Evaluating Design Improvements With SONNET 3 in Experienced Cochlear Implant Users
Phase: NA
Conditions: Hearing Loss, Sensorineural
Sponsor: Med-El Corporation

 
 
 
 
Evaluating Design Improvements with SONNET 3 in 
Experienced Cochlear Implant Users 
IDE NUMBER G240188   
 
IDE Sponsor: MED-EL Corporation 
2645 Meridian Pkwy 
Durham, NC 27713 
 
Version Number:  v.2.0 
August 02, 2024 
 
 
 
 

Evaluating Design Improvements with SONNET 3 in Experienced Cochlear Implant Users 
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Table of Contents 
Table of Contents .................................................................................................................................................... ii 
LIST OF ABBREVIATIONS ....................................................................................................................................... 1 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
1 
Protocol Summary.......................................................................................................................................... 2 
1.1 
Synopsis ............................................................................................................................................... 2 
1.2 
Schematic of Study Design ................................................................................................................ 4 
2  
INTRODUCTION ............................................................................................................................................ 5 
2.1 
Study Rationale ................................................................................................................................... 5 
2.2 
Background .......................................................................................................................................... 5 
2.3 
RISK/BENEFIT ASSESSMENT ........................................................................................................ 6 
2.3.1 
Known Potential Risks .................................................................................................... 6 
2.3.2 
Known Potential Benefits ................................................................................................ 7 
2.2.3 
Assessment of Known Potential Risks and Benefits .................................................. 7 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 8 
4 
STUDY DESIGN ............................................................................................................................................ 9 
4.1 
Overall Study Design .......................................................................................................................... 9 
4.2 
Scientific Rationale for Study Design ............................................................................................... 9 
4.3 End of Study Definition .................................................................................................................................... 9 
5 
STUDY ENROLLMENT AND WITHDRAWAL ........................................................................................... 9 
5.1 
Participant Inclusion Criteria .............................................................................................................. 9 
5.2 
Participant Exclusion Criteria ............................................................................................................. 9 
5.3 
Strategies for Recruitment and Retention...................................................................................... 10 
5.4 
Participant Withdrawal or termination ............................................................................................. 10 
5.4.1 
Reasons for Withdrawal or Termination ..................................................................... 10 
5.4.2 
Handling of Participant Withdrawals or termination .................................................. 10 
6 
STUDY DEVICE ........................................................................................................................................... 11 
6.1 
Study Device Description ................................................................................................................. 11 
6.1.1 
Classification .................................................................................................................. 11 
6.1.2 
Details of Manufacturer ................................................................................................. 11 
6.1.3 
General Description ....................................................................................................... 11 
6.1.4 
Mechanisms of Action ................................................................................................... 13 
6.2 
Study Device Control ........................................................................................................................ 13 
6.2.1 
Acquisition ....................................................................................................................... 13 
6.2.2 
Labeling  .......................................................................................................................... 14 
6.2.3 
Storage  .......................................................................................................................... 14 
6.2.4 
Accountability ................................................................................................................. 14 
7 
STUDY PROCEDURES AND SCHEDULE ............................................................................................. 14 
7.1 
Study Procedures .............................................................................................................................. 14 
7.1.1 
Study specific procedures ............................................................................................ 14 
7.1.2 
Study Intervals ................................................................................................................ 15 
7.2 
Study Schedule .................................................................................................................................. 15 
7.2.1 
Potential Participant Identification ............................................................................... 15 
7.2.2 
Visit 1: Enrollment/Baseline.......................................................................................... 15 
7.2.3 
Visit 2: 3-Week Interval ................................................................................................. 16 
7.2.4 
Enrollment Conclusion .................................................................................................. 16 

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7.2.5 
Schedule of Events Table ............................................................................................. 16 
7.3 
Precautionary Procedures................................................................................................................ 16 
7.4 
Prohibited Procedures ...................................................................................................................... 16 
8 
ASSESSMENT OF SAFETY ...................................................................................................................... 17 
8.1 
Definitions and Classifications ......................................................................................................... 17 
8.1.1 
Definition of Adverse Events (AE) ............................................................................... 17 
8.1.2 
Definition of Adverse Device Effects (ADE) ............................................................... 17 
8.1.3 
Definition of Serious Adverse Events (SAE) .............................................................. 17 
8.1.4 
Definition of Unanticipated Adverse Device Effects (UADE) ................................... 17 
8.2 
Time Period and Frequency for Event Assessment and Follow-Up .......................................... 17 
8.3 
Reporting Procedures ....................................................................................................................... 18 
8.3.1 
Adverse Event Reporting .............................................................................................. 18 
8.3.2 
Unanticipated Serious Adverse Device Effect Reporting ......................................... 20 
8.4 
Study Halting Rules ........................................................................................................................... 20 
9 
CLINICAL MONITORING............................................................................................................................ 20 
10 
STATISTICAL CONSIDERATIONS .......................................................................................................... 22 
10.1 
Statistical Hypotheses ...................................................................................................................... 22 
10.2 
Sample Size ....................................................................................................................................... 22 
10.3 
Analysis Datasets .............................................................................................................................. 23 
10.4 
Description of Statistical Methods ................................................................................................... 23 
10.4.1 
General Approach .......................................................................................................... 23 
10.4.2 
Analysis of the Primary Effectiveness Endpoint ........................................................ 23 
10.4.3 
Analysis of the Secondary Endpoint(s)....................................................................... 23 
10.4.4 
Safety Analyses ............................................................................................................. 24 
10.4.5 
Adherence and Retention Analyses ............................................................................ 24 
10.4.6  
Baseline Descriptive Statistics ..................................................................................... 24 
10.4.7 
Planned Interim Analyses ............................................................................................. 24 
10.4.8 
Additional Sub-Group Analyses ................................................................................... 24 
10.4.9 
Multiple Comparison/Multiplicity .................................................................................. 24 
10.4.10 
Tabulation of Individual Response Data..................................................................... 24 
10.4.11 
Exploratory Analyses..................................................................................................... 24 
10.5 
Measures to Minimize Bias .............................................................................................................. 24 
10.6 
Site poolability .................................................................................................................................... 24 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS .................................. 24 
12 
QUALITY ASSURANCE AND QUALITY CONTROL ............................................................................. 25 
13 
ETHICS/PROTECTION OF HUMAN PARTICIPANTS .......................................................................... 25 
13.1 
Ethical Standard ................................................................................................................................ 25 
13.2 
Institutional Review Board................................................................................................................ 25 
13.3 
Informed Consent Process .............................................................................................................. 25 
13.3.1 
Consent Documents Provided to Participants ........................................................... 25 
13.3.2 
Consent Procedures and Documentation .................................................................. 26 
13.4 
Participant and data Confidentiality ................................................................................................ 26 
14 
DATA HANDLING AND RECORD KEEPING ......................................................................................... 27 
14.1 
Data Collection and Management Responsibilities ...................................................................... 27 
14.2 
Study Records Retention ................................................................................................................. 27 
14.3 
Protocol Deviations ........................................................................................................................... 28 

