# Cochlear

- Location (FDA's records): Lone Tree, CO
- FDA decisions: 3 (2023–2025): 3 510(k) clearances
- Product codes: KCT (1), PFO (1), LXB (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 2 (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 whose devices it cites most
- Cochlear Americas: 2 (https://510kreport.com/company/cochlear-americas)
- Dentsply Sirona: 1 (https://510kreport.com/company/dentsply-sirona)
- Entific Medical Systems, Inc.: 1 (https://510kreport.com/company/entific-medical-systems)

## Firms that cite its devices most
- Cochlear Americas: 2 (https://510kreport.com/company/cochlear-americas)

## Its most-cited devices
- K223672: Instrument Case P1340904 (2023), cited by 1
- K231204: Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App (2023), cited by 1

## Recent decisions
- K250215: Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand (May 29, 2025)
- K231204: Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App (Aug 18, 2023)
- K223672: Instrument Case P1340904 (Mar 21, 2023)

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