# K964216: Starkey TM-3, TM-5 High Frequency Tinnitus Masker

- Pathway: 510(k) (Traditional)
- Applicant: Starkey Laboratories, Inc.
- Decided: Dec 6, 1996 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
Longest line of descent: 1 generation back to K940667 (1994). 1 ancestor in all.
6 later devices descend from it; 4 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)
- K940667: Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing Aid, Starkey Laboratories, Inc. (1994) Summary page 1.

## Most influential descendants
- K982451: Ttcghi-T and TTCTN3-T-T (1999), 2 descendants of its own
- K021202: Ultraquiet (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

## Indications for use
To generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)

Source page: https://510kreport.com/device/K964216
Methodology: https://510kreport.com/methodology