BEUDAMED
    Product Code: MHE FDA class 3

    Implant, Auditory Brainstem

    Unknown

    The Auditory Brainstem Implant is a surgically placed neural stimulation device that bypasses the cochlea and auditory nerve to directly stimulate the cochlear nucleus in the brainstem, providing sound perception for patients with non-functional auditory nerves, typically due to neurofibromatosis type 2 or other causes of bilateral auditory nerve loss. As a Class 3 device, it requires Premarket Approval (PMA) from the FDA, reflecting the highest level of regulatory scrutiny due to the significant risks associated with deep neural implantation. It is reviewed by the Ear, Nose, and Throat (ENT) panel and carries an implant flag, indicating it is surgically placed inside the body. No regulation number or medical specialty code is assigned in the classification database.

    View on FDA
    510(k)s
    0
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MHE
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    EN
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.