# K133308: Tinnitus Soundsupport

- Pathway: 510(k) (Traditional)
- Applicant: Oticon A/S
- Decided: Mar 18, 2014 after 141 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: 6 generations back to K974501 (1998). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 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 3.
- K123450: Phonak Tinnitus Balance, Phonak, LLC (2013) Summary page 1.

## Most influential descendants
- K151719: REVE134 (2015), 1 descendant of its own
- K221168: Tinnitogram Signal Generator (2023), 0 descendants of its own

## Indications for use
Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief to patients suffering from tinnitus as part of a tinnitus management program. The target population is the adult population (>18yrs). Tinnitus SoundSupport is targeted for licensed hearing care professionals (audiologists, hearing aid specialists, or otolaryngologists) who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of Tinnitus SoundSupport must be done by a hearing care professional participating in a tinnitus management program.

Source page: https://510kreport.com/device/K133308
Methodology: https://510kreport.com/methodology