Nuheara Welcomes Landmark FDA Proposed Rules for Over-the-Counter Hearing Aids

Nuheara is already undertaking clinical trials of a self-fit hearing aid and plans to file a 510(k) to launch one of the first products available

San Rafael, California, UNITED STATES


SAN FRANCISCO, Oct. 21, 2021 (GLOBE NEWSWIRE) -- Nuheara (ASX: NUH), the developer of smart and affordable hearing solutions that transform the way people hear, 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 U.S. FDA has proposed a rule to establish a new category of over-the-counter (OTC) hearing aids.

In a world first, the new rule will 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 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 as a result of certain U.S. State and Federal regulations.

The proposed rule is 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, a further 60-day allowance is made before the rule is in effect.

Commenting on the U.S. FDA’s proposal, Nuheara Co-founder & CEO Justin Miller said:

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

“Any hearing aid that would be sold within the new OTC category 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.”

ABOUT NUHEARA
Nuheara is a global leader in smart hearing technology which changes people’s lives by enhancing the power to hear. Nuheara has developed proprietary, multi-functional, personalized 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 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 optical chains 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/.

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[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.

Media Contact
Maura Yepez
Firebrand Communications for Nuheara
nuheara@firebrand.marketing
415 848 9175