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510(k) Data Aggregation

    K Number
    K133352
    Device Name
    HYPERSOUND AUDIO SYSTEM (HSS)
    Manufacturer
    HYPERSOUND HEALTH, INC.
    Date Cleared
    2014-02-12

    (104 days)

    Product Code
    EPF
    Regulation Number
    874.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    HYPERSOUND HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HyperSound Group Auditory Trainer is indicated for use as a group auditory trainer or group hearing aid used to communicate simultaneously with one or more listeners with or without hearing loss and with or without the use of hearing aids in order to improve clarity and comprehension of sounds generated from sources such as a microphone, CD/DVD player, TV, Stereo System or other sound generation systems.
    Device Description
    The HyperSound Audio System (HSS) utilizes a specially designed emitter (speaker) that delivers beamlike sound that is clear to the listener. The beamed audio content begins to demodulate in the air within six inches of the emitter and results in a cone-like transmission of sound waves that can be directed towards the listener. This device is intended for sale as an over-the-counter product and can be used with any sound source and at any distance from 3 feet to 50 feet or more from the emitters (speakers). Ultrasonic technology has been used for many years in industry and is also utilized in medical devices, such as ultrasonic nebulizers. The ultrasonic sound waves this product is based upon have also used in commercial and localized communications, and they are below the ultrasonic sound safety limits established by OSHA as required by OSHA Noise Standard, 29 CFR 1910.95. The device consists of an amplifier, software, and an emitter (speaker). No ear plugs or head phones are required to use this device. The device is distant from and does not touch the intended patient/user.
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