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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAudioKey 1.0 and AudioLink
Generic Nameimplant, cochlear
Applicant
MED-EL CORP.
furstenweg 77a
innsbruck 6020
PMA NumberP000025
Supplement NumberS109
Date Received01/31/2019
Decision Date05/08/2019
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for AudioKey 1.0 and AudioLink. AudioKey 1.0 is an optional mobile medical application (App) that runs on smartphones with either the iOS or Android operating systems. When used with a compatible audio processor, AudioKey 1.0 (with smartphone) permits the same remote-control functions as the existing approved FineTuner remote control. AudioLink is an optional wireless hardware accessory that serves as an interface between an existing compatible MED-EL audio processor and a smartphone installed with AudioKey 1.0.
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