BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Earlens Contact Hearing Aid

    K Number: K182480 · Decision Jan 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    3
    Review Days
    137

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    Basic Information

    Device Name
    Earlens Contact Hearing Aid
    K Number
    K182480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3315
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Earlens Corporation
    Date Received
    September 10, 2018
    Decision Date
    January 25, 2019
    Product Code
    PLK
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PLK Tympanic Membrane Direct Contact Hearing Aid

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    Other Clearances by Earlens Corporation

    K Number Device Name
    K153634 Wireless Earlens Light Driven Hearing Aid
    DEN150002 EarLens Contact Hearing Device