Cochlear Osia® 3(I) Sound Processor +6 more— 510(k) K260902
Substantially EquivalentCochlear Americas
FDA 510(k) clearance K260902 for Cochlear Osia® 3(I) Sound Processor +6 more, Substantially Equivalent on 2026-07-10. Applicant: Cochlear Americas. Device class: 2.
Summary
Cochlear Americas' clearance lists seven Cochlear Osia items: the Osia 3(I) and Osia 3 Sound Processors, the Osia 3 Charger, Osia 3 Aqua+, Osia Fitting Software 3, the Osia Smart App, and the Osia System. They're filed under PFO, active implantable bone conduction hearing systems.
Class II, 21 CFR 874.3340. Ear, Nose, and Throat is both the classification panel and the review panel. It was a Traditional 510(k).
Cochlear Americas filed from Lone Tree, Colorado. Review took 114 calendar days (March 18 to July 10, 2026).
Clearance details
- Device name as filed
- 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
- Applicant
- Cochlear Americas
- Product code
- Product code PFO
- Device class
- Class 2
- Regulation
- 21 CFR 874.3340
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lone Tree, CO, US
Recent devices under product code PFO
view all- K240614 — Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
- K240155 — Cochlear Osia System
- K231204 — Cochlear Osia® System +6 more
- K220922 — Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
- K201983 — BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)
More clearances from Cochlear Americas
view all- K231604 — Instrument Case
- K212136 — Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
- K202048 — Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
- K191921 — Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments
- K190589 — Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
Adverse events under product code PFO
product code PFO- Injury
- 2,752
- Total
- 2,752
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.