Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System
Conditions: Hearing Loss, Ear Diseases, Hearing Disorders, Otolaryngological Disease
Sponsor: Advanced Bionics

Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System 
Version # 1.2 / Version Date: May 26, 2021                    Confidential 
 
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Evaluation of Remote Fitting in Adult and Pediatric Users of 
the HiResolution Bionic Ear System 
 
 
 
 
 
 
 
 
 
 
Reference ID: CR0121 
Version: 1.2 
Version Date: May 26, 2021 
 
 
 
Contact information 
 
Sponsor 
Advanced Bionics LLC 
Sponsor Address: 
25815 Westinghouse Place 
 
Valencia, CA  91355 
 
USA 
 
 
 

Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System 
Version # 1.2 / Version Date: May 26, 2021                    Confidential 
 
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Table of Contents 
 
1. 
Synopsis ......................................................................................................................... 4 
2. 
Glossary and Abbreviations ............................................................................................ 6 
3. 
Background and Purpose of the Investigation ................................................................. 6 
4. 
Investigational Device Description .................................................................................. 7 
4.1 
Target CI DS Fitting Software ..................................................................................... 7 
4.2 
AB Remote DS App .................................................................................................... 7 
4.3 
Naída CI M DS Sound Processors .............................................................................. 8 
5. 
Study Design and Justification ........................................................................................ 8 
6. 
Objectives ..................................................................................................................... 10 
7. 
Study Protocol .............................................................................................................. 10 
7.1 
Subject Population and Selection Criteria ................................................................. 10 
7.1.1 Inclusion Criteria All Subjects ................................................................................ 10 
7.1.2 Inclusion Criteria Specific to ARH Group ............................................................... 10 
7.1.3 Exclusion Criteria All Subjects ............................................................................... 10 
7.2 
Study Endpoints ........................................................................................................ 11 
7.2.1 Efficacy ................................................................................................................. 11 
7.2.2 Supporting data ..................................................................................................... 11 
7.2.3 Safety .................................................................................................................... 11 
7.3 
Study Procedures ..................................................................................................... 11 
7.3.1 Audiometric Measures: .......................................................................................... 11 
7.3.2 Speech Perception Measures: .............................................................................. 12 
7.3.3 AzBio Sentence Test ............................................................................................. 12 
7.3.4 Questionnaires ...................................................................................................... 12 
7.4 
Study Visits and Visit Windows ................................................................................. 12 
7.4.1 Schedule of Events ............................................................................................... 12 
7.4.2 Visit 1 .................................................................................................................... 13 
7.4.3 Visit 2 .................................................................................................................... 13 
7.4.4 Visit 3 .................................................................................................................... 14 
7.5 
Withdrawal of Subjects .............................................................................................. 14 
8. 
Statistics ....................................................................................................................... 15 
8.1 
Sample Size Justification .......................................................................................... 15 
8.2 
Data Analyses ........................................................................................................... 16 
8.2.1 Efficacy Endpoints ................................................................................................. 17 
8.2.2 Supporting Data .................................................................................................... 17 
8.2.3 Analyses of Individual Results ............................................................................... 18 
8.2.4 Safety Endpoint ..................................................................................................... 18 
8.2.5 Supporting Data .................................................................................................... 18 
9. 
Adverse Events and Device Deficiencies ...................................................................... 19 
9.1 
Adverse Event Definitions and Classifications ........................................................... 19 
9.1.1 Serious Adverse Event .......................................................................................... 19 
9.1.2 Adverse Device Effect and Serious Adverse Device Effect ................................... 19 
9.1.3 Unanticipated Adverse Device Effect .................................................................... 19 
9.2 
Adverse Event Reporting .......................................................................................... 19 
9.3 
Anticipated Adverse Events ...................................................................................... 20 
9.4 
Device Deficiencies ................................................................................................... 21 
10. 
Informed Consent Process............................................................................................ 21 
10.1 
Health Insurance Portability and Accountability Act (HIPAA) ..................................... 21 
11. 
Vulnerable Population ................................................................................................... 21 
11.1 
Pediatric Subjects ..................................................................................................... 21 
12. 
Benefits and Risks ........................................................................................................ 22 
12.1 
Benefits ..................................................................................................................... 22 
12.2 
Risk related to Approved Products ............................................................................ 22 
12.3 
Risk related to Investigational Hardware ................................................................... 22 

Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System 
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12.4 
Risk related to Investigational Software .................................................................... 22 
13. 
Suspension or Premature Termination .......................................................................... 23 
13.1 
Criteria for Terminating the Study.............................................................................. 23 
13.2 
Criteria for Suspending or Terminating a Study Center ............................................. 23 
14. 
Monitoring, Device Accountability and Data Management............................................. 23 
14.1 
Monitoring Procedures .............................................................................................. 23 
14.2 
Device Accountability ................................................................................................ 24 
14.3 
Data Management Procedures / Case Report Forms ................................................ 24 
15. 
Statements of Compliance ............................................................................................ 25 
15.1 
Study Conduct .......................................................................................................... 25 
15.2 
Institutional Review Board ......................................................................................... 25 
15.3 
Documents and Records ........................................................................................... 25 
15.3.1 
Pre-Study Documentation Requirements .......................................................... 25 
15.3.2 
Study Documentation ........................................................................................ 26 
15.3.3 
Record Retention .............................................................................................. 26 
15.3.4 
Inspection of Records ........................................................................................ 26 
15.4 
Study Audits .............................................................................................................. 26 
15.5 
Study Funding ........................................................................................................... 26 
16. 
Amendments and Deviations ........................................................................................ 27 
16.1 
Protocol Amendments ............................................................................................... 27 
16.2 
Protocol Deviations ................................................................................................... 27 
16.1 
Emergency Deviations .............................................................................................. 27 
17. 
Publication Policy .......................................................................................................... 27 
18. 
Bibliography .................................................................................................................. 27 
19. 
Study Sites, Investigators and External Organizations .................................................. 28 
19.1 
Study Sites and Investigators .................................................................................... 28 
19.2 
External Organizations .............................................................................................. 28 
20. 
Revision History (if applicable) ...................................................................................... 29 
CIP Investigator Signature Page .............................................................................................. 30 
 
 
APPENDICES 
APPENDIX A1: RISKS OF INVESTIGATIONAL HARDWARE 
APPENDIX A2: RISKS OF INVESTIGATIONAL SOFTWARE 
APPENDIX B: CASE REPORT FORMS (CRFS) 
APPENDIX C1: INFORMED CONSENT FORM (ICF) TEMPLATE 
APPENDIX C2: ASSENT INFORMATION SHEET TEMPLATE 
APPENDIX D: REPORT OF PRIOR INVESTIGATIONS / INVESTIGATOR BROCHURE 
 
 

