BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P960058 · Supplement: S032 · Decision Dec 16, 2003
    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
    S032
    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
    December 16, 2003
    Date Received
    December 9, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN OPTIONAL ACCESSORY ITEM THAT CAN BE USED WITH THE PLATINUM HEADPIECE AND AURIA HEADPIECE. THIS ITEM, NAMED HEADPIECE SPACER, IS A PASSIVE PIECE OF ELASTOMER INTENDED TO BE PLACED BETWEEN THE HEADPIECE INNER SURFACE AND THE PATIENT'S SCALP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12-MONTHS TO 17 YEARS, 11-MONTHS OF AGE).

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear