BEUDAMED
    Product Code: MPV FDA class 3

    Implant, Hearing, Active, Middle Ear, Partially Implanted

    Unknown

    The Partially Implanted Active Middle Ear Hearing Implant is an ear, nose, and throat device that combines implanted components within the middle ear with external components to amplify and transmit sound, treating sensorineural or mixed hearing loss in patients who cannot benefit adequately from conventional hearing aids. Classified as FDA Class 3 due to its high-risk implantable nature, it requires Premarket Approval (PMA). The product code is MPV, and it carries an implant flag.

    View on FDA
    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MPV
    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 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.