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1. 
 Synopsis 
Study Title 
Evaluation of Remote Fitting in Adult and Pediatric Users of 
the HiResolution Bionic Ear System 
Sponsor  
Advanced Bionics, LLC 
Investigational Devices 
Target CI DS fitting software 
AB Remote DS app 
Naída CI M DS Sound Processor 
Study Design 
Prospective within-subjects repeated-measures study 
Study Population 
17 users 13 years or older implanted with a HiResolution Bionic 
Ear System  
Up to 5 subjects will be enrolled in a confirmatory Aidable 
Residual Hearing (ARH) group and 12 subjects will be enrolled 
in an Electric Only (EO) cohort. 
Inclusion Criteria All Subjects 
• Ability to provide Informed Consent/Assent 
• 13 years of age or older  
• Unilateral or bilateral user of a HiResolutionTM Bionic Ear 
System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM 
Ultra, HiResTM Ultra 3D) 
• Minimum of 6 months of CI experience with a minimum of 
1 month experience with a Naída CI or Sky CI sound 
processor 
• At least moderate open-set speech recognition abilities 
(defined as speech in quiet score ≥ 60% as assessed at 
Visit 1) 
• Minimum average score ≥ 3 on the Mobile Device 
Proficiency Questionnaire (MDPQ-16) 
• English language proficiency as determined by the 
Investigator 
• Willingness to use a BTE sound processor for the duration 
of the study 
Inclusion Criteria Specific to ARH 
Group 
• Residual low frequency hearing sensitivity (pure tone 
average of < 70 dB HL for 125, 250, and 500 Hz) and a 
severe‐to‐profound high‐frequency sensorineural hearing 
loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 
3000, 4,000, and 8,000 Hz) in the implanted ear for 
unilaterally implanted subjects and in both ears for 
bilaterally implanted subjects 
• Willingness to use an in‐canal acoustic earhook for the 
duration of the study 
Exclusion Criteria All Subjects 
• Clinical presentation indicative of potential implanted 
device malfunction 
• Unrealistic expectations regarding potential benefits, risks 
and limitations of the investigational device as determined 
by the Investigator 
• Unwillingness or inability of subject to comply with all 
investigational requirements as determined by the 
Investigator 
Primary Study/ Efficacy 
Objectives 
The primary efficacy objective is to demonstrate that speech 
recognition in quiet after remote fitting is no worse than 
speech recognition in quiet after in-office fitting. 

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Primary Study/Efficacy Endpoints The primary efficacy endpoint are the chronic remote fitting 
AzBio sentence scores in quiet at Visit 3 as compared to 
chronic in-office fitting AzBio sentence scores in quiet at Visit 
2.  
Safety Objective 
The safety objective is absence of unanticipated adverse 
device effects related to remote fitting. 
Supporting Data 
• Analysis of subjective outcome measures  
• Analysis of custom subject remote fitting satisfaction 
questionnaire 
• Analysis of custom audiologist remote fitting satisfaction 
questionnaire 
• Analysis of subject reimbursement questionnaire 
• Analysis of acute speech perception data 
• Analysis of in-office fitting vs remote fitting duration 
• Analysis of psychophysical data 
Study Schedule & Duration 
Visit 1:  
• Informed Consent/Assent 
• Demographics & Audiological History 
• Mobile Device Proficiency Questionnaire 
• Reimbursement Questionnaire 
• Audiometric Thresholds 
• Speech in Quiet, Personal Sound Processor 
• Confirmation of Eligibility 
• Naída CI M DS Sound Processor In-Office Fitting 
• Acute Speech in Quiet, Naída CI M DS Sound 
Processor 
Visit 2: 2-3 weeks after Visit 1 
• Subjective Outcome Measure Questionnaire  
• Chronic Speech in Quiet, Naída CI M DS Sound 
Processor 
• Naída CI M DS Sound Processor Remote Fitting via 
Smart Phone App 
• Acute Speech in Quiet, Naída CI M DS Sound 
Processor 
• Custom Subject Remote Fitting Satisfaction 
Questionnaire 
• Custom Audiologist Remote Fitting Satisfaction 
Questionnaire 
Visit 3: 2-3 weeks after Visit 2 
• Subjective Outcome Measure Questionnaire  
• Chronic Speech in Quiet, Naída CI M DS Sound 
Processor 
 
 
 

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2. 
Glossary and Abbreviations 
AB Remote app 
Commercially available mobile application 
AB Remote DS app 
Investigational research version of the AB Remote app 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
ARH 
Aidable Residual Hearing 
BTE 
Behind-the-ear 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Forms 
dB 
Decibel 
eCRF 
Electronic Case Report Forms 
EDC 
Electronic Data Capture 
HiResolution™ (HiRes) 
Bionic Ear cochlear 
implant system 
An implantable medical device system designed to provide 
individuals who have severe-to-profound hearing loss with access 
to sound and improved perception of speech via electrical 
stimulation of the hearing nerve. It consists of (1) an externally 
worn sound processor (2) internal implant device with receiver 
stimulator electronics package and electrode array, and (3) a 
custom fitting software used to program the external sound 
processor. 
Hz 
Hertz 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
ListPlayer 
ListPlayer 3.0 is a proprietary, validated Advanced Bionics 
software used for speech performance testing 
MDPQ-16 
Mobile Device Proficiency Questionnaire Short Form 
Naída CI M DS 
Investigational sound processor used for remote fitting 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
Sound Processor 
The external part of a cochlear implant system that captures 
sound and converts it to digital information 
SPL 
Sound Pressure Level 
Target CI 
Commercially available fitting software  
Target CI DS 
Investigational research version of Target CI fitting software  
UADE 
Unanticipated Adverse Device Effect 
3. 
Background and Purpose of the Investigation 
Advanced Bionics is introducing a remote fitting option to enable audiologists to perform follow-
up fittings for unilateral or bilateral CI recipients with or without acoustic earhook. This option is 
intended to be used for recipients of the HiResolution Bionic Ear System 13 years or older. The 
remote fitting option will allow the audiologist to connect to the subject’s sound processor via a 
smartphone app. 

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Figure 2: Study Workflow 
 
 

Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System 
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Adverse events (AEs) will be tracked and reported to the FDA according to the requirements of 
an IDE investigation until the study is closed. The AEs will be recorded and tracked between 
completion of the informed consent form and two weeks after the participant completes the study.  
6. 
Objectives 
The primary efficacy objective is to demonstrate non-inferiority of speech recognition in quiet after 
remote fitting as compared to speech recognition in quiet after in-office fitting. 
7. 
Study Protocol 
7.1 
Subject Population and Selection Criteria 
Advanced Bionics expects to fit up to 17 HiResolution Bionic Ear system users 13 years or 
older via remote fitting in this clinical study across up to 5 study sites in the United States. 
This study population is expected to be representative of the target population for remote 
fitting. An individual is considered to be enrolled as a study participant once the informed 
consent document has been signed and dated. It is anticipated that more than 17 subjects 
will be enrolled in the study as some may not meet the inclusion / exclusion criteria. Prior to 
recruitment, written approval of the investigational plan and informed consent form will be 
obtained from the FDA and associated participating study center Institutional Review Boards 
(IRB). Study participants are required to meet the study inclusion criteria as determined by 
the Principal Investigator. Depending on the outcome of their audiogram, eligible subjects 
will be enrolled for aidable residual hearing (ARH) fitting with an acoustic earhook. 
Unilaterally implanted subjects not meeting ARH fitting criteria will be enrolled for electric 
only (EO) fitting. Bilaterally implanted subjects meeting ARH criteria only in one ear will be 
screen failed. 
Enrollment in the study is expected to occur over a period of approximately 6 months. 
Subjects meeting inclusion criteria will participate in 3 study visits over approximately 4-6 
weeks. 
7.1.1 Inclusion Criteria All Subjects 
• Ability to provide Informed Consent/Assent 
• 13 years of age or older  
• Unilateral or bilateral user of a HiResolutionTM Bionic Ear System (HiRes 
90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D) 
• Minimum of 6 months of CI experience with a minimum of 1 month experience 
with a Naída CI or Sky CI sound processor 
• At least moderate open-set speech recognition abilities (defined as speech in 
quiet score ≥ 60% as assessed at Visit 1) 
• Minimum average score ≥ 3 on the Mobile Device Proficiency Questionnaire 
(MDPQ-16) 
• English language proficiency as determined by the Investigator 
• Willingness to use a BTE sound processor for the duration of the study 
7.1.2 Inclusion Criteria Specific to ARH Group 
• Residual low frequency hearing sensitivity (pure tone average of < 70 dB HL for 
125, 250, and 500 Hz) and a severe‐to‐profound high‐frequency sensorineural 
hearing loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, 
and 8,000 Hz) in the implanted ear for unilaterally implanted subjects and in 
both ears for bilaterally implanted subjects 
• Willingness to use an in‐canal acoustic earhook for the duration of the study 
7.1.3 Exclusion Criteria All Subjects 
• Clinical presentation indicative of potential device malfunction 

