# Cochlear Americas

- Location (FDA's records): Centennial, CO
- FDA decisions: 27 (1984–2026): 21 510(k) clearances and 6 original PMA approvals
- Product codes: LXB (12), PFO (5), MCM (4), MAH (3), MHE (1), KCT (1), PGQ (1)
- 510(k) review time since 2016: median 114 days, against 110 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 30 (20 its own); citations of its devices by later devices: 28 (20 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cochlear Bone Anchored Systems AB: 4 (https://510kreport.com/company/cochlear-bone-anchored-systems)
- Entific Medical Systems, Inc.: 2 (https://510kreport.com/company/entific-medical-systems)
- Cochlear: 2 (https://510kreport.com/company/cochlear)
- Med-El Elektromedizinische Geraete GmbH: 1 (https://510kreport.com/company/med-el-elektromedizinische-geraete)
- Oticon Medical AB: 1 (https://510kreport.com/company/oticon-medical)

## Firms that cite its devices most
- Cochlear: 2 (https://510kreport.com/company/cochlear)
- Med-El Elektromedizinische Geraete GmbH: 1 (https://510kreport.com/company/med-el-elektromedizinische-geraete)
- Cochlear Bone Anchored Systems AB: 1 (https://510kreport.com/company/cochlear-bone-anchored-systems)
- Oticon Medical AB: 1 (https://510kreport.com/company/oticon-medical)
- Sophono, Inc.: 1 (https://510kreport.com/company/sophono)
- Shokz Health Global Limited: 1 (https://510kreport.com/company/shokz-health-global)
- Sounduct: 1 (https://510kreport.com/company/sounduct)

## Its most-cited devices
- K142907: Baha 5 Sound Processor (2015), cited by 4
- K081606: Baha Intenso (2008), cited by 3
- K100360: BIA300 Series Implant and Abutment, BI300 Implant, BA300 Abutment (2010), cited by 3
- K161123: Baha 5 Power Sound Processor (2016), cited by 3
- K110996: Baha 3 Power Sound Processor (2011), cited by 2
- K202048: Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App (2021), cited by 2

## Recent decisions
- K260902: Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® System (Jul 10, 2026)
- K240155: Cochlear Osia System (Apr 18, 2024)
- K231604: Instrument Case (Aug 24, 2023)
- K220922: Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit (Jul 27, 2022)
- K212136: Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App (Sep 29, 2021)
- K202048: Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App (Feb 23, 2021)
- K191921: Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments (Nov 15, 2019)
- K190589: Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments (Jul 3, 2019)

Source page: https://510kreport.com/company/cochlear-americas