# General Hearing Instruments, Inc.

- Location (FDA's records): Harahan, LA
- FDA decisions: 5 (1985–2006): 5 510(k) clearances
- Product codes: ESD (4), KLW (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 5 (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
- Decibel Instruments, Inc.: 1 (https://510kreport.com/company/decibel-instruments)
- Tinnitus Treatment Centers, Inc.: 1 (https://510kreport.com/company/tinnitus-treatment-centers)
- Magnatone Hearing Aid Corp. Dba Persona Medical: 1 (https://510kreport.com/company/magnatone-hearing-aid-dba-persona-medical)
- Duearity AB: 1 (https://510kreport.com/company/duearity)
- Audifon-USA, Inc.: 1 (https://510kreport.com/company/audifon-usa)

## Its most-cited devices
- K974751: Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-Cic (1998), cited by 3
- K850123: IN-TH-Ear Hearing Aid (1985), cited by 1
- K061459: Tranquil Tri-Bte (2006), cited by 1

## Recent decisions
- K061459: Tranquil Tri-Bte (Jun 30, 2006)
- K974751: Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-Cic (Mar 6, 1998)
- K971399: Auris AE, Auris TL, Auris HS, Auris AC, Auris MM, Auris Coe, Auris Cic (Jun 13, 1997)
- K943144: Auris Cic (Jul 20, 1994)
- K850123: IN-TH-Ear Hearing Aid (Mar 21, 1985)

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