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• Unrealistic expectations regarding potential benefits, risks and limitations of the 
investigational device as determined by the Investigator 
• Unwillingness or inability of subject to comply with all investigational 
requirements as determined by the Investigator 
7.2 
Study Endpoints 
7.2.1 Efficacy  
The purpose of the proposed study is to evaluate speech performance efficacy 
objectives. The primary efficacy endpoints are chronic remote fitting AzBio sentence 
scores in quiet at Visit 3 as compared to chronic in-office AzBio sentence scores in 
quiet at Visit 2. 
7.2.2 Supporting data 
In addition to acute speech performance, psychophysical data and fitting durations, 
information from subjective questionnaires will be collected as supporting data: 
• 
Information regarding study participants experience during fitting sessions will 
be collected via a Subject Remote Fitting Satisfaction Questionnaire. 
• 
Information regarding study participants listening experience during the chronic 
periods will be collected via a SSQ-12 questionnaire. 
• 
Information regarding study participants reimbursement situation will be 
collected via a Reimbursement Questionnaire. 
• 
Information regarding investigators’ experience during fitting sessions will be 
collected via an Audiologist Remote Fitting Satisfaction Questionnaire. 
• 
Information regarding acute speech perception will be collected in form of AzBio 
sentence scores collected immediately after in-office and remote fitting, 
respectively. 
• 
Information regarding duration of in-office and remote fitting durations will be 
collected during the fitting sessions. 
• 
Information regarding psychophysical data will be collected during the fitting 
sessions. 
7.2.3 Safety  
Adverse event data will be collected and evaluated during the study to ensure that 
the safety of patients is maintained as per requirements of an IDE and respective 
center Institutional Review Board guidelines for reporting. The primary safety 
endpoint is the absence of unanticipated adverse device effects related to remote 
fitting. 
7.3 
Study Procedures 
Advanced Bionics staff may be present during study procedures for the purpose of guiding 
investigators with regards to per protocol performance of these procedures. As this 
potentially involves contact with study subjects, Advanced Bionics staff will conduct these 
activities in a way that they do not bias data integrity. No study procedures will be performed 
by Advanced Bionics staff. 
7.3.1 Audiometric Measures: 
Unaided air conduction hearing thresholds (in dB HL) will be measured for the 
implanted ear(s) using the centers calibrated audiometer and standard audiometric 
technique for pure-tone air conduction testing.  
Unaided air conduction thresholds using insert earphones at octave and inter-octave 
frequencies will be obtained (125, 250, 500, 1000, 2000, 3000, 4000 and 8000 Hz). 

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7.3.2 Speech Perception Measures: 
All speech perception testing will be conducted using recorded stimuli presented 
from a single loudspeaker in, at a minimum, a single-walled sound booth capable of 
accommodating the calibrated speaker orientation. Soundfield levels will be 
calibrated to 74 dB SPL using a microphone placed at the approximate position of 
the subject’s head (one meter from loudspeaker). 
Speech perception measures in the soundfield are to be administered unilaterally for 
unilaterally implanted subjects and bilaterally for bilaterally implanted subjects via a 
loudspeaker at 0° azimuth at a distance of one meter from the subject. Speech 
signals will be presented at 60 dBA.  
Devices will be removed from the non‐test ear (if necessary) for unilaterally 
implanted subjects and foam plugs will be used to isolate the test ear for unilateral 
users.  
7.3.3 AzBio Sentence Test 
The AzBio Sentence Test (Spahr et al., 2012) is a validated test of open-set 
sentence recognition ability. The test will be administered in quiet at 60 dBA (target 
0° azimuth). The test is scored as total number of words correct which will be 
expressed for reporting as percentage correct. The sentence tokens include both 
male and female speakers.  
Acute AzBio sentence testing will be performed immediately following in-office and 
remote fitting sessions, respectively. Chronic AzBio sentence testing will performed 
at the beginning of each follow-up visit. 
7.3.4 Questionnaires 
Subjects will be completing a Mobile Device Proficiency Questionnaire (MDPQ-16), 
subjective outcome measures questionnaires (SSQ-12), a reimbursement 
questionnaire and a custom remote fitting satisfaction questionnaire. In addition, 
audiologists will be completing a custom remote fitting satisfaction questionnaire. 
Questionnaires may be completed on paper or electronically in the EDC system. 
7.4 
Study Visits and Visit Windows 
7.4.1 Schedule of Events 
Procedure 
Visit 1 
Visit 2 
Visit 3 
Informed Consent/Assent 

Demographics & Audiological History 

Mobile Device Proficiency Questionnaire 

Reimbursement Questionnaire 

Audiometric Thresholds 

AzBio in Quiet, Personal Sound Processor 

Confirmation of Eligibility 

Naída CI M DS Sound Processor In-Office Fitting 

Naída CI M DS Sound Processor Remote Fitting via Smart 
Phone App 

Acute AzBio in Quiet, Naída CI M DS Sound Processor 


Chronic AzBio in Quiet, Naída CI M DS Sound Processor 


Subjective Outcome Measure Questionnaire (SSQ-12) 


Custom Subject Remote Fitting Satisfaction Questionnaire 
&
Custom Audiologist Remote Fitting Satisfaction Questionnaire 
&
Adverse Event Assessment 



