Nuheara Limited (ASX: NUH) has commenced its clinical trial with the National Acoustics Laboratories (NAL), to support Nuheara’s planned expansion into clinically tested and regulatory approved hearing aids.
The clinical trial of Nuheara’s proprietary hardware and software will allow people to self-fit Nuheara’s hearing aids, that are designed to be sold over the counter, at retail stores and online.
Following the success of the trial, which is being completed in conjunction with biocompatibility testing and obtaining UL certification, Nuheara plans to proceed with a 510(k) submission to the U.S. Food and Drug Administration (FDA) for approval of a Class II, self-fitting air conduction, wireless hearing aid – 21 CFR Part 874.3325, Product Code: QDD (Self-fit Category). This FDA submission is expected to be made during Q1 of the 2022 calendar year.
The planned submission is also part of the Company’s plan to secure broad FDA self-fit hearing aid clearance in time to meet the expected demand for a new category of Over-The-Counter(OTC) hearing aids in the US. In July 2021, President Biden ordered the FDA to produce regulations by mid-November for this OTC category, which is specifically targeting individuals with perceived mild to moderate hearing loss.
OTC hearing aids will be a different class of hearing aid from the current FDA Self-fit Category. Nuheara’s clinical trial plan provides the potential of having multiple self-fit hearing aid products in the US market.
Self-fit technology for hearing aids is the only way to solve the problem of providing better hearing for the millions of people who need hearing assistance but are locked out because of high prices and the lack of access to a professional intervention,” said Justin Miller, CEO and Co-founder of Nuheara.
“This clinical trial is our next step as a medical device company, specifically in the US$8 billion regulated global hearing aid market.
“Following Bose’s creation of the Self-fit Category of hearing aids with the FDA, Nuheara intends to be the second company in the world to seek approval for a self-fitting hearing aid. A successful clinical trial would enable us to tackle both the unregulated and regulated US hearing market with an end-to-end range of affordable and accessible hearable and hearing aid devices.
“We take pride in our innovation, our engineering and our determination to end the cost and disempowering process of obtaining hearing aids. Our excellent and award-winning technology is one factor, but ultimately our ability to deliver a hearing aid with self-fit functionality, will be a gamechanger for those people who don’t want the expense or inconvenience of the traditional hearing aid channel.”
Following the US FDA submission, a successful clinical trial will also provide Nuheara with the basis to enter any regulated market globally, through further regional based regulatory submissions.
