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    K Number
    DEN100025
    Device Name
    WIDEXLINK IN CLEAR SERIES HEARING AIDS
    Manufacturer
    OFFICE RESEARCH IN CLINICAL AMPLIFICTION
    Date Cleared
    2011-03-31

    (169 days)

    Product Code
    OSM
    Regulation Number
    874.3305
    Why did this record match?
    Product Code :

    OSM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CLEAR440 - PASSION (or C4-PA) hearing aid is a digital wireless air conduction hearing aid that amplifies sounds for individuals with a hearing impairment. The device is indicated for individuals with a full range of hearing loss severity (from slight (16 to 25 dB HL) to profound (90+ dB HL)) and all hearing loss configurations. The device is to be programmed by hearing healthcare professionals (audiologists, hearing aid specialists, otolaryngologists) who are trained in hearing (re)habilitation.
    Device Description
    The C4-PA is a digital air-conduction hearing aid that uses WidexLink, a wireless radio technology to enable communication between a pair of hearing aids and/or between the hearing aid(s) and certain device system accessories. Accessories for WidexLink include the optional remote control (RC-DEX) and the Widex-specific programming module (TM-DEX).
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