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Each of the four CDs included in the DTM-4 CD set (CD#1, CD#2, CD#3 and CD#4), and each of the four tapes included the DTM-4 TAPE set (TAPE#1, TAPE#2, TAPE#3 and TAPE#4), provide digital tinnitus masking when operated on any commercially available CD or tape player respectively, using any commercially available headphones or speakers. CD#1 and TAPE#1 provide digital tinnitus masking sounds only and are indicated for temporary relief of tinnitus symptoms. CD#2, CD#3, CD#4, TAPE#2, TAPE#3 and TAPE#4 provide digital tinnitus masking sounds plus relaxation messages, alpha-rhythms (a gentle musical sound generated on electronic musical instruments), music and/or nature sounds, and are indicated for temporary relief of tinnitus symptoms and the promotion of relaxation during the tinnitus masking process.

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The provided document is a 510(k) summary for a "Digital Tinnitus Masking System" (DTM-4). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial with specific acceptance criteria and detailed performance studies typical for novel devices.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set size.

This 510(k) submission primarily defines the device, its indications for use, and an FDA determination of substantial equivalence to a predicate device. It confirms that the device can proceed to market subject to general controls and existing regulations, but it does not include the detailed performance study results that would typically be presented against explicit acceptance criteria.

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