Medical device and consumer electronics manufacturer, Nuheara Limited (ASX:NUH) (Company or Nuheara) announced that it received US Food and Drug Administration (FDA) clearance for its Self-Fitting OTC Hearing Aid. 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,” according to the company.

Following the OTC hearing aid law going into effect on October 17, 2022 in the US, Nuheara plans to bring to market its first medical device as the HP Hearing PRO under its worldwide Trademark License Agreement for use of HP trademarks on Nuheara’s hearing aids, personal sound amplification devices, and accessories.

The Nuheara HP Hearing PRO self-fitting OTC hearing aid approved by the FDA brings “medical grade hearing aid technology combined with highly desired features of wireless ear buds into a multifunctional device” that will be sold in the US online and in retail stores, including Best Buy, Crutchfield,, and

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 $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.

Commenting on Nuheara’s receipt of US FDA clearance and the launch of the HP Hearing PRO, Co-founder and Managing Director, Justin Miller said: “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. 

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.”

US-based Nuheara CEO John R. Luna said: “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.” 

About HP Hearing PRO Self-Fitting OTC Hearing Aids 

The HP Hearing PRO self-fitting OTC hearing aids are “innovative products that look nothing like a traditional hearing aid. Built to medical device standards and meeting all FDA requirements for safety and efficacy,” the HP Hearing PRO features the Ear ID™ self-fitting software and technology powered by Nuheara. The Ear ID™ has been clinically proven to be substantially equivalent to a professionally fit hearing aid1. 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, according to the company. This ability for the consumer to self-fit through the HP Hearing application, for iOS and Android platform mobile devices, allow “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, Nuheara says.

In addition to the HP Hearing PRO’s capabilities as an OTC hearing aid, this product 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:

  • HP Hearing app for iOS and Android
  • Rechargeable built-in Li-ion batteries
  • Charge Case for on-the-go charging

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 huge benefit for consumers in restaurants or social situations where background noise makes understanding speech difficult,” Nuheara says.

Further information can be found at:

  1. Clinical Investigation Report: Validation of Nuheara Self-Fit Hearing Aid, Version 4,January 31, 2022 by National Acoustic Laboratories (NAL), Australia.
  2. Ibid.

Source: Nuheara