# K021202: Ultraquiet

- Pathway: 510(k) (Traditional)
- Applicant: Sound Technique System, LLC
- Decided: Jul 13, 2002 after 88 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). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003559: Tci (Tinnitus Control Instrument), Siemens Hearing Instruments, Inc. (2001) Summary page 2.
- K981704: AUREX-3, Adm Tronics Unltd, Inc. (1998) Summary page 2.
- K964216: Starkey TM-3, TM-5 High Frequency Tinnitus Masker, Starkey Laboratories, Inc. (1996) Summary page 2.

## Cited in the summary but kept off the family tree
- K982452: Tinnitus Treatment Centers' TTC GHI-T and TTC TN3-T-T devices. 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 2.

## Most influential descendants
- K070648: The Inhibitor, Model 001 (2007), 0 descendants of its own

## Indications for use
The UltraQuietTM device is intended for use in the treatment and control of tinnitus. It consists of a low-level amplifier that converts pre-recorded sound into bone-conducted masking noise that is applied to the mastoid region of the head through a behind-the-ear transducer. The UltraQuietTM device produces sound of sufficient intensity and bandwidth to mask tinnitus. This device is used in conjunction with diagnosis and therapy by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapy. UltraQuietTM is indicated for the treatment of tinnitus in individuals over 18 years of age that report tinnitus.

Source page: https://510kreport.com/device/K021202
Methodology: https://510kreport.com/methodology