Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K171506
    Device Name
    Easyscreen
    Manufacturer
    Maico Diagnostics GmbH
    Date Cleared
    2017-08-29

    (98 days)

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

    Maico Diagnostics GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device DPOAE and TEOAE modules are intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions or Transient Otoacoustic Emissions technology. The target population for the modules includes all ages. The device ABR module is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for the ABR module is newborns and infants up to 6 months of age. The easyScreen is intended to be used by audiologists, ENTs, hearing healthcare professionals, or other trained technicians in a hospital, clinic, healthcare facility or other suitable quiet environment as defined in standard ISO 8253-1.
    Device Description
    The device is audiometric equipment used for testing of inner ear and auditory brainstem abnormalities. easyScreen features a touch-screen display and user-friendly software in a compact hardware design. easyScreen can be purchased with various licenses allowing you to perform different hearing screening tests. easyScreen uses auditory brainstem response (ABR) technology to screen patients for hearing loss. A modified click stimulus, the CE-Chirp , of 35 dB nHL is delivered into the patient's ear while electrodes placed on the patient's head measure EEG activity. The EEG is processed and analyzed automatically using the easyScreen's response detection algorithm. When a response is detected, the screening is stopped automatically and a Pass result is assigned to the test ear. When no response is detected after 3 minutes of EEG activity has been processed, a Refer result is assigned. Auditory brainstem response (ABR) test produces a short acoustic stimulus and measures via transcutaneous electrodes the auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones presented in sequence to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. Transient otoacoustic emissions (TEOAE) technology uses a click stimulus to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. The response can be divided into frequency bands for assessment. The easyScreen consists of a handheld unit that utilizes a touchscreen display and a rechargeable battery. A simple cradle is included to support charging of the device's battery. The device supports Bluetooth communication with a label printer for the purpose of printing screening results.
    Ask a Question
    K Number
    K162210
    Device Name
    touchTymp
    Manufacturer
    MAICO DIAGNOSTICS GMBH
    Date Cleared
    2016-11-16

    (103 days)

    Product Code
    ETY
    Regulation Number
    874.1090
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAICO DIAGNOSTICS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The touchTymp tympanometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflex audiometry.
    Device Description
    The touchTymp is an auditory impedance analyser. The device is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of middle ear pathologies. The device is also used to measure the acoustic reflex threshold which occurs due to contractions of the stapedial muscle following exposure to a strong stimulus. This test allow to assess between central and peripheral pathologies and to identify where the patients uncomfortable loudness level may reside. The instrument is software controlled. The software controls the probe (tone and pressure) stimuli, measures the result and presents the result on a built in display. All functions are set and interpreted by the operator. The technological characteristics are substantially equivalent with predicate device. All technological characteristics are in compliance with the consensus standard ANSI S3.39 for auditory impedance testers.
    Ask a Question

    Page 1 of 1