BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960058 · Supplement: S122 · Decision Nov 14, 2017
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    HiResolution Bionic Ear System
    PMA Number
    P960058
    Supplement Number
    S122
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 14, 2017
    Date Received
    June 5, 2017
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval order for the Naida CI Q90 Acoustic Earhook (Acoustic Earhook) that is intended for use with the approved Naida CI Q90 Sound Processor.