BEUDAMED
    Product Code: PGQ FDA class 3

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    Unknown

    The Cochlear Implant with Combined Electrical Stimulation and Acoustic Amplification is an advanced hearing implant intended to provide electrical stimulation to the mid-to-high frequency cochlear region while also delivering acoustic amplification to residual low-frequency hearing regions, for patients with partial hearing loss. It is an FDA Class 3 device, requiring Pre-Market Approval (PMA) due to its high-risk implantable nature, reviewed by the Ear, Nose, and Throat (EN) panel. The product code is PGQ, and the device is flagged as an implant. No regulation number has been assigned.

    View on FDA
    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PGQ
    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

    Definition

    Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity.

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.