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510(k) Data Aggregation

    K Number
    K070118
    Device Name
    OTOGRAM, CA3350
    Manufacturer
    TYMPANY, INC.
    Date Cleared
    2007-03-07

    (54 days)

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

    TYMPANY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Otogram is an auditory diagnostic instrument intended to administer, under supervision by a trained healthcare professional, a battery of diagnostic and screening procedures that include the following: 1) Pure tone air and bone conduction audiometry with automated masking 2) Speech recognition threshold with automated masking 3) Speech discrimination with automated masking 4) Tympanometry 5) Acoustic reflex threshold, both ipsilateral and contralateral 6) Distortion product otoacoustic emissions 7) Pure tone Stenger 8) Patient survey The Otogram is indicated for use by trained healthcare professionals on both adult and pediatric subjects for measurement of audiometric parameters to identify and supply data to help diagnose hearing loss and ear disorders.
    Device Description
    The Otogram CA3350 is a computer-controlled, audiometric instrument combining the functions of an Audiometer, Distortion Product Otoacoustic Emissions Analyzer and Auditory Acoustic Impedance/Admittance Tester (i.e. Tympanometer). The device is controlled through the use of ASCII commands transmitted over a standard RS-232 communication port. Control software is installed on the supplied PC.
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    K Number
    K041853
    Device Name
    OTOGRAM
    Manufacturer
    TYMPANY, INC.
    Date Cleared
    2004-09-03

    (57 days)

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

    TYMPANY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "Otogram" can perform the functions of: Pure tone and speech audiometer, 1. Impedance audiometer (tympanometry, acoustic reflex), and 2. Distortion product otoacoustic emissions analyzer. 3. The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.
    Device Description
    The Otogram is a computer-controlled, audiometric instrument combining the functions of an Audiometer, a Impedance Instrument, and a DPOAE Instrument. The device is controlled through the use of ASCII commands transmitted over a standard RS-232 communication port. Control software is installed on the supplied PC. The device performs comprehensive audiometry; tympanometry, acoustic reflex; and otoacoustic emissions. Additional features include manual audiometer and NOAH v.3 compliant (hearing aid fitting software). Available in multiple languages, including English, Spanish, Russian, Mandarin, Vietnamese, and Korean.
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