Device Accountability 



& Only if remote fitting was successfully completed 

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7.4.2 Visit 1 
This visit is performed at the audiologist’s office.  
• 
After informed consent/assent, subject’s demographics and hearing history will 
be captured.  
• 
Subjects’ technical competency will be determined using the Mobile Device 
Proficiency (MDPQ-16) questionnaire and subjects will complete a Reimbursement 
Questionnaire. 
• 
Speech perception in quiet will be tested using the subject’s personal sound 
processor to determine eligibility for the study.  
• 
Audiometric thresholds are used to determine whether subjects are considered 
to have aidable residual hearing (ARH). Subjects not meeting the ARH criteria 
will be fitted under the electric-only criteria (EO). Audiometric thresholds will be 
determined for the implanted ear only for unilaterally implanted subjects and for 
both ears individually for bilaterally implanted subjects. 
➢ Bilateral subjects meeting the ARH inclusion criteria in both ears will be 
enrolled in the ARH group. Bilateral subjects meeting ARH criteria in only 
one ear will be screen failed. 
• 
Subjects who meet inclusion and do not meet exclusion criteria are then fit with 
a Naída CI M DS sound processor in the audiologist’s office. Unilateral ARH 
subjects will be fitted with an acoustic earhook and EO subjects will be fitted with 
a T-mic. Bilateral subjects meeting the ARH criteria will be fitted with an acoustic 
earhook in both ears. Fitting parameters on the Naída CI M DS sound processor 
should mimic the parameters on the subject’s personal sound processor as 
closely as possible and be adjusted for comfort and sound quality as needed. 
Program settings will include two programs, one AutoSense OS program with 
and a second manually selected Calm situation program. This will be considered 
the in-office fitting. 
• 
Acute speech perception in quiet is performed to confirm the in-office fitting on 
the Naída CI M DS sound processor.  
• 
Adverse events and device observations are collected, as needed, and device 
accountability is performed. 
• 
Following the visit, the subject will test the Naída CI M DS sound processor 
chronically for 2-3 weeks during their day-to-day activities. 
7.4.3 Visit 2 
Visit 2 will occur 2-3 weeks after Visit 1.  
• 
The visit will start at the audiologist’s office with subjects completing a subjective 
outcome measures questionnaire.  
• 
Chronic speech perception in quiet will be tested using AzBio sentences. 
• 
In addition, the audiologist will introduce the remote fitting application to the 
subject and will pair the smartphone with the subject’s Naída CI M DS sound 
processor. For the purposes of the study, a dedicated fitting smartphone will be 
used that is only used for remote fitting.  
• 
The subject will then move to the remote fitting location. The audiologist will 
initiate the remote fitting session through Target CI DS, and the subject will open 
the application on the remote fitting smartphone. Both parties will engage 
verbally to ensure audibility and visualization via smartphone video during the 
call. The audiologist then remotely connects to the subject’s sound processor to 
begin the fitting session. The fitting will include measurement of impedances, 
measurement of electrode-specific neural response imaging (NRI), programming 
of M levels, and live speech stimulation to confirm acceptability of adjustments. 
Fittings for AHR subjects will include a review of acoustic and electric cutoff 
frequencies and gains at 65 dB. Additional adjustments may be made as needed 
to ensure comfort and clarity of the Map and to ensure acceptability of the fitting 

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during the subject’s chronic wear period. The audiologist and subject will then 
confirm the completion of the fitting and both parties close their respective 
remote fitting session applications.  
➢ Should technical issues occur during the remote fitting session, the 
audiologist will first try to mitigate the issues, for example by instructing the 
subject to turn off their outgoing video or to move to a different location in 
case of poor connection. 
➢ The audiologist will re-schedule the remote fitting session should the 
remote app fitting not be completed because technical issues could not be 
mitigated during the session. Adverse events and/or device observations 
are collected and device accountability is performed, as needed. 
➢ If remote fitting cannot be completed due to non-technical reasons (e.g. 
subject was not able to sufficiently communicate with the audiologist via 
the app), the subject will be exited from the study. Reasons for non-
completion of the remote fitting will be documented. Adverse events and/or 
device observations are collected and device accountability is performed. 
• 
After the remote fitting session is successfully completed, the subject will rejoin 
the audiologist in person for acute speech perception in quiet to confirm the 
remote fitting on the Naída CI M DS sound processor.  
• 
In addition, the audiologist and the subject each will complete a custom remote 
fitting satisfaction questionnaire.  
• 
Adverse events and device observations are collected and device accountability 
is performed, as needed. 
• 
Following the visit, the subject will test the remotely-fitted Naída CI M DS sound 
processor chronically for 2-3 weeks during their day-to-day activities. 
7.4.4 Visit 3 
Visit 3 will occur 2-3 weeks after the Visit 2. 
• 
This visit is performed at the audiologist’s office and begins with subjects 
completing a subjective outcome measures questionnaire.  
• 
In addition, chronic speech perception in quiet will be tested.  
• 
Adverse events and device observations are collected, as needed, and device 
accountability is performed. 
• 
The subject will then return the Naída CI M DS sound processor and return to 
using their personal sound processor. Standard clinical follow-up is 
recommended after subjects exit the study. 
7.5 
Withdrawal of Subjects 
Study participants may withdraw from the study at any time, with or without reason, and 
without prejudice to further treatment. The study site Investigator(s) and/or study Sponsor 
have the right to discontinue study participants. Participants can be discontinued for the 
following reasons: 
• 
Voluntary withdrawal of consent made by the participant 
• 
A safety concern identified by the Principal Investigator, the Sponsor, or any third party 
• 
Inability of the subject to perform the tasks necessary to provide usable data for the 
study 
• 
Failure to respond after three documented attempts to contact the subject (lost to follow-
up). Potential reasons will be documented. 
Once a subject is withdrawn or discontinued they will be required to return the Naída CI M 
DS sound processor utilized for the study. Subjects who withdraw or who are discontinued 
from the study will be reported accordingly to the Institutional Review Board. If a subject 
was discontinued because of a device-related adverse event or serious adverse event 

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than -10 percentage points for AzBio in quiet mode, which will support that the 
Investigational condition is non-inferior to the Control condition. Previous data supported 
6.24% SD for the primary efficacy endpoint. As shown in Table 1 below, with a sample size 
of 8 complete pairs there is 97% power to rule out a -10% null hypothesis supporting non-
inferiority for a one-sided 2.5% test with statistical significance.  
Table 1: Paired t-tests to reject the null hypotheses for non-inferiority and superiority 
Non-
Inferiority 
Test significance level,  
0.025 
 1 or 2 sided test? 
1 
Null hypothesis mean difference, 0 
-10 
Alternative mean difference, A 
0 
Paired SD,  
6.24 
Effect size,  = |A - 0| /  
1.603 
Power (%) 
97 
N 
8 
These calculations are based on the T-distribution non-centrality factor as follows: 
(
)



0
,
−
=

n
T NCF
n
 
observed based on the non-centrality factor: 
𝑃𝑜𝑤𝑒𝑟= 𝑇𝑛−1(𝑇𝑛−1
−1 (0.975), 𝑛−1, 𝛿= 𝑇𝑛,𝑁𝐶𝐹) 
The above sample size calculation provides the minimum sample size for the EO cohort. In 
addition, 5 ARH subjects will be enrolled in the study to provide confirmatory data for the 
electric and acoustic fitting mode for subjects wearing an acoustic earhook. The incidence 
of acoustic earhook use among Advanced Bionics recipients is low, less than 2.5% of US 
recipients. As such, a confirmatory sample of 5 subjects is considered sufficient in order to 
provide clinical data via descriptive statistics. Outcomes after remote fitting are expected to 
be similar between the EO cohort and the ARH group. The total sample size was expanded 
to 17 (12 EO and 5 ARH) as the expected dropout rate due to withdrawals or lost to follow-
up is not expected to exceed 4 subjects. Based on a sample size of 17, the upper bound of 
the exact event rate was calculated in order to provide complication rates. If no events are 
observed in 17 subjects, then 16.2% is the upper bound for a one-sided 95% confidence 
interval on this event rate.  
8.2 
Data Analyses 
Subjects will be analyzed separately for the AzBio in quiet mode for remote fitting 
(Investigational) and for the in-office fitting (Control) as well as the paired difference. All 
enrolled subjects that meet the inclusion / exclusion criteria will be included in the intent-to-
treat (ITT) population. The analysis will be repeated for the per-protocol (PP) population 
excluding subjects with major protocol deviations. Protocol deviations will be classified as 
major if they affect data integrity for the primary endpoint or subject safety as defined in 
Table 2 below. 
 
