- Nuheara (NUH) will see its hearing aids sold directly to consumers in the US without a medical exam
- In a world first, the US Food and Drug Administration made a landmark final ruling allowing hearing aids within the over the counter category to be sold directly to consumers without a medical exam or audiologist fitting
- There is now a 60-day enactment period until sales can begin, anticipated for mid-October 2022
- Nuheara says it’s well positioned for the new ruling, which will see its OTC hearing aids become available at Best Buy retail stores in the US
- Nuheara shares soar 32.4 per cent, trading at 24.5 cents at 12:41 pm AEST
Nuheara (NUH) will see its hearing aids sold directly to consumers without a medical exam.
In a world first, the US Food and Drug Administration made a landmark final ruling, establishing a regulatory category for over-the-counter (OTC) hearing aids in the United States.
The ruling allows hearing aids within the OTC category to be sold directly to consumers in stores or online without a medical exam or fitting by an audiologist.
There is now a 60-day enactment period until sales can begin, anticipated for mid-October 2022.
After receiving over 1000 public comment submissions on the proposed rule, the FDA’s change will upend the hearing aid industry and unlock barriers to entry for the estimated 38 million Americans who experience a form of hearing loss.
Nuheara’s Co-Founder and Managing Director, Justin Miller said in one sweep the FDA has revolutionised the way people can access hearing aids in the US.
“The FDA hasn’t just created an extra OTC category, it has completely overhauled the categorisation of all hearing aids into two categories: OTC and prescription,” Justin Miller said.
“We have been patiently waiting for, and anticipating, these guidelines for five years.”
“Changing the hearing landscape through accessibility and affordability is why we set out on this journey eight years ago. This ruling is in complete alignment with Nuheara’s strategy and one which the company has been focused on over the last 18 months.”
Nuheara said it’s well positioned for the new ruling with its OTC hearing aids, which will be initially available at Best Buy retail stores in the US.
The company said OTC hearing aids will become a significant part of Nuheara’s future as it continues to bring new hearing products to market.
Nuheara shares soared 32.4 per cent, trading at 24.5 cents at 12:41 pm AEST.