Hearing technology specialist, Nuheara Limited (ASX: NUH), is preparing to commence a clinical trial to test the safety and effectiveness of its newly developed range of hearing aid products, to support a planned expansion into clinically tested and regulatory approved medical devices.
Nuheara has engaged National Acoustics Laboratories (NAL) under the terms of a Clinical Trial Agreement (CTA), the pricing of which is not considered material, to assist with conducting the clinical trial.
Co-founder and CEO, Justin Miller, said the results of the clinical trial will allow Nuheara to expand 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).
“This clinical trial is the first step of our evolution to a medical device company, specifically in the over US$8 billion regulated global hearing aid market,” Mr Miller said.
“Our breakthrough hearable products, which are non-regulated, have laid a solid foundation for our technology and future products to operate in.
“Nuheara is well positioned for clinical trial success, with our Ear ID already clinically validated. We are a global pioneer in embedding the hearing aid prescription protocols (NAL-NL2) into our range of IQbuds.
“A successful clinical trial will enable us to tackle any regulated hearing device market in the world, with our end-to-end range of affordable and accessible hearable and hearing aid devices,” said Mr Miller.
Nuheara’s CTA project team is led by US based audiologist and clinical/regulatory consultant, Deborah Arthur. Ms Arthur has been providing regulatory, clinical, and quality leadership over the last 30 years in the medical device environment, shepherding novel products, especially for Ear, Nose and Throat (ENT) applications, through the regulatory approval process including the De Novo hearing aid applications for Earlens Corporation and Bose Corporation.
She has previously held executive management roles in regulatory, clinical, and/or quality at Cochlear Americas, MED-EL NA, Smith & Nephew, Symphonix Devices, Inc, and MetaCure Inc. As previously announced, Nuheara has registered its company with the FDA.
Mr Miller said a successful medical device clinical trial will provide Nuheara with the basis to enter any regulated hearing device market, globally. It will also provide potential pathways for the Company to enter the Over-TheCounter (OTC) hearing aid market as the FDA releases their OTC guidelines, expected in October 2021.
The detailed structure of the trial is being determined by Nuheara and NAL and will be responsive to trial results and circumstances; NAL is developing detailed protocols for the trial.
