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OpenTrials
Completed

NCT Number: NCT06817928

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

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.

Completed

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Key information

Conditions

Cochlear Implants

Sex eligibility

All sexes

Study type

Observational

Primary location

MED-EL Elektromedizinische Geräte GmbH

Innsbruck, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Lack of compliance with any inclusion criteria

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. App user ratings obtained via user survey

    Time frame: At time of device use

  2. App usage time obtained from data logging information

    Time frame: up to 12 months

  3. Audio processor use obtained from data logging information

    Time frame: up to 12 months

  4. • 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

  5. Device-related complications collected via user survey

    Time frame: At time of device use

Sponsors and collaborators

Lead sponsor

MED-EL Elektromedizinische Geräte GesmbH

Industry

Registry information

Official study title

Evaluation of the AudioKey 3 App

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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