NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S123 · decided 2015-04-02
Approval details
- PMA number
- P970051
- Supplement
- S123
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2014-10-02
- Decision date
- 2015-04-02
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR NEW DIGITAL SOUND PROCESSOR FIRMWARE FEATURES AS PART OF THE COCHLEAR NUCLEUS IMPLANT SYSTEM. THESE FEATURES INCLUDE A WIND NOISE REDUCTION (WNR) ALGORITHM, A SIGNAL-TO-NOISE RATIO-BASED NOISE REDUCTION (SNR-NR) FUNCTION, AND AN AUTOMATIC ENVIRONMENTAL CLASSIFIER (SCAN) FUNCTION.
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