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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.
 
DeviceSONNET/SONNET EAS AUDIO PROCESSORS AND MAESTRO 6.0
Generic Nameimplant, cochlear
Applicant
MED-EL CORP.
furstenweg 77a
innsbruck 6020
PMA NumberP000025
Supplement NumberS089
Date Received08/22/2016
Decision Date02/16/2017
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the new front end cochlear implant signal processing features (Microphone Directionality and Wind Noise Reduction) in the SONNET and SONNET EAS audio processors and the fitting of these features with the MAESTRO 6.0 software.”
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