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Cochlear

3 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand (K250215)Cochlear2025-05-29
Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App (K231204)Cochlear2023-08-18
Instrument Case P1340904 (K223672)Cochlear2023-03-21

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