 

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Table 2: Major Protocol Deviations 
Protocol deviations 
affecting data integrity of 
the primary endpoint 
Chronic speech perception testing not performed in, at a minimum, 
a single-walled sound booth. 
Chronic speech perception testing performed without prior 
calibration of sound field levels to 74dB SPL. 
Chronic speech perception testing not performed at 0° azimuth. 
Chronic speech perception testing not performed at a distance of 
one meter from the subject. 
Chronic speech perception testing not performed with speech 
signals presented at 60 dBA. 
Chronic speech perception testing performed without removing 
hearing devices (if necessary) from contralateral ear for unilaterally 
implanted subjects. 
Chronic speech perception testing performed without using foam 
plugs in contralateral ear for unilaterally implanted subjects with 
residual hearing in the contralateral ear. 
Chronic speech perception testing not performed using two lists of 
AzBio sentences. 
Chronic speech perception testing not performed bilaterally for 
bilaterally implanted subjects. 
Protocol deviations 
affecting subject safety 
Protocol deviations that result in a serious adverse event 
8.2.1 Efficacy Endpoints 
The primary efficacy endpoint is chronic speech recognition using AzBio sentence 
tests in quiet for remote fitting vs. in-office fitting. Non-inferiority analysis will be 
based on a paired t-tests looking at the mean difference in scores (D) calculated 
from the chronic remote fitting speech perception testing (investigational) minus the 
chronic in-office fitting speech perception scores. Unilateral and bilateral 
involvement will be additionally considered in two separate manners for the primary 
effectiveness analysis endpoint to assess the remote vs local difference. First, the 
unilateral and the bilateral subjects will be analyzed as separate subgroups. Second, 
a linear regression analysis for the paired difference will include a covariate for 
whether the subject is unilateral (reference group) or bilateral in order to evaluate 
the laterality effect. Clinical significance is defined as ruling out a -10 percentage 
point difference by rejecting the null hypotheses, indicating that the means of the 
paired differences are greater than – 10 percentage points, as evidence that the 
remote fitting is non-inferior to the in-office fitting. 
Because the study includes follow-up visits, the possibility exists that some study 
participants will not complete the entire test protocol. Multiple imputation will be used 
to analyze the primary efficacy endpoint (SAS PROC MIANALYZE; Little and Rubin 
[2002]). Subject values will be imputed using observed test scores and selected 
baseline variables.  
8.2.2 Supporting Data 
The following supporting data will also be evaluated using descriptive statistics:  

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• 
subjective outcome measures  
• 
custom subject remote fitting satisfaction questionnaire 
• 
custom audiologist remote fitting satisfaction questionnaire 
• 
subject reimbursement questionnaire 
• 
acute speech perception data 
• 
in-office fitting vs remote fitting duration 
• 
psychophysical data 
• 
duration of in-office vs remote fitting. 
8.2.3 Analyses of Individual Results  
A critical difference score will be used to determine whether individual subjects 
demonstrate a significant decrease in performance between the Investigational 
(remote fitting) and Control (in-office fitting) conditions. Specifically, the criterion 
value for the critical difference score will be based upon the test-retest variance on 
the AzBio test. Gifford (2008) provided a set of data on 35 listeners for the AzBio 
sentences, wherein two lists of sentences were presented one after the other to 
cochlear implant recipients. Based on those data, the expected variability between 
lists has a standard deviation σ of 3.8%. The critical difference score can be 
computed based on the assumption that (1) the difference scores have a normal 
distribution, and (2) the difference scores are deemed significant if, under the null 
hypothesis, the probability of the difference score exceeding the critical score is 1%. 
Under these assumptions, the critical improvement (or decrement) score CS is equal 
to: 
CS = σ * b 
In the above equation, b = 2.33, the percentile of the normal curve corresponding to 
the desired values of  = 0.01, one-tailed test. Using Gifford’s σ value, the critical 
difference score for AzBio sentences is 8.9%. 
The number and percentage of subjects exceeding, within, and below the critical 
difference (Investigational - Control) score will be tabulated. The shift will be 
summarized for both the Experimental and Control results indicating improved, the 
same, or deteriorated. Further the difference between the two strategies will be 
evaluated and classified as better for the Experimental strategy, the same for both 
strategies, or better for the Control strategy. A two-sided exact binomial test will be 
used to evaluate the null hypothesis that the distribution of subjects showing a 
performance difference (Investigational is better or Control is better) is distributed 
equally. This analysis will provide an additional indication of the efficacy of remote 
fitting relative to in-office fitting based upon individual data. 
8.2.4 Safety Endpoint 
The safety objective is the absence of unanticipated adverse device effects related 
to remote fitting. 
8.2.5 Supporting Data 
Subjective outcome measures, remote fitting acceptability questionnaire data, data 
from reimbursement questionnaires, acute speech perception data, fitting durations 
and psychophysiological data will be analyzed descriptively. Descriptive statistics 
will consist of counts, means, and standard deviations for quantitative variables and 
frequency and percent relative frequency for categorical variables. 
Additionally, subject demographics and study results will be presented descriptively 
to assess site heterogenity. 

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9. 
Adverse Events and Device Deficiencies 
An adverse event (AE) is defined as any undesirable clinical occurrence experienced by a study 
subject when using the HiResolution System or when undergoing research procedures, whether 
or not the AE is considered to be device-related. The definition of an AE also includes any event 
related to any study procedures or to any underlying medical condition present at baseline that 
increases in severity during the study. An underlying medical condition that was present at the 
time of enrollment will not be reported as an AE, but any increase in severity during the study will 
be reported as an AE.  
All device-related and non-device-related adverse events (AEs) will be tracked and reported 
accordingly throughout the study as defined above in the investigational plan and in accordance 
with requirements of an IDE investigation. The AEs will be recorded and tracked between 
completion of the informed consent form (signed and dated) and two weeks after the participant’s 
last study visit. The number and percent of all subjects experiencing adverse events will be 
summarized by type, status and frequency of event. Adverse Events will be recorded and will 
include but are not limited to the following information [refer to Appendix B for Case Report Forms 
(CRFs)]: 
9.1 
Adverse Event Definitions and Classifications 
9.1.1 Serious Adverse Event 
A serious adverse event (SAE) is an event that: a) led to a death, or b) led to a 
serious deterioration in the health of the subject that:  
• 
resulted in a life-threatening illness or injury, 
• 
resulted in a permanent impairment of a body structure or of a body function, 
• 
required inpatient hospitalization or prolongation of existing hospitalization, 
• 
resulted in medical or surgical intervention to prevent permanent impairment to 
body structure or a body function, or 
• 
led to fetal distress, fetal death or a congenital abnormality or birth defect. 
9.1.2 Adverse Device Effect and Serious Adverse Device Effect 
An adverse device effect (ADE) is any untoward and unintended response to a 
medical device. A serious adverse device effect (SADE) is an event related to the 
device that resulted in any of the consequences characteristic of a serious adverse 
event (SAE) or that might have led to any of the consequences if suitable action had 
not been taken or interventions had not been made or if circumstances had been 
less opportune. 
9.1.3 Unanticipated Adverse Device Effect 
An unanticipated adverse device effect (UADE) is any serious adverse effect on 
health or safety; 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; or any other 
unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects. 
9.2 
Adverse Event Reporting 
All adverse events and adverse device effects, serious and non-serious, will be recorded on 
the Adverse Event Report Case Report Form [CRF] (see Appendix B for all CRFs). 
Information to be recorded on the CRF should include, but is not limited to: 
• 
Date of onset of the adverse event 
• 
Description of the event, duration and severity 
• 
Seriousness 
• 
Relatedness 

