BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Hearing, Active, Middle Ear, Totally Implanted

    PMA: P090018 · Supplement: S039 · Decision Feb 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Implant, Hearing, Active, Middle Ear, Totally Implanted
    Trade Name
    Esteem
    PMA Number
    P090018
    Supplement Number
    S039
    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
    February 24, 2020
    Date Received
    September 5, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the following changes to the post-approval study (i.e., the New Enrollment 2 study, approved under P090018/S030) for your device: (a) use the evaluable bone conduction data at 1 month as a safety endpoint to measure cochlear stability collected from the 45 subjects used for the efficacy endpoints (SRT and WRS), and (b) supplement the AE safety endpoints (SAEs including facial paresis/paralysis at 1 month) with data from a retrospective review of charts from patients not participating in the post-approval study.

    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