NUCLEUS COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S140 · decided 2016-06-20
Approval details
- PMA number
- P970051
- Supplement
- S140
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2015-12-23
- Decision date
- 2016-06-20
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for the optional acoustic component amplifies low frequency sound, and sends it into the ear canal. The acoustic component is intended to provide access to these low frequency sounds for some Cochlear Nucleus implant recipients.The acoustic component is indicated for recipients of traditional Cochlear Nucleus implants with unaided air conduction thresholds less than or equal to 85 dB HL between 125 Hz and 2000 Hz following surgery. The acoustic component should only be used when behavio
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