(83 days)
For use in treatment and control of tinnitus.
Not Found
This document is a 510(k) clearance letter for a tinnitus masker device called "Aurex-3". It does not contain information about acceptance criteria or a study proving device performance. The letter corrects a previous error regarding the device's classification (from OTC to prescription) and confirms its substantial equivalence to a legally marketed predicate device.
Therefore, I cannot provide the requested information based on the provided text. The document is strictly administrative in nature, concerning regulatory classification and marketing clearance, not technical performance or study data.
§ 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.