Neuro Cochlear Implant System
FDA premarket approval P200021 · decided 2021-06-23
Approval details
- PMA number
- P200021
- Trade name
- Neuro Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Oticon Medical
- Date received
- 2020-03-23
- Decision date
- 2021-06-23
- Days to decision
- 457 days
- Decision code
- APWD
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- 06220 Vallauris
- Statement
- Approval for Neuro Cochlear Implant System (NCIS)The Neuro Cochlear Implant System (NCIS) is indicated for individuals eighteen (18) years of age or older, with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aid(s).Severe-to-profound hearing loss is determined by a pure-tone average (PTA) superior or equal (?) to 70 dB HL at 500, 1000 and 2000 Hz. Limited benefit from amplification is defined by scores of 50% or less on Heari
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