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
FDA 510(k) clearance K231204 · decided 2023-08-18
Clearance details
- K-number
- K231204
- Device name
- 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
- Applicant
- Cochlear
- Decision
- Substantially Equivalent
- Date received
- 2023-04-27
- Decision date
- 2023-08-18
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- PFO
- Device class
- 2
- Regulation number
- 874.3340
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Lone Tree, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| 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 (K260902) | Cochlear Americas | 2026-07-10 |
| Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS (K240614) | Oticon Medical AB | 2024-07-10 |
| Cochlear Osia System (K240155) | Cochlear Americas | 2024-04-18 |
| Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit (K220922) | Cochlear Americas | 2022-07-27 |
| BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) (K201983) | Med-El Elektromedizinische Geraete GmbH | 2020-10-09 |
| BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote (K200504) | Med-El Elektromedizinische Geraete GmbH | 2020-07-29 |
| Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments (K191921) | Cochlear Americas | 2019-11-15 |
| BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) (K191457) | Med-El Elektromedizinische Geraete GmbH | 2019-09-18 |
| Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments (K190589) | Cochlear Americas | 2019-07-03 |
| Bonebridge (K183373) | Med-El Elektromedizinische Geraete GmbH | 2019-03-07 |
| Bonebridge (DEN170009) | Med-El Elektromedizinische Geraete GmbH | 2018-07-20 |
Recalls involving this device
No recalls on record reference this clearance.