# K151719: REVE134

- Pathway: 510(k) (Traditional)
- Applicant: Kw Ear Lab, Inc.
- Decided: Oct 9, 2015 after 106 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: 7 generations back to K974501 (1998). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133308: Tinnitus Soundsupport, Oticon A/S (2014) Summary page 4.
- K110932: Tinnitus Sound Generator Module, Gn Resound A/S (2011) Summary page 4.

## Most influential descendants
- K221168: Tinnitogram Signal Generator (2023), 0 descendants of its own

## Indications for use
REVE134 is a sound generating software used in a Tinnitus Management Program designed to provide temporary relief for people experiencing tinnitus symptoms. It is intended primarily for adults over 18 years of age, but may also be used for children 5 years of age or older. REVE134 is for use by hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. A hearing healthcare professional should recommend that a patient listen to the REVE134 signal for 30 minutes twice a day at the barely audible level (minimally detectable level).

Source page: https://510kreport.com/device/K151719
Methodology: https://510kreport.com/methodology