# K982432: Pillow Masker, C2007M, C2008M,CE2000, Wonder Ear, Mini Wonder Ear, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-

- Pathway: 510(k) (Traditional)
- Applicant: Tinnitus Treatment Centers, Inc.
- Decided: Jan 25, 1999 after 196 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 1.
- K974501: Digital Tinnitus Masking System, Petroff Audio Technologies (1998) Summary page 1.
- K963838: Starkey TM Air Conduction Tinnitus Masker, Starkey Laboratories, Inc. (1996) Summary page 1.
- K791790: Model TM5 Behind Ear Tinnitus Masker, Starkey Laboratories, Inc. (1979) Summary page 1.

## Cited in the summary but kept off the family tree
- K977475: General Hearing Inst. Tranquil Tinnitus Masker. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
These combination tinnitus masker and hearing aid devices can be used by people who not only have tinnitus but who also have a hearing impairment. These devices will comply with 21 CFR 801.420 and 801.421 and will include additional labeling for hearing aids. The noise is a broad-band white noise signal that can be housed in a variety of In-The-Ear or Behind-The-Ear (hearing aid type) shells. The noise can be 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 noise generated from the tinnitus devices. 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. These same tinnitus masking devices can also be used by individuals who desire to mask out ambient environmental noise (e.g. office noise, outside noise, music, and other obtrusive noises).

Source page: https://510kreport.com/device/K982432
Methodology: https://510kreport.com/methodology