BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    PMA: P130016 · Supplement: S058 · Decision Oct 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
    Trade Name
    Nucleus® Hybrid™ L24 Cochlear Implant System
    PMA Number
    P130016
    Supplement Number
    S058
    Device Class
    FDA Class 3
    Product Code
    PGQ
    Generic Name
    Cochlear implant with combined electrical stimulation and acoustic amplification
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 16, 2025
    Date Received
    July 21, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Cochlear™ ECochG Measures v3.0 software module within the Cochlear™ Clinical Extension Platform, to provide compatibility with devices approved under P970051/S225 (CI1000 Series implants, CP1110 Sound Processor, and CP1110S Surgical Processor) and existing acoustic components used with these new devices, in addition to devices already compatible with v2.0. The name of the software module is also changed from v2.0 Cochlear Research Platform ECochG Software module (within Cochlear Research Platform) to v3.0 Cochlear ECochG Measures module (within Cochlear Clinical Extension Platform).

    Classifications

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

    Product Code Device Name
    PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification