# K151558: Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System

- Pathway: 510(k) (Traditional)
- Applicant: Neurotherapies Reset GmbH
- Decided: Jan 20, 2016 after 224 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Desyncra™ for Tinnitus Therapy System is intended to provide relief from the disturbance of subjective tinnitus while using the system. With regular use (over several months) as part of a tinnitus management program it may provide relief to the patient when not using the system. The Desyncra™ for Tinnitus Therapy System is a patient device for home use. The Desyncra™ for Tinnitus Therapy System is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment. Stimulation needs to be applied for several hours a day over a period of weeks or months. The target population is adults over 18 years of age.

Source page: https://510kreport.com/device/K151558
Methodology: https://510kreport.com/methodology