BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P960058 · Supplement: S058 · Decision Jul 2, 2007
    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
    S058
    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
    July 2, 2007
    Date Received
    May 7, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THREE ?VACUUM BAKE AIR FLOW ENHANCEMENTS? TO THE HIRES90K COCHLEAR IMPLANT, AS FOLLOWS: 1) THE BOTTOM COVER SHIELD INSIDE THE HIRES90K CASE WAS MODIFIED FROM HAVING A ?V?-SHAPED CHANNEL TO HAVING A LARGER ?U?-SHAPED CHANNEL. 2) HOLES WERE ADDED TO THE INSULATING KAPTON DISC. 3) SLOTS WERE IMPLEMENTED INSIDE THE FEEDTHROUGH CASE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR INDIVIDUALS AGED 12-MONTHS AND OLDER WITH SEVERE-TO-PROFOUND SENSORINEURAL HEARING LOSS TO RESTORE A LEVEL OF AUDITORY SENSATION VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear