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Cochlear Americas

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories7
Latest FDA decision2026-07-10
TypeNumberDevice NameCodeDateActions
510(k) K260902 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® SystemPFO2026-07-10 View
PMA P970051 Implant, cochlearMCM2026-04-30 View
PMA P000015 Implant, auditory brainstemMHE2026-04-30 View
PMA P130016 Cochlear implant with combined electrical stimulation and acoustic amplificationPGQ2026-04-30 View
PMA P890027 Implant, cochlearMCM2025-07-03 View
PMA P840024 Implant, cochlearMCM2025-07-03 View
510(k) K240155 Cochlear Osia SystemPFO2024-04-18 View
510(k) K231604 Instrument CaseKCT2023-08-24 View
510(k) K220922 Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitPFO2022-07-27 View
510(k) K212136 Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppLXB2021-09-29 View
510(k) K202048 Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart AppLXB2021-02-23 View
510(k) K191921 Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical InstrumentsPFO2019-11-15 View
510(k) K190589 Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical InstrumentsPFO2019-07-03 View
510(k) K182116 BA310 Abutment, BIA310 Implant/AbutmentMAH2018-12-19 View
510(k) K171088 Cochlear Baha SoundArcLXB2017-06-07 View
510(k) K161123 Baha 5 Power Sound ProcessorLXB2016-05-20 View
510(k) K153245 Baha 5 Super Power Sound ProcessorLXB2016-03-02 View
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