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14.4 
Publication and Data Sharing Policy .............................................................................................. 28 
15 
CONFLICT OF INTEREST POLICY ......................................................................................................... 28 
16  
LITERATURE REFERENCES ................................................................................................................... 29 
 
 

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LIST OF ABBREVIATIONS 
 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AP 
Audio Processor 
CFR 
Code of Federal Regulations 
CI 
Cochlear Implant 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
IC 
Informed Consent 
IDE 
Investigational Device Exemption 
IRB 
Investigational Review Board 
PI 
Principal Investigator 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOP 
Standard Operating Procedure 
UADE 
Unanticipated Adverse Device Effect 
 
STATEMENT OF COMPLIANCE 
The trial will be conducted in accordance with Good Clinical Practice (GCP), as required by the 
following:  
• 
United States Code of Federal Regulations (CFR) applicable to clinical studies (21 CFR Part 
50, 21 CFR Part 54, 21 CFR Part 56, 21 CFR Part 58, 21 CFR Part 812) 
• 
Good Clinical Practices 
All investigators involved in the conduct of this study will be informed about their obligations in 
meeting the above commitments. The protocol and consent forms will be reviewed and 
approved by the Institutional Review Board (IRB) before participants are enrolled. Any 
amendment to the protocol will be reviewed and approved by the IRB before changes are 
implemented to the study.  
 
 

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1 
PROTOCOL SUMMARY 
 
1.1 
SYNOPSIS 
Title: 
Evaluating Design Improvements with SONNET 3 (EAS) in Experienced 
Cochlear Implant Users 
Study Description: 
This prospective IDE study will use a single-arm, repeated measures 
design with subjects serving as their own control. Participants will be 
experienced cochlear implant (CI) users wearing an approved MED-EL 
audio processor. The study will demonstrate patient-reported 
improvement in processor design, usability, and satisfaction with the 
SONNET 3 (EAS) (EAS) Audio Processor compared to their existing 
audio processor. Participants will complete a take-home trial with the 
SONNET 3 (EAS). At Visit 2, participants will complete a custom 
questionnaire comparing design and usability with SONNET 3 (EAS) 
(EAS) to their existing audio processor.  
Objectives: 
 
Primary Objective: To demonstrate patient-reported improvement in 
processor design with the SONNET 3 (EAS) (EAS) audio processor 
compared to the existing audio processor. 
Secondary Objectives: To compare user experience  with the SONNET 
3 (EAS) (EAS) audio processor to the existing audio processor. 
Endpoints: 
Primary Endpoint: At least 77% of participants will report 
improvement (mean score >3 on a 6-point Likert scale) in  processor 
design with the SONNET 3 (EAS) (EAS) compared to the existing audio 
processor on the Design subsection of the Audio Processor 
Comparison Survey (APCS) at Visit 2. 
Secondary Endpoints: 
1. Summary 
of 
patient-reported 
satisfaction 
ratings 
on 
subsections of the Audio Processor Comparison Survey (APCS) 
with SONNET 3 (EAS) (EAS) at Visit 2. 
2. Summary of audiologist-reported satisfaction ratings on 
subsections of the Audiologist Survey at enrollment 
conclusion. 
Study Population: 
This study will include 20 experienced MED-EL CI users who are 
consistently wearing a SONNET (EAS) or SONNET 2 (EAS) audio 
processor at ≥12 months post-activation and are able to complete the 
study procedures.  
 
 
Description of Sites 
Enrolling Participants: 
One (1) US academic medical center will enroll participants  
Description of Study 
Device: 
Participants will be experienced MED-EL CI recipients using the 
commercially available SONNET (EAS) or SONNET 2 (EAS) audio 
processor (MED-EL Elektromedizinische Geräte GmbH, Innsbruck, 
Austria). For the experimental procedure, participants will be fit with a 
SONNET 3 (EAS) (EAS) audio processor (MED-EL Elektromedizinische 
Geräte GmbH, Innsbruck, Austria). The SONNET 3 (EAS) (EAS) audio 
processor is an external component and is indicated for use on 

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patients who have been implanted with a MED-EL cochlear implant. 
The SONNET 3 (EAS) (EAS) audio processor consists of the control unit, 
coil, coil cable, microphone cover, earhook, and battery pack. SONNET 
3 (EAS) (EAS) is programmed with the MAESTRO 11.0 or higher Fitting 
Software (MED-EL Elektromedizinische Geräte GmbH, Innsbruck, 
Austria).  
Study Duration: 
Enrollment is expected to take 12 months, and participant follow-up 
will last up to 1 month. The estimated time from the first subject’s 
first visit to the last subject’s last visit is 13 months. 
Participant Duration: 
Each subject’s participation will last approximately 1 month from 
enrollment to the final study visit.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.2 
SCHEMATIC OF STUDY DESIGN 
 
 
 
 
 
 
Visit 1: Enrollment
• Informed consent or assent (if required)
• Parental permission (if applicable)
• Participant leaves with SONNET 3
• See Study Schedule (Section 7.2) and Schedule of Events Table (Section 7.2.5) for more detail
Visit 2: 3-Week Follow Up
• Audio Processor Comparison Survey completed by participant
• See Study Schedule (Section 7.2) and Schedule of Events Table (Section 7.2.5) for more detail
Enrollment Conclusion
• Audiologist Survey completed by study team
• See Study Schedule (Section 7.2) and Schedule of Events Table (Section 7.2.5) for more detail

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2  
INTRODUCTION 
 
2.1 
STUDY RATIONALE 
Cochlear implant audio processors capture and deliver acoustic signals to the internal device. 
They accomplish this through dual-microphone technology and signal processing algorithms 
developed to preferentially detect and enhance speech signals relative to background noise. The 
audio processor is worn all waking hours, every day for best outcomes. The requirements of a 
reliable audio processor are two-fold; reliable performance of signal processing and front-end 
microphone features ensures clear speech, while a comfortable design reduces barriers to 
wearing the device all waking hours.  
Manufacturers of cochlear implants release periodic updates to processor design to enhance 
usability and the listening experience. Insurance companies in the United States are typically 
contracted to subsidize the purchase of new processors every 5 years, depending on the 
coverage plan and the region. However, insurance providers may deny coverage for new 
processors without data to support the efficacy of new technology compared to previous 
processor designs. 
2.2 
BACKGROUND  
The SONNET 3 (EAS) audio processor (AP) is MED-EL’s latest BTE design (Innsbruck, Austria) and 
improves upon the existing SONNET/SONNET 2 (EAS) APs with enhanced physical design and 
Bluetooth useability. The SONNET 3 (EAS) is programmed with MAESTRO 11 software, both of 
which have been submitted to the FDA for approval in June 2024 (refer to submission 
P000025/S131). MAESTRO 11 includes minor improvements in the user interface (see section 
6.1.3). The SONNET 3 (EAS) offers a smaller and lighter design for better wearing comfort on the 
ear (see section 6.1.3). New earhook options, including a large earhook and a flexible silicone 
earhook designed for improved flexibility on the pinna, allow the recipient to further customize 
their wearing options. Bluetooth streaming in the SONNET 3 (EAS) is simplified with an 
integrated 2.4GHz receiver that no longer needs an intermediary device to stream music, phone 
calls, and other audio from smart devices. These design changes are an answer to the field’s 
request for lighter wearing options with integrated streaming capabilities. 
In 2012, Lorens and colleagues compared subjective benefit of a new audio processor (AP) 
design in a group of 10 experienced electro-acoustic stimulation (EAS) CI recipients who were 
utilizing the MED-EL DUET AP. Subjects were upgraded to the DUET 2 AP and completed a 
custom questionnaire at three intervals during a 3-month trial to study the effects of user 
preference over time. The custom survey compared aspects of user-perceived listening ability 
and wearing comfort with DUET 2 to the DUET AP. Subjects’ preference for the sound quality of 
speech with DUET 2 improved at each interval, achieving 34% preference over the DUET AP by 
the 3-month interval. Overall, 70% of subjects were either very satisfied or satisfied with the 

