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Opening the market to over-the-counter hearing aids: Something Congress can agree on

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We are a nation divided:  Democrats versus Republicans, Red States versus Blue States. On countless major issues, consensus seems impossible.  But there is one thing that members of the Congress apparently can agree on: Hearing aids are too darned expensive.

At $2,500 apiece, hearing aids are beyond the reach of many Americans — especially seniors who are most likely to need them (among people 70 and older, two-thirds have a hearing loss affecting their daily conversation).  The cost of hearing aids is not covered by Medicare, or by most insurance companies.  But hearing loss has serious health consequences:  research has shown that it is associated with isolation, depression, and the risk of developing dementia. Only one in five people with a hearing loss uses a hearing aid. If hearing aids were widely available, the potential benefits to societal health and well-being are immense. 

{mosads}For this to happen, the Food and Drug Administration (FDA) needs to change the way it regulates hearing aids. That’s according to recent reports from two national blue-ribbon panels, one at the President’s Council of Advisors on Science and Technology (PCAST), and the other at the National Academies of Science, Engineering, and Medicine. Both recommend that the FDA create a new regulatory classification for over-the-counter (OTC) hearing aids, and performance standards for those new devices. OTC aids would be targeted to adults who are in the earlier stages of hearing loss (so-called “mild to moderate” loss).

To appreciate why this regulatory change would be so powerful, it’s important to understand the status quo. Six firms (only one of which is based in the U.S.) dominate the hearing aid market, producing 98 percent of all devices sold.  New market entrants are rare for a number of reasons, including most importantly, regulations that restrict hearing aids to only being sold by hearing professionals.  Distribution is effectively blocked to newcomers due to close relationships between existing manufacturers and those professionals (audiologists, hearing aid dispensers, and physicians). In this low-competition market where professionals serve as the gatekeepers to hearing aids, innovation is slow to reach patients and hearing aids remain expensive.  Features such as wireless connectivity and rechargeable batteries — amenities that have long been standard for consumer electronics — are sold as costly “extras” in the world of hearing aids.

By opening the market to OTC aids, manufacturers of consumer electronics — from giants such as Apple and Samsung to small startups — could enter the hearing aid space and sell directly to consumers. Studies show that high-quality OTC hearing devices can perform just as well as costly hearing aids, for people with mild-to-moderate hearing loss. These devices are designed to retail between $150 and $299.

How would this work from the consumer perspective?  The development of a regulatory classification for OTC hearing aids by the FDA would provide standards to ensure these devices are both safe and effective. Hearing aids could be sold in a number of venues, including pharmacies, grocery stores, and other retailers. In our experience, some people can learn to use a simple hearing aid with little assistance. Others need more help.  Audiologists, the professionals who now dispense most of the hearing aids in the US, should be well equipped to offer that support on a fee-for-service basis to consumers who have purchased an OTC hearing aid.

In a rare snippet of good news to come out of Congress this session, there’s a bipartisan push to make it happen: proposed by Sens. Elizabeth Warren (D-Mass.) and Charles Grassley (R-Iowa) in the Senate (as S.670), and Reps. Joe Kennedy III (D-Mass) and Marsha Blackburn (R-Tenn.) in the House of Representatives (as HR 1652), the “Over the Counter Hearing Aids Act” instructs the FDA to redo these outdated regulations that have kept innovators out of the hearing aid market. But the legislation is under attack from some professional societies and industry groups who are benefitting the most from keeping hearing aids expensive. Some groups are lobbying specifically for the legislation to be handicapped so that the functionality of these devices can only be used to address mild hearing losses, thereby preventing nearly half of all seniors with more advanced forms of hearing loss from being able to benefit from these OTC hearing aids.

To be sure, price isn’t the only obstacle to hearing aid use. Vanity and stigma matter too. But if buying a hearing aid were as easy as going to a drugstore and aids started working seamlessly with our smartphones and other electronics, stigma would likely drop. And it’s important to note that hearing aids aren’t the answer to everything for people with hearing loss: environmental modifications to reduce background noise and rehabilitative strategies for communicating in challenging listening situations are important too. But having the opportunity to own a hearing aid is critical, and it’s something that is now out of reach for too many.

Warren and Grassley. Kennedy and Blackburn.  These names are not usually allied. In these divisive times, wouldn’t it be wonderful if our Congress could come together on an issue that has such potential to improve the lives of so many Americans?

Jan Blustein MD, PhD is Professor of health policy, medicine and population health at New York University.  She does research on hearing loss in older people, and strategies to mitigate disability. Frank R. Lin, MD, PhD is Associate Professor of otolaryngology, geriatric medicine, mental health, and epidemiology at Johns Hopkins University. His research covers the epidemiology of hearing loss in the US, the health consequences of hearing loss, and the potential of hearing aids to improve health and well being. Dr. Blustein and Dr. Lin both serve on the board of trustees of the Hearing Loss Association of America.

The views expressed by this author are their own and are not the views of The Hill.

Tags Charles Grassley Elizabeth Warren Marsha Blackburn

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