# K061459: Tranquil Tri-Bte

- Pathway: 510(k) (Special)
- Applicant: General Hearing Instruments, Inc.
- Decided: Jun 30, 2006 after 35 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K223694: Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) (2023), 0 descendants of its own

## Indications for use
The Tranquil TRI-BTE is for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists.

Source page: https://510kreport.com/device/K061459
Methodology: https://510kreport.com/methodology