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510(k) Data Aggregation

    K Number
    K123624
    Device Name
    OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM
    Manufacturer
    MIMOSA ACOUSTICS, INC.
    Date Cleared
    2013-03-28

    (125 days)

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

    MIMOSA ACOUSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the OtoStat DPOAE Measurement is to determine the presence of cochlear function. The intended use of the OtoStat MEPA Middle Ear Power Analyzer is to characterize the middle ear status and to assist in diagnosing middle ear pathologies. The intended use of the OtoStat DPOAE+MEPA is to determine the presence of cochlear and middle ear functions and to assist in differential diagnosis between cochlear and middle ear dysfunctions. The OtoStat MEPA system measures various acoustic properties of the ear, namely power reflectance, power absorbance, transmittance, wideband immittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear.
    Device Description
    The OtoStat is a small portable handheld audiometric measurement device for measuring either DPOAE (distortion product otoacoustic emission), MEPA (middle ear power analysis), or both, where DPOAE is for evaluating cochlear function and MEPA for middle and outer ear status. Both MEPA and DPOAE measurements present acoustic stimulus into the ear canal via the loudspeakers in the acoustic ear probe, then record the complex pressure frequency responses via the microphone in the same acoustic ear probe. The responses are then analyzed and displayed against relevant normative data with recommended pass/refer indication for the trained user to determine the cochlear and middle ear status and for differential diagnosis.
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    K Number
    K063338
    Device Name
    HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
    Manufacturer
    MIMOSA ACOUSTICS, INC.
    Date Cleared
    2007-01-04

    (59 days)

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

    MIMOSA ACOUSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer is to characterize inner-ear status and to assist in diagnosing inner-ear pathologies. The HearID+TE system measures various acoustic properties of the inner ear, namely otoacoustic emission sound pressure level, signal-to-noise ratio, and reproducibility. These three properties may be measured within prescribed frequency bands or wideband. These measures allow for the evaluation of the functional condition of the inner ear, assuming a normal middle and outer ear. The HearID+TE system is suitable for all populations, including newborn infants. The HearID+TE system is to be used by trained personnel only.
    Device Description
    HearID Transient-Evoked Otoacoustic Emission Analyzer (HearID+TE, T2001, and T2K)
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    K Number
    K053216
    Device Name
    HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
    Manufacturer
    MIMOSA ACOUSTICS, INC.
    Date Cleared
    2006-02-10

    (85 days)

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

    MIMOSA ACOUSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the HearID-wbMEPA Middle Ear Power Analyzer is to characterize the middle ear status and to assist in diagnosing middle ear pathologies. The HearID-wbMEPA system measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear. The devices are suitable for all populations including new-born infants. The devices are to be used by trained personnel only.
    Device Description
    The HearID system comes in two versions: HearID_b-wbMEPA, and HearID_e-wbMEPA, where the difference is the variation of the hardware platform.
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    K Number
    K981460
    Device Name
    CUB DIS II DPOAE MEASUREMENT SYSTEM
    Manufacturer
    MIMOSA ACOUSTICS, INC.
    Date Cleared
    1998-05-20

    (27 days)

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

    MIMOSA ACOUSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of The CUB®DIS II™ DPOAE Measurement System is to determine the presence of cochlear function.
    Device Description
    The CUBEDIS II TM DPOAE Measurement system is designed to provide acoustic stimuli for, and rapid clinical measurement and evaluation of, odd order distortion product tones generated by the cochlea and measured in the ear canal, at the audiometric frequencies (or other frequencies, as desired), between 500 through 8,000 Hz with no known artifacts, a low noise floor system, and a high signal-to-noise ratio.
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