Nucleus Hybrid Cochlear Implant
FDA premarket approval P130016/S048 · decided 2022-10-31
Approval details
- PMA number
- P130016
- Supplement
- S048
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Nucleus Hybrid Cochlear Implant
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2022-04-26
- Decision date
- 2022-10-31
- Days to decision
- 188 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- for a new sound processor (Nucleus 8 Sound Processor) and two supporting software devices (Custom Sound Pro and Nucleus Smart App
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