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Nuheara Ltd (ASX:NUH) has announced that it has received FDA clearance for the company's HP Hearing PRO self-fitting over-the-counter (OTC) hearing aid which will be available for $699 at retail stores including Best Buy, Crutchfield, Amazon.com, and HPHearingPRO.com.
Nuheara’s HP Hearing PRO has been cleared by the FDA for both 874.3325 self-fitting and the 800.30 OTC hearing aid classifications under a new product classification code “QUH”. This follows the FDA's publication of its final OTC Hearing Aid Rule on October 17, establishing a regulatory category for OTC Hearing Aids in the United States. Nuheara plans to bring to market its first medical device as the HP Hearing PRO under its worldwide Trademark License Agreement for use of Hewlett-Packard (HP) trademarks on Nuheara’s hearing aids, personal sound amplification devices, and accessories.
According to Nuheara, the HP Hearing PRO self-fitting OTC hearing aids are built to medical device standards and feature the Ear ID™ self-fitting software and technology powered by Nuheara. The Ear ID has been clinically proven to be substantially equivalent to a hearing aid.1 The proprietary Ear ID software tests the wearer’s individual hearing thresholds from low frequency to high frequency in each ear, then automatically programs the HP Hearing PRO hearing aids for each ear.
This ability for the consumer to self-fit through the HP Hearing app, compatible with both iOS and Android platform mobile devices, allows for a quick and easy acclimation experience for the consumer, says the company. The entire acclimation experiences takes about 10-15 minutes from unboxing through customization of the user’s personalized profile to accommodate their perceived mild to moderate hearing loss.
In addition to the HP Hearing PRO’s capabilities as an OTC hearing aid, the device streams media and phone calls via Bluetooth®. The Active Noise Cancellation is designed to minimize background noise for an immersive sound experience when streaming phone calls or music. Additional features reportedly include:
The HP Hearing PRO has been clinically validated2 through research completed by the National Acoustic Laboratories (NAL) to provide a 30% speech understanding improvement in the presence of noise using the directional microphone feature called Focus. This is a significant benefit for consumers in restaurants or social situations where background noise makes understanding speech difficult. Now, at the touch of the HP Hearing app, a wearer can switch the directional microphone settings to Focus on sounds towards their front, quickly allowing for immediate improvement in speech understanding, reports the company.
According to Nuheara, initial orders have been placed from retailers and ecommerce partners for availability throughout the US. The recommended retail price of the HP Hearing PRO hearing aids along with a charge case for on-the-go charging is US$699.
In April 2022, Nuheara announced a worldwide Trademark License Agreement to develop, manufacture, and market its hearing aid products under the HP brand trademarks through the end of 2027. The initial focus with these trademarks will be in the US market.
HP Inc, headquartered in Palo Alto, Calif, is the world’s second-largest personal computer company, and manufactures laptops, Chromebooks, monitors, printers and related supplies, as well as 3D printing solutions.
Nuheara is a public company listed on the Australian Stock Exchange that develops, manufacturers, and markets smart hearable devices. The company's IQbuds2 MAX earbuds offered at $500 have been deemed by HearingTracker to be among the best in class as a smart, rechargeable, Bluetooth-compatible, hearing-enhancement wireless earbud. In 2021, Nuheara transformed its operations to include medical device manufacturing for its hearing aid products in anticipation of the OTC hearing aid class, and in 2022, it established its US headquarters in Bellevue, Wash, appointing hearing industry veteran John Luna as its new Chief Revenue Officer and President Americas (and now CEO). 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.
“This is a very significant day for Nuheara,” said Nuheara Co-founder and Managing Director Justin Miller in a press statement. “Since establishing the business in 2015, we have been driven by our ambitious vision that our affordable and leading-edge hearing devices could help to solve the consumer imbalance of accessibility. 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.
“How fitting for our efforts, that concurrent with receiving our 510(k) clearance from the US FDA, over the counter sales can also commence in the US,” continued Miller. “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 recognized and trusted brands in the world. Not surprisingly, the response from retailers has been strong, and we are well-placed to deliver Nuheara’s sophisticated hearing solutions to the growing OTC hearing aid market.”
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“Today is historic for Nuheara and what we’ve accomplished receiving the first US FDA 510(k) clearance with the new product classification for self-fitting, air conduction, over the counter hearing aids,” commented NuHeara CEO John Luna. “We are excited to bring the HP Hearing PRO to the 38 million US consumers who need an affordable over-the-counter hearing solution. We are proud of our global Nuheara team for the work involved to bring the product to market and drive continued value to all stakeholders. The powerful combination of Nuheara’s technology and experience along with HP’s brand recognition in the US, will translate to consumer confidence in their purchase of the HP Hearing PRO in this new OTC hearing aid category. We are already seeing signs of this from the retailers, given the high level of initial orders received.”
For more details, see the HP Hearing PRO website.
