Nuheara Limited (ASX: NUH) (Company or Nuheara), transforming the way people hear by creating smart and affordable hearing solutions, welcomes US President Biden’s July 9, 2021 Executive Order which sets a deadline of 120 days for the Department of Health and Human Services to publish a proposed rule to allow hearing aids to be sold over the counter (OTC).

Commenting on US President Biden’s Executive Order, Nuheara Co-founder & CEO Justin Miller said:

“We are delighted with the Biden Administration’s effort to establish a definitive timeline in issuing the OTC guidelines.  We expect the revised guidelines will have a material impact on the US hearing market, by ensuring hearing aids become more affordable and accessible. President Biden’s commitment to hearing health changes the status quo and has the potential to make hearing health ubiquitous.”

The Executive Order states:

Hearing aids are so expensive that only 14% of the approximately 48 million Americans with hearing loss use them. On average, they cost more than $5,000 per pair, and those costs are often not covered by health insurance. A major driver of the expense is that consumers must get them from a doctor or a specialist, even though experts agree that medical evaluation is not necessary. Rather, this requirement serves only as red tape and a barrier to more companies selling hearing aids. The four largest hearing aid manufacturers now control 84% of the market. 

Nuheara has long been an active supporter of the proposed changes to US hearing laws, with momentum to switch hearing aids in the USA from prescription to OTC growing for some time¹˒². In 2017, the former US President Trump, signed the Over-the-Counter Hearing Aid Act authorising OTC sales of hearing devices and giving the Food and Drug Administration until 2020 to establish guidelines for direct sales of hearing aids.  The onset of COVID-19 caused some delays in issuing these guidelines.

President Biden said:

“Right now, when you need a hearing aid you can’t just walk into a pharmacy and pick one up over the counter, you have to get one from a doctor or a specialist. Not only does that make getting a hearing aid more inconvenient it makes it considerably more expensive.

“It also makes it harder for new companies to compete, innovate and sell hearing aids at lower prices. As a result, a pair of hearing aids can cost thousands of dollars, which is a big reason why only one in seven Americans with hearing loss use a hearing aid.

“The FDA is going to issue rule changes so that hearing aids can be sold over the counter. That’s something the last administration was supposed to have done but didn’t do.  We are going to get it done.”

President Biden added that his order would result in a pair of hearing aids costing hundreds, not thousands, of dollars.


Justin Miller Ronn Bechler, Market Eye
Managing Director and CEO Email: [email protected]
Nuheara Limited Phone: + 61 400 009 774



Nuheara is a global leader in smart hearing technology which change people’s lives by enhancing the power to hear. Nuheara has 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 IQbuds² MAX.  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/.

July 14th, 2021