BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid

    K Number: K230538 · Decision Jun 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    109

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    Basic Information

    Device Name
    All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
    K Number
    K230538
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3325
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sonova AG
    Date Received
    February 27, 2023
    Decision Date
    June 16, 2023
    Product Code
    QUH
    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
    QUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter

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    Other Clearances by Sonova AG

    K Number Device Name
    K232999 Lyric4 Hearing Aid