# K171243: audifon Tinnitus-Module

- Pathway: 510(k) (Abbreviated)
- Applicant: Audiofon USA, Inc.
- Decided: Oct 19, 2017 after 174 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 K003558 (2001). 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)
- K130514: Audifon Arriva Cic, IS, IS+, M, S, S+, X TRT, Audifon Vico, Audifon Prado, Audifon Elia, Cic, IS, IS+, M, S TRT, Audifon-USA, Inc. (2013) Summary page 4.

## Indications for use
audifon Tinnitus-Module is a tool intended to generate sound as part of a Tinnitus Retraining Therapy (TRT) protocol designed to provide temporary relief for people experiencing tinnitus symptoms. The module can be embedded in a hearing aid. audifon Tinnitus-Module is intended for adults over 18 years of age. audifon Tinnitus-Module is targeted for licensed hearing care professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of audifon Tinnitus-Module must be done by a hearing care professional participating in a tinnitus management program.

Source page: https://510kreport.com/device/K171243
Methodology: https://510kreport.com/methodology