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Cochlear gets US FDA approval for Osia 2 ear implant
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The Market Intelligence Platform
Australia's Cochlear Ltd. said the U.S. Food and Drug Administration approved its Osia 2 System, an implantable hearing solution that uses wireless technology.
The healthcare equipment company expects to make the device commercially available for patients in the U.S. in early 2020.
The FDA also approved Cochlear's Nucleus Profile Plus series ear implant in June. The agency classifies cochlear implants as Class III devices, which go through the highest level of regulatory scrutiny.