SONNET/SONNET EAS AUDIO PROCESSORS AND MAESTRO 6.0
FDA premarket approval P000025/S089 · decided 2017-02-16
Approval details
- PMA number
- P000025
- Supplement
- S089
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SONNET/SONNET EAS AUDIO PROCESSORS AND MAESTRO 6.0
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2016-08-22
- Decision date
- 2017-02-16
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- 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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