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wearing comfort of the DUET 2, and no subject was dissatisfied with the wearing comfort of the 
DUET 2. Results suggest that experience with a new processor is important when measuring 
subjective impressions of these changes in AP design. The authors concluded that conversion 
from the old to the new AP model greatly improved patient satisfaction.  
In 2015, Martin et al. gathered data from both implant recipients and professionals on the ease 
of use of the new Naída CI Q70 (Naída CI) AP from Advanced Bionics, and on the usefulness of 
the new functions and features available. Existing CI users who had recently upgraded to Naida 
CI answered a 25-question custom survey which included a section directly comparing the user’s 
previous AP to the Naida CI AP. Feedback from professionals was captured through a 30-
question survey probing their impressions on usability and fitting. In total, 186 subjects across 
10 countries, and 23 professionals across 11 sites responded to the survey. The Naida CI was 
rated as similar or better than the previous AP models by more than 79% of the subjects for all 
areas. The new design of the Naida CI was rated as being better by 83% of subjects. 
Professionals ranked the Naida CI processor first in design compared to other previous models. 
Overall results showed high satisfaction with the new AP from users of all ages and experience 
levels, as well as from professionals.  
Warren et al., 2019 compared subjective impressions of experienced Cochlear brand Nucleus 5 
and Nucleus 6 AP users who trialed the Nucleus 7 AP. Comparative satisfaction with self-
reported  hearing ability and usability with the new AP was captured via a custom survey after 3 
months using the device. The majority of subjects reported improvement in perceived hearing 
ability and device usability with the new AP design compared to their existing audio processor, 
with an average of 83% of participants (n=35) responding positively (>50 on a 100-point scale) to 
questions comparing features of the new AP to the existing model. The authors conclude that 
the assessment of effectiveness of ergonomic improvements in AP design are best captured 
through subjective evaluation after providing the user with adequate time and experience with 
the device to assess the comparative benefits to their previous device. 
The purpose of this study is to evaluate patient-reported improvement in design and comfort 
with SONNET 3 (EAS) over the existing AP models available, and to measure patient-reported 
impressions of usability and satisfaction with the SONNET 3 (EAS) AP. 
2.3 
RISK/BENEFIT ASSESSMENT 
 
2.3.1 KNOWN POTENTIAL RISKS  
 
Any cochlear implant processor poses a risk of skin irritation or sensitivity to the processor 
materials. Materials in the SONNET 3 (EAS) (EAS) Audio Processor do not differ from those in the 
FDA-approved SONNET/SONNET 2 (EAS) Audio Processors. MED-EL has performed biological 
safety and compatibility testing with materials in the SONNET 3 (EAS) (EAS), and subjects with a 
skin or scalp condition that would preclude use of the audio processor will be excluded from this 
study. All cochlear implant processors and fitting software also pose a risk of overstimulation 

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and exposure to unwanted or uncomfortable sounds. The processor can be removed from the 
head at any time to immediately stop stimulation. 
There is a remote chance that technical failure or suboptimal fitting of any audio processor leads 
to unwanted sensations, missing information, suboptimal hearing, or lack of benefit. Study 
participants who wish to stop using the SONNET 3 (EAS) (EAS) Audio Processor before study 
completion may withdraw from the study at any time and continue using their existing audio 
processor. Participants who experience poorer sound quality or performance with SONNET 3 
(EAS) (EAS) may be reprogrammed after testing at Visit 2. 
2.3.2 KNOWN POTENTIAL BENEFITS  
Advances in audio processor design may provide improved wearing comfort, usability, 
satisfaction, and durability with the SONNET 3 (EAS) (EAS) Audio Processor. This study will 
evaluate potential benefits to inform future device labeling, insurance coverage, clinical 
guidance, and product development for all MED-EL cochlear implant users. After completing 
Visit 2, study participants may choose to keep the SONNET 3 (EAS) (EAS) Audio Processor or 
return the SONNET 3 (EAS) (EAS) and continue using their existing audio processor. 
 
2.2.3 ASSESSMENT OF KNOWN POTENTIAL RISKS AND BENEFITS  
 This study will include experienced MED-EL CI users who have worn an FDA-approved SONNET 
(EAS) or SONNET 2 (EAS) Audio Processor (P000025/S078 and P000025/S112, respectively) for at 
least 12 months. The SONNET/SONNET 2 (EAS) Audio Processors (AP) are part of the MED-EL 
Cochlear Implant System (P000025). The SONNET 3 (EAS) (EAS) AP is not expected to pose any 
greater risk of harm to participants than SONNET/SONNET 2 (EAS) APs. Advances in technology 
with SONNET 3 (EAS) (EAS) may provide new design features to improve wearing comfort and 
streamlined connectivity to improve usability. Thus, the benefits of SONNET 3 (EAS) (EAS) are 
expected to outweigh the residual risk in this population. Periodic advances in audio processor 
technology are standard practice and expected in the field of cochlear implants. This study in 
intended to collect clinical data on patient-reported satisfaction and performance with SONNET 
3 (EAS) (EAS) before commercial availability in the United States to assist with future product 
launch and insurance coverage. 
 
 
 
 
 

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3 
OBJECTIVES AND ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
Primary 
 
 
To demonstrate patient-
reported improvement in 
processor design with the 
SONNET 3 (EAS) (EAS) 
Audio Processor (AP) 
compared to the existing 
AP. 
At least 77% of participants 
will report improvement  in 
processor design with 
SONNET 3 (EAS) (EAS) 
compared to the existing AP 
on the Design subsection of 
the Audio Processor 
Comparison Survey (APCS) at 
Visit 2.  
Based on changes in size, weight, 
and earhook, we expect the 
majority of users to report 
improved design with SONNET 3  
(EAS). Warren et al., 20191 
compared useability of a novel AP 
to the existing design and found 
that, 77% of participants reported 
improvement in design. A mean 
score >3 (6-point Likert scale) on 
the APCS Design subsection will 
indicate agreement with improved 
design of SONNET 3 (EAS). 
Secondary 
 
 
To compare user 
experience with the 
SONNET 3 (EAS) (EAS) 
Audio Processor to the 
existing AP. 
 
