BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Implant, Cochlear

    PMA: P200021 · Decision Jun 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    Neuro Cochlear Implant System
    PMA Number
    P200021
    Device Class
    FDA Class 3
    Product Code
    MCM
    Generic Name
    Implant, cochlear
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    June 23, 2021
    Date Received
    March 23, 2020
    Expedited Review
    N
    Docket Number
    21M-0615

    Advisory Committee 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.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MCM Implant, Cochlear