# K982451: Ttcghi-T and TTCTN3-T-T

- Pathway: 510(k) (Traditional)
- Applicant: Tinnitus Treatment Centers, Inc.
- Decided: May 7, 1999 after 296 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
Longest line of descent: 2 generations back to K940667 (1994). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964216: Starkey TM-3, TM-5 High Frequency Tinnitus Masker, Starkey Laboratories, Inc. (1996) Summary page 2.
- K974501: Digital Tinnitus Masking System, Petroff Audio Technologies (1998) Summary page 2.
- K963838: Starkey TM Air Conduction Tinnitus Masker, Starkey Laboratories, Inc. (1996) Summary page 2.
- K791790: Model TM5 Behind Ear Tinnitus Masker, Starkey Laboratories, Inc. (1979) Summary page 2.
- K974751: Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-Cic, General Hearing Instruments, Inc. (1998) Summary page 2.

## Most influential descendants
- K132965: Solace Sound Generators (2014), 0 descendants of its own
- K031624: Tinnitus RX (2003), 0 descendants of its own

## Indications for use
The noise used in the Tinnitus Adaptation Therapy program is a broad-band noise that has been recorded onto a standard audio cassette and can be played on any commercially available audio cassette player and listened to through any commercially available headphones or speakers. The noise is used as an adjunct to assist individuals with tinnitus to learn to refocus their attention away from their tinnitus and towards an alternate sound such as the recorded noise. The level of the noise should be adjusted by the individual to a level below their tinnitus so that both the noise and the tinnitus can be heard simultaneously. However, if the individual wishes to completely “mask-out” the tinnitus then the noise could be adjusted so that the noise is louder than the tinnitus. The other audio tapes in the Tinnitus Adaptation Therapy program consist of relaxation exercises and cognitive retraining lessons to further assist the individual with tinnitus to learn to refocus their attention away from their tinnitus. The noise and the relaxation/cognitive tapes, when used in a comprehensive tinnitus adaptation therapy program, are indicated for the temporary relief of tinnitus symptoms and the promotion of relaxation during the tinnitus adaptation process.

Source page: https://510kreport.com/device/K982451
Methodology: https://510kreport.com/methodology