Nuheara Limited provided an update on its clinical trial and pathway to FDA 510(K) submission¹ for the Company's pending entrance into the U.S. hearing aid market, in line with its expansion plans into global medical devices. The Nuheara sponsored clinical trial, conducted by National Acoustics Laboratory (NAL), has been completed with all participants data now collected. NAL is expected to publish the final clinical trial report by the end of January 2022.

This is an important milestone on the path to US FDA 510(K) submission and regulatory clearance.