BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P970051 · Supplement: S205 · Decision Jan 10, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    Nucleus 24 Cochlear Implant System
    PMA Number
    P970051
    Supplement Number
    S205
    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
    January 10, 2022
    Date Received
    May 28, 2021
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    22M-0071

    Advisory Committee Statement

    Approval for the Cochlear Nucleus 24 cochlear implant system. The device is indicated for individuals with unilateral hearing loss who meet the following criteria:1) Individuals 5 years or older who have one ear with a severe to profound sensorineural hearing loss and obtain limited benefit from an appropriately fitted unilateral hearing device and one ear with normal or near normal hearing. a) In the ear to be implanted, a severe to profound sensorineural hearing loss defined as a PTA at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz of > 80 dB HL; andb) In the contralateral ear, normal or near normal hearing is defined as a PTA at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz <= 30 dB HL.2) Limited benefit from an appropriately fit unilateral hearing device is defined as a score of less than or equal to 5% on a Consonant Nucleus Consonant (CNC) word test. For individuals between 5 years and 18 years of age, insufficient functional access to sound in the ear to be implanted must be determined by aided speech perception test scores of 10% or less on developmentally appropriate word lists when tested in the ear to be implanted alone.3) It is recommended that prior to cochlear implantation, individuals with SSD have at least two (2) weeks to one (1) month experience wearing appropriately fit Contralateral Routing of Signal (CROS) hearing aid or another suitable hearing device.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear