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Key highlights:

  • US. Food and Drug Administration has issued a landmark proposal intended to improve access to, and reduce the cost of, hearing aid technology for millions of Americans by establishing a new over-the-counter category
  • Nuheara is already well progressed, currently undertaking clinical trials of a self-fit hearing aid and intends to file a 510(k) to become one of the first products available in this proposed new category
  • Potentially opens a very substantial regulated market opportunity for Nuheara – approximately 30 million Americans, people with some trouble hearing, who don’t currently use hearing devices

Nuheara Limited (ASX: NUH) (Company or Nuheara), transforming the way people hear by creating smart and affordable hearing solutions, welcomes the U.S. Food and Drug Administration (FDA) issuing its landmark proposal intended to improve access to, and reduce the cost of, hearing aid technology for millions of Americans[1].  The US FDA has proposed a rule to establish a new category of over-the-counter (OTC) hearing aids.

In a world first, and most significantly for Nuheara, when finalised the proposed rule would allow hearing aids within the OTC category to be sold directly to consumers in stores or online without a medical exam or fitting by an audiologist.  The rule is designed to help increase competition in the US market, while ensuring the safety and effectiveness of OTC and prescription hearing aids.

The proposed rule opens up a very substantial market opportunity for Nuheara.  Approximately 37.5 million American adults aged 18 and over report some trouble hearing, yet only about one-fifth of people who could benefit from a hearing aid use one[2].  This leaves 30 million Americans that don’t use hearing aids given cost, access, social stigma related to hearing loss, perceived value of the devices or certain US State and Federal regulations.

The proposed rule is now open for public comment for a period of 90 days, after which the FDA will review the comments which could take up to 120 days.  Once the review is complete and the final rule published, an allowance of a further 60 days is made before the rule is in effect.

Commenting on the US FDA’s landmark proposal, Nuheara Co-founder & CEO Justin Miller said:

“In one sweep, the FDA has revolutionised the way people will be able to access hearing aids and hearing devices in the US. The FDA hasn’t just created an extra category, it has completely overhauled the categorisation of all hearing aids into two categories: over-the-counter and prescription.

“Any hearing aid that would be sold within the new OTC category to be created will require a clinical trial and a 510(k) submission.  Nuheara is already ahead of the curve on this, as we are currently undertaking clinical trials of a self-fit hearing aid and intend to file a 510(k) to become one of the first products available in this category.

“For decades hearing aid manufacturers have simply relied on in-house studies to bring new hearing aids to market.  The proposed rule now levels the playing field and holds hearing aid manufacturers to account on the efficacy of their products.  All incumbent hearing aid manufacturers will now have to conduct external trials and file subsequent 510(k) submissions.

“This is transformational for the hearing industry and advantageous to the hearing consumer who will be protected in the knowledge any OTC hearing aid has had a full FDA review with a 510(k) submission.

“Nuheara’s five years of Direct-To-Consumer [DTC] and traditional retail sales experience, with big US retailers such as Best Buy and Walgreens, places us at the forefront in leading the way with OTC offerings.   This new OTC ruling, along with our experience, our technology, and our clinical trial place us in the prime position to deliver Nuheara’s more accessible and affordable hearing devices to the 30 million Americans that suffer from some form of hearing loss and currently do not use hearing aids.  We are uniquely placed to rapidly grow once the new rule is finalised, and importantly improve US consumers’ lives with Nuheara’s hearing solutions.”


Justin Miller Ronn Bechler, Market Eye
Managing Director and CEO Email: [email protected]
Nuheara Limited Phone: + 61 400 009 774
Maura Yepez, Firebrand Ranya Alkadamani
Email: [email protected] Email: [email protected]
Phone: +1 415 848 9175 Phone: +61 434 664 589



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 Stock Exchange (ASX).

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.

The Company’s mission is to transform the way people hear by creating smart hearing solutions that are both accessible and affordable.

For further information, please visit https://www.nuheara.com/.

[1] Refer to https://www.federalregister.gov/documents/2021/10/20/2021-22473/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids.

[2] Source: https://www.fda.gov/news-events/press-announcements/fda-issues-landmark-proposal-improve-access-hearing-aid-technology-millions-americans.

October 22nd, 2021