# K122876: Multiflex Tinnitus Technology

- Pathway: 510(k) (Traditional)
- Applicant: Starkey Laboratories
- Decided: Oct 31, 2012 after 42 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: 5 generations back to K974501 (1998). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110932: Tinnitus Sound Generator Module, Gn Resound A/S (2011) Summary page 1.

## Most influential descendants
- K201370: Multiflex Tinnitus Technology (2020), 0 descendants of its own

## Indications for use
The Multiflex Tinnitus Technologym is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age. The Multiflex Tinnitus Technologym is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Multiflex Tinnitus Technology Mmust be done by a hearing professional participating in a Tinnitus Management Program.

Source page: https://510kreport.com/device/K122876
Methodology: https://510kreport.com/methodology