BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S129 · Decision Oct 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    MED-EL CI System
    PMA Number
    P000025
    Supplement Number
    S129
    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
    October 3, 2024
    Date Received
    October 25, 2023
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    24M-4668

    Advisory Committee Statement

    The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement for the MED-EL Cochlear Implant (CI) System for expanding the indications for use. The expanded device indications include individuals with bilateral hearing loss who meet the following criteria:The MED-EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with debilitating sensorineural hearing loss who obtain limited benefit from acoustic amplification in the ear(s) to be implanted and is indicated for the following patient populations: • Individuals of eighteen (18) years of age or older with bilateral moderate to profound sensorineural hearing loss who obtain limited benefit from appropriately-fit hearing aids. These individuals typically demonstrate a low-frequency pure-tone average of greater than 40 dB HL (at 250 Hz, 500 Hz, and 1000 Hz) and thresholds not better than 65 dB HL at 3000-8000 Hz. Limited benefit from hearing aids is defined by test scores of 50% correct or less in the ear to be implanted and 60% or less in the non-implant ear on recorded tests of monosyllabic word recognition (Consonant-Nucleus-Consonant [CNC] Words).• MED-EL strongly recommends a hearing aid trial prior to implantation (if not already completed), but radiological evidence of cochlear ossification may preclude a hearing aid trial.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear