BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P960058 · Supplement: S079 · Decision Mar 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    HARMONY HIRESOLUTION BIONIC EAR SYSTEM
    PMA Number
    P960058
    Supplement Number
    S079
    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 18, 2009
    Date Received
    February 23, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE HIRES 90K MOCK-UP AS STERILE INSTEAD OF NON-STERILE, AND TO ESTABLISH THE SHELF LIFE AT THREE YEARS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HARMONY HIRESOLUTION BIONIC EAR SYSTEM HIRES 90K MOCK-UP (MOCK-UP) AND IS INDICATED FOR INDIVIDUALS AGED TWELVE MONTHS AND OLDER WITH SEVERE-TO PROFOUND SENSORINEURAL HEARING LOSS 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