Nuheara Limited (ASX: NUH) (Company or Nuheara) announced that it will commence 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.
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Nuheara has engaged National Acoustic 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.
The results of the clinical trial will allow Nuheara to expand its global hearing solutions by meeting hearing aid compliance requirements initially with the US Food and Drug Administration (FDA), the European Union (CE Mark), and the Australian Therapeutic Goods Administration (TGA).
Commenting on the medical device clinical trial, Nuheara Co-founder and CEO Justin Miller said: “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 market¹. 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.”
Nuheara’s CTA project team is led by US-based audiologist and clinical/regulatory consultant, Deborah Arthur. 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 FDA². A successful medical device clinical trial will provide Nuheara with the basis to enter any regulated hearing device market, globally, according to the company’s announcement. It will also provide “potential pathways for the Company to enter the Over-The-Counter (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. The Company expects to provide updates to the market as it reaches relevant milestones throughout the clinical testing including ethical approval, recruitment, trial commencement, and results. The timing of those milestones will depend on the success or otherwise of the trial. As is usual for clinical trials of this type, the ethical approval will be sought externally, in this instance from the Hearing Australia Human Research Ethics Committee.
- Fortune Business Insights, Oct 2019
- Nuheara website. NUH Receives FDA Registration. Press release. Published March 9, 2021.