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• 
Treatment/Intervention – course of action taken 
• 
Outcome/Status (Resolved, Improved, Stable, Worse, Unchanged). In case of an SAE, 
the subject must be followed until the serious adverse device effect is resolved or no 
reasonable improvement is expected.  
Investigators should immediately report any SAEs, SADEs and UADEs to Advanced Bionics 
at ClinicalResearch@AdvancedBionics.com. Evaluation of any SAE, SADE, or UADE will 
be conducted promptly. Confirmed UADEs will be reported to the FDA according to 21 CFR 
Part 812.150(b) (1) within 10 days after receiving notice of the event, to participating 
Investigators and to IRBs according to their requirements. If it is determined that an event 
or effect presents an unreasonable risk to subjects, this study, or those parts of the study 
presenting that risk, will be terminated no later than 5 working days after the determination 
is made and no later than 15 working days after Advanced Bionics/Clinical Research first 
received notice of the event. 
9.3 
Anticipated Adverse Events 
The risks associated with the investigational products include but are not limited to: 
• 
There is a possibility that speech and environmental sounds may sound different or 
louder than what the subjects are accustomed to hearing or that subjects may not like 
the sound quality of the study sound processor used in the study. This risk occurs with 
all changes to sound-processing, and subjects should be advised of this possibility. If a 
subject cannot tolerate using the study sound processor or does not like the sound 
quality, they can return to using their own sound processor with their baseline 
programming. In this event, the subject will be withdrawn from the study. 
• 
Subjects may experience some overly loud sounds that result in discomfort. If such loud 
sounds occur, they can be stopped immediately by removing the headpiece and/or the 
entire external device. 
• 
Subjects may experience neural tissue damage in the event of chronic overstimulation.  
• 
There is risk of facial nerve stimulation. This risk can be mitigated through 
reprogramming of the device. 
• 
Subjects may experience intermittent sound or short-term loss of functionality while 
wearing the device or while being programmed. The intermittency can be eliminated by 
changing the headpiece, reprogramming the sound processor, or exchanging the sound 
processor. 
• 
Subjects may have permanent residual acoustic or natural hearing damage due to 
excessive acoustic power.  
• 
Subjects may experience skin or tissue irritation because of the device materials or the 
equipment may overheat or otherwise malfunction, causing tissue damage.  
• 
Subjects will be exposed to small parts that pose a choking hazard. Care should be 
taken to avoid choking and the outcomes of choking, such as endoscopic surgery or 
death.  
• 
Exposure to electromagnetic emissions from the device (external sound processor, 
internal device) may adversely interfere with other electronic medical devices 
• 
Subjects should only use accessories compatible or designed for the study sound 
processor (such as the battery chargers) in order to avoid electric shock. 
• 
Static electricity can potentially damage sensitive electronic components such as the 
ones used in the cochlear implant system.  
A complete listing of the risks can be found in Appendix A; all risks listed are considered 
anticipated Adverse Events. Risks are minimized by device safety testing but cannot be 
completely eliminated. At any time, subjects may discontinue use of the study sound 
processor, and return to using their own sound processor and baseline program. If subjects 
stop using the study sound processor during the study, they will be withdrawn from the 
study. 

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In all case, the event(s) will be recorded and the incidence of such events reported as part 
of the results analysis. 
9.4 
Device Deficiencies 
Events that involve a device issue or observation need to be reported as Device 
Observations and Deficiencies (DODs) via the Electronic Data Capture system. Adverse 
event reporting takes precedent over DOD reporting. Therefore it is not necessary to report 
an event as a DOD if it has already been reported as an AE because it led to a medical 
occurrence for the subject. 
10. Informed Consent Process 
A study site’s Informed Consent Form template and Informed Assent Form template with center 
specific/required language must be provided to Advanced Bionics for approval prior to submission 
to the Institutional Review Board (IRB). Advanced Bionics will provide an informed consent and 
informed assent template and assistance in adapting the templates to conform to local 
requirements (Appendix C). All informed consent and informed assent documents and patient 
information sheets must contain the minimum elements as mandated by FDA (21 CFR Part 50) 
and will be subject to approval by Advanced Bionics as well as the IRB.  
Before enrollment, the study will be explained to each prospective study candidate. Candidates 
will be asked to read the approved informed consent form and given the opportunity to ask 
questions. Once all questions have been answered and the Investigator is assured that the 
individual understands the implications of participating in the study, the subject will be asked to 
sign and date the informed consent form. The Investigator will provide a copy of the informed 
consent form to each subject. The process for pediatric subjects is described in section 11. 
Study subjects will receive a small payment at each visit for their time and effort and will be 
reimbursed for travel related cost. 
If an amendment to the protocol changes the scope or activities associated with a subject’s 
participation, or increases the potential risk to the subject, the informed consent and informed 
assent forms must be revised and submitted to the IRB for review and approval. Actively enrolled 
study participants are re-consented accordingly if affected by the amendment. The revised 
informed consent and informed assent forms must be used to obtain consent from any new 
subject who is enrolled in the study after the date of the approval of the amendment. 
10.1 
Health Insurance Portability and Accountability Act (HIPAA) 
All subjects must sign a HIPAA authorization form prior to participation in the study. The 
Investigator will prepare the HIPAA authorization form according to their institution’s policy 
and provide it to Advanced Bionics for approval. Advanced Bionics will provide a template 
HIPAA research authorization form for reference. All subjects must sign the authorization 
form prior to participation in the study if the HIPAA information is not included in the 
institution’s informed consent. 
11. Vulnerable Population 
11.1 
Pediatric Subjects 
HiResolution Bionic Ear System is approved for use in pediatric patients between 12 months 
and 17 years with profound bilateral sensorineural hearing loss, and in adults 18 years and 
up with severe to profound bilateral sensorineural hearing loss. Advanced Bionics 
recognizes that the benefit/risk profiles of remote fitting could be different among patients of 
different age ranges, especially with regards to pediatric patients at very young ages. 
Therefore remote fitting is intended to be used in follow-up programming of Advanced 
Bionics cochlear implant recipients 13 years and older who are able to self-report a 
preference for different fitting characteristics (e.g., mapping or features). The benefits of 
remote fitting are the same for pediatric subjects as for adults (see section 12.1). While 

