# K040330: Quiescence

- Pathway: 510(k) (Traditional)
- Applicant: Spectral Visualization & Development, Inc.
- Decided: Apr 12, 2004 after 61 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.
23 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030791: Anmp (Acoustic Neuro Modulation Protocol), Tinnitech, Ltd. (2003) Summary page 1.

## Most influential descendants
- K073636: Tinnitus Sound Generator Module (2008), 22 descendants of its own
- K110932: Tinnitus Sound Generator Module (2011), 13 descendants of its own
- K111293: Soundcure Serenade Tinnitus Treatment System (2011), 6 descendants of its own
- K150171: Tinnitus Sound Generator Module (2015), 3 descendants of its own
- K123450: Phonak Tinnitus Balance (2013), 3 descendants of its own

## Indications for use
This software device, Quiescence™, is indicated for use by otolaryngologists, audiologists, and hearing-aid dispensers (collectively referred to as healthcare professionals) for generating custom masking sounds to mask tinnitus as part of a tinnitus management program. The target population of the device is adults (18 years and over) who report experiencing tinnitus, which may or may not be accompanied with hearing loss. Patients should receive a medical evaluation by a licensed physician who specializes in diseases of the ear to rule-out medically or surgically treatable diseases for which tinnitus is a symptom before proceeding with non-medical tinnitus management.

Source page: https://510kreport.com/device/K040330
Methodology: https://510kreport.com/methodology