Cochlear ImplantsNCT06817928
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
An observational study of Cochlear Implants, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cochlear Implants
- How many people
- 46 participants
- Where
- 1 siteAustria
- Study dates
- 31 Mar 2025to 19 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: MED-EL CI and audio processor users MED-EL AudioKey 3 users
Who may be able to join
- MED-EL CI and audio processor users
- MED-EL AudioKey 3 users
Who cannot join
- Lack of compliance with any inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cochlear Implants
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At time of device use
Secondary outcomes (5)
App user ratings obtained via user survey
Measured: At time of device use
App usage time obtained from data logging information
Measured: up to 12 months
Audio processor use obtained from data logging information
Measured: up to 12 months
• Type of implants, audio processors, auditory scenes (e.g. speech in quiet or noise) obtained from data logging information
Measured: up to 12 months
Device-related complications collected via user survey
Measured: At time of device use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start31 Mar 2025
- Primary completion19 May 2025
- Study completion19 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- More trials run by MED-EL Elektromedizinische Geräte GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817928
- Sponsor's protocol ID
- AKEY3_MED-EL_CRD_2024_03
- Status last verified
- Aug 2025
- First submitted
- 30 Jan 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the AudioKey 3 App
- ClinicalTrials.gov ID
- NCT06817928
- Acronym / sponsor ID
- AKEY3_MED-EL_CRD_2024_03
- Conditions
- Cochlear Implants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- MED-EL CI and audio processor users MED-EL AudioKey 3 users
Key inclusion criteria (2 listed)
- MED-EL CI and audio processor users
- MED-EL AudioKey 3 users
Key exclusion criteria (1 listed)
- Lack of compliance with any inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
App user ratings obtained via user survey
Time frame: At time of device use
App usage time obtained from data logging information
Time frame: up to 12 months
Audio processor use obtained from data logging information
Time frame: 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
Device-related complications collected via user survey
Time frame: At time of device use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Implants, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.