Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K151025
    Device Name
    iHearTest
    Manufacturer
    IHEAR MEDICAL, INC.
    Date Cleared
    2015-12-29

    (257 days)

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

    IHEAR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iHearTest is an air-conduction over the counter hearing screener for profiling your hearing ability based on guidelines by the World Health Organization (WHO). The iHearTest is intended for home use by adults of at least 18 years of age. Hearing test results are displayed on the computer screen and stored in our HIPAA-compliant remote server for review anytime using secure online access.
    Device Description
    The iHearTest is an over the counter (OTC) hearing screener for profiling hearing ability based on guidelines by the World Health Organization (WHO). The iHearTest is intended for home use by adults of at least 18 years of age. The iHearTest Software System consists of: The iHearUSB device for connection to a personal computer via USB port. Factory calibrated in-ear earphones, marked for right and left ears, with 3 tip sizes. iHearTest software application. Instructions and warranty information provided in the User Guide and online. A quick Install guide to assist in the initial software installation, registering the USB device, and initiating the iHearTest. The iHearTest Software System requires a standard personal computer (PC) with USB port running Microsoft Windows or OS X. The iHearTest software application is a browser-based software application executed from the consumer's personal computer that provides the user interface for a hearing screening test on the PC's monitor, controls the output of test sound signals from an iHearUSB device connected to the PC's USB port, displays hearing test results and sends the results to a remote HIPAA compliant server for review anytime by the consumer using secure online access, and conducts periodic checks of earphone calibration via the calibration tool incorporated into the iHearUSB device. The iHearTest kit is designed to produce air-conducted sounds via the in-ear earphone within the supra-threshold range of 25-85 dB HL at test frequencies of 500, 1000, 2000 and 4000 Hz. The iHearTest software application prompts the user to respond to test sounds and determines the individual's hearing level at each test frequency. The user's overall hearing ability is then computed and displayed for both the right and left ear with a recommendation for potential hearing aid use as per WHO guidelines. The iHearUSB device incorporates a microphone for sensing the background noise during the hearing screening process, and ensuring that the background noise is within an acceptable level range.
    Ask a Question

    Page 1 of 1