By Dr. Carrie D. Wolinetz, OSTP Deputy Director for Health and Life Sciences
Dr. Francis S. Collins, Co-Chair, President’s Council of Advisors on Science and Technology and President’s Acting Science Advisor
Maybe you’ve seen one of those viral videos, where technology – from cochlear implants to hearing aids – allows a baby to hear their mother’s voice for the first time. The astonishment and joy on the baby’s face creates an infectious shared experience. You can’t help but smile. Using science and technology to improve the lives of all Americans is what drives the work of the White House Office of Science & Technology Policy. And while the arc of national science and technology policy can be long, this week it bent towards access for a greater number of Americans who rely on hearing technologies to overcome hearing loss.
Today, the Food and Drug Administration (FDA) released a Final Rule – a rule issued by a Federal regulatory agency after public consultation – to make some hearing aids available for purchase over-the-counter (OTC), eliminating significant barriers to the 30 million Americans who suffer hearing loss in one or both ears.
Hearing aids are especially useful for individuals who have hearing loss resulting from damage to the sensory cells – or hair cells – of the inner ear, from disease, aging, or injury. The device amplifies sound vibrations so that remaining sensory cells are able to detect the signal and convey it via nerve cells to the brain.
Access to hearing aid technology was first raised by the President’s Council of Advisors on Science & Technology (PCAST) in 2015, in their report Aging America & Hearing Loss: Imperative of Improved Hearing Technologies. The PCAST recommended that the FDA create a new category of OTC hearing aids and associated hearing tests, in order to drive down costs, increase access, and open up a market space for creative innovation. In their letter to the President, PCAST noted that this was a critical health equity issue, pointing out that among those who could benefit from this technology only “a small fraction of this group seek out and use assistive hearing technologies, including hearing aids, and that rate is even smaller among low income and racial and ethnic minorities.”
Congress then took up PCAST’s recommendations in 2017, and led by Senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA), as well as Representatives Joe Kennedy (D-MA) and (now Senator) Marsha Blackburn (R-TN), passed the bipartisan Over-the-Counter Hearing Aid Act as part of the FDA Reauthorization Act. This law charged FDA with developing guidelines to make equitable access to OTC hearing aids a reality.
While working through the demands of the COVID-19 pandemic, the Biden-Harris Administration issued a landmark Executive Order on Promoting Competition in the American Economy within its first six months, outlining a series of tangible actions to spur innovation and competition, including a deadline for FDA steps to allow hearing aids to be sold over the counter.
The new final rule represents a huge step forward in what the original PCAST report termed the “substantial national problem” of untreated hearing loss. Millions of Americans will be able to access hearing aids more easily and cheaply. The rule is expected to lower the cost of hearing aids by hundreds—or even thousands—of dollars, and to open the door to new competition and innovation. Consumers can expect to see lower-cost hearing aids in stores as soon as mid-October, when the final rule takes effect.
This is a great example of a policy that will make a measurable positive difference in the lives of Americans all over the country, people whose hearing loss – through age or other causes – has the real-world effect of causing social isolation, safety concerns, stigma, and other health and social issues. As President Biden recently said of PCAST, “They are asking these questions as a call to action, to inspire, to help us imagine the future and to figure out how to make it real and improve the lives of the American people and people around the world.”
This fall, people who need them should find hearing aids available at their local pharmacy, just like reading glasses and at-home tests. Because we know that the wonders of technological innovation only matter when they are accessible.
Want to learn more about what real-world science & technology policy issues PCAST is advising the President on today? Visit https://www.whitehouse.gov/pcast/ to view public meeting webcasts and read reports and proceedings.