Neuro Cochlear Implant System

FDA Premarket Approval P200021

Pre-market Approval Supplement Details

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 hearing in noise test (hint) sentences in quiet or noise, in the best-aided listening condition. Unless already appropriately fitted with hearing aids, it is recommended that candidates undergo a hearing aid trial period of three (3) months.

DeviceNeuro Cochlear Implant System
Generic NameImplant, Cochlear
ApplicantOticon Medical
Date Received2020-03-23
Decision Date2021-06-23
PMAP200021
SupplementS
Product CodeMCM 
Advisory CommitteeEar Nose & Throat
Expedited ReviewNo
Combination Product No
Applicant Address Oticon Medical 2720 Chemin Saint Bernard vallauris 06220

Supplemental Filings

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Supplement NumberDateSupplement Type
P200021Original Filing

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