# Intelligent Hearing Systems

- Location (FDA's records): Miami, FL
- FDA decisions: 13 (1991–2017): 13 510(k) clearances
- Product codes: GWJ (8), GWL (2), EWO (2), GXY (1)
- Predicates its devices cite: 19 (10 its own); citations of its devices by later devices: 15 (10 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
- Bio-Logic Systems Corp.: 3 (https://510kreport.com/company/bio-logic-systems)
- Viasys Healthcare GmbH: 1 (https://510kreport.com/company/viasys-healthcare)
- Nicolet Instrument Corp.: 1 (https://510kreport.com/company/nicolet-instrument)
- Xomed, Inc.: 1 (https://510kreport.com/company/xomed)
- Gn Otometrics A/S: 1 (https://510kreport.com/company/gn-otometrics-a-s)
- Otodynamics, Ltd.: 1 (https://510kreport.com/company/otodynamics)
- Grason-Stadler, Inc.: 1 (https://510kreport.com/company/grason-stadler)

## Firms that cite its devices most
- Grason-Stadler, Inc.: 2 (https://510kreport.com/company/grason-stadler)
- Natus Medical, Inc.: 1 (https://510kreport.com/company/natus-medical)
- Strohl Medical Technologies: 1 (https://510kreport.com/company/strohl-medical-technologies)
- Sle Limited: 1 (https://510kreport.com/company/sle)

## Its most-cited devices
- K070608: Smartep, Model M010000 (2007), cited by 3
- K031051: Smartep-Assr, Model M811007 (2004), cited by 2
- K925648: Smart-Screener (Auditory) (1993), cited by 2
- K904926: Smart-EP (1991), cited by 2
- K052060: Opti-Amp DC-Powered (2005), cited by 1
- K964426: Smartoae (1997), cited by 1

## Recent decisions
- K163326: SmartEP (Sep 29, 2017)
- K090579: Smartscreener-PLUS2 (Jul 7, 2009)
- K073384: Smart Coupler, Model M015401 (Feb 28, 2008)
- K070608: Smartep, Model M010000 (Jul 18, 2007)
- K063402: Wick Electrode, Model M019260 (Dec 11, 2006)
- K061443: Smart Usblite, Model M011120 (Jun 23, 2006)
- K052060: Opti-Amp DC-Powered (Aug 31, 2005)
- K031051: Smartep-Assr, Model M811007 (Feb 20, 2004)

Source page: https://510kreport.com/company/intelligent-hearing-systems