|
Device | SONNET/SONNET EAS AUDIO PROCESSORS AND MAESTRO 6.0 |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S089 |
Date Received | 08/22/2016 |
Decision Date | 02/16/2017 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 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.” |