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establish an OTC hearing aid category (limited to adults with perceived mild to moderate hearing losses) and release a draft guidance within 3 years.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.
