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510(k) Data Aggregation

    K Number
    K013977
    Device Name
    ECHO-SCREEN T, TA, TD, TDA, TC
    Manufacturer
    FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC.
    Date Cleared
    2002-06-14

    (193 days)

    Product Code
    GWJ
    Regulation Number
    882.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fischer-Zoth Audiologic Systems model family "Echo-Screen T" consisting of Echo-screen T, Echo-Screen TA, Echo-Screen TD, Echo-Screen TDA and Echo-Screen TC are based upon Otoacoustic Emissions (OAE) and Auditory Brainstem Response (ABR) technology. The device is intended to screen hearing for newborns through adults, including geriatric patients. The device does not measure hearing per se, but helps to determine whether or not a hearing loss may be present. The "Echo-Screen T" product family consists of handheld, automated OAE and ABR based hearing screening systems which are easy to use. The measurement flow is menu guided and the evaluation is based upon signal statistics. The "Echo-Screen T" devices are intended to be used by trained personnel in a medical or school environment. The "Echo-Screen T" models are not intended for fitting assistive listening devices such as hearing aids or cochlear implants.
    Device Description
    The Fischer-Zoth Audiologic Systems model family 'Echo-Screen T' consisting of Echoscreen T. Echo-Screen TA. Echo-Screen TD. Echo-Screen TDA. Echo-Screen TC are based upon Otoacoustic Emissions (OAE) and Auditory Brainstem Response (ABR) technology. The 'Echo-Screen T' product family are handheld, automated OAE- and ABR based hearing screening systems which are easy to be used. The measurement flow is menu guided and the evaluation is based upon signal statistics.
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    K Number
    K982642
    Device Name
    ECHO-SCREEN
    Manufacturer
    FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC.
    Date Cleared
    1998-10-21

    (84 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Echo-Screen Otoacoustic Emissions Test Instrument is a hand-held instrument with an attached probe (that is placed in the outer ear canal) which emits sound that evokes otoacoustic emissions. A microphone in the probe picks up the emissions if any are present, and the device then analyzes the emissions and mathematically separates noise from cochlear emissions. The presence of these emissions indicates cochlear function in adults, infants and children. The instrument requires no active participation from the patient. Otoacoustic emissions (OAEs) are low-level audio-frequency sounds that are generated by the outer hair cells of the cochlea in response to sound input. The presence of OAEs is an indication of cochlear function. If the Echo-Screen signals a "pass" reading as it analyzes the presence of OAEs, the clinician can determine that the cochlea is operating normally.
    Device Description
    The Fischer-Zoth Audiologic System model 'Echo-Screen' is based upon Otoacoustic Emissions and it is similar to the Grason Stadler Inc. GSI70 AudioPath Screener and the Otodynamics OAE Analyser, model ILO88. The 'echo-screen' is a handheld, automated OAE-based screeming-system which is easy to use. The measurement flow is menu guided and the evaluation is based upon signal statistics.
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