# K013827: TST - Suppressor Model #1000

- Pathway: 510(k) (Traditional)
- Applicant: Neurosim Limited
- Decided: May 21, 2002 after 183 days
- Product code: KLW (Masker, Tinnitus)
- Device class: 2
- Regulation: 21 CFR 874.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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 transducers. The TST Suppressor 1000 is indicated for adult (over 18 years of age) Tinnitus sufferers who experience relief of their Tinnitus symptoms when using the device and where such people have fair to excellent hearing in the frequency range 100 Hz to 8,000 Hz (8 kHz), and 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 when operated on the digital audio player, using commercially available earphones or headphones.

Source page: https://510kreport.com/device/K013827
Methodology: https://510kreport.com/methodology