| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LXB | — | — | — | 1 | 2025-05-29 |
| PFO | Active Implantable Bone Conduction Hearing System | Class II | Ear, Nose, Throat | 1 | 2023-08-18 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | General Hospital | 1 | 2023-03-21 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-05-29 | K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | LXB | — | — |
| 2023-08-18 | 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 | PFO | Class II | Ear, Nose, Throat |
| 2023-03-21 | K223672 | Instrument Case P1340904 | KCT | Class II | General Hospital |