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audiological care for pediatric patients in this age range is similar to adults, it is still important 
to ensure that remote fitting is a suitable option for these pediatric age group. Therefore 
Advanced Bionics is planning to enroll pediatric subjects 13 years of age and older in this 
study. After informed consent is obtained from a parent / legal guardian, informed assent 
will be obtained from the pediatric subject. The informed assent process will closely follow 
the informed consent process for adult subjects.  
Governing IRBs will give special consideration to protecting the welfare of vulnerable 
subjects per federal regulations. The study will only enroll pediatric subjects who have the 
ability to understand the requirements of the study and who are able to communicate 
untoward experience or preference for different fitting characteristics, as determined by the 
Investigator. After exiting the study, pediatric subjects will return to using their personal 
sound processor and will be followed per standard clinical care. 
12. Benefits and Risks 
12.1 
Benefits 
Recipients of the HiResolution Bionic Ear System 13 years and older will significantly benefit 
from the option of remote fitting in lieu of in-office follow up fitting visits at their center. Many 
recipients live a considerable distance from their cochlear implant center and traveling to 
the center for in-office follow-up visits can pose a significant burden. In addition, remote 
fitting provides recipients who are not able to drive themselves the possibility to connect 
with their audiologist without having to rely on others for transportation. Remote fitting can 
also protect vulnerable subjects in cases where in-person contact poses a health risk, for 
example during a global pandemic. These benefits are expected to outweigh the risks. 
12.2 
Risk related to Approved Products 
 
 The 
risks associated with use of the approved products are contained in those products’ 
instructions for use. 
12.3 
Risk related to Investigational Hardware 
 
(
 The risk analysis contains the 
determination that the benefit provided by this use-case outweighs any residual risk. The 
full report is presented in Appendix A. 
12.4 
Risk related to Investigational Software 
 
 
 The risk analysis contains the determination that the benefit provided by this 
use-case outweighs any residual risk. The full report is presented in Appendix A.  
In addition, the following risks are related to remote fitting: 
• 
 
 
 
 
 
 
 
 
 
 
 
 

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• 
 
 
13. Suspension or Premature Termination 
13.1 
Criteria for Terminating the Study 
Advanced Bionics reserves the right to terminate the study at any time. However, this right 
will be exercised only for valid scientific or business reasons, or because of issues related 
to protection of research subjects. Investigators and IRBs will be notified in writing in the 
event of termination. If the study is prematurely terminated or suspended, the Principal 
Investigator will promptly inform study participants, provide the reason(s) for the termination 
or suspension and changes to the study visit schedule, as applicable. Any subjects that 
have not completed the study at the time of termination will be required to return the study 
sound processor and will resume using their personal sound processor.  
No special follow-up procedures are required following the end or termination of the study 
as subject will be returning the study Naída CI M DS sound processor and returning to using 
their personal sound processor. The same applies to subjects who withdraw consent or are 
lost to follow-up. Should the study be temporarily halted, subjects will be asked to return the 
study Naída CI M DS sound processor until a determination is made whether the study will 
continue.  
13.2 
Criteria for Suspending or Terminating a Study Center 
After the study begins, Advanced Bionics reserves the right to suspend enrollment of 
subjects at a study center or terminate a study center’s participation in the study at any time 
if (1) no subjects have been enrolled, (2) the center has multiple or severe unjustified 
protocol violations or (3) the center fails to follow remedial actions for protocol violations. 
Any subjects enrolled at this center that have not completed the study at the time of 
termination will be required to return the study sound processor and will resume using their 
personal sound processor. 
Possible reasons for suspending or terminating a center include: 
• 
Investigator non-compliance. 
• 
Repeated failure to complete or submit eCRFs in a timely manner. 
• 
Failure to obtain written informed consent from each subject. 
• 
Failure to report an SAE or UADE to Advanced Bionics within 10 days of when the event 
occurred. 
14. Monitoring, Device Accountability and Data Management 
14.1 
Monitoring Procedures 
Independent monitoring of the study for clinical protocol compliance will be conducted 
periodically to oversee compliance with the regulatory and clinical aspects of the study. The 
Clinical Monitor will maintain current knowledge of the study through observation, review of 
study records and source documentation, and discussion of the study with the investigators 
and delegated study personnel. The study site will assist the monitor by providing access to 
all relevant study materials, including source data. 
Site Initiation Training will be performed before a site enrolls subjects into the study. Periodic 
monitoring will be performed on-site as well as remotely throughout the study and a Close-
Out Visit will be performed after all subjects at a site have completed the study. Details of 
clinical site monitoring are documented in a Clinical Monitoring Plan.  
Clinical Monitors will be members of the Clinical Research Department of Advanced Bionics 
who have been trained on the study investigational plan, monitoring procedures, and 

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standard operating procedures based on Good Clinical Practice and other applicable 
Federal regulations. 
The following or otherwise designated Advanced Bionics Clinical Research Department 
Personnel will be responsible for conducting the study monitoring: 
 
Address: 
Advanced Bionics, LLC 
Clinical Research Department 
28515 Westinghouse Place 
Valencia, CA 91355 
 
14.2 
Device Accountability 
Participants will be fitted with a Naída CI M DS sound processor at their participating study 
center. The investigational devices will be shipped with the following label: "CAUTION--
Investigational device. Limited by Federal (or United States) law to investigational use." The 
serial numbers for the Naída CI M DS sound processors will be logged at the study site for 
each study participant.  
The statement "CAUTION--Investigational device. Limited by Federal (or United States) law 
to investigational use" will be placed onto the study laptop with the investigational Target CI 
DS software as well as the smartphones programmed with the investigational remote fitting 
app.  
Advanced Bionics will track all investigational study laptops and smartphones sent to study 
centers using the manufacturer serial numbers. Study centers will return the investigational 
devices to Advanced Bionics after all subjects have been exited from the study and 
Advanced Bionics will track the receipt of those devices. 
14.3 
Data Management Procedures / Case Report Forms 
Advanced Bionics will provide study centers with access to a study specific Electronic Data 
Capture (EDC) system meeting 21 CFR part 11 requirements. Details of the data 
management procedures are documented in the study specific Data Management Plan. 
Data must be submitted according to protocol requirements for all enrolled subjects as soon 
as possible after the visit. Electronic Case Report Forms (eCRFs) provided for this study 
will be used to submit data (Appendix B). Each subject will be assigned a unique identifier 
at the time of the first visit, which will be used on all eCRFs.  
The EDC database will be locked prior to analysis of the data and data will be retained 
indefinitely. Study Investigators will be provided with an electronic copy of the EDC database 
containing only the data from their subjects. 

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15. Statements of Compliance 
15.1 
Study Conduct 
The Investigator must agree that the study will be conducted according to the protocol, the 
principles of Good Clinical Practices (GCPs) outlined in 21 CFR parts 50, 56, and 812, the 
World Medical Association Declaration of Helsinki, and internal Standard Operating 
Procedures (SOPs). In addition, the Investigator will conduct all aspects of this study in 
accordance with FDA and local regulations as well as ISO 14155.  
The Investigator will assure proper implementation and conduct of the study including those 
study-related duties delegated to other appropriately qualified individuals designated on the 
Investigator Agreement page. The Investigator will assure that all study personnel cooperate 
with monitoring and audits, and will demonstrate due diligence in recruiting and retaining 
study subjects. 
15.2 
Institutional Review Board 
Before initiation of the study, the Investigator must obtain approval of the research protocol, 
informed consent form, and subject recruitment materials from the governing IRB in 
compliance with the provisions specified by the FDA (21 CFR Part 56) and other applicable 
regulatory agencies. Although Advanced Bionics clinical research staff may assist with IRB 
applications, the Investigator is responsible for assuring compliance of the center’s 
respective IRB with applicable regulations and any additional requirements imposed by the 
IRB.  
A copy of the written IRB approval of the protocol, informed consent, IRB application 
materials, and recruitment advertising (if applicable) must be provided to Advanced Bionics 
prior to initiation of the study. The approval letter must be signed by the IRB chairman or 
designee, specify the IRB name and address, identify the clinical protocol by title and/or 
protocol number, and include the date that approval was granted. The Investigator is 
responsible for obtaining continued review of the clinical study at intervals not exceeding 
one year or as otherwise specified by the IRB. The Investigator must provide Advanced 
Bionics with written documentation of the review and materials submitted to the IRB for 
continuing approval.  
Investigators must notify the IRB promptly regarding all SAEs that occur at their site, in 
accordance with local reporting policy, and report other safety information provided by 
Advanced Bionics to the IRB. 
15.3 
Documents and Records 
15.3.1 Pre-Study Documentation Requirements 
Prior to obtaining consent from any subjects, the following documents are required:  
• 
A copy of the Investigator Agreement, signed and dated by the Principal 
Investigator 
• 
A signed and dated copy of the Clinical Trial Agreement  
• 
Financial Disclosure for the Principal Investigator and Sub-Investigator(s), if 
applicable 
• 
A copy of the written IRB approval of the protocol 
• 
A copy of the approved Informed Consent Form and written IRB approval of the 
form  
• 
A copy of the signed and dated curriculum vitae of the Principal Investigator and 
Sub-Investigator(s), if applicable 
• 
Copies of state licenses of the designated study site Investigators (surgeons and 
audiologists) 

