(224 days)
The Desyncra™ for Tinnitus Therapy System is intended to provide relief from the disturbance of subjective tinnitus while using the system. With regular use (over several months) as part of a tinnitus management program it may provide relief to the patient when not using the system.
The Desyncra™ for Tinnitus Therapy System is a patient device for home use.
The Desyncra™ for Tinnitus Therapy System is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment.
Stimulation needs to be applied for several hours a day over a period of weeks or months.
The target population is adults over 18 years of age.
Not Found
Unfortunately, the provided text does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or any details of a study proving the device meets acceptance criteria.
The document is a 510(k) "Substantial Equivalence Determination" letter from the FDA to Neurotherapies Reset Gmbh. It states that the device, Desyncra For Tinnitus Therapy System, is substantially equivalent to legally marketed predicate devices. It also lists the "Indications for Use" for the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on this document.
§ 874.3400 Tinnitus masker.
(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.