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510(k) Data Aggregation

    K Number
    K040330
    Device Name
    QUIESCENCE
    Manufacturer
    SPECTRAL VISUALIZATION & DEVELOPMENT, INC.
    Date Cleared
    2004-04-12

    (61 days)

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

    **SPECTRAL VISUALIZATION **& DEVELOPMENT, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This software device, Quiescence™, is indicated for use by otolaryngologists, and hearing-aid dispensers (collectively referred to as healthcare professionals) for generating custom masking sounds to mask timitus as part of a tinnitus management program. The target population of the device is adults (18 years and over) who report experiencing timitus, which may or may not be accompanied with hearing loss. Patients should receive a medical evaluation by a licensed physician who specializes in diseases of the ear to rule-out medically or surgically reatable diseases for which tinaitus is a symptom before proceeding with non-medical tinnitus management.
    Device Description
    Quiescence provides a means for healthcare professionals to custom-make masking sounds for tinnitus patients. This software allows the healthcare professional to try different masking sounds on the patients until one or more suitable ones are found. The masking sounds will be stored to the computer hard disk. This allows the stored masking sound to be written or recorded into other convenient formats such as CD and MP3 player for playback.
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