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15.3.2 Study Documentation 
Study records are comprised of source documents, eCRFs, and all other 
administrative documents including, for example, IRB correspondence, clinical trial 
materials and supplies shipment manifests, monitoring follow-up letters, and study-
related correspondence with Advanced Bionics. A study-specific binder will be 
provided with instructions for maintenance of study records. 
Source documentation is defined as any hand-written or computer-generated 
document that contains medical information or test results that have been collected 
for or are in support of the protocol specifications. For example, these documents 
may include audiograms, results from imaging, lab reports, clinic notes, subject 
questionnaires, and telephone logs. All draft, preliminary, and pre-final versions of a 
report also are considered source documents, including faxed reports or data and 
hard copies of test results. 
15.3.3 Record Retention 
All study records (e.g., protocol, IRB correspondence and approvals, eCRFs, patient 
records, consent forms, reports) must be maintained for a minimum of 2 years after 
the last approval of a marketing application in an International Conference on 
Harmonization (ICH) region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least 2 years have elapsed since 
the formal discontinuation of clinical development of the study intervention. These 
documents should be retained for a longer period, however, if required by local 
regulations. After this time records may be transferred to Advanced Bionics for 
indefinite storage. 
If an Investigator opts to discontinue participation in the study, all records will be 
transferred to a mutually agreed designee (i.e., another Investigator). This transfer 
is subject to Advanced Bionics’ approval and will be documented in writing with 
copies sent to Advanced Bionics. If an Investigator leaves the site at which the study 
was conducted, Advanced Bionics shall be contacted regarding the disposition of 
documents. 
15.3.4 Inspection of Records 
In the event of an audit, the Investigator agrees to allow representatives of the study 
Sponsor, FDA or other regulatory authorities to access all study records. 
Investigators should notify the study Sponsor promptly if an audit request is received 
from any regulatory or government agency. A copy of the audit findings if conducted 
should be forwarded to the study Sponsor following the conclusion of the visit.  
15.4 
Study Audits 
Advanced Bionics’ internal auditors or contract auditors may evaluate the conduct of the 
study. These parties will have access to all study-related documents. Advanced Bionics 
audit reports are confidential and proprietary. 
15.5 
Study Funding 
The study is funded by Advanced Bionics; financial agreements with the participating 
centers are addressed in a separate agreement.  
 
 

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16. Amendments and Deviations 
16.1 
Protocol Amendments 
Any changes to the protocol must be implemented through a formal protocol amendment. 
Amendments to the protocol may be initiated by Advanced Bionics or at the request of the 
Investigator. In either case, a formal amendment cannot be initiated until it has been 
approved by Advanced Bionics, FDA, and the IRB. 
16.2 
Protocol Deviations 
A protocol deviation refers to a study-related activity that is not in compliance with the 
approved investigational plan/protocol such as an assessment or part thereof are completed 
incorrectly or omitted or a participant not returning at a defined study interval. Deviation 
events are to be reported accordingly on a protocol deviation report form in the Electronic 
Data Capture system. Deviations from the clinical protocol and protocol requirements 
including GCP guidelines will be reviewed and evaluated on an ongoing basis. Appropriate 
corrective actions will be implemented as necessary. Dependent on nature of deviation, the 
Investigator may be required to notify the IRB.  
16.1 Emergency Deviations 
Investigators are not allowed to deviate from the protocol, unless required to protect the 
rights, safety, or well-being of subjects. Emergency deviations or modifications to the 
protocol may be initiated without Advanced Bionics or IRB approval (21 CFR 50.24) only in 
cases where an immediate apparent hazard to subjects must be avoided. Emergency 
deviations or modifications must be reported to Advanced Bionics and the IRB no later than 
24 hours after the emergency.  
17. Publication Policy 
This clinical study will be registered with clinicaltrials.gov and results will be made publicly 
available. 
Advanced Bionics intends to publish the results of the clinical investigation in a peer reviewed 
journal. Authorship for the publication of the multi-center data will be jointly decided between 
Advanced Bionics and the Investigators. Further details of the publication policy will be governed 
by the Clinical Trial Agreement between Advanced Bionics and the participating institutions. 
18. Bibliography 
• 
Gifford RG, Shallop JK, Peterson MA. (2008) Speech recognition materials and ceiling effects: 
Considerations for cochlear implant programs. Audiol Neurotol 13: 263-271. 
• 
Little RJA and Rubin DB. (2002) Statistical Analysis with Missing Data. Wiley 
• 
Petrovcic A, Boot WR, Burnik T, Dolnicar V. (2019) Improving the Measurement of Older 
Adults' Mobile Device Proficiency: Results and Implications from a Study of Older Adult 
Smartphone Users 
• 
Roque NA and Boot WR. (2018) A New Tool for Assessing Mobile Device Proficiency in Older 
Adults: The Mobile Device Proficiency Questionnaire. Journal of Applied Gerontology 37(2): 
131–156 
• 
Rubinstein JT, Parkinson WS, Tyler RS, Gantz BJ. (1999) Residual speech recognition and 
cochlear implant performance: effects of implantation criteria. Am J Otol 20(4):445-52. 
• 
Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, 
Cook S. (2012) Development and validation of the AzBio sentence lists. Ear Hear. 33(1): 112-
7.  
• 
Tyler RS, Summerfield QA. (1996) Cochlear Implantation: Relationships with Research on 
Auditory Deprivation and Acclimatization, Ear Hear 17(3): 38S-50S 
 
 

Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System 
Version # 1.2 / Version Date: May 26, 2021                    Confidential 
 
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CIP Investigator Signature Page 
 
I, the undersigned, have read and understand the protocol specified above and agree on its 
content. I agree to perform and conduct the study as described in the protocol and in 
accordance with the relevant parts of the ICH Guidelines for GCP, ISO 14155, the Declaration 
of Helsinki, and the pertinent individual country laws/regulations.  
 
In addition, I assume responsibility for protocol compliance for persons to whom I delegate 
study related tasks.  
 
Study Center: 
 _______________________________  
Principal Investigator Name:   
 _______________________________  
Principal Investigator Signature: 
 _______________________________  
Signature Date: 
 _______________________________