Cochlear Implants
Conditions
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.
Interventions
None listed
Sponsors
MED-EL Elektromedizinische Geräte GesmbH
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* MED-EL CI and audio processor users * MED-EL AudioKey 3 users
Exclusion criteria
* Lack of compliance with any inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The primary objective of this clinical investigation is to confirm the performance of the AudioKey 3 app as assessed by a user survey |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Austria
Outcome results
None listed