WASHINGTON (dpa-AFX) - Cochlear Limited has received FDA approval in September for the company's Cochlear Remote Assist solution in the Nucleus and Baha Systems. Cochlear noted that the FDA approval for the implant solution and FDA clearance for the Baha solution are the first step in commercializing the product offering, anticipated spring 2022.
Cochlear said it will immediately begin a controlled market release of Remote Assist in the U.S. by partnering with hearing healthcare providers and hospitals.
The company expects Remote Assist approval in Canada in late 2021 for the Nucleus System and early 2022 for the Baha System.
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