# K974501: Digital Tinnitus Masking System

- Pathway: 510(k) (Traditional)
- Applicant: Petroff Audio Technologies
- Decided: Jan 20, 1998 after 53 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
No predicates in its family tree.
34 later devices descend from it; 6 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K030791: Anmp (Acoustic Neuro Modulation Protocol) (2003), 31 descendants of its own
- K040330: Quiescence (2004), 23 descendants of its own
- K073636: Tinnitus Sound Generator Module (2008), 22 descendants of its own
- K110932: Tinnitus Sound Generator Module (2011), 13 descendants of its own
- K043274: Neuromonics Tinnitus Treatment (2005), 7 descendants of its own

## Indications for use
Each of the four CDs included in the DTM-4 CD set (CD#1, CD#2, CD#3 and CD#4), and each of the four tapes included the DTM-4 TAPE set (TAPE#1, TAPE#2, TAPE#3 and TAPE#4), provide digital tinnitus masking when operated on any commercially available CD or tape player respectively, using any commercially available headphones or speakers. CD#1 and TAPE#1 provide digital tinnitus masking sounds only and are indicated for temporary relief of tinnitus symptoms. CD#2, CD#3, CD#4, TAPE#2, TAPE#3 and TAPE#4 provide digital tinnitus masking sounds plus relaxation messages, alpha-rhythms (a gentle musical sound generated on electronic musical instruments}), music and/or nature sounds, and are indicated for temporary relief of tinnitus symptoms and the promotion of relaxation during the tinnitus masking process.

Source page: https://510kreport.com/device/K974501
Methodology: https://510kreport.com/methodology