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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNeuro Cochlear Implant System
Generic NameImplant, cochlear
ApplicantOticon Medical
2720 Chemin Saint Bernard
Vallauris 06220
PMA NumberP200021
Date Received03/23/2020
Decision Date06/23/2021
Withdrawal Date 04/09/2024
Product Code MCM 
Docket Number 21M-0615
Notice Date 06/29/2021
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination ProductNo
Approval Order 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 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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S009 S010 S011 S012 
S013 S014 
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