- Nuheara’s hearing aid, HP Hearing Pro, has received US Food and Drug Administration clearance to be sold over-the-counter
- HP hearing pro has also received clearance as self-fitting and is set to be sold to people experiencing mild to moderate hearing loss for significantly cheaper than other hearing aids
- The clearance comes after a landmark law in the US established a regulatory category for over-the-counter hearing aids, allowing easier access for Americans suffering hearing loss
- Retailers have placed their initial orders throughout the US, and have been recommended to charge the hearing aids at a retail price of around $1045 Australian dollars each
- This is significantly cheaper than the historic average cost of hearings aids of around $4 and a half thousand-US-dollars
- Shares in Nuheara are up 36.4 per cent following the news, trading at 22.5 cents at 1:04 pm AEDT
Nuheara (NUH) has received clearance from the US Food and Drug Administration (FDA) for its self-fitting over-the-counter (OTC) hearing aid, HP Hearing Pro.
The company’s HP Hearing PRO has been cleared by the FDA under a new product classification code “QUH”.
Following landmark law establishing a regulatory category for OTC hearing aids in the US, the company plans to bring to market its first medical device as the HP Hearing PRO under its worldwide trademark licence agreement for use of HP trademarks on its hearing aids, personal sound amplification devices and accessories.
Retailers and ecommerce partners have placed their initial orders throughout the US, charging the hearing aids at a recommended retail price of US$699 (A$1045) which includes a charge case for on-the-go charging.
Commenting on Nuheara FDA clearance and the hearing aids launch, Co-founder and
Managing Director Justin Miller called it “a very significant day”.
“There have been many major achievements and challenges along the way for Nuheara but today’s monumental milestone sees that vision become a reality, made possible by the passion, commitment and support of our great team, business partners, customers and shareholders.
“Even better that our first hearing aid product for this new market, the HP Hearing PRO, will now be released under one of the most recognised and trusted brands in the world.”
Nuheara said it’s well positioned for the new ruling with its OTC hearing aids, which will become a significant part of Nuheara’s future as it continues to bring new hearing products to market.
Shares in Nuheara were up 36.4 per cent, trading at 22.5 cents at 1:04 pm AEDT.