# K070599: Customized Sound Therapy (CST)

- Pathway: 510(k) (Abbreviated)
- Applicant: Tinnitus Otosound Products, LLC
- Decided: Jul 13, 2007 after 133 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 K974501 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974501: Digital Tinnitus Masking System, Petroff Audio Technologies (1998) Summary page 2.
- K030791: Anmp (Acoustic Neuro Modulation Protocol), Tinnitech, Ltd. (2003) Summary page 2.

## Indications for use
The CST system is a CD with software that enables a qualified healthcare professional to identify, with the patient's verbal input, the sounds that most closely match the patient's tinnitus. The device is indicated to mask and intermittently mask tinnitus as part of a tinnitus management program. The target population for the device is adults (18 years and over) who present with tinnitus, that may or may not be accompanied with hearing loss at the higher frequencies, and who are participating in a tinnitus management program.

Source page: https://510kreport.com/device/K070599
Methodology: https://510kreport.com/methodology