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510(k) Data Aggregation

    K Number
    K012306
    Device Name
    AUDIOSCAN VERIFIT, MODEL VF-1
    Manufacturer
    ETYMONIC DESIGN, INC.
    Date Cleared
    2001-09-21

    (60 days)

    Product Code
    ETW
    Regulation Number
    874.3310
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETYMONIC DESIGN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Audioscan® Verifit™ is a hearing aid analysis system that is an electronic reference device used by manufacturers and dispensers of hearing aids intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid coupled to an ear simulator in a test chamber or a hearing aid when worn by a patient.
    Device Description
    The Audioscan® Verifit™ is a hearing aid analysis system. The system is integrated with a hearing test chamber physically separated from the display/control unit. Signal processing and analysis is carried out digitally, with the exception of the microphone preamplifiers and output amplifiers. It includes a fluorescent backlit active color display, thermal line printer, and various connectors for peripherals and microphones. It has two stimulus channels and two measurement channels. The hearing aid test chamber has a working space of 8" x 5" x 1.5" (approx.), two 2" x 3" Independent speakers, and induction coils for Telephone Magnetic Field Simulator and a 20 cm diameter test loop. It also includes a battery simulator. The real-ear measurement component has two 2" x 3" ducted ports speakers and a Silicone 1.0mm diameter x 75mm probe microphone tube.
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