# K030791: Anmp (Acoustic Neuro Modulation Protocol)

- Pathway: 510(k) (Traditional)
- Applicant: Tinnitech, Ltd.
- Decided: Apr 17, 2003 after 36 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: 1 generation back to K974501 (1998). 2 ancestors in all.
31 later devices descend from it; 6 cite it directly.
0 of 34 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 3.
- K011364: Custom Tci (Tinnitus Control Instrument), Siemens Hearing Instruments, Inc. (2001)

## Most influential descendants
- 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
- K111293: Soundcure Serenade Tinnitus Treatment System (2011), 6 descendants of its own

## Indications for use
The TinniTech ANMP System comprises two (2) mini compact disks and a portable, stereo, MP3 mini compact disc player with earphones. The discs have been prerecorded 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 discs are reproduced by the mini compact disc player and delivered to the ears by the earphones supplied with the player. The device is indicated for adult (18 years and over) tinnitus sufferers who may or may not suffer higher frequencies hearing loss and are participating in a tinnitus management program. The TinniTech ANMP 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 non-medical tinnitus management. The Tinnitech ANMP System may be used to completely mask and intermittently mask tinnitus.

Source page: https://510kreport.com/device/K030791
Methodology: https://510kreport.com/methodology