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510(k) Data Aggregation

    K Number
    K091552
    Device Name
    SWITCH TRT
    Manufacturer
    AUDIFON GMBH & CO. KG
    Date Cleared
    2009-08-12

    (77 days)

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

    **AUDIFON GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The switch 8 TRT is addressed to the adult population with a chronic persistent ringing in the ears (Tinnitus), who also need or desire amplification. The amplification suits the needs of a mild to a moderate hearing loss. It may be used for masking tinnitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear.
    Device Description
    The switch 8 TRT is a digital noise generator and hearing aid that was developed to be used in a tinnitus retraining therapy. This product has four different programs, which can be programmed in shape and level to fit the individual users' needs. The programming can be done with a standard HI-PRO and the audifit software. Within the software the amplification of the combi-masker can be fitted to the individual needs. The noise can be adjusted in shape with lowcut and high-cut filters and in the output level. It is housed in a standard receiver-in-the-ear instrument housing.
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