By David Cannington, Co-Founder of Nuheara

President Trump today signed into law the Over-the-Counter Hearing Aid Act 2017. This bill was first introduced in the Senate in March of this year, and later passed on August 3, 2017 with bi-partisan support.

Nuheara is thrilled about the passage of the OTC Hearing Aid Act of 2017 as it will drive a new era in hearing health for  millions of people in the USA who experience mild to moderate hearing loss.

The Purpose of the OTC Hearing Aid Act

It’s important to understand the potential impact of this bill on the hearing health industry. The intended purpose of the legislation is not to replace hearing aids, but to dramatically improve accessibility for people who have mild-to-moderate hearing loss. For those individuals with advanced or severe hearing loss, a prescription grade hearing aid recommended by a hearing care professional is still advised. For those with less severe hearing loss, new tools for self-treatment will be available at a wider range of retail outlets as well as at a significantly lower retail price compared to existing hearing aids.

AARP estimates the population of hearing challenged people in USA at over 30 million and only 20% are using hearing aids. As a result, there is a large population of hearing challenged people who are underserved and this represents a growing market opportunity for hearing companies to serve.

Nuheara’s Founding Vision Preempted the OTC Hearing Aid Act

When we founded Nuheara, hearing health was at the forefront of our thinking.

We first started this journey over 10 years ago with a previous hearing technology company that sold smart headsets to the industrial sector, allowing workers to separate speech from background noise in loud industrial environments.

This eventually sparked the idea for Nuheara and our first commercial product  IQbuds™. IQbuds™ was designed to deliver sophisticated hearing technology in a form factor that is socially acceptable to hundreds of millions of people around the world, giving them the control to hear what they want to hear and connect to their digital devices.

The OTC Hearing Aid Act is a manifestation of this original vision and it’s why Nuheara is poised to leverage this exciting new market opportunity!

Consumers Will Be the Big Beneficiaries

Until now, consumers who experienced mild-to-moderate hearing loss had few options to solve their hearing challenges.

One option has been the use of devices that are classified as Personal Sound Amplification Products (PSAP). They are significantly cheaper than hearing aids, but mostly only offer a rudimentary amplification solution. PSAP’s cannot legally be marketed to people with hearing loss as a “hearing aid,” only to those with normal hearing as an amplification device.

In the last 12 months, a new category of hearing devices, termed “hearables” or Assistive Audio devices, have found their way to market via the consumer electronics channel. Products like IQbuds™ can now be found in retail stores such as BestBuy and Brookstone.

IQbuds™ and other hearables offer advancements in smart amplification above and beyond the typical PSAP. Combining sophisticated digital signal processing technology with advanced microphone, audio and Bluetooth capabilities, these products provide a new alternative for consumers looking for hearing assistance for mild-to-moderate hearing loss.

With the new OTC Hearing Aid Act, companies like Nuheara are now poised to deliver solutions across a range of retail channels that don’t require the consumer to visit a Hearing Care Professional Clinic. Importantly, this new category of hearing products will offer advanced capabilities at significantly lower prices compared to hearing aids.

This is not the first time we have seen consumer choice opening up at retail in a health-related category. Over-the-counter reading glasses have now found a place in retail stores, offering consumers an alternative to visiting an optometrist for people with mild-to-moderate eyesight challenges. The same will unfold in the hearing health category.

Quality Standards Must Be Maintained

The OTC Hearing Aid Act will potentially stimulate innovation in the hearing technology industry as consumer electronic companies scramble to bring products to market.

Hearing aid companies have invested hundreds of millions of dollars in research and development to improve their products. The fact is, developing hearing technology is not easy and it’s a difficult leap for traditional consumer electronic companies.

Industry bodies such as the Consumer Technology Association are already developing standards to be applied to this new industry category. In addition, the proposed legislation would require the Food and Drug Administration (FDA) to regulate this new category of OTC hearing aids to ensure they meet the same high standards for safety, consumer labeling and manufacturing protection that all other medical devices must meet. This will give consumers the option to purchase a safe, high-quality, FDA-regulated device at lower cost.

Quality standards will need to be maintained and technology innovation continued by those legitimate hearing technology companies for the true value of the legislation to filter down to the 30 million consumers in need.


Nuheara has been supportive of the OTC Hearing Aid Act and has been working with industry bodies to encourage its enactment. The company will continue to work with these organizations to ensure the correct standards are developed that deliver real benefits to consumers.

August 17th, 2017