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510(k) Data Aggregation

    K Number
    K973880
    Device Name
    SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM
    Manufacturer
    SONIX TECHNOLOGIES, INC.
    Date Cleared
    1998-01-12

    (90 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONIX TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonix Hearing Aid Fitting and Programming System is a lightweight hand-held batterypowered device intended for use in fitting and programming Sonix hearing aids using individual patient audiogram and/or loudness data. It also provides database storage of patient identification information, audiogram, loudness information and hearing aid selection and fitting parameters.
    Device Description
    The Sonix Hearing Aid Fitting and Programming System is a hand-held, battery-powered, portable device used to fit and program Sonix hearing aids and to store certain patient data.
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