# Starkey Laboratories, Inc.

- Location (FDA's records): Eden Prairie, MN
- FDA decisions: 61 (1977–2020): 61 510(k) clearances
- Names in FDA's records: Starkey Laboratories, Inc. (60); Starkey Laboratories (1)
- Product codes: ESD (39), KLW (10), ETW (4), EWO (3), KHL (1), BWF (1), ERA (1), LXB (1), LRB (1)
- Predicates its devices cite: 9 (8 its own); citations of its devices by later devices: 23 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gn Resound A/S: 1 (https://510kreport.com/company/gn-resound-a-s)

## Firms that cite its devices most
- Tinnitus Treatment Centers, Inc.: 6 (https://510kreport.com/company/tinnitus-treatment-centers)
- Hearing Innovations, Inc.: 2 (https://510kreport.com/company/hearing-innovations)
- Decibel Instruments, Inc.: 1 (https://510kreport.com/company/decibel-instruments)
- United Hearing Systems, Inc.: 1 (https://510kreport.com/company/united-hearing-systems)
- Sound Technique System, LLC: 1 (https://510kreport.com/company/sound-technique-system)
- Melmedtronics, Inc.: 1 (https://510kreport.com/company/melmedtronics)
- Audifon-USA, Inc.: 1 (https://510kreport.com/company/audifon-usa)
- Wordcomp International Communication Group (Wicg): 1 (https://510kreport.com/company/wordcomp-international-communication-group-wicg)

## Its most-cited devices
- K963838: Starkey TM Air Conduction Tinnitus Masker (1996), cited by 4
- K964216: Starkey TM-3, TM-5 High Frequency Tinnitus Masker (1996), cited by 4
- K791790: Model TM5 Behind Ear Tinnitus Masker (1979), cited by 3
- K940667: Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing Aid (1994), cited by 3
- K923784: Starkey SM Series Bte Hearing Aids (1992), cited by 2
- K122876: Multiflex Tinnitus Technology (2012), cited by 1

## Recent decisions
- K201370: Multiflex Tinnitus Technology (Jun 19, 2020)
- K122876: Multiflex Tinnitus Technology (Oct 31, 2012)
- K030180: Crescent Tinnitus Retaining Sound Generator (Sep 17, 2003)
- K970952: Precise Impression Kit (May 2, 1997)
- K964245: Precise, Tynmpanette, and Xacto Impression Kits (Feb 4, 1997)
- K964340: Portarem-3000, PFS-6000 (Jan 10, 1997)
- K964216: Starkey TM-3, TM-5 High Frequency Tinnitus Masker (Dec 6, 1996)
- K964214: Starkey a-13 Sequel Programmable, a-13 K-Amp Programmable Air Conduction Hearing Aids (Nov 27, 1996)

Source page: https://510kreport.com/company/starkey-laboratories