# FDA 510(k) cleared: 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

> fda · VERIFIED · 2026-07-10

Applicant: Cochlear Americas · Substantially Equivalent

- Company: Cochlear Americas
- Sector: 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
- Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260902

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Source: MedFuel Intel news monitor. Verification tier: VERIFIED. Informational only, not investment advice. Corrections: media@medfuelinc.com.