Investigating the Performance and Safety of the AudioKey 3, a Device That Provides Remote Control Options and Status Information for Compatible MED-EL Audio Processors, by Analyzing Data Logged by the App and Responses to a User Survey

August 25, 2025 updated by: MED-EL Elektromedizinische Geräte GesmbH

Evaluation of the AudioKey 3 App

Investigating the performance and safety of the AudioKey 3, a device that provides remote control options and status information for compatible MED-EL audio processors, by analyzing data logged by the app and responses to a user survey.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • MED-EL Elektromedizinische Geräte GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

MED-EL CI and audio processor users MED-EL AudioKey 3 users

Description

Inclusion Criteria:

  • MED-EL CI and audio processor users
  • MED-EL AudioKey 3 users

Exclusion Criteria:

  • Lack of compliance with any inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary objective of this clinical investigation is to confirm the performance of the AudioKey 3 app as assessed by a user survey
Time Frame: At time of device use
The primary objective of this clinical investigation is to confirm the performance of the AudioKey 3 app as assessed by a user survey
At time of device use

Secondary Outcome Measures

Outcome Measure
Time Frame
App user ratings obtained via user survey
Time Frame: At time of device use
At time of device use
App usage time obtained from data logging information
Time Frame: up to 12 months
up to 12 months
Audio processor use obtained from data logging information
Time Frame: up to 12 months
up to 12 months
• Type of implants, audio processors, auditory scenes (e.g. speech in quiet or noise) obtained from data logging information
Time Frame: up to 12 months
up to 12 months
Device-related complications collected via user survey
Time Frame: At time of device use
At time of device use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MED-EL Elektromedizinische Geräte GesmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2025

Primary Completion (Actual)

May 19, 2025

Study Completion (Actual)

May 19, 2025

Study Registration Dates

First Submitted

January 30, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • AKEY3_MED-EL_CRD_2024_03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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