Nuheara Limited provided an update on its clinical trial and pathway to FDA 510(K) approval for the Company's clinically tested and regulatory approved hearing aids, in line with its expansion plans into medical devices. Recruitment of candidates for the clinical trial being conducted by National Acoustics Laboratory has now been completed. This is an important milestone on the path to regulatory approval. Of further significance, more than 50% of candidates have now commenced the trial, with the remaining candidates expected to commence within the next week. Nuheara has also engaged NAMSA, the world's only 100% medical device-focused contract research organisation, and a U.S. FDA ASCA-accredited medical device biocompatibility laboratory, to conduct Cytotoxicity, Irritation and Sensitisation testing. The testing was conducted in accordance with ISO standards, to demonstrate biocompatibility of Nuheara's proposed hearing aid devices. In accordance with these standards, the following excellent results were recorded: Cytotoxicity testing was found to meet requirements. Irritation testing outcomes resulted in a Primary Irritation Index of zero. Sensitisation testing showed no evidence of contact sensitisation.