BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S109 · Decision May 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    AudioKey 1.0 and AudioLink
    PMA Number
    P000025
    Supplement Number
    S109
    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
    May 8, 2019
    Date Received
    January 31, 2019
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for AudioKey 1.0 and AudioLink. AudioKey 1.0 is an optional mobile medical application (App) that runs on smartphones with either the iOS or Android operating systems. When used with a compatible audio processor, AudioKey 1.0 (with smartphone) permits the same remote-control functions as the existing approved FineTuner remote control. AudioLink is an optional wireless hardware accessory that serves as an interface between an existing compatible MED-EL audio processor and a smartphone installed with AudioKey 1.0.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear