Headphone or insert 
earphone used for testing] 
iv. 
RECD: Select [average] 
v. 
Binaural: Select [Yes] 
vi. 
Language: Select [Non tonal] 
 
 
 
 
 
 
D. 
Audiometric Threshold Entry 
i. 
On the Threshold entry prompt, enter each threshold from the initial screening using a 
mouse or an external keyboard. Left click the mouse to enter a point. Click again to 
delete the point. On the keyboard, the arrow keys change frequency and level and the 
ENTER key on the numeric keypad enters or deletes a point. The keyboard's numeric 
keypad can also be used to type in data. Switch sides by moving mouse cursor over to 
other side.  
ii. 
Use the X button to erase the curve next to it.  
iii. 
Use the Copy button at the bottom of the entry screen to copy points on either side to the 
other side if there are data on one side and no data on the other. The button is disabled 
and does nothing if both sides contain data or both sides do not contain data.  
iv. 
Click [check] to save the data and exit the entry screen. In case of error: Click [X] to exit 
the entry screen without saving the data. 
 
E. 
Fitting to Targets for Average Speech 

  
i.
 
Follow the instructions in Speechmap screen choices to enter audiometric data 
and select the fitting rule (NAL-NL2).  
ii. 
Click [play] in the "2" area to start the test. Once the test is started, click the [Stimulus] 
list button to select the stimulus type. Select “Speech-ISTS” as the stimulus type. Click 
the [Level] list button and select a stimulus level of 65 dB. The upper bar in this area 
shows the SII for the unaided stimulus at 65 dB SPL.  
iii. 
PRO-FIT ONLY: While the passage is being presented, adjust the hearing instrument's 
frequency shaping and gain for average sounds so that the middle curve (the LTASS) 
falls within the target range, shown by the 
  symbols.  
iv. 
Click [record] to signal average and store a complete passage. Repeat as necessary. 
v. 
In case of error: Click [black square] to stop the test without recording any test data. 
vi. 
Upon completion of a test recording, a colored Aided Audibar shows the SII for the aided 
average speech signal. The difference between the unaided and aided SII score (and the 
associated length of their respective 'Audibars') visually quantifies the speech 
intelligibility improvement for soft speech likely provided by the hearing instrument 
being fit. 
 
17.0 REFERENCES 
1. Cox, R.M. & Alexander, G.C. (1995).  The Abbreviated Profile of Hearing Aid Benefit 
(APHAB).  Ear & Hearing, 16, 176-186. 

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2. Killion, M. C., Niquette, P. A., Gudmundsen, G. I., Revit,L. J., & Banerjee, S. (2004). 
Development of a quick speech-in-noise test for measuring signal-to-noise ratio loss 
in normal-hearing and hearing-impaired listeners. Journal of the Acoustical Society 
of America, 116, 2395–2405. 
3. McArdle, R. A., & Wilson, R. H. (2006). Homogeneity of the 18 QuickSIN lists. Journal 
of the American Academy of Audiology, 17, 157–167. 
4. Sabin, A.T., Van Tasell, D.J., Rabinowitz, B. & Dhar, S. (2020).  Validation of a self-
fitting method for over-the-counter hearing aids. Trends in Hearing, 24, 1-19. 
 
18.0 APPENDICES 
Appendix A: 
List of Abbreviations 
ADE 
 Adverse Device Event 
AE 
APHAB 
 Adverse Event 
Abbreviated Profile of Hearing Aid Benefit 
CFR 
Code of Federal Regulations  
CIP 
Clinical Investigation Plan 
FDA 
U.S. Food and Drug Administration 
GCP 
Good Clinical Practices 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption 
IEC 
NAL-NL2 
Independent Ethics Committee 
National Acoustics Laboratories' Nonlinear prescription, Version 2 
PRO 
Patient-Reported Outcome 
QA 
Quality Assurance 
QC 
QuickSIN 
REAG 
REAR 
REOR 
Quality Control 
Quick Speech-In-Noise test 
Real-Ear Aided Gain 
Real-Ear Aided Response 
Real-Ear Occluded Response 

REUR  
Real-Ear Unaided Response 
SAE 
SNR 
Serious Adverse Event 
Signal-to-Noise Ratio 
TAE 
Treatment-Emergent AEs 
UADE 
Unanticipated Adverse Device Effect 
WHO 
World Health Organization 
Appendix B: 
Investigational Sites 
United States, Illinois 
Northwestern University 
Evanston, Illinois, United States, 60209 
Contact: Sumitrajit Dhar, PhD          
United States, Tennessee 
Vanderbilt University 
Nashville, Tennessee, United States, 37235 
Contact: Todd Ricketts, PhD 
   
United States, Illinois 
Sertoma Speech and Hearing Center 
 
Palos Hills, Illinois, United States, 60465 
Contact: Tom Wardzala, AuD