Nuheara Limited (ASX: NUH) (Company or Nuheara), transforming the way people hear by creating smart and affordable hearing solutions, is pleased to announce that it has received ethics approval from the Australian Hearing Human Research Ethics Committee (AHHREC) to commence its medical device clinical trial.
The Company recently announced (17 August 2021) that it had engaged National Acoustics Laboratories to conduct a clinical trial to test the safety and effectiveness of Nuheara’s newly developed range of hearing aid products, to support Nuheara’s planned expansion into clinically tested and regulatory approved medical devices.
Commenting on this milestone, Nuheara Co-founder, Managing Director & 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 [FDA], the European Union [CE Mark] and the Australian Therapeutic Goods Administration [TGA]. Receiving regulatory approval will open substantial new market opportunities for Nuheara in the US, Europe and Australia.”
-ENDS-
This announcement was approved for release on ASX by the Board of Nuheara Limited.
| INVESTOR AND MEDIA ENQUIRIES: | ||
| Ronn Bechler, Market Eye | ||
| Email: [email protected] | ||
| Phone: + 61 400 009 774 |
ABOUT NUHEARA
Nuheara is a global leader in smart hearing technology which change people’s lives by enhancing the power to hear. Nuheara has developed proprietary, multi-functional, personalised intelligent hearing devices that augments a person’s hearing. Nuheara is headquartered in Perth, Australia and was the first consumer wearables technology company to be listed on the Australian Stock Exchange (ASX).
In 2016, the Company released its revolutionary wireless earbuds, IQbuds, which allow consumers to augment their hearing according to their personal hearing preferences and connect hands free with their voice-enabled smart devices. In 2020 Nuheara released its third generation IQbuds² MAX. Nuheara products are now sold Direct to Consumer (DTC) and in major consumer electronics retailers, professional hearing clinics, pharmacies and optical chains around the world.
The Company’s mission is to transform the way people hear by creating smart hearing solutions that are both accessible and affordable. For further information, please visit https://www.nuheara.com
