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 Type
OBSERVATIONAL
Enrollment
46
MED-EL Elektromedizinische Geräte GmbH
Innsbruck, Austria
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
Time frame: At time of device use
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
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