Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K110973
    Device Name
    IE-ZEN (IN CLEAR SERIES HEARING AID)
    Manufacturer
    Date Cleared
    2011-05-05

    (29 days)

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

    WIDEX USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 1E-Zen program is intended to provide a relaxing sound background for adults (21 years and older) who desire to listen to such a background in quiet. It may be used as a sound therapy tool in a tinnitus treatment program that is programmed by a licensed hearing healthcare professional (audiologists, hearing aid specialists, otolaryngologists) who is trained in tinnitus management. The IE-Zen program is intended to be used in quiet where hearing everyday sounds is not critical.
    Device Description
    The CLEAR series hearing aids (including CLEAR440. CLEAR330. CLEAR220 and super-power SUPER440 and SUPER220 - also privately labeled as REVIVE700. REVIVE640, REVIVE630, REVIVE707 and REVIVE637) are digital wireless air conduction hearing aids all using the WidexLink radio. The different series represent different price points for the CLEAR hearing aids (see discussion of difference in application). The WidexLink is a low power proprietary radio, which enables communication between hearing aids and from other peripheral units. We have two units which can communicate with the CLEAR hearing aids: a simple remote control (RC-DEX) which can change volume and program in the hearing aid and a programming unit (TM-DEX) which is used in combination with a universal programming interface nEARcom/NoahLink programming system. A detailed description of the WidexLink platform is available in the 510K application (K101699). The added feature to the approved CLEAR440 hearing aid is the optional inter-ear Zen (IE-Zen) feature. Wireless is used in the IE-Zen to identify if the Zen program is used in a monaural mode or binaural mode. The IE-Zen is a tool that generates and delivers a relaxing sound background. It may also be used as a sound source to distract and/or mask tinnitus in tinnitus sufferers. A broadband noise and 5 melodic tone patterns that are generated using fractal mathematics can be selected as Zen programs. The clinician can adjust the characteristics (intensity, pitch and tempo) of each program and the patient can retrieve up to 3 programs with the touch of a program button. The IE-Zen can be used with or without amplification.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1