Australian hearable pioneers Nuheara announced that the company has received the "historic and first of its kind" FDA 510(k) premarket clearance for both an 874.3325 Self-fitting Hearing Aid and the 800.30 Over The Counter (OTC) hearing aid classification. This gives clearance for Nuheara to launch a "Self-Fitting Air-Conduction Hearing Aid, Over The Counter" product, which will be launched in the US market as the HP Hearing PRO.
After multiple years of development efforts and multiple iterations of the concept, Nuheara finally gained recognition for bringing hearing aid functionality into true wireless earbuds with the launch of the Nuheara IQbuds2 MAX. In 2021, Nuheara established a partnership with Hewlett-Packard (HP) to introduce the work-oriented HP Elite Wireless Earbuds, combining ANC with personalization and customization features from its own products, and signed a worldwide Trademark License Agreement for use of HP trademarks on Nuheara’s hearing aids, personal sound amplification devices and accessories.
Nuheara now received the US Food and Drug Administration (FDA) 510(k) premarket clearance to address the OTC Hearing Aid market and will once again leverage that brand partnership to launch the HP Hearing PRO Self-Fitting OTC Hearing Aids in the US market, instead of using the Nuheara brand. This will be its first medical device to use the Nuheara Self-Fitting with Ear ID proprietary software via the HP Hearing mobile application.
The product concept is said to offer a 30% improvement in speech in noise with the use of Focus directional microphones, improving the ability to follow conversations and reduce background noise, as validated in clinical research conducted on the Nuheara Self-Fit Hearing Aid by the National Acoustic Laboratories, in Australia.
The HP Hearing PRO self-fitting OTC hearing aid will be a different proposal from other OTC products revealed until now, mainly for the fact that it will truly combine medical grade hearing aid technology with the highly desired features of true wireless earbuds. This is generally considered to be key to remove any existing stigma associated with traditional hearing-aid form-factors, supported by the fact that the multifunctional device that will be sold in the US online and in retail stores, including Best Buy, Crutchfield, Amazon.com, and www.HPHearingPRO.com.
Initial orders have been placed from retailers and ecommerce partners for availability throughout the US. The recommended retail price for a pair of HP Hearing PRO hearing aids along with a charge case for on-the-go charging is US$699.00.
The OTC hearing aid rule enactment in the US allows hearing aids within the OTC category, for perceived mild to moderate hearing loss, to be sold directly to consumers in retail stores or online. Access to hearing solutions in retail is something that Nuheara has been developing with its hearable products sales over the past 5 years. As such, the business is well placed to take immediate and significant advantage of the regulation changes.
“This is a very significant day for Nuheara’s patient and committed shareholders, employees, business partners and customers. 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 milestone sees that vision become a reality, made possible by the passion, commitment and support of our great team, business partners, customers and shareholders," says Justin Miller, HP Hearing PRO, Co-founder and Managing Director.
"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. 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," he adds.
"Today is historic for Nuheara and what we’ve accomplished receiving the first 510(k) clearance with the new product classification for self-fitting, air conduction, over the counter hearing aids. 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,” states US-based Nuheara CEO John R. Luna.
The HP Hearing PRO features the Ear ID self-fitting software and technology powered by Nuheara, which tests the wearer’s individual hearing thresholds from low frequency to high frequency in each ear, then automatically programs the devices for each ear. This ability for the consumer to self-fit through the HP Hearing application, for iOS and Android platform mobile devices, allows a quick and easy acclimation experience for the consumer. 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 rechargeable HP Hearing PRO streams media and phone calls via Bluetooth. The Active Noise Cancellation minimizes background noise for an immersive sound experience when streaming phone calls or music. Additional features include the ability to switch the directional microphone settings to Focus on sounds towards the front, quickly allowing for immediate improvement in speech understanding, simply via touch on the earbuds.
www.nuheara.com | www.HPHearingPRO.com
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Nuheara Receives FDA Clearance for Self-Fitting OTC Hearing Aids and Launches HP Hearing PRO
October 31 2022, 09:10
Australian hearable pioneers Nuheara announced that the company has received the "historic and first of its kind" FDA 510(k) premarket clearance for both an 874.3325 Self-fitting Hearing Aid and the 800.30 Over The Counter (OTC) hearing aid classification. This gives clearance for Nuheara to launch a "Self-Fitting Air-Conduction Hearing Aid, Over The Counter" product, which will be launched in the US market as the HP Hearing PRO.
About Joao Martins
Since 2013, Joao Martins leads audioXpress as editor-in-chief of the US-based magazine and website, the leading audio electronics, audio product development and design publication, working also as international editor for Voice Coil, the leading periodical for... Read more