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510(k) Data Aggregation

    K Number
    K221168
    Device Name
    Tinnitogram Signal Generator
    Manufacturer
    Goldenear Company, Inc.
    Date Cleared
    2023-02-01

    (285 days)

    Product Code
    KLW
    Regulation Number
    874.3400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Goldenear Company, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tinnitogram™ Signal Generator is a sound generating software used in a Timitus Management Program designed to provide temporary relief for people experiencing timitus symptoms. It is intended primarily for adults over 18 years of ages, but may also be used for children 5 years of age or older. Tinnitogram™ Signal Generator is for use by hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. A hearing healthcare professional should recommend that patient listen to the Timitogram™ Signal Generator signal for 30 minutes twice a day at the barely audible level (minimally detectable level).
    Device Description
    GOLDENEAR COMPANY's TINNITOGRAM™ SIGNAL GENERATOR is a software as a medical device recommended to use a PC (desktop or laptop computer). TINNITOGRAM™ SIGNAL GENERATOR is fitted to the patient by the healthcare professional. The software enables qualified professional to create customized sounds with specific frequency range for sound therapy/masking. Device type is Stand-alone software as a medical device. The tinnitus masking signal is generated through a pre-process of securing the patient's customized signal. The test to find tinnitus frequencies, the pre-process, is performed automatically and this masking signal is generated at patient's barely audible level.
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