 
 
 
 
Summary of patient-reported 
satisfaction ratings (6-point 
Likert scale) on subsections 
of the APCS with SONNET 3 
(EAS) (EAS) at Visit 2. 
The APCS includes the Bluetooth 
Pairing, Backwards Compatibility, 
and Parent Impressions subsections 
to assess different areas of SONNET 
3 (EAS) (EAS) usability. 
Summary of audiologist-
reported satisfaction ratings 
on subsections of the 
Audiologist Survey at 
enrollment conclusion. 
The Audiologist Survey assesses the 
clinician perspective on usability 
improvements with SONNET 3 
(EAS) (EAS). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4 
STUDY DESIGN 
 
4.1 
OVERALL STUDY DESIGN 
This prospective, single-site IDE study uses an open-label, single-arm, repeated-measures design 
with participants serving as their own control. One US academic medical center will enroll 20 
experienced MED-EL CI users to evaluate the design and usability of the SONNET 3 (EAS) Audio 
Processor (AP). Participants may enroll before or at Visit 1. Each participant will complete a 3-
week trial with the SONNET 3 (EAS) AP. Participants will return 2-4 weeks after Visit 1 to 
complete a custom survey comparing AP design (Visit 2). Study objectives will assess patient-
reported improvement in AP design and compare usability  with the SONNET 3 (EAS) AP to 
participants’ existing SONNET (EAS) or SONNET 2 (EAS) AP. The primary endpoint will 
demonstrate superiority of the  SONNET 3 (EAS) AP design compared to the existing AP designs.  
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
Randomization is not appropriate for this study. A repeated-measures, within-participant design 
using participants as their own control enables clinically meaningful comparisons that account 
for patient heterogeneity. 
4.3 END OF STUDY DEFINITION 
An individual’s participation is considered complete when the participant completes the last 
visit, or the last procedure shown in the Schedule of Events Table in 7.2.5.  
5 
STUDY ENROLLMENT AND WITHDRAWAL 
 
5.1 
PARTICIPANT INCLUSION CRITERIA 
Participants must meet all inclusion criteria below: 
• 
Implanted with a MED-EL cochlear implant in at least one ear 
• 
≥ 12 months since activation of the MED-EL audio processor 
• 
Consistently using a SONNET (EAS) or SONNET 2 (EAS) Audio Processor 
• 
Ability to complete all study procedures 
• 
Participant and parental (if applicable) commitment to comply with all study procedures 
for the duration of the study 
5.2 
PARTICIPANT EXCLUSION CRITERIA 
Participants must not meet any exclusion criteria below: 
• 
Evidence that hearing loss is retrocochlear in origin 

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• 
Unable to provide reliable feedback during cochlear implant programming  
• 
Skin or scalp condition precluding use of the SONNET 3 (EAS) Audio Processor 
• 
Unrealistic participant or parent (if applicable) motivation or expectations 
• 
Participants without a stable fitting map at enrollment e.g., due to changes in hearing, 
global health status, etc. 
5.3 
STRATEGIES FOR RECRUITMENT AND RETENTION 
The current study aims to enroll 20 participants. Potential participants will be recruited through 
the outpatient clinics at a single academic medical center. The site may review existing records 
for patients to determine potential participants. Participants may also be recruited by their 
clinical audiologists, who will refer the potential participant to the clinical research team to 
verify candidacy. Parents or legal guardians must provide permission for participants under 18 
years of age to participate. The IRB will determine needs and age required for assent. 
Parental/guardian permission and assent must be explained and signed before enrollment 
testing. 
5.4 
PARTICIPANT WITHDRAWAL OR TERMINATION 
 
5.4.1 REASONS FOR WITHDRAWAL OR TERMINATION 
Participants or their parents/legal guardians may choose to withdraw from the study at any 
point during participation. The site principal investigator may terminate an individual’s 
participation in the study for reasons outlined below: 
• 
Noncompliance with the study protocol 
• 
Health concerns that prevent required follow-up procedures or interval visits 
The site investigators should report participant withdrawals and terminations to study monitors 
as soon as possible. Subjects who withdraw prior to completion of Visit 2 will be required to 
return the SONNET 3 (EAS) Audio Processor to receive compensation for Visit 1. Participants 
who are considered lost-to-follow-up should also be reported to study monitors immediately. 
Every effort should be made to contact participants lost-to-follow-up and determine the reason 
for noncompliance. If the SONNET 3 (EAS) is not returned, the subject’s clinical audiologist will 
be made aware so that efforts can be made to retrieve the study device at a clinical follow-up 
appointment.  
5.4.2 HANDLING OF PARTICIPANT WITHDRAWALS OR TERMINATION 
Withdrawn participants will continue to be seen by their clinical audiologist for regular follow-up 
care, but no additional data will be collected. Participants who sign the informed consent/assent 
form but do not complete all study intervals may be replaced and will return any study 
equipment to the site. Baseline data collected on withdrawn subjects who are replaced will not 
be included in the modified intent-to-treat (mITT) or per population (PP) analysis datasets.  

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6 
STUDY DEVICE 
 
6.1 
STUDY DEVICE DESCRIPTION 
 
6.1.1 CLASSIFICATION 
The SONNET 3 (EAS) Audio Processor is an external component intended for use with the MED-
EL Cochlear Implant System, a class III medical device (P000025). All study participants will be 
experienced MED-EL CI users who have been wearing an FDA-approved SONNET (EAS) or 
SONNET 2 (EAS) Audio Processor (P000025/S078 and P000025/S112, respectively) for at least 12 
months. Details of the SONNET 3 (EAS) classification can be located in the FDA submission 
P000025/S131 (June 28, 2024).  
6.1.2 DETAILS OF MANUFACTURER 
The SONNET 3 (EAS) Audio Processor is manufactured by MED-EL Elektromedizinische Geräte 
GmbH. MED-EL Corporation is the US importer and the sponsor of this clinical trial. 
6.1.3 GENERAL DESCRIPTION 
The SONNET 3 (EAS) is a cochlear implant audio processor designed to capture and transmit 
acoustic sound to the surgically implanted internal device. The SONNET 3 (EAS) is designed to be 
worn behind the ear and is comprised of the control unit, battery pack, earhook, microphone 
cover, DL-Coil, coil cable, and magnet (see diagram from SONNET 3 (EAS)/SONNET 3 (EAS) EAS 
User Manual3 below). 
 

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The SONNET 3 (EAS) is the third generation SONNET processor. It improves upon the previous 
generations in earhook design, size, and Bluetooth streaming capability. The SONNET 3 (EAS) is 
lighter in weight (SONNET/SONNET 2: 10.6 g) and shorter (SONNET/SONNET 2: 56.7 mm) than 
SONNET/SONNET 2 (see SONNET 3 (EAS)3 specifications below). 
 
The SONNET 3 (EAS) has more earhook options, including a flexible silicone earhook and a large 
earhook to accommodate different pinna sizes. Status indicator lights are visible through the 
earhook, making viewing easier for users and guardians (see below). 
                                  
 
 
The microphone cover is smaller and designed with an easier mechanism for replacement (see 
below).  
                            
 
The new touch key feature gives users the ability to adjust program or activate ‘Standby 
Mode’ simply by tapping the audio processor.  

