# K791790: Model TM5 Behind Ear Tinnitus Masker

- Pathway: 510(k) (Traditional)
- Applicant: Starkey Laboratories, Inc.
- Decided: Oct 26, 1979 after 45 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 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
- K982451: Ttcghi-T and TTCTN3-T-T (1999), 2 descendants of its own
- K013253: Hisonic-TRD Tinnitus Relief Device (2002), 1 descendant of its own
- K132965: Solace Sound Generators (2014), 0 descendants of its own
- K070648: The Inhibitor, Model 001 (2007), 0 descendants of its own
- K031624: Tinnitus RX (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K791790
Methodology: https://510kreport.com/methodology