Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K093715
    Device Name
    EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE
    Date Cleared
    2010-12-22

    (386 days)

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

    MAGNATONE HEARING AID CORP. DBA PERSONA MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Evok series is designed for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists. The target population for this product is primarily the adult population 18 vears of age and older. The target group for this product includes individuals reporting tinnitus who can also benefit from an air conduction hearing aid.
    Device Description
    Our devices are a combination of a hearing aid and a tinnitus masker in the same instrument. They are prescribed for those people with hearing loss who do not have significant relief with a hearing aid alone. Dispenser or user adjustments permit selection of broad band or high or low frequency emphasis noise and aid response. It is essentially a tinnitus masker with a hearing aid added. Programmable volume controls are provided: one for noise level and the other for hearing aid gain. The dispenser, audiologist or user can mix the amount of noise and amplification as required.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1