NUCLEUS HYBRID L24 IMPLANT SYSTEM
FDA premarket approval P130016/S005 · decided 2014-11-12
Approval details
- PMA number
- P130016
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2014-05-01
- Decision date
- 2014-11-12
- Days to decision
- 195 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR CP900 SERIES SOUND PROCESSOR FIRMWARE FEATURES AS PART OF THE NUCLEUS HYBRID L24 COCHLEAR 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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