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510(k) Data Aggregation

    K Number
    K043274
    Device Name
    NEUROMONICS TINNITUS TREATMENT
    Manufacturer
    NEUROMONICS PTY LTD
    Date Cleared
    2005-01-28

    (63 days)

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

    NEUROMONICS PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neuromonics Tinnitus Treatment System has been designed solely and specifically for delivering and monitoring the audio stimulus required for the Neuromonics Tinnitus Treatment. The Neuromonics Tinnitus Treatment is intended to provide relief from the disturbance of tinnitus, while using the system, and with reqular use (over several months) may provide relief to the patient whilst not using the system. The Neuromonics Tinnitus Treatment System comprises a SD Memory Card that is pre-recorded with selected relaxation audio and other sounds spectrally adapted to suit the particular patient's hearing thresholds. The system is indicated to provide a high degree of interaction (or masking) and intermittent interaction / masking with the patients' tinnitus perception, as part of the Neuromonics tinnitus management program. The addition of the music is to aid the promotion of relaxation during the tinnitus masking process. The Neuromonics Tinnitus Treatment System is intended to interact and intermittently interact with the patients tinnitus as part of a tinnitus management program. The addition of the music is to aid the promotion of relaxation during the tinnitus interaction process. The Neuromonics Tinnitus Treatment System comprises an SD Memory Card, the Neuromonics Processor, a portable, stereo, MP3 player, and Earphones. The Memory Card has been pre-recorded with selected relaxation music and other sounds spectrally adjusted to suit the particular patient's spectral hearing thresholds as shown by their audiogram. The sounds on the SD Memory Card are reproduced by the Neuromonics Processor and delivered to the ears by the Bang and Olufsen earphones. The device is indicated for adult (18 years and over) tinnitus sufferers who may or may not suffer hearing loss and are participating in the Neuromonics Tinnitus Treatment. The Neuromonics Tinnitus Treatment System is for home use under the direction of an appropriately qualified healthcare professional such as an otolaryngologist. an audiologist, or a licensed hearing aid dealer. Patients should receive a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) to rule out medically or surgically treatable diseases for which tinnitus is a symptom before proceeding with the Neuromonics Tinnitus Treatment. The Neuromonics Tinnitus Treatment System may be used to fully and intermittently interact with / mask their tinnitus perception.
    Device Description
    The Neuromonics Tinnitus Treatment System comprises an SD Memory Card, the Neuromonics Processor, a portable, stereo, MP3 player, and Earphones. The Memory Card has been pre-recorded with selected relaxation music and other sounds spectrally adjusted to suit the particular patient's spectral hearing thresholds as shown by their audiogram. The sounds on the SD Memory Card are reproduced by the Neuromonics Processor and delivered to the ears by the Bang and Olufsen earphones.
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