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510(k) Data Aggregation

    K Number
    K130494
    Device Name
    UNITRON TINNITUS MASKER FEATURE
    Manufacturer
    Date Cleared
    2013-05-07

    (70 days)

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

    UNITRON HEARING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Unitron's tinnitus masker is a broadband sound generator available in Unitron Era hearing aid platforms. It provides a means of sound enrichment therapy that can be used as part of a personalized tinnitus management program to provide temporary relief from tinnitus. Tinnitus masker is intended for adults 18 years of age or older who have both hearing loss and tinnitus. The tinnitus masker within the air conduction hearing instrument is fitted by a hearing health care professional familiar with diagnosis and management of tinnitus. The underlying principle of sound enrichment is to provide supplementary noise stimulation which can help defocus your attention from your tinnitus and avoid negative reactions. Sound enrichment, coupled with instructional counseling, is an established approach to managing tinnitus.
    Device Description
    Unitron's Tinnitus Masker feature is a noise generator available as an option, in Unitron Era hearing aid platforms providing a sound enrichment source, to provide stimulation to the auditory system, as part of a comprehensive tinnitus management program that works to help distract the wearer's attention from the sound of their tinnitus.
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