BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P840024 · Supplement: S077 · Decision Sep 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    AUDALLION BEAMFORMER
    PMA Number
    P840024
    Supplement Number
    S077
    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
    September 25, 1998
    Date Received
    September 21, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval of four minor design changes to the Audallion Beamformer Noise Reduction System: 1)switch on/off circuit improvements 2) replacement of the LC filter with an RC filter 3) battery spring design change 4) a minor software change pertaining to the volume default. With reference to item 1), the resistor value change would improve the switch on/off of the Audiallion regarding item 2), the RC filter will improve the rejction of the overall RF interference. For item 3), changing the battery spring design will ensure the proper battery contact position, reducing the likelihood of battery discharge. Item 4) pertains to a software change that will retain the user's volume setting whenever s/he cycles through the available procesor settings on the Audallion, enabling the device to be more user friendly.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear