Benefits of Bimodal Streaming for MED-EL Cochlear Implants: Early User Experience With the AudioKey Application and Starkey Hearing Aids
Phase: NA
Conditions: Hearing Loss, Sensorineural, Sensorineural Hearing Loss, Bilateral, Cochlear Implant Recipients, Asymmetric Hearing Loss
Sponsor: Med-El Corporation

MED-EL US 2501 
 
MED-EL Corporation 
Clinical Research Protocol 
 
CONFIDENTIAL 
 
Version 1.0 
April 17, 2025 
Page 1 
 
CONFIDENTIAL:  This material is the property of the study sponsor. Do not disclose or use except as authorized in 
writing by MED-EL Corporation 
 
 
 
 
 
 
Research Protocol 
 
Benefits of Bimodal Streaming for MED-EL Cochlear Implants: Early user 
experience with the AudioKey Application and Starkey Hearing Aids  
Version 1.0 
 
Protocol Number:  MED-EL US 2501 
 
 
 
 
Sponsor: 
 
MED-EL Corporation 
2645 Meridian Parkway 
Suite 100 
Durham, NC  27713 
 
Toll-free:  888-633-3524 
 
 

MED-EL US 2501 
 
MED-EL Corporation 
Clinical Research Protocol 
 
CONFIDENTIAL 
 
Version 1.0 
April 17, 2025 
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CONFIDENTIAL:  This material is the property of the study sponsor. Do not disclose or use except as authorized in 
writing by MED-EL Corporation 
 
CONTACT INFORMATION 
 
MED-EL Corporation, USA 
Toll-free:  888-633-3524 
 
 
 
Allison Racey, Au.D.  
 
 
 
 
 
Email:  allison.racey@medel.com 
Vice President  
 
 
 
 
 
Phone:  1-888-633-3524 
Contracts 
 
 
 
 
 
 
 
 
Brittany Wilson, Au. D.   
 
 
 
 
Email: brittany.wilson@medel.com 
Clinical Research Project Manager 
 
 
 
Phone : 1-888-633-3524 
Investigator, Sponsor  
Project Management / Clinical Support 
 
 
Katelyn Glassman, Au.D. 
 
 
 
 
Email:  katelyn.glassman@medel.com 
Senior Manager, Site-Initiated Research  
 
 
Phone:  1-888-633-3524 
Principal Investigator, Sponsor 
Clinical Support  
 
 
 
 
 
 
 
Ivy Chen 
 
 
 
 
 
 
Email: ivy.chen@medel.com 
Research Coordinator   
 
 
 
 
Phone:  1-888-633-3524 
IRB Support / Contracts / Invoicing 
 
 
 
 
 
 
 
 
 
 
 

MED-EL US 2501 
 
MED-EL Corporation 
Clinical Research Protocol 
 
CONFIDENTIAL 
 
Version 1.0 
April 17, 2025 
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CONFIDENTIAL:  This material is the property of the study sponsor. Do not disclose or use except as authorized in 
writing by MED-EL Corporation 
 
 
Benefits of Bimodal Streaming for MED-EL Cochlear Implants: Early user 
experience with the AudioKey Application and Starkey Hearing Aids 
 
