# K112752: Tinnitus Therapy System Anm T30 CR

- Pathway: 510(k) (Traditional)
- Applicant: Anm Adaptive Neuromodulation GmbH
- Decided: Dec 16, 2011 after 86 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: 3 generations back to K974501 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043274: Neuromonics Tinnitus Treatment, Neuromonics Pty, Ltd. (2005) Summary page 1.
- K030791: Anmp (Acoustic Neuro Modulation Protocol), Tinnitech, Ltd. (2003) Summary page 1.

## Indications for use
The ANM T30 CR® Tinnitus Therapy System is intended to provide relief from the disturbance of tinnitus while using the system, and with regular use (over several months) may provide relief to the patient when not using the system. The ANM T30 CR® Stimulator is a patient device for home use. The ANM T30 CR® Stimulator is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment. Stimulation needs to be applied for several hours a day over a period of weeks or months. The target population is adults over 18 years of age.

Source page: https://510kreport.com/device/K112752
Methodology: https://510kreport.com/methodology