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The audio processor is equipped with 2.4 GHz Bluetooth® ⁶ wireless technology. This 
technology allows the audio processor to connect to certain mobile devices wirelessly 
(smartphone, tablet, etc.). 
The SONNET 3 (EAS) processor is intended for use in patients who have been implanted with a 
MED-EL cochlear implant (SYNCHRONY/SYNCHRONY 2 (PIN), SONATA, MED-EL CONCERT, 
PULSAR, COMBI40/COMBI40+). 
The SONNET 3 (EAS) Audio Processor is programmed with MAESTRO System Software 114 or 
higher. MAESTRO 11 builds off of previous versions with the following new features and 
changes:  
• 
Support the programming of SONNET 3 (EAS) and SONNET 3 (EAS) EAS audio processors 
• 
New user interface for the Configuration options dialog  
• 
New dialog for configuration of audio input options with additional options for 
programming SONNET 3 (EAS) processors 
• 
Allows the configuration of wireless streaming options for SONNET 3 (EAS) 
 
6.1.4 MECHANISMS OF ACTION 
The SONNET 3 (EAS) Audio Processor control unit is programmed using MAESTRO 11 System 
Software or higher. Once programmed, the control unit is powered via the battery pack and 
worn on the ear. The control unit captures the acoustic signal via processor microphones, then 
applies dynamic range compression so that the signal can be converted into electrical output. 
Maplaw adjustments provide additional gain to the input signal to enhance soft speech before 
the signal is encoded into electrical pulses. Signal processing algorithms are applied to the 
speech signal, which is converted into an electrical signal and transmitted via the cable-coil to 
the internal device for auditory sensation.  
6.2 
STUDY DEVICE CONTROL 
 
6.2.1 ACQUISITION 
MED-EL Corporation will provide MAESTRO 11 or higher software and the necessary Activation 
Key to the site on a standalone laptop via a loaner agreement for study purposes. MED-EL will 
also provide an allotment of SONNET 3 (EAS) audio processors to the site via a loaner 
agreement. The site will notify MED-EL of the assigned processor serial number associated with 

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each participant. At the conclusion of their participation in the study, each participant may 
choose to keep the SONNET 3 (EAS), at which time the audio processor warranty will be 
registered and activated in accordance with standard SOPs. When the study is completed, the 
site will return any unused/returned SONNET 3 (EAS) audio processors and the loaner laptop to 
MED-EL.  
6.2.2 LABELING 
Outer packaging on study devices will be labeled with stickers that read: "CAUTION - 
Investigational Device. Limited by Federal (or United States) law to investigational use.”  
6.2.3 STORAGE 
The study site should store devices labeled for investigational use separately from approved 
devices for non-study patients. There are no additional requirements for storage of the device. 
6.2.4 ACCOUNTABILITY 
MED-EL will be responsible for creating and storing records related to device accountability and 
traceability. Shipment records, including name and address of the study site, participant ID, 
device information, date of shipment, and serial numbers, will be stored at MED-EL according to 
the relevant SOPs. Study devices returned to MED-EL will be documented and stored 
accordingly.  
7 
STUDY PROCEDURES AND SCHEDULE 
 
7.1 
STUDY PROCEDURES 
 
7.1.1 STUDY SPECIFIC PROCEDURES  
The following procedures will be performed during the study and will be documented for each 
participant enrolled: 
• 
Informed consent: Site study personnel will review the IC form with potential 
participants and obtain signature prior to initiating study activities. Participants will be 
allowed to ask questions and may withdraw consent at any time. 
• 
Parental/Legal Guardian permission: Site study personnel will review the parental 
permission form with the parents/legal guardians and obtain parental permission before 
starting study activities. Parents/guardians will be allowed to ask questions and may 
withdraw consent at any time. 
• 
Assent: If required by the IRB, site study personnel will review the assent form with the 
potential participant and obtain assent before starting study activities. Potential 
participants will be allowed to ask questions and may withdraw assent at any time. 

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• 
Patient-Reported Outcomes:  
o Audio Processor Comparison Survey (APCS): Participants will complete the APCS 
at Visit 2. The APCS  includes questions arranged into four subsections that 
assess user or parent satisfaction with design, Bluetooth pairing, and backwards 
compatibility with the SONNET 3 (EAS) compared to the existing audio 
processor. Responses are captured with a 6-point Likert scale, and responses 
from the Design subsection will be analyzed for the primary endpoint. 
Responses on all other subsections will be summarized for the secondary 
endpoint.  
• 
Audiologist Outcomes: 
o Audiologist Survey: This custom survey assesses clinician impressions of device 
usability with SONNET 3 (EAS) compared to the existing models, 
SONNET/SONNET 2 (EAS). The survey features three subsections and responses 
are captured with a 6-point Likert scale. This survey will be completed by the 
audiologists upon conclusion of enrollment.  
7.1.2 STUDY INTERVALS 
• 
Visit 1: Enrollment/Baseline 
• 
Visit 2: 3-week Interval (2-4 weeks after Visit 1) 
• 
Enrollment Conclusion 
Testing can occur outside of the provided window with prior approval from MED-EL. 
7.2 
STUDY SCHEDULE  
 
7.2.1 POTENTIAL PARTICIPANT IDENTIFICATION 
Potential participants will be recruited through the outpatient clinics at a single academic 
medical center. The site may review existing records for patients to determine potential 
participants. Participants may also be recruited by their clinical audiologists, who will refer the 
potential participant to the clinical research team to verify candidacy. Study-related procedures 
will occur after informed consent or parental permission and assent (if required) forms have 
been explained and signed. Participants who are suitable candidates for the study should 
complete the enrollment/baseline procedures in Section 7.2.2.  
7.2.2 VISIT 1: ENROLLMENT/BASELINE 
• 
Informed consent 
• 
Parent/Legal Guardian permission (if applicable) 
• 
Assent (if applicable and required by IRB) 
• 
The participant’s existing fitting map will be converted for use with SONNET 3 (EAS), 
keeping all fitting parameters identical to their current fitting MAP  

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• 
Participant instructed on use of SONNET 3 (EAS) AP for take-home trial 
• 
Visit 1 case report form (CRF) is completed 
7.2.3 VISIT 2: 3-WEEK INTERVAL 
• 
Audio Processor Comparison Survey is completed by subject 
• 
Visit 2 CRF is completed  
7.2.4 ENROLLMENT CONCLUSION 
• 
Audiologist Survey is completed 
7.2.5 SCHEDULE OF EVENTS TABLE 
 
 
 
 
Enrollment 
Visit 1 
Visit 2 
Enrollment 
Conclusion 
Informed Consent 
X 
 
 
 
Audio Processor Comparison Survey 
 
 
X 
 
Study Exit 
 
 
X 
 
Audiologist Survey 
 
 
 
X 
 
7.3 
PRECAUTIONARY PROCEDURES  
Not applicable 
7.4 
PROHIBITED PROCEDURES  
Participants should have a stable map before enrolling. The goal is to compare the same fitting 
map in each process to isolate only characteristics that are new to SONNET 3 (EAS). Unilateral 
and bilateral study participants will receive one SONNET 3 (EAS) Audio Processor for the take-
home trial period and should avoid reprogramming the existing audio processor on either ear 
between study visits. 
 
