# K011364: Custom Tci (Tinnitus Control Instrument)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Hearing Instruments, Inc.
- Decided: Jun 7, 2001 after 34 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.
32 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K011364
Methodology: https://510kreport.com/methodology