BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P960058 · Supplement: S131 · Decision Aug 30, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    HiResolution Bionic Ear System
    PMA Number
    P960058
    Supplement Number
    S131
    Device Class
    FDA Class 3
    Product Code
    MCM
    Generic Name
    Implant, cochlear
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 30, 2019
    Date Received
    September 7, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the HiRes Fidelity 120 and HiRes Optima sound processing strategies for adults and pediatric patients 12 months and older.Approval of the ClearVoice and Front-End Processing features of StereoZoom, UltraZoom, SoundRelax, WindBlock, and EchoBlock for pediatric population 6 years and older.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear