BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P960058 · Supplement: S091 · Decision Apr 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
    PMA Number
    P960058
    Supplement Number
    S091
    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
    April 27, 2012
    Date Received
    September 30, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF DESIGN CHANGES IMPLEMENTED IN THE APPROVED HIRES 90K COCHLEAR IMPLANT DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME "HIRES+90KR ADVANTAGE", HEREAFTER REFERRED TO AS "ADVANTAGE." THIS MODIFIED COCHLEAR IMPLANT DESIGN WILL BEMARKETED UNDER A NEW MODEL NUMBER (CI-1500-XXX) AND THE BRAND NAME FOR THE HIRES 90K COCHLEAR IMPLANT, "AURIA HARMONY HIRCSOLUTION BIONIC EAR SYSTEM" WILL BE CHANGED TO "HIRESOLUTION BIONIC EAR SYSTEM." THE ADVANTAGE IMPLANT INCLUDES THE FOLLOWING: A REINFORCED ANTENNA COIL AND AN INTEGRATED SILICONS POCKET FOR THE MAGNET. THE IMPLANT DIGITAL INTEGRATED CIRCUIT HAS ALSO BEEN REVISED TO INCLUDE THE LATEST WAFER ASSEMBLY PROCESSES.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear