Nuheara begins medical device clinical trial for hearing aid products
Nuheara Limited, an Australian audio wearables company, has launched a medical device clinical trial to evaluate the safety and effectiveness of its newly developed range of hearing aid products.
The hearing solutions provider said that the clinical study will support its planned expansion into clinically tested and regulatory approved medical devices.
Nuheara said that under a clinical trial agreement (CTA), it is working with National Acoustics Laboratories (NAL) to help it in carrying out the clinical trial of the hearing aid products.
The Perth-based smart hearing technology provider said that the outcome of the medical device clinical trial will enable it to grow its global hearing solutions by satisfying the hearing aid compliance requirements initially with the US Food and Drug Administration (FDA), the European Union (CE Mark), as well as the Australian Therapeutic Goods Administration (TGA).
Justin Miller — Nuheara Co-founder and CEO 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 market. 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 had previously registered itself with the FDA. The audio wearables company said that a successful medical device clinical trial will give it the basis to foray into any regulated hearing device market, around the world.
Furthermore, it will give potential pathways for entering into the over-the-counter (OTC) hearing aid market as the FDA publishes its OTC guidelines, which is expected to be in October 2021.