- Nuheara (NUH) receives ethics approval from the Australian Hearing Human Research Ethics Committee (AHHREC) to kick off its medical device clinical trial
- This follows the company’s recent engagement with National Acoustics Laboratories to conduct a clinical trial to test the safety and effectiveness of Nuheara’s newly developed range of hearing products
- Recruitment has already begun for the trial, which the company says supports its planned expansion into clinically tested and regulatory approved medical devices
- Nuheara shares are down 3.33 per cent, trading at 2.9 cents at 11:20 am AEST
Nuheara (NUH) has received ethics approval from the Australian Hearing Human Research Ethics Committee (AHHREC) to commence its medical device clinical trial.
Nuheara has been working to develop multi-functional, personalised, intelligent hearing devices that augment a person’s hearing.
This follows the company’s recent announcement that it engaged with the National Acoustics Laboratories to conduct a clinical trial to test the safety and effectiveness of Nuheara’s newly developed range of hearing products.
The company said this supports its planned expansion into clinically tested and regulatory approved medical devices.
Nuheara Co-founder, Managing Director and CEO Justin Miller said National Acoustics Laboratories has now commenced recruiting for Nuheara’s medical device clinical trial.
“We look forward to receiving the results of this trial, which we believe will support Nuheara in expanding its global hearing solutions by meeting hearing aid compliance requirements initially with the U.S. Food and Drug Administration, the European Union and the Australian Therapeutic Goods Administration.”
“Receiving regulatory approval will open substantial new market opportunities for Nuheara in the US, Europe and Australia.”
Nuheara shares were down 3.33 per cent, trading at 2.9 cents at 11:20 am AEST.