# K091552: Switch TRT

- Pathway: 510(k) (Abbreviated)
- Applicant: Audifon GmbH & Co. KG
- Decided: Aug 12, 2009 after 77 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: 1 generation back to K003558 (2001). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003558: Tci Combi (Tinnitus Control Instrument Combination), Siemens Hearing Instruments, Inc. (2001) Summary page 1.

## Most influential descendants
- K130514: Audifon Arriva Cic, IS, IS+, M, S, S+, X TRT, Audifon Vico, Audifon Prado, Audifon Elia, Cic, IS, IS+, M, S TRT (2013), 1 descendant of its own
- K171243: audifon Tinnitus-Module (2017), 0 descendants of its own
- K130417: Audifon Sueno Cic, Audifon Sueno S, Audifon Sueno T Cic, Audifon Sueno T S (2013), 0 descendants of its own

## Indications for use
The switch TRT is addressed to the adult population with a chronic persistent ringing in the ears (Tinnitus), who do not need or desire amplification. It may be used for masking tinnitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear. The switch 8 TRT is addressed to the adult population with a chronic persistent ringing in the ears (Tinnitus), who also need or desire amplification. The amplification suits the needs of a mild to a moderate hearing loss. It may be used for masking tinnitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear.

Source page: https://510kreport.com/device/K091552
Methodology: https://510kreport.com/methodology