FDA 510(k) clearance · back to tracker
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
Cochlear Americas cleared K260902 on 2026-07-10, decision: substantially equivalent
K-number
K260902
Sponsor
Cochlear Americas
Device
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
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-07-10
Product code
PFO
Advisory committee
Ear, Nose, Throat
Medical specialty
Ear, Nose, Throat
Regulation number
874.3340
Official FDA record
Open K260902on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
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Try the sandboxSource
Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.