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    K Number
    K223848
    Device Name
    Intrisound™ Tuned Lumen® 155 Hearing Aids
    Manufacturer
    Tuned Ltd
    Date Cleared
    2023-09-08

    (260 days)

    Product Code
    QUH, OUH
    Regulation Number
    874.3325
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tuned Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intrisound™ Tuned Lumen® 155 are self-fitting, wireless air conduction hearing aids, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are to meet the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.
    Device Description
    The Intrisound™ Tuned Lumen® 155 Hearing Aid is a wireless, self-fitting air conduction hearing aid. It features digital signal processing (16 channel wide dynamic input compression, 3 layer fastacting output compression, 16 channel noise reduction, feedback cancellation), bi-directional microphone with windscreen, volume and program control, 12 band equalizer, self-selectable tube and ear tips, and customization through the Tuned Mobile Application. The Tuned Mobile Application aims to detect accurate auditory thresholds, partnering with a smart phone application to deliver user-customized sound through the Intrisound™ Tuned Lumen® 155 Hearing Aid. These thresholds are used to program the device using a proprietary algorithm.
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