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510(k) Data Aggregation

    K Number
    K021202
    Device Name
    ULTRAQUIET
    Manufacturer
    SOUND TECHNIQUE SYSTEM, LLC
    Date Cleared
    2002-07-13

    (88 days)

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

    SOUND TECHNIQUE SYSTEM, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UltraQuiet™ device is intended for use in the treatment and control of tinnitus. It consists of a low-level amplifier that converts pre-recorded sound into bone-conducted masking noise that is applied to the mastoid region of the head through a behind-the-ear transducer. The UltraQuiet™ device produces sound of sufficient intensity and bandwidth to mask tinnitus. This device is used in conjunction with diagnosis and therapy by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapy. UltraQuiet™ is indicated for the treatment of tinnitus in individuals over 18 years of age that report tinnitus.
    Device Description
    The UltraQuiet™ consists of (1) a compact disc (CD) with recorded sound or an MP3 player, (2) an audio amplifier with AC adapter power supply, and (3) a headband/bone-conduction transducer assembly.
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