# K011366: Custom Tci-Combi (Tinnitus Control Instrument Combination)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Hearing Instruments, Inc.
- Decided: Jun 1, 2001 after 28 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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
- 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

Source page: https://510kreport.com/device/K011366
Methodology: https://510kreport.com/methodology