 
 
 

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8 
ASSESSMENT OF SAFETY 
 
8.1 
DEFINITIONS AND CLASSIFICATIONS 
 
8.1.1 DEFINITION OF ADVERSE EVENTS (AE) 
An adverse event is any unfavorable change in the health of a participant that happens during a 
clinical study or immediately after the study has ended. This change may or may not be caused 
by the intervention studied (Glossary of Common Site Terms - ClinicalTrials.gov). 
8.1.2 DEFINITION OF ADVERSE DEVICE EFFECTS (ADE) 
Adverse events will be reported as related to the study device if the event is known to occur 
with audio processor use or programming in the MAESTRO System Software, or if there is a 
reasonable possibility that the audio processor or programming software caused the event. 
Reasonable possibility means that there is evidence to suggest a causal relationship between 
the study device and the event. Events occurring immediately after programming the device or 
use of the audio processor during the trial may also suggest a device-related adverse event. 
8.1.3 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) 
Adverse events are considered serious when they result in death or any injury or illness that is 
life-threatening, results in permanent impairment or damage to the body, or requires medical or 
surgical intervention to prevent permanent harm to the body. 
8.1.4 DEFINITION OF UNANTICIPATED ADVERSE DEVICE EFFECTS (UADE) 
Unanticipated adverse device effects are defined as any event not previously known to occur 
with audio processor or software use. Risks associated with the device are detailed in Section 
2.3.1 above. Events can be unexpected in nature, severity, or degree of incidence. This definition 
could include an unanticipated adverse device effect or other serious adverse effect associated 
with the device, if the problem was not previously identified in nature, severity, or degree of 
incidence. 
8.2 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an adverse event may be brought to the attention of investigators during 
study visits, interim visits, or phone calls during the study. All adverse device effects will be 
recorded on the Adverse Event Report Form (CRF), including event description, date of onset, 
time of onset, relationship to the device, seriousness, unexpectedness, and the date/time of 
resolution (if applicable). Adverse events will continue to be followed until reaching adequate 
resolution or stabilization. Additional information for an ongoing adverse event will be reported 
as part of the same event and will not constitute a new event. 

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8.3 
REPORTING PROCEDURES 
 
8.3.1 ADVERSE EVENT REPORTING  
Any adverse device effect discovered during the study should be recorded on the Adverse Event 
CRF by an investigator and reported to MED-EL. Investigators are responsible for determining if 
the adverse event meets the definitions for device -related, serious, and/or unanticipated. 
Questions regarding classification should be directed to the MED-EL Clinical Monitor. All ADEs 
should be reported to the MED-EL Clinical Monitor in a timely manner. All adverse device effects 
will be reported to the FDA and to relevant IRBs in the annual report. Investigators should 
reference the flow chart below (Figure 1) and Section 8.3.2 to determine appropriate reporting 
procedures, depending on AE type. 

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(FIGURE 2) 
AE 
OCCURRENCE
CLASSIFY AE & 
REPORT TO 
MED-EL
AE CASE 
REPORT FORM
Report to MED-
EL within 10 days 
of occurrence
Adverse 
Device Effect
Serious Adverse 
Device Effect
Unanticipated 
Adverse Device 
Effect
Unanticipated, 
Serious Adverse 
Device Effect
Is the AE 
related to 
the device?
Is this an 
Unanticipated 
Serious 
Adverse 
Device Effect?
Annual 
Report
Check local IRB 
requirements
YES
NO
INVESTIGATOR
INVESTIGATOR
MED-EL
INVESTIGATOR
PROCESS
What
DOCUMENTATION
Is needed?
Who is
RESPONSIBLE 
for the 
documentation?
Report to FDA & 
IRB within 10 days 
of occurrence
MED-EL (FDA) & 
Investigator (IRB)
NO
YES
NOT REPORTABLE

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8.3.2 UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECT REPORTING  
If the investigator determines that the adverse event is unanticipated, serious, and device -
related, the CRF should be submitted to the MED-EL Study Monitor no later than 10 working 
days after becoming aware of the event. Additionally, the investigator should notify the 
reviewing IRB of the unanticipated serious adverse device effect within 10 working days. 
Upon receiving this documentation, MED-EL will review and submit the information to FDA 
within 10 working days. Additional reports concerning the effect will be submitted upon FDA 
request. 
8.4 
STUDY HALTING RULES  
MED-EL will review all serious, unanticipated adverse device effects to determine if the study 
should continue per the protocol, be modified, or be discontinued. Examples of findings that 
would trigger a safety review are the number of serious adverse events occurring overall, the 
number of occurrences of a particular type of serious adverse event, or increased frequency of 
events (e.g., device deficiencies). If findings indicate that the study or protocol should be 
reconsidered, MED-EL will inform FDA of the disposition of the study. 
A stopping rule of three unanticipated serious adverse device effects would prompt suspension 
of enrollment and/or study intervention use. Based on the definitions of an Adverse Device 
Effect, Serious Adverse Event, and Unanticipated Adverse Event provided in Sections 8.1.2, 
8.1.3, and 8.1.4, respectively, a Serious unanticipated Serious Adverse Device Effect:  
1. Results in death, injury, or illness that is life-threatening; results in permanent 
impairment or damage to the body; or requires medical or surgical intervention to 
prevent death, life-threatening injury/illness, or permanent harm to the body,  
2. Is unanticipated in nature, severity, or frequency from the known potential risks, 
3. Is related or possibly related to participation in the research, 
4. Suggests that the research places participants or others at a greater risk of harm than 
was previously known or recognized, and 
5. There is a reasonable possibility that the device caused the event  
 
9 
CLINICAL MONITORING 
Clinical monitoring is conducted to ensure that the rights and well-being of subjects are 
protected, that study data are accurate, complete, and verifiable, and that the study is being 
conducted in compliance with the approved protocol/amendment(s), with GCP, and with 
applicable regulatory requirements. MED-EL Corporation personnel and/or a qualified Contract 
Research Organization (CRO) will be responsible for monitoring this investigation according to 
MED-EL Corporation’s SOPs.  

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Clinical monitors will conduct on-site pre-study site visits at each prospective site. During this 
visit, the monitor will evaluate the facilities and staff and review study-specific details and 
obligations with investigators. Investigators will demonstrate understanding of the following 
information at the conclusion of the pre-study site visit:  
• 
Obligation to conduct the study in accordance with the investigator agreement, GCP, 
and other applicable regulations  
• 
Device accountability and traceability requirements for investigational devices  
• 
Requirements for a well-controlled study  
• 
Investigator’s role in the process of obtaining parental permission  
• 
Obligation to obtain and maintain IRB approval  
• 
Importance of complete and accurate study records, including source documentation  
• 
Required monitoring and clinical monitor access to the study records  
• 
Time commitments for investigators involved in the study  
• 
Details specific to the investigational plan  
 
Once the study and enrollment have begun, periodic monitoring will occur. The type and 
frequency of these visits will depend on the number of subjects enrolled, the completion or 
accuracy of study records received by MED-EL, and the occurrence of adverse events and 
protocol deviations. These periodic site visits will evaluate whether:  
• 
The facilities continue to be acceptable for the study  
• 
The protocol is being followed  
• 
Changes to the protocol have been reported to and approved by the IRB  
• 
Verification of source documentation and source data  
• 
Reports to the Sponsor and IRB are accurate, complete, and on time  
 
After completion of any monitoring visit, the clinical monitor will document the observations, 
conclusions, and corrective actions taken to address any findings. The documentation will 
include the visit date, name of the monitor, name of the investigator and site, and address of 
the site. Case report forms and other related study documentation will be reviewed as MED-EL 
receives the completed paperwork throughout the study. Completed study records will be 
reviewed 100% for missing data entries. Accuracy of study records will be monitored based on 
the investigator’s history, accuracy of study records, the rate of adverse events, and the 
occurrence of protocol deviations. 
 
