(183 days)
The TST Suppressor 1000 device is selected sound tracks delivered to the ear by a Standard digital audio player and using an air-conduction earpiece or headphone type transadeers: The 151 Saperience relief of their Tinnitus symptoms when using the Hintus Sunerers who expending fair to excellent hearing in the frequency range 100 device and vince out. Pan there is no more than 35 dB loss in the affected ear in that frequency range and where their Tinnitus is unilateral or bilateral.
The TST Suppressor 1000 is for home use.
Each TST Suppressor 1000 device may be used to suppress the symptoms of tinnitus Eden 191 Suppresser Loigital audio player, using commercially available earphones or headphones.
The TST Suppressor 1000 device is selected sound tracks delivered to the ear by a Standard digital audio player and using an air-conduction earpiece or headphone type transadeers.
The provided text is a 510(k) premarket notification approval letter for the TST Suppressor 1000, a tinnitus masker. It includes the indications for use but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on detailed performance study results.
§ 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.