PERTH, AUSTRALIA and BELLEVUE, WASHINGTON, USA — Medical device and consumer electronics manufacturer, Nuheara Limited (ASX:NUH) has announced the commercial availability of its HP Hearing PRO self-fitting, air-conduction, OTC hearing aids through Fuel Medical member clinics in the US.
Nuheara’s HP Hearing PRO is the first product cleared through the FDA’s 510(k) process for both 874.3325 self-fitting and the 800.30 OTC hearing aid classifications under a new product classification code “QUH”. The HP Hearing PRO is a CES® 2023 Innovation Awards Honoree.
Fuel Medical’s over 3000 Ear, Nose and Throat (ENT) practice, audiology practice, university medical clinic and hospital brick and mortar medical based clinics will have the opportunity to offer Nuheara’s HP Hearing PRO throughout the US.
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.
“Fuel Medical and Nuheara began working together 3 years ago in anticipation of the FDA over-the-counter regulation changes. 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
“Fuel chose to partner with Nuheara because the HP Hearing PRO is at the forefront of providing quality amplification in the developing over-the-counter hearing device segment of our industry,” said Fuel Medical’s Co-founder Shawn Parker. “We are excited to help Nuheara bring the new HP Hearing PRO product to our member practices for their patients in need of an over-the-counter hearing solution.”
“I’ve worked with the Fuel Medical’s founders and management team for over 25 years and know they will be successful with their member’s 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,” said Nuheara’s US-based CEO, John Luna. “Nuheara’s technology and retail experience along with a medical practice point of distribution builds on our omnichannel strategy for both unassisted and assisted sales opportunities for the HP Hearing PRO.
ABOUT NUHEARA
Nuheara is a global leader in smart hearing technology which change people’s lives by enhancing the power to hear. As a global pioneer in Hearable products, Nuheara developed proprietary, multi-functional, personalised intelligent hearing devices that augments a person’s hearing. Nuheara is headquartered in Perth, Australia and was the first consumer wearables technology company to be listed on the Australian Securities Exchange (ASX). The Company also has a USA office located in Seattle, Washington. In 2016, the Company released its revolutionary wireless earbuds, IQbuds, which allow consumers to augment their hearing according to their personal hearing preferences and connect hands free with their voice-enabled smart devices. In 2020 Nuheara released its third-generation hearable the IQbuds² MAX. In 2021, Nuheara transformed its operations to include medical device manufacturing for its hearing aid products to meet global demand for mild to moderate hearing loss. Nuheara products are now sold Direct to Consumer (DTC) and in major consumer electronics retailers, professional hearing clinics, pharmacies, and speciality retailers around the world.
ABOUT FUEL MEDICAL
As the leading business advisory company serving audiology and ear, nose and throat practices across the nation, Fuel Medical Group provides an award-winning array of custom insights, tools and actionable solutions that enhance practice performance and impact patient outcomes.