 
 
 
 
 

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10 
STATISTICAL CONSIDERATIONS   
 
10.1 
STATISTICAL HYPOTHESES 
Primary Endpoint: 
At least 77% of participants will report improvement (mean score >3 on a 6-point Likert scale) in  
processor design with the SONNET 3 (EAS) compared to the existing audio processor on the 
Design subsection of the Audio Processor Comparison Survey (APCS) at Visit 2. 
Secondary Endpoints: 
1. Summary of patient-reported satisfaction rating (6-point Likert scale) on subsections of 
the Audio Processor Comparison Survey (APCS) with SONNET 3 (EAS) at Visit 2. 
2. Summary of audiologist-reported satisfaction ratings on subsections of the Audiologist 
Survey at enrollment conclusion. 
10.2 
SAMPLE SIZE 
The sample size estimate is based on attaining adequate power to test the primary hypothesis 
that at least 77% of participants will report subjective improvement in audio processor design 
with SONNET 3 (EAS) over the existing processor based on a single survey. The hypothesis test is 
a one-sample, one-sided test of the proportion of participants reporting an average score of >3 
on the Audio Processor Comparison Survey (APCS) compared to 77%, based on the clinical trial 
for the Cochlear Nucleus 7 audio processor, where an average of 77% of participants responded 
with greater than neutral agreement (>50 on a 100-point scale) on survey questions addressing 
satisfaction with improved comfort with the new audio processor. For the purpose of this 
sample size calculation, 77% will represent the desired participant response proportion. 
A power analysis was conducted using a binomial two-proportion test with the package ‘pwr’ in 
R. Using a 95% confidence interval, a sample size of 20 participants would provide 85% 
probability of rejecting the null hypothesis (H0< 77%).  Calculations are based on the following 
assumptions: 
• 
Hypothesized proportion: H0: p<0.77;  
• 
Expected proportion: H1: p≥0.77 
• 
Significance level = 0.05 
• 
One-sided 
• 
Effect size h=0.36 
 
 

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10.3 
ANALYSIS DATASETS 
The intent-to-treat (ITT) population is defined as all enrolled participants including withdrawn 
participants who have been replaced. The modified ITT (mITT) population is defined as all 
participants who completed Visit 1 and Visit 2. The per protocol (PP) population is defined as 
participants who: 
• 
Completed Visit 1 and Visit 2 
• 
Were using the SONNET 3 (EAS) device consistently throughout the trial period 
• 
Are free from major protocol deviations, including but not limited to: 
o Non-use of the SONNET 3 (EAS) during the trial 
o Missing test measures from one or more intervals 
o Evidence of not meeting inclusion/exclusion criteria after completion of 
study intervals 
Analysis for the primary endpoint will be completed on the mITT and the PP populations. 
10.4 
DESCRIPTION OF STATISTICAL METHODS 
 
10.4.1 GENERAL APPROACH 
Continuous variables will be summarized using mean, median, inter-quartile range, minimum, 
and maximum values. Categorical variables will be summarized using counts and percents. 
Testing of the primary endpoint will be done at the 0.05 level of significance.  
10.4.2 ANALYSIS OF THE PRIMARY EFFECTIVENESS ENDPOINT 
The proportion of participants reporting design superiority with SONNET 3 (EAS) on the APCS 
will be calculated for the primary endpoint The participant’s responses to the Design subsection 
questions will be averaged and the proportion of participants who rated >3 on average will be 
compared to the hypothesized proportion of 77%. The statistical hypothesis for the primary 
endpoint is defined as:  
 
H0: p<0.77 
 
H1: p≥0.77 
where p is the proportion of participants who responded with a mean score of >3.  
10.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
All endpoints will be summarized using descriptive statistics outlined in Section 10.4.1. 
Descriptive statistics will be compared across intervals and audio processor type. 
 

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10.4.4 SAFETY ANALYSES 
Not applicable 
10.4.5 ADHERENCE AND RETENTION ANALYSES 
Not applicable 
10.4.6  BASELINE DESCRIPTIVE STATISTICS 
Baseline demographics will be summarized using mean, median, inter-quartile range, minimum, 
and maximum values. Categorical variables will be summarized using counts and percents. 
10.4.7 PLANNED INTERIM ANALYSES  
No interim analysis will be conducted for this study. 
10.4.8 ADDITIONAL SUB-GROUP ANALYSES 
If sample size permits, results of the secondary endpoints will be stratified by age and existing 
audio processor model. 
10.4.9 MULTIPLE COMPARISON/MULTIPLICITY 
Not applicable 
10.4.10 
TABULATION OF INDIVIDUAL RESPONSE DATA 
Individual responses on the Audio Processor Comparison Survey and the Audiologist Survey will 
be summarized separate from group analysis.  
10.4.11 
EXPLORATORY ANALYSES 
Not applicable 
10.5 
MEASURES TO MINIMIZE BIAS 
This study utilizes a paired design where participants act as their own control. This reduces bias 
by accounting for within participant variability.  
10.6 
SITE POOLABILITY 
Not applicable 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
Source documentation should be kept as part of the participant’s medical records. Source 
documentation (e.g., medical history, audiologic history) should be accessible to the clinical 

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study monitors, as needed, for comparison to CRFs. Additionally, FDA may audit any 
investigational site and would require access to source documentation at that time. Medical 
records kept on each participant will include information about the participant’s participation in 
the clinical trial. 
12 
QUALITY ASSURANCE AND QUALITY CONTROL 
MED-EL will implement all necessary procedures to ensure the integrity of CRFs. As part of the 
periodic monitoring visits, the clinical monitor will compare all study records to the source 
documents and ADD-source data to verify accuracy. When CRFs are received, the forms will be 
reviewed for completeness and to identify any inconsistencies or errors. Investigators will be 
trained to make corrections only by approved methods. Any discrepancies found in the CRFs by 
the Clinical Monitor should be brought to the attention of the investigator. 
For the data management process, data may be entered into a database using accepted data 
entry techniques. Database validation will be performed after the last study interval has been 
completed. A more comprehensive evaluation of the database will be performed as required 
i.e., data analysis. 
13 
ETHICS/PROTECTION OF HUMAN PARTICIPANTS  
 
