BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Hearing, Active, Middle Ear, Totally Implanted

    PMA: P090018 · Supplement: S042 · Decision May 21, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Implant, Hearing, Active, Middle Ear, Totally Implanted
    Trade Name
    Esteem®
    PMA Number
    P090018
    Supplement Number
    S042
    Device Class
    FDA Class 3
    Product Code
    OAF
    Generic Name
    Implant, hearing, active, middle ear, totally implanted
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 21, 2026
    Date Received
    February 19, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a new laser reflector material used with Laser Doppler Vibrometer (LDV) measurements during the implantation procedure.

    Classifications

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

    Product Code Device Name
    OAF Implant, Hearing, Active, Middle Ear, Totally Implanted