# Siemens Hearing Instruments, Inc.

- Location (FDA's records): Piscataway, NJ
- FDA decisions: 42 (1984–2007): 42 510(k) clearances
- Product codes: ESD (36), KLW (3), ETW (2), ESF (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 14 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Hansaton Akustik GmbH: 3 (https://510kreport.com/company/hansaton-akustik)
- Tinnitech, Ltd.: 1 (https://510kreport.com/company/tinnitech)
- Widex Hearing Aid Co., Inc.: 1 (https://510kreport.com/company/widex-hearing-aid)
- Audifon GmbH & Co. KG: 1 (https://510kreport.com/company/audifon)
- Sound Technique System, LLC: 1 (https://510kreport.com/company/sound-technique-system)
- Melmedtronics, Inc.: 1 (https://510kreport.com/company/melmedtronics)
- Hearing Innovations, Inc.: 1 (https://510kreport.com/company/hearing-innovations)
- Neuromonics Pty, Ltd.: 1 (https://510kreport.com/company/neuromonics)

## Its most-cited devices
- K003558: Tci Combi (Tinnitus Control Instrument Combination) (2001), cited by 5
- K003559: Tci (Tinnitus Control Instrument) (2001), cited by 3
- K011366: Custom Tci-Combi (Tinnitus Control Instrument Combination) (2001), cited by 2
- K011364: Custom Tci (Tinnitus Control Instrument) (2001), cited by 2
- K071462: Unity 2 Hia & Probe ( for Use with Unity 2) (2007), cited by 1
- K951828: Full Dynamic Range Compression Behind the Ear Hearing Instrument (1995), cited by 1

## Recent decisions
- K071462: Unity 2 Hia & Probe ( for Use with Unity 2) (Jun 5, 2007)
- K011364: Custom Tci (Tinnitus Control Instrument) (Jun 7, 2001)
- K011366: Custom Tci-Combi (Tinnitus Control Instrument Combination) (Jun 1, 2001)
- K003559: Tci (Tinnitus Control Instrument) (Apr 26, 2001)
- K003558: Tci Combi (Tinnitus Control Instrument Combination) (Apr 24, 2001)
- K972998: Prisma (Sep 5, 1997)
- K962170: Siemens Vita 160 Series Pocket Hearing Instrument: Vita 162E,166M,168PP (Jul 25, 1996)
- K952940: Personal Programmer 2000 (Jul 26, 1995)

Source page: https://510kreport.com/company/siemens-hearing-instruments
