BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Auditory Brainstem

    PMA: P000015 · Supplement: S053 · Decision Jul 3, 2025
    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
    Supplement Number
    S053
    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
    July 3, 2025
    Date Received
    January 9, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    1.A new series of Cochlear™ Nucleus® Implants: the CI1000 Series implants2.An updated sound processor with accessories: Nucleus® 8 Sound Processor 3.Two new sound processors with accessories: Kanso® 3 Sound Processor compatible with the CI1000 Series implants and Kanso® 3 Sound Processor compatible with commercial CI24RE, CI500 and CI600 Series implants4.A new Surgical Processor compatible with the CI1000 Series implants5.Three updated supporting software devices: Nucleus® SmartNav, Nucleus® Smart App, Custom Sound® Pro6.A new supporting software module: Cochlear™ Objective Measures

    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