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510(k) Data Aggregation

    K Number
    K171243
    Device Name
    audifon Tinnitus-Module
    Manufacturer
    audiofon USA Inc.
    Date Cleared
    2017-10-19

    (174 days)

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

    audiofon USA Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    audifon Tinnitus-Module is a tool intended to generate sound as part of a Tinnitus Retraining Therapy (TRT) protocol designed to provide temporary relief for people experiencing tinnitus symptoms. The module in a hearing aid. audifon Tinnitus-Module is intended for adults over 18 years of age. audifon Tinnitus-Module is targeted for licensed hearing care professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of audifon Timitus-Module must be done by a hearing care professional participating in a tinnitus management program.
    Device Description
    The above mentioned audifon Tinnitus module is a digital noise generator which was developed to be used in a tinnitus retraining therapy. This product has up to four different programs, which can be programmed in shape and level to fit the individual user's needs. The programming can be done with a standard HI-PRO and the audifon audifit software. Within the software the amplification of the device can be fitted to the individual needs. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It can be housed in a standard In-the-ear instrument housing, in a standard behind-the-ear instrument housing as well as in standard receiver-in-the ear housing.
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