# K061111: Tinnitus Phase-Out

- Pathway: 510(k) (Special)
- Applicant: Tinnitus Control, Inc.
- Decided: May 16, 2006 after 25 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 K974501 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030791: Anmp (Acoustic Neuro Modulation Protocol), Tinnitech, Ltd. (2003) Summary page 1.

## Indications for use
The Tinnitus Phase-Out is intended to provide the temporary relief of tinnitus symptoms.

Source page: https://510kreport.com/device/K061111
Methodology: https://510kreport.com/methodology