# K130514: Audifon Arriva Cic, IS, IS+, M, S, S+, X TRT, Audifon Vico, Audifon Prado, Audifon Elia, Cic, IS, IS+, M, S TRT

- Pathway: 510(k) (Abbreviated)
- Applicant: Audifon-USA, Inc.
- Decided: Nov 21, 2013 after 267 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 K003558 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091552: Switch TRT, Audifon GmbH & Co. KG (2009) Summary page 2.

## Most influential descendants
- K171243: audifon Tinnitus-Module (2017), 0 descendants of its own

## Indications for use
The combined devices are intended for the adult population suffering from a chronic persistent ringing in the ears (Tinnitus), who also need or desire amplification. The amplification suits the needs of a slight to a profound hearing loss (see table below). The products may also be used for masking Tinnitus as part of a Tinnitus Retraining Therapy (TRT) protocol and should be utilized only in consultation with a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist.

Source page: https://510kreport.com/device/K130514
Methodology: https://510kreport.com/methodology