# K003558: Tci Combi (Tinnitus Control Instrument Combination)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Hearing Instruments, Inc.
- Decided: Apr 24, 2001 after 158 days
- Product code: ESD (Hearing Aid, Air-Conduction, Prescription)
- Device class: 1
- Regulation: 21 CFR 874.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
29 later devices descend from it; 5 cite it directly.
0 of 30 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
- K073636: Tinnitus Sound Generator Module (2008), 22 descendants of its own
- K110932: Tinnitus Sound Generator Module (2011), 13 descendants of its own
- K111293: Soundcure Serenade Tinnitus Treatment System (2011), 6 descendants of its own
- K150171: Tinnitus Sound Generator Module (2015), 3 descendants of its own
- K123450: Phonak Tinnitus Balance (2013), 3 descendants of its own

Source page: https://510kreport.com/device/K003558
Methodology: https://510kreport.com/methodology