BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Auditory Brainstem

    PMA: P000015 · Decision Oct 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Implant, Auditory Brainstem
    Trade Name
    NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
    PMA Number
    P000015
    Device Class
    FDA Class 3
    Product Code
    MHE
    Generic Name
    Implant, auditory brainstem
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 20, 2000
    Date Received
    March 29, 2000
    Expedited Review
    Y
    Docket Number
    00M-1659

    Advisory Committee Statement

    APPROVAL FOR THE NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI) SYSTEM, WHICH IS INTENDED TO RESTORE USEFUL HEARING VIA ELECTRICAL STIMULATION OF THE COCHLEAR NUCLEUS. THE DEVICE IS INDICATED FOR INDIVIDUALS 12 YEARS OF AGE OR OLDER, WHO HAVE BEEN DIAGNOSED WITH NEUROFIBROMATOSIS TYPE 2 (NF2). IMPLANTATION MAY OCCUR DURING FIRST OR SECOND-SIDE TUMOR REMOVAL, OR IN PATIENTS WITH PREVIOUSLY REMOVED ACOUSTIC TUMORS BILATERALLY. BECAUSE THE SURGICAL PROCEDURE FOR TUMOR EXCISION AND ELECTRODE PLACEMENT ELIMINATES RESIDUAL HEARING, PREOPERATIVE AUDIOLOGICAL CRITERIA ARE NOT RELEVANT. PROSPECTIVE IMPLANT RECIPIENTS AND THEIR FAMILIES SHOULD HAVE APPROPRIATE EXPECTATIONS, REGARDING THE POTENTIAL BENEFITS OF AN AUDITORY BRAINSTEM IMPLANT AND SHOULD BE HIGHLY MOTIVATED TO PARTICIPATE IN THE POSTOPEARATIVE REHABILITATION PROCESS.

    Classifications

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

    Product Code Device Name
    MHE Implant, Auditory Brainstem