1. Introduction 
 
This study aims to capture early user feedback from bimodal MED-EL cochlear implant 
(CI) recipients using a novel audio streaming paradigm that allows direct, simultaneous 
streaming from an iOS or Android device to both their CI audio processor and hearing 
aid. Streaming audio has become ubiquitous and for many patients it is an important 
part of daily listening habits. Individuals with hearing loss may rely more heavily on 
Bluetooth streaming to their hearing devices as background noise disparately affects 
their ability to understand speech. Until now, direct, simultaneous Bluetooth streaming 
to a MED-EL cochlear implant audio processor and a hearing aid was possible only for 
Android users, with iOS users requiring a third-party intermediary device in order to 
receive sounds to both devices. MED-EL Elektromedizinische Geräte GmbH (Austria) 
recently partnered with Starkey Laboratories, Inc. to develop a bimodal solution that 
streamlines Bluetooth pairing and allows audio streaming from an iOS device to both 
ears for patients using a compatible MED-EL audio processor and Starkey hearing aid. 
MED-EL CI recipients will be able to configure their audio processor for direct streaming 
with a compatible Starkey hearing aid in the AudioKey application. Once configured in 
the application, recipients can stream phone calls and media directly from the iOS 
device to their CI audio processor and hearing aid for a binaural listening experience. 
This innovation brings Bluetooth streaming access to bimodal MED-EL recipients using 
iOS or Android devices which may provide improvements to these users’ overall 
satisfaction with their hearing devices and may ultimately reduce their need for 
technical support from their audiologist. This study aims to capture feedback from early 
adopters of this new bimodal streaming paradigm between MED-EL and Starkey 
devices, and to measure ease of use and overall satisfaction with this technology.    
 
2. Aims and Objectives 
 
2.1. 
Specific Aim 1: To evaluate subjective user satisfaction with and improvement in 
aspects of hearing with bimodal streaming when compared to their previous 
streaming setup. 
 
2.2. 
Specific Aim 2: To compare changes in participant streaming behavior and 
satisfaction with bimodal streaming from Baseline to 1-Week. 
 
 

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3. Study Sites and Investigators 
 
3.1. 
Up to three (3) sites will participate. Sites will complete study procedures in 
accordance with the protocol including subject consent, device fitting as 
applicable survey distribution, and data entry.  
 
3.2. 
Each site will obtain Investigational Review Board (IRB) approval and/or 
acknowledgment of exempt status prior to beginning subject enrollment.  The 
Primary Investigator and Co-Investigator(s) for each site will sign Investigator 
Agreements and will be expected to collect and submit data in accordance with 
the requirements of this protocol. 
 
4. Device Description(s) 
 
4.1. 
AudioKey application: The MED-EL AudioKey application is a software product 
which can be used with compatible non-implantable MED-EL products. It is 
intended to be used on a smartphone with internet connection to remotely 
control compatible MED-EL audio processors and to provide status information 
of compatible non-implantable MED-EL products. The AudioKey application is 
intended to be used by individuals who received at least one of the compatible 
MED-EL audio processors and caregivers of these individuals. The AudioKey 
application allows users to customize personal settings, locate lost or misplaced 
audio processors using the Find My Processor functionality, review device usage 
statistics of the connected audio processors, and quickly access user manuals. 
AudioKey can configure devices for Bluetooth streaming including MED-EL audio 
processors, streaming devices (AudioStream, AudioLink), and compatible Starkey 
hearing aids. AudioKey is available for free download in Google Play and Apple  
application stores. 
 
5. Potential Benefits 
 
5.1. 
Bimodal streaming of audio to both ears may provide the following benefits to 
the listener: 
 
5.1.1. Improvement in clarity and sound quality of music, calls, and other audio 
streamed from the cellphone  
 
5.1.2. Increased enjoyment of music when streamed from the cellphone  
 
5.1.3. Reduced listening effort when streaming phone calls from the cellphone  
 

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5.1.4. Improvement in overall satisfaction with streaming audio from the cellphone  
 
5.1.5. Improvement in overall satisfaction with hearing devices  
 
6. Potential Risks 
 
6.1. 
The AudioKey application does not perform as expected 
 
6.2. 
The audio processor does not receive changes initiated by the AudioKey 
application 
 
6.3. 
Loud sound sensations are perceived by the listener during audio streaming  
 
7. Study Population and Sample Size 
 
7.1. 
Study Population: Adults who have already been implanted with a MED-EL 
cochlear implant and who are utilizing a Starkey hearing aid that is compatible 
with the AudioKey application will be recruited for participation.  
 
7.2. 
Sample Size: This study will enroll 10 to 20 subjects with a goal of enrolling at 
least 10 subjects for analysis of the primary endpoint.  
8. Duration of the Investigation 
 
8.1. 
Subject recruitment is expected to take place over a period of 6 months. Data 
will be collected on each subject for a period of up to 3 weeks.  
 
8.2. 
Data management and analysis is expected to be completed over the course of 3 
months following final subject completion. The total expected duration of the 
investigation is 10 months. 
 
9. Study Design 
 
9.1. Prospective, multicenter study. 
 
9.2. Test Materials and Administration 
 
9.2.1. Baseline User Survey: The baseline user survey is intended to be completed 
by the subject at the baseline interval. Survey questions ask for the subject’s 
experience with Bluetooth streaming and their satisfaction ratings of their 

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current hearing abilities, hearing devices, and Bluetooth streaming set-up. 
Subjects who participated in the pairing process of AudioKey application are 
asked for their rating on ease of use.  
  
9.2.2. 1-Week User Survey: The 1-week user survey is intended to be completed by 
the subject after they have completed a trial with AudioKey application. 
Survey questions ask for the subject’s success with maintaining a Bluetooth 
connection to AudioKey application and their subjective ratings on 
improvement in clarity, sound quality, enjoyment and ease of listening to 
different inputs when streaming with AudioKey, as well as improvement in 
their global satisfaction with their current hearing devices with added use of 
AudioKey, and likelihood of continued use of AudioKey application.  
 
10. Test Intervals and Procedures 
 
10.1. Baseline Visit (completed after subject is consented) 
 
10.1.1. The subject’s hearing aid and audio processor are verified by the study site to 
be functioning appropriately prior to study procedures.  
 
10.1.2. The AudioKey application is installed on the subject’s cellphone if not already 
downloaded. The subject’s audio processor and hearing aid are paired to 
AudioKey application. Subject is then trained on application use for bimodal 
streaming during the 1-week trial.  
 
10.1.3. The Baseline User Survey is completed by the subject.  
 
10.2. 1-Week Visit (1-3 weeks after Baseline) 
 
10.2.1. Subjects complete the 1-Week User Survey. Subjects who have agreed to 
receive surveys electronically receive a link to complete the survey via 
email. Subjects who have not agreed to complete the survey electronically 
are provided a paper copy of the survey and are asked to return it to their 
investigative site promptly after completion. 
 
10.2.2. Subject participation in the study is complete once the 1-Week User Survey 
is received.  
 
11. Subject Selection and Withdrawal 
 
11.1. Inclusion Criteria: 

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11.1.1. Implanted with a MED-EL cochlear implant in one ear   
 
11.1.2. Consistently using a MED-EL audio processor that is compatible with 
AudioKey (SONNET (EAS), SONNNET 2 (EAS), SONNET 3 (EAS), RONDO 3) 
 
11.1.3. Has access to a MED-EL streaming device if needed (SONNET 
(EAS)/SONNET2 (EAS)/RONDO 3 users)  
 
11.1.4. Using a Starkey hearing aid in the nonimplanted ear that is compatible with 
the AudioKey application 
 
11.1.5. Using a smartphone that can support the AudioKey application  
 
11.1.6. Able to complete a survey via cellphone or computer  
 
11.1.7. Prior experience with Bluetooth streaming OR expressed motivation to 
Bluetooth stream to hearing devices  
 
11.1.8. Ability to complete all study procedures including provide responses to 
survey questions  
 
11.2. 
Exclusion Criteria:   
 
11.2.1. Unable to provide reliable feedback 
 
11.2.2. Unable to operate a smartphone with or without assistance 
 
11.3. 
Subject Withdrawal: 
 
11.3.1. Subjects may choose to withdraw themselves from the study at any point 
during participation without fear of repercussion. 
 
11.3.2. Investigators should report subject withdrawals, terminations, and subjects 
who are lost-to-follow up to the Sponsor immediately. Every effort should 
be made to contact subjects lost-to-follow-up and determine reason for 
noncompliance.  
 
11.3.3. The principal investigator may terminate subject participation from the 
study due to noncompliance with the study protocol or health concerns that 
prevent required participation.  

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11.3.4. Withdrawn subjects will continue to be seen by their clinical audiologist but 
no additional data will be collected.  
 
12. Database and Statistical Analysis 
 
12.1. MED-EL North American Clinical Research Department, the study sponsor, will 
complete data entry, database management, and statistical analysis.  
 
13. Statistics and analysis plan 
 
13.1. 
Descriptive statistics will be used to report baseline characteristics (e.g., age, 
duration of CI use). Quantitative data will be presented as the mean and 
standard deviation (SD) or median and range (minimum and maximum).  
 
13.2. 
Specific Aim 1: To evaluate subjective user satisfaction with and improvement 
in aspects of hearing with bimodal streaming when compared to their previous 
streaming set-up. 
 
13.2.1. Subject responses on the 1-week survey will be reported using descriptive 
statistics including the percentage response rates for each 
question/domain. 
 
13.3. 
Specific Aim 2: To compare changes in subject streaming behavior and 
satisfaction with bimodal streaming from baseline to 1-week. 
 
13.3.1. The change in subject response from the baseline to 1-week survey will be 
summarized using descriptive statistics for the following 
questions/domains:  
 
13.3.1.1. 
Frequency of Bluetooth streaming 
 
13.3.1.2. 
Satisfaction with bimodal streaming 
 
14. Monitoring 
 

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14.1. Database entry and associated source data (paper surveys and case report 
forms) will be monitored periodically by the Sponsor.  
 
15. Data Management 
 
15.1. 
Copies of completed case report forms (CRFs) and surveys will be submitted to 
the Sponsor through secure email. Surveys completed electronically will be 
captured and stored in a secure electronic survey application. Personal 
identifiable information is excluded from CRFs and surveys to ensure protection 
of subject’s personal information. The sponsor will use an unambiguous subject 
identification code to allow identification of all the data reported for each 
subject, to ensure confidentiality.  Data will be extracted from case report forms 
and surveys and manually entered into a controlled network database.  
 
16. Investigator Agreement 
 
16.1. 
Prior to commencement of the Clinical Investigation at each Site, the 
investigators shall have signed the Investigator Agreement, obtained IRB 
approval or exemption for this Investigational Plan and any associated consent 
materials to be used, and submitted the documentation required by 21 CFR Part 
812 to the Sponsor. 
 
17. Investigational Review Board (IRB) 
 
17.1. 
The protocol and associated materials will be reviewed by a centralized IRB to 
ensure protection of human subjects during the retrospective review of medical 
records. In addition, the IRB at each investigational site will review the 
investigational plan and any consent materials, if required, prior to study start. 
Sites will provide a copy of IRB approval or institutional IRB acknowledgement 
of centralized IRB approval to the study sponsor prior to data upload.  
 
18. Informed Consent 
 
18.1. 
The consent form included with the protocol will be provided to each 
investigative site. 
 

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18.2. 
Written documentation of Subject’s consent must be obtained prior to initiating 
data collection. The Subject must be verbally 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 consent. Subjects shall 
have sufficient opportunity to consider participation in the study. The 
investigator will explain the research study to the potential Subject, discuss 
their rights as research Subjects, and answer any questions that arise.  
 
18.3. 
Subjects are then invited to sign and date the consent form, indicating their 
consent for enrollment. The investigator administering the consent will also sign 
and date the form to indicate the document was sufficiently explained and the 
Subject signature was witnessed. Only the Investigator or study personnel 
expressly approved by their ethics committee may administer consent. The 
Investigator will retain the original copy of the consent form, signed, and dated 
by the Subject, in the Investigator’s study file. A duplicate shall be provided to 
the Subject, who is now a subject of the trial. 
 
18.4. 
Subjects may withdraw consent to participate at any time without prejudice. 
Data collected prior to withdrawal will be included in the analyzed data set.  
 
19. Study Budget 
 
19.1. A study budget will be provided to the investigator which will include subject 
compensation. Subjects will receive reasonable compensation for their time and 
participation in the study. 
 
20. Publication 
 
20.1. Individual centers may use their results for publication and presentation, but the 
Sponsor has the right to review the material prior to submission for 
publication/presentation. Additionally, the Sponsor has a right to collaborate 
with study sites on publications and presentations