BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Hypoglossal Nerve, Implanted, Apnea

    PMA: P240024 · Decision Aug 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stimulator, Hypoglossal Nerve, Implanted, Apnea
    Trade Name
    Genio® System 2.1
    PMA Number
    P240024
    Device Class
    FDA Class 3
    Product Code
    MNQ
    Generic Name
    Stimulator, hypoglossal nerve, implanted, apnea
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 8, 2025
    Date Received
    July 1, 2024
    Expedited Review
    N
    Docket Number
    25M-3345

    Advisory Committee Statement

    Approval for The Nyxoah Genio System 2.1, which includes the Implantable Stimulator Model #2954, Surgical Template, External Stimulator, Disposable Patch, Activation Chip Model #2364, Charging Unit Model #2238, Sleep Lab Application, Repeater, and Smartphone Application. It is indicated for use in the treatment of moderate to severe Obstructive Sleep Apnea (OSA) (apnea-hypopnea index [AHI] of greater than or equal to 15 and less than or equal to 65). The device is intended for adult patients 22 years of age and older who have been confirmed to fail, cannot tolerate or are ineligible to be treated with current standard of care treatments including lifestyle modifications, positive airway pressure (PAP) treatments (such as continuous positive airway pressure [CPAP] or bi-level positive airway pressure [BiPAP] machines), oral appliances (such as mandibular advancement devices), and pharmacotherapy (such as tirzepatide). PAP failure is defined as an inability to eliminate OSA (residual AHI of greater than 15 despite PAP usage), and PAP intolerance is defined as: 1. Inability to use PAP (at least 5 nights per week of usage; usage defined as greater than 4 hours of use per night), or 2. Unwillingness to use PAP (PAP therapy initiated and subsequently discontinued by choice).

    Classifications

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

    Product Code Device Name
    MNQ Stimulator, Hypoglossal Nerve, Implanted, Apnea