NCT06817928

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 31, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

January 30, 2025

Last Update Submit

August 25, 2025

Conditions

Cochlear Implants

Outcome Measures

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

    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 Outcomes (5)

  • App user ratings obtained via user survey

    At time of device use

  • App usage time obtained from data logging information

    up to 12 months

  • Audio processor use obtained from data logging information

    up to 12 months

  • • Type of implants, audio processors, auditory scenes (e.g. speech in quiet or noise) obtained from data logging information

    up to 12 months

  • Device-related complications collected via user survey

    At time of device use

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MED-EL Elektromedizinische Geräte GmbH

Innsbruck, Austria

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2025

First Posted

February 10, 2025

Study Start

March 31, 2025

Primary Completion

May 19, 2025

Study Completion

May 19, 2025

Last Updated

August 26, 2025

Record last verified: 2025-08

Locations

AU(1)