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510(k) Data Aggregation

    K Number
    K151719
    Device Name
    REVE134
    Manufacturer
    KW EAR LAB, INC
    Date Cleared
    2015-10-09

    (106 days)

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

    KW EAR LAB, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    REVE134 is a sound generating software used in a Tinnitus Management Program designed to provide temporary relief for people experiencing tinnitus symptoms. It is intended primarily for adults over 18 years of age, but may also be used for children 5 years of age or older. REVE134 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 a patient listen to the REVE134 signal for 30 minutes twice a day at the barely audible level (minimally detectable level).
    Device Description
    KW EAR LAB'S REVE134 consists of software installed in PC (desktop or laptop computer). REVE134 is fitted to the patient by the hearing healthcare professional. The software enables qualified professional to create customized sounds with specific frequency range for sound therapy/masking. REVE134 software can generate either modulated white noise (233~12912 Hz) or modulated narrow band noises or tones with specific frequency range. One narrow band noise has a frequency range of approximately 1/3 octave.
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