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510(k) Data Aggregation

    K Number
    K161562
    Device Name
    Sound Options Tinnitus Treatment
    Manufacturer
    Sound Options Tinnitus Treatments Inc.
    Date Cleared
    2016-09-28

    (114 days)

    Product Code
    KLW
    Regulation Number
    874.3400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sound Options Tinnitus Treatments Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device, Sound Options Timitus Treatment, version SO 2.0, is for the temporary relief of tinnitus symptoms. The device is a software application that embeds sounds and spectral content into music to relieve patients suffering from timitus and can be used as part of a timitus management program for adults 18 years and older. The device is for prescription use by a physician, audiologist or other healthcare professional.
    Device Description
    The device is a software application that embeds sounds and spectral content into music to relieve patients suffering from tinnitus and can be used as part of a tinnitus management program. The Sound Options device software version is 2.0. The device comprises of tinnitus pitch match and audiogram submission software for health care professionals (Web Software) and Sound Options software application for sound therapy generation (manufacturer use only)
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