- Nuheara’s (NUH) HP Hearing PRO hearing aids have become commercially available through Fuel Medical member clinics in the US
- The HP Hearing PRO is the first product cleared through the Food and Drug Administration’s 510(k) process under a new product classification code
- The hearing aids are self-fitting and air-conduction and will be available over the counter (OTC) at Fuel clinics
- Fuel Medical has over 3000 practices across the US through which it can distribute the product, including clinics for ENT, audiology, university medical and hospitals
- Nuheara shares are trading at 21.5 cents at 12:22 pm AEDT
Nuheara’s (NUH) HP Hearing PRO hearing aids have been made commercially available through Fuel Medical member clinics in the US.
The hearing aids are self-fitting and air-conduction and will be available over the counter (OTC). The HP Hearing PRO is the first product cleared through the FDA’s 510(k) process under a new product classification code, ‘QUH’.
Fuel Medical will offer Nuheara’s HP Hearing PRO throughout the US across its 3000 practices, which cover ear, nose and throat (ENT), audiology, university medical clinics and hospital brick-and-mortar medical-based clinics.
“I’ve worked with Fuel Medical’s founders and management team for over 25 years and know they will be successful with their members integrating the HP Hearing PRO and OTC hearing aids as hearing solution options to their patients who have a mild-to-moderate hearing loss and looking for a pair of self-fitting hearing aids under US$700,” Nuheara US-based CEO John Luna said.
“With the OTC hearing aid retail opportunity now in place, and our HP Hearing PRO product launched last month, I am delighted that we are able to work together to offer Fuel’s member clinics our FDA-cleared self-fitting OTC hearing aid,” Nuheara Co-founder and Managing Director Justin Miller said.
The recommended retail price for a pair of HP Hearing PRO hearing aids, along with an on-the-go charging case is US$699.00 (A$1017).
Nuheara shares were trading at 21.5 cents at 12:22 pm AEDT.