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The Tranquil TRI-BTE is for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists.

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The provided document is a 510(k) substantial equivalence letter for the "Tranquil TRI-BTE" Tinnitus Masker. This type of letter does not typically contain detailed information about acceptance criteria or specific study protocols and results for device performance. It confirms that the device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness.

Therefore, based on the content of the provided document, I cannot answer the questions regarding acceptance criteria and the study that proves the device meets them. The document primarily focuses on the regulatory determination of substantial equivalence and general requirements for marketing the device.

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