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510(k) Data Aggregation

    K Number
    K220303
    Device Name
    MDHearingAid app, MDHearingAid Smart hearing aids
    Manufacturer
    MDHearingAid
    Date Cleared
    2022-08-04

    (183 days)

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

    MDHearingAid

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MDHearing Smart Hearing Aids are self-fitting 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. No Pre-programming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
    Device Description
    The MDHearing Smart Hearing Aid is a self-fitting wireless air conduction hearing aid system consisting of the Intricon Lumen 200B hardware and the MDHearing mobile application, which is an "app" compatible only with MDHearing devices of a Smart Hearing Aid product line, designed to interface with a user's compatible smartphone or tablet to personalize and manipulate the device and its settings. The wireless hearing aid incorporates microphones and a receiver encased in the behind-the-ear (BTE) hearing aid body, delivering amplified sound to the ear via standard thin tubing coupled to an earpiece for audio input into the ear. The hearing aid can be controlled wirelessly via Bluetooth Low Energy® using the MDHearing app or manually with on-device push buttons for changing volume and programs. The controls accessible through the MDHearing app and on the hearing aids are used to configure parameters, settings, and listening modes of the devices. The MDHearing Smart Hearing Aid is powered by a standard disposable size 312 zinc-air hearing aid battery.
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