# K043274: Neuromonics Tinnitus Treatment

- Pathway: 510(k) (Traditional)
- Applicant: Neuromonics Pty, Ltd.
- Decided: Jan 28, 2005 after 63 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.
7 later devices descend from it; 2 cite it directly.
0 of 11 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 2.
- K974501: Digital Tinnitus Masking System, Petroff Audio Technologies (1998) Summary page 2.
- K011364: Custom Tci (Tinnitus Control Instrument), Siemens Hearing Instruments, Inc. (2001) Summary page 3.

## Most influential descendants
- K080955: Zen Program (Mind 440 Hearing Aid) (2008), 5 descendants of its own
- K110973: IE-Zen (in Clear Series Hearing Aid) (2011), 4 descendants of its own
- K123450: Phonak Tinnitus Balance (2013), 3 descendants of its own
- K133308: Tinnitus Soundsupport (2014), 2 descendants of its own
- K151719: REVE134 (2015), 1 descendant of its own

## Indications for use
The Neuromonics Tinnitus Treatment System comprises an SD Memory Card, the Neuromonics Processor, a portable, stereo, MP3 player, and Earphones. The Memory Card has been pre-recorded with selected relaxation music and other sounds spectrally adjusted to suit the particular patient’s spectral hearing thresholds as shown by their audiogram. The sounds on the SD Memory Card are reproduced by the Neuromonics Processor and delivered to the ears by the Bang and Olufsen earphones. The device is indicated for adult (18 years and over) tinnitus sufferers who may or may not suffer hearing loss and are participating in the Neuromonics Tinnitus Treatment. The Neuromonics Tinnitus Treatment System is for home use under the direction of an appropriately qualified healthcare professional such as-an otolaryngologist, an audiologist, or a licensed hearing aid dealer. Patients should receive a medical evaluation by a licensed physician (preferably a 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 the Neuromonics Tinnitus Treatment. The Neuromonics Tinnitus Treatment System may be used to fully and intermittently interact with / mask their tinnitus perception.

Source page: https://510kreport.com/device/K043274
Methodology: https://510kreport.com/methodology