13.1 
ETHICAL STANDARD  
The investigator will ensure that the study is conducted in accordance with regulations for the 
protection of human participants found in 21 CRF Part 50, 21 CRF Part 56. 
13.2 
INSTITUTIONAL REVIEW BOARD  
The protocol, informed consent (IC) form, parental/guardian permission form, assent form, and 
any recruitment or participant materials will be submitted to the IRB for review and approval. 
IRB approval of both the protocol and consent forms must be obtained prior to beginning 
enrollment. Any amendment to the study protocol must also receive IRB approval before those 
changes are implemented in the study. Changes to any of the consent forms will also be 
submitted to the IRB; at that time, a determination will be made as to whether or not 
participants or parents/guardians who previously provided consent need to be re-consented. 
13.3 
INFORMED CONSENT PROCESS  
 
13.3.1 CONSENT DOCUMENTS PROVIDED TO PARTICIPANTS 
A consent, parental /legal guardian permission, or assent form with detailed descriptions of the 
study device, study procedures, and risks will be given to the participant. Written 
documentation of IC, parental permission, and assent (if required by the IRB) is required prior to 

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initiating any study-related activities. The IC, parental permission, and assent templates included 
with this protocol will be provided to the site. 
13.3.2 CONSENT PROCEDURES AND DOCUMENTATION 
Informed consent, assent (when required), or parental permission will be obtained before the 
candidate participates in any study-related activities. Potential participants must be informed as 
to the purpose of the study and the potential risks and benefits known, or that can be 
reasonably predicted or expected. These risks are described in the written consent form. 
Consent, parent permission, and assent forms will be IRB approved and the participant or 
parent/guardian will be asked to read and review the document. The investigator will explain 
the research study to the participant or guardian and will answer any questions that may arise. 
All participants or guardians will receive a verbal explanation of the purpose, procedures, and 
potential risks of the study, as well as their rights as research participants. 
The participant or guardian will sign the IC, assent, or parental permission form prior to being 
enrolled in the study. The investigator administering the IC will sign and date the form to 
indicate the document was sufficiently explained to the participant or guardian and their 
signature was witnessed. Consent may be withdrawn at any time during participation in the 
study. A copy of the signed IC will be provided to the participant or guardian, while the original 
will be retained by the investigator in the study file. 
13.4 
PARTICIPANT AND DATA CONFIDENTIALITY  
The study protocol, documentation, data, and all other information generated will be kept in 
strict confidence. No information concerning the study, or the data will be released to any 
unauthorized third party, without prior written approval of MED-EL. The investigator will 
guarantee that all persons involved will respect the confidentiality of any information 
concerning the clinical trial participants. 
All parties involved in a clinical investigation will maintain strict confidentiality to assure the 
protection of privacy of a participant participating in the clinical investigation. Likewise, 
appropriate measures will be taken to avoid the access of non-authorized persons to the clinical 
trial data. 
All information provided to the investigator by MED-EL will be kept strictly confidential and 
confined to the personnel involved in conducting the trial. Such personnel will be informed of 
the confidential nature of the information. It is recognized that this information may be 
communicated in confidence to the relevant IRB. In addition, no reports or information about 
the trial or its progress will be provided to anyone not involved in the trial, other than MED-EL or 
the relevant IRB, except if required by applicable law or regulation. 

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All data provided to MED-EL will be identified by a unique participant ID, thereby ensuring that 
the participant’s identity remains unknown. The participants should be informed in writing that 
their data will be stored and analyzed in a computer, with confidentiality maintained in 
accordance with applicable regulations. 
The participants should also be informed that authorized representatives of MED-EL and/or 
regulatory authorities may require access to parts of the site records (relevant to the study), 
including medical history, for data verification. The investigator is responsible for keeping a 
subject identification list of all subjects screened and enrolled. 
14 
DATA HANDLING AND RECORD KEEPING  
 
14.1 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Prior to initiation of the study, investigators who may complete CRFs and are responsible for 
maintaining appropriate documentation will be identified. The investigator will be responsible 
for maintaining complete and accurate documentation of study procedures and medical 
records, including IC forms, for the duration of the study. Correspondence with the IRB, Clinical 
Monitor, and MED-EL in general should also be maintained. Data on participants will be 
collected in an anonymous manner, and any records sent to MED-EL should be de-identified. 
The investigator is responsible for ensuring completeness, legibility, and accuracy of the 
recorded data. Source documentation should be completed in a neat, legible manner to ensure 
accurate interpretation of the data. When making changes or corrections, cross out the original 
entry with a single line, and initial and date the change. Do not erase, write over, or use 
correction fluid or tape on the original document. 
Copies of the electronic CRF will be provided for use as source documents, as needed, and 
maintained for recording data for each participant enrolled in the study. Data reported in the 
electronic CRF derived from source documents should be consistent with the source document. 
Any discrepancies should be explained and captured in a note and maintained in the 
participant’s official study record. 
14.2 
STUDY RECORDS RETENTION  
Upon completion of the study, it is the investigator’s responsibility to maintain all study records 
in a safe and secure location. Study-related documents should be kept for the duration of the 
study, as required by 21 CFR Part 812.40 and the institution’s IRB. No study documents will be 
destroyed during this period. Investigators will contact MED-EL if study documents must be 
moved to a different storage location during this period. 
 

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14.3 
PROTOCOL DEVIATIONS  
Any noncompliance with the protocol or with GCP requirements will be reported to MED-EL in 
the protocol deviation log as a protocol deviation. Protocol deviations may be on the part of the 
investigator, participant, or other study staff. Corrective actions will be implemented based on 
the type and frequency of protocol deviations from each site. Investigators are responsible for 
being familiar with the protocol and regulations and to be vigilant regarding potential protocol 
deviations. Deviations should be submitted to MED-EL and the IRB in a timely manner, as 
required. 
14.4 
PUBLICATION AND DATA SHARING POLICY 
All results generated in this study will be considered strictly confidential. The site investigator 
may not submit the results for publication without prior written permission of MED-EL.  
At the written request of MED-EL, investigators may submit the results for presentation at 
conferences.  
15 
CONFLICT OF INTEREST POLICY 
Any actual conflict of interest of persons who have a role in the design, conduct, analysis, 
publication, or other aspect of this trial will be disclosed and managed.  
 

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16  
LITERATURE REFERENCES  
1. Lorens A, Malgorzata Z, Skarzynski H. A new audio processor for combined electric and 
acoustic stimulation for the treatment of partial deafness. Acta Oto-Laryngol. 2012;132: 
739-750. 
2. Martin J, Poncet-Wallet C, Illg A, Perrin-Webb S, Henderson L, Noël-Petroff N, Auletta G, 
Grazia Barezzani M, Houri K, Indian Research Group, Bagus H, Hoppe U, Humphries J, 
van Treeck W, Briaire JJ, Brendel M, Mathias N. Multicentre evaluation of the Naída CI 
Q70 sound processor: feedback from cochlear implant users and professionals. Audiol 
Res. 2016;6(2), 160. 
3. Warren CD, Nel E, Boyd PJ. Controlled comparative clinical trial of hearing benefit 
outcomes for users of the Cochlear™ Nucleus® 7 Sound Processor with mobile 
connectivity. Cochlear Implants Int. 2019;20(3), 116-126. 
 
Version 
Date 
Significant Revisions  
1.0 
02 August 2024 
Original version 
2.0 
19 August 2024 
Revised sample size calculation and statistical test for 
primary endpoint