- Nuheara (NUH) completes recruitment for its clinical trial to support its expansion into regulatory-approved hearing aids
- More than 50 per cent of the candidates have begun the trial, with the remaining expected to begin within the next week
- The company says it remains on target to submit its FDA 510(K) submission in the first quarter of 2022
- Nuheara remained steady today at 1.9 cents per share
Nuheara (NUH) has completed recruitment for its clinical trial to support its expansion into regulatory-approved hearing aids.
More than 50 per cent of its candidates have now begun the trial, with the remaining expected to begin within the next week.
Nuheara has also engaged NAMSA, the world’s only solely medical device-focused contract research organisation and medical device biocompatibility laboratory, to conduct cytotoxicity, irritation and sensitisation testing.
The testing is hoped to demonstrate biocompatibility of Nuheara’s proposed hearing aid devices.
Previous cytotoxicity testing was found to meet requirements and sensitisation testing showed no evidence of contact sensitisation.
Managing Director and CEO Justin Miller said the company is pleased with the progress it’s been making with its clinical trial and successful completion of the biocompatibility testing.
“These are important milestones on our planned path to FDA 510(K) submission, which remains on target for the first quarter of 2022,” said Justin Miller.
“With regulatory changes being implemented to the hearing sector in the US, we have a company defining and vast opportunity to expand into medical devices in advance of future over the counter (OTC) hearing aid products and sales in the US.
“The proposed and pending FDA OTC regulations are expected to be enacted in late 2022, and the work we are doing now to support regulatory approved hearing aids will allow Nuheara to reach and service the approximately 38 million American adults who report some level of hearing difficulty,.”
Nuheara remained steady today at 1.9 cents per share.