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.
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
- 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.