BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P960058 · Supplement: S100 · Decision Mar 12, 2013
    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
    S100
    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
    March 12, 2013
    Date Received
    November 13, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE HIRES OPTIMA SOUND PROCESSING STRATEGY. HIRES OPTIMA IS A MODIFICATION OF THE HIRES FIDELITY 120 STRATEGY, AND IS INTENDED TO OPTIMIZE POWER EFFICIENCY. THIS NEW STRATEGY IMPROVES BATTERY LIFE WITHOUT COMPROMISING THE LISTENING BENEFITS OF THE HIRESOLUTION BIONIC EAR SYSTEM.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear