# K031624: Tinnitus RX

- Pathway: 510(k) (Traditional)
- Applicant: Tinnitus Control, Inc.
- Decided: Jul 24, 2003 after 62 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: 3 generations back to K940667 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982451: Ttcghi-T and TTCTN3-T-T, Tinnitus Treatment Centers, Inc. (1999) Summary page 2.
- K030791: Anmp (Acoustic Neuro Modulation Protocol), Tinnitech, Ltd. (2003)

## Indications for use
The Tinnitus Rx consists of a personalized sound recorded onto a compact disc (CD) that can be played on commercially available players and listened to through commercially available headphones. The recorded sound is equivalent to that generated by a qualified hearing healthcare professional who has followed the treatment regimen utilized in the clinical study (provided in the 510(k)). The device is indicated for adult (18 years and over) tinnitus sufferers who may or may not suffer higher frequencies hearing loss and are participating in a tinnitus management program. The Tinnitus Rx is for home use under the direction of an appropriately qualified healthcare professional. Patients should receive a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) to rule out medically or surgically treatable diseases for which tinnitus is a symptom before proceeding with non-medical tinnitus management. The Tinnitus Rx is intended for the temporary relief of tinnitus symptoms.

Source page: https://510kreport.com/device/K031624
Methodology: https://510kreport.com/methodology