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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.
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| 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 | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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MED-EL CI and audio processor users MED-EL AudioKey 3 users
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MED-EL Elektromedizinische Geräte GmbH | Innsbruck | Austria |
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| 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 |