​PCAST Recommends Changes to Promote Innovation in Hearing Technologies

Untreated, age-related hearing loss is a significant national problem. With the population 65 and older in the United States expected to reach 80 million in the next 25 years, the number of people with hearing loss will rise dramatically. Already, a quarter of adults between 60 and 69 years, more than half of adults between 70 and 79 years, and almost 80 percent of those older than 80 years have difficulty hearing – that’s almost 30 million Americans. 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.

The President’s Council of Advisors on Science and Technology (PCAST) believes there is an opportunity to enhance the pace of innovation, decrease cost, and improve the capability, convenience, and use of assistive hearing devices for individuals whose hearing has diminished in a mild to moderate way with age. Today, we delivered a letter report to the President, Aging America & Hearing Loss: Imperative of Improved Hearing Technologies, that examines these issues and includes several recommendations as part of our larger study about how technologies can help Americans remain independent as they age.

With the average price of just one hearing aid costing more than $2,300, and most consumers paying double that to get one for each ear, it’s not surprising that we found high costs to be a major obstacle for many people. Most people also have to cover the costs entirely out of pocket as Medicare and most insurance do not cover hearing aids. Bundling services also drives up the costs, meaning consumers must pay for a professional evaluation and fitting, the hearing devices, and follow up appointments and adjustments all at once, whether they use them or not.

We also found that hearing aids have not experienced the dramatic reduction in price or increases in features and innovations as seen in other consumer electronics. Following a wave of industry acquisitions, just six hearing-aid manufacturing companies – most of them based outside of the United States – have dominated the industry for the past 15 years.

In this report, PCAST identified a few recommendations for changes the Federal Government can make that we believe will simultaneously decrease the cost of hearing aids, spur technology innovation, and increase consumer choice options. The recommendations we sent to the President for consideration include:

• The Federal Trade Commission (FTC) should enable a hearing-aid prescription process similar to what is available for eyeglasses and contact lenses, giving consumers a greater diversity of choices and the opportunity to shop around without being locked into the cost of a particular device or service.
• The Food and Drug Administration (FDA) should create a new category for “basic” hearing aids and associated hearing tests that are meant for sale over-the-counter. This would allow entrepreneurs and innovators to enter the market and open a space for creative solutions to improve mild-to-moderate, age-related hearing loss with devices that can be sold widely, allowing consumers to buy a basic hearing aid at the local pharmacy, online, or at a retail store for significantly less. 
• The FDA should rescind its previous draft guidance about Personal Sound Amplification Products and allow these devices to make truthful claims about capabilities like improving hearing or understanding in situations where environmental noise or crowded rooms might interfere with speech intelligibility.

While these changes would likely disrupt the current business practices of hearing aid manufacturers and dispensers, they would also dramatically increase competition and increase new choices for the millions of Americans who will soon be experiencing hearing loss for the first time.

Christine Cassel and Ed Penhoet are members of PCAST and co-chairs of the PCAST Hearing Technologies Working Group.

PCAST is an advisory group of the Nation’s leading scientists and engineers, appointed by the President to augment the science and tech­nology advice available to him from inside the White House and from cabinet departments and other Federal agencies. For more information about PCAST, please visit the PCAST website.