NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S172 · decided 2020-03-17
Approval details
- PMA number
- P970051
- Supplement
- S172
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2017-10-10
- Decision date
- 2020-03-17
- Days to decision
- 889 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for the IFU for Nucleus 24 Cochlear Implant System: 1) The Nucleus 24 Cochlear Implant System is intended for individuals 18 years of age or older who have bilateral, pre, peri or postlinguistic sensorineural hearing impairment and obtain limited benefit from appropriate binaural hearing aids.2) These individuals typically have moderate to profound hearing loss in the low frequencies and profound (>= 90 dB HL) hearing loss in the mid to high speech frequencies. Limited benefit from ampl
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