# K223694: Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)

- Pathway: 510(k) (Traditional)
- Applicant: Duearity AB
- Decided: Jun 30, 2023 after 203 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 K061459 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061459: Tranquil Tri-Bte, General Hearing Instruments, Inc. (2006) Summary page 4.

## Indications for use
Tinearity G1 is intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noise to provide relief for patients with normal hearing in the home healthcare environment. The device is for prescription use only. The target population is adult population over 18 years of age. Tinearity G1 is applied on intact skin at the mastoid bone and transfers sound through bone conduction to the cochlea. Hearing health care professional shall be consulted for diagnosis, fitting of devices, and follow-up care.

Source page: https://510kreport.com/device/K223694
Methodology: https://510kreport.com/methodology