Biden’s Latest Executive Order Is a Boon for People with Hearing Loss

otc hearing aids biden executive order
July 12, 2021

Editor’s Note: Today’s post is written by Richard Einhorn, a hearing technology consultant, composer, hearing aid wearer, and a recording producer/engineer.

In this post, Richard explains why we, as people with hearing loss, should care about the pending Over the Counter hearing aid regulations.


President Biden’s Order Highlights the Need for OTC Hearing Aids 


On July 9, President Biden issued a comprehensive Executive Order which, among other things, called for the Department of Health and Human Services (HHS) to “consider proposed rules” for OTC hearing aids for people with perceived mild to moderate hearing losses within 120 days. 

This is potentially a very important development for the hearing health community, one that will increase access and innovation in hearing technologies. 

Around 48 million Americans have a significant level of hearing loss. Yet less than 30% use hearing aids.  Among the common reasons cited are the expense, the trips to an audiologist for fitting, and limited usefulness in very noisy situations like crowded restaurants. 

As a result, people with hearing loss can wait up to 10 years before doing something about it. The impact is serious, affecting the ability to earn a living, increasing people’s social isolation, and in older Americans, there may be a link with onset and severity of dementia. Many observers believe that if affordable Over the Counter (OTC) hearing aids were available, more people who need it would adopt hearing tech earlier.


Timeline to OTC Hearing Aids


There is a considerable amount of confusion about what OTC hearing aids entail. As an aid to understanding the issue, here is a simplified timeline of how this initiative came to be. 

2015 — The President’s Council of Advisors on Science and Technology (PCAST) recommends the FDA create an OTC hearing aid category. 

2016 — The National Academy of Sciences Engineering and Medicine (NASEM) issued a landmark report which, among other things, recommended the establishment of regulated OTC hearing devices. 

2017 — The bipartisan Grassley/Warren Over the Counter Hearing Aid act was signed into law directing FDA to establish an OTC hearing aid category (limited to adults with perceived mild to moderate hearing losses) and release a draft guidance within 3 years. 

2020 — The FDA missed the deadline for the NPRM (notice of proposed rulemaking) for OTC hearing aids.

July 2021 — President Biden released an executive order calling, among other initiatives, for HHS to “consider proposed rules” for OTC hearing aids within 120 days. 


The Benefits of OTC Hearing Aids Are Debated in the Industry 


OTC hearing aids have prompted considerable debate and discussion. For those who support safe, efficacious, and FDA-regulated OTC hearing aids, the import of an OTC hearing aid option is significant:

  • Much lower prices: ~About $500/pair vs often more than ~$5000/pair
  • Earlier adoption of hearing technology by people who badly need help
  • Simplification of purchase: just go into a pharmacy and buy them
  • Simplification of setup and self-fitting: devices can be configured by the user (but an audiologist may also be involved)
  • More innovation: OTC hearing aids will fully integrate and may extend consumer-based noise cancelling and removal technologies
  • More competition within the hearing aid industry will provide consumers with wider freedom of choice

But there are also concerns:

  • Safety: Will people damage their hearing or miss serious co-morbidities? 
  • Economics: How will audiologists who are already squeezed on price by companies and consumers alike survive financially? 
  • Bad experience with OTC devices could further delay seeking professional help. Will the proposed rules do enough to ensure both safety and efficacy? 
  • Jurisdictional: What impact will a federal OTC policy have on state rules for hearing aids?
  • No one will buy them. Maybe price is not a major factor in hearing aid uptake? 


Possible Benefits Outweigh the Risks

Speaking as both a person with hearing loss and as someone who has studied the issue of OTC hearing technology for many years, I believe the benefits of OTC hearing aids (for mild to moderate losses only) could be substantial and that the concerns can be fruitfully addressed fairly quickly by involving all stakeholders, including knowledgeable potential users of these devices.

The future impact of some concerns is not fully knowable. But what is known is that, at present, hearing aids are not used at all by many people with milder hearing losses who could benefit from them and who, at present, are not being seen by audiologists.

What is also known is that change is coming. For example, already Apple’s AirPods Pro can be configured for amplified hearing personalization using an audiogram. FDA oversight will ensure safety and efficacy of such technologies, bringing quality “digital hearing health” to users who need it. 

Hearing health technology is changing, and that is a good thing. Access to quality, affordable hearing technology is also a good thing. And all of us who care about improving hearing health should encourage wider use of such technology. President Biden’s Executive Order to move forward OTC hearing aids is an important step towards a more inclusive, and much expanded field of hearing health. 


About the author

Richard Einhorn is a hearing health technology consultant and professional composer whose music is performed around the world. Richard has consulted with Jacoti since 2014. He is a regular contributor to hearing health journals and has spoken numerous times on hearing technology to the FDA, the National Academies of Sciences, Engineering, and Technology, and at hearing technology companies. 

  1. The idea of reducing prices is certainly a noble exercise. But the hearing aid industry is a very limited one and the market is too small to generate price reducing strategies. The cost of processing technology is rising due to dealing with brain functions and spatial orientation. Without the need for brain improvement needs, the hearing aid over the counter is a wasteful device, and not just a waste of money, but adds to damage in the cochlear nerve system, and creates “hidden hearing loss”. This is a finding by Dr. Kujawa and Dr. Liberman at Harvard Medical School.
    Solution: Keep the technology at the highest level since we are dealing with brain issues. deal with pricing incentives instead! Don’t mess with hearing aid technology with regulations on what to control in the hearing aids of today!

  2. Only very small percentage of people who need hearing amplification use hearing aids such as hearing aids is, indeed, a small market compared to Bluetooth True Wireless Stereo (TWS) earbuds. But we shall not judge about the market according to sales of the products that serves less than 5% of those 1.3 billion who need it. The product doesn’t fit the market, the markets (actually the people) need something different, something disruptive. OTC hearing aids is a step in the right direction, but it will not be the game changer. It can grab 50% of traditional market and increase the penetration by 10%, but it will not change the whole picture. By introducing “conversation boost” in AirPods Pro Apple is initiating the true progress to provide a solution for people with mild-to-moderate hearing loss. It is free, it is up to the user, it is used by millions of people without a trace of hearing loss. There are some things missing in Apple solution yet such as hearing assessment, but it will be introduced in a near future. Other brands will follow soon and my company Alango Technologies is going to help them. We have the technology polished in our BeHear product line that users love and we know how to make it working on every chipset used today in Bluetooth headsets and earbuds.
    And replying to Anjan’s comment, there is no brain issues here. As a DSP technology provider, we know everything about it. The famous fitting formulas by NAL have nothing to do with the brain. It is all about hearing thresholds at various frequencies, recruitment region and attack/release times of multi-channel dynamic range processing. It is math and psycho-acoustics, not magic.

Leave a Reply