Over-the-counter hearing aids: A long overdue alternative for millions of Americans
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Opinion contributions recently published in The Hill assert that legislation now making its way through Congress to allow certain types of hearing aids to be sold over the counter represent a “sudden push” for changes in existing regulation that wouldn’t help consumers. We strongly disagree.

Current regulations for the sale of hearing aids in the U.S. have remained largely unchanged since they were first approved by the Food and Drug Administration (FDA) in 1977. In 1977, Jimmy Carter was the president of the United States, the U.S. Federal Debt was about $706 Million, the Dow Jones Industrial Average closed the year at 831, and a gallon of gasoline cost $0.65. In many ways, it seems like this was much more than 40 years ago. Also in 1977, the very first “Apple II” computers were sold, NASA completed its first test flight of the space shuttle, and the very first “Star Wars” movie was released. It was a long time ago.

These FDA regulations required the involvement of professionals, such as hearing-aid dispensers, audiologists, or physicians, in the provision of hearing aids to consumers. Medical clearance, or the waiver of that clearance, was needed prior to the purchase of hearing aids. It was a different world in 1977 and many things have come and gone since then, but the regulation of hearing aids by the FDA has remained largely intact. One consequence of this regulation of hearing aids by the FDA has been the creation of a closed market with the nature of that market driven primarily by six world-wide manufacturers of hearing aids (one in the U.S.).

Over the forty years from 1977-2017, the uptake of hearing aids by those with hearing loss has remained at about 20 percent. That is, of those who could likely benefit from hearing aids, only one in five sought them out and purchased them. Again, for forty years, this has been the status quo in hearing healthcare. We are opposed to “fixing something that’s not broken,” but that is not the case here. The system is broken. It is time to try some new approaches. It is time to get hearing aids to the millions of Americans who need them; the 80 percent who could be helped by them but who can’t access them or afford them.

In 2009, we had the opportunity to participate in a working group organized collaboratively by the National Institute on Deafness and other Communication Disorders (NIDCD) and the Department of Veterans Affairs (VA). Participants in the working group included audiologists, hearing scientists, hearing aid manufacturers, engineers, physicians, people with hearing loss and others from industries and professions outside of hearing healthcare, from the U.S. and around the world. The overarching conclusion from the working group was that the hearing healthcare needs of millions of Americans with mild-to-moderate hearing loss, especially millions of older Americans, were not being met and had not been met for decades. The group reviewed the evidence in support of this conclusion and, importantly, offered a range of potential solutions, many of which would require additional research. One point of emphasis for improving the accessibility and affordability of hearing healthcare of Americans with mild-to-moderate hearing loss was to establish other ways to deliver hearing aids to those with hearing loss, including empowering consumers to select their own hearing aids.

Since 2009, the NIDCD has funded, and continues to fund, research projects addressing the research agenda outlined by the working group. This research has provided evidence that further supports alternative ways to provide hearing aids to adults with mild-to-moderate hearing loss. More recently, other groups, including the President’s Council of Advisors on Science and Technology (PCAST) in 2015 and the National Academies of Science, Engineering and Medicine (NASEM) in 2016, have strongly advocated for alternative ways of providing hearing aids to adults with mild-to-moderate hearing loss. A consumer-decides over-the-counter (OTC) approach, common in many other areas of healthcare, has been advocated as an alternative to the current broken system of professional-guarded access; a system that has failed to address the needs of millions of adults with mild-to-moderate hearing loss in America.

Congress now has the opportunity, for the first time in 40 years, to empower consumers with hearing loss as they strive to manage their hearing needs. In the Senate, Sens. Elizabeth WarrenElizabeth Ann WarrenWarren on family separation policy: Trump is ‘taking America to a dark and ugly place’ Overnight Defense: States pull National Guard troops over family separation policy | Senators question pick for Afghan commander | US leaves UN Human Rights Council On The Money — Sponsored by Prudential — Markets roiled by Trump's new tariff threat | Trump lashes out at Canada over trade | Warren looks to block Trump pick for consumer agency MORE (D-Mass.) and Charles GrassleyCharles (Chuck) Ernest GrassleyOn The Money — Sponsored by Prudential — Markets roiled by Trump's new tariff threat | Trump lashes out at Canada over trade | Warren looks to block Trump pick for consumer agency The Hill's Morning Report — Sponsored by PhRMA — Defiant Trump meets with House GOP amid border blowback Republican senator calls for face-to-face with EPA’s Pruitt MORE (R-Iowa), as S.670, and, in the House, Reps. Joe Kennedy III (D-Mass) and Marsha BlackburnMarsha BlackburnWhat the net neutrality repeal means Dem Senate super PAC reserves million in fall TV ads Scalise throws support behind Black, Blackburn ahead of Tennessee primary MORE (R-Tenn.), as HR 1652, have, in bipartisan fashion, crafted the “Over the Counter Hearing Aids Act” which instructs the FDA to redo these outdated 1977 regulations and open the door to a consumer-driven OTC approach. Importantly, this proposed new category of devices, designed for adults with mild-to-moderate hearing loss, remain under the purview of the FDA. Equally important, this new category of OTC devices does not supplant traditional hearing aids, which will continue to be regulated by the FDA and at the state level. State licensure and dispensing regulations will remain in place and in force for traditional hearing aids dispensed by hearing healthcare professionals. Traditional hearing aids and the professional-controlled means of delivering them to the consumer have met the needs of 20 percent of those Americans with hearing loss. Those who desire professional expertise to assist in the provision of traditional hearing aids will continue to be able to seek it. For the 80 percent of adults with mild-to-moderate hearing loss who need help, but have found that help too difficult to access or too expensive to justify, the option to directly select their own devices at a lower cost will offer an exciting new alternative. After forty years, the time is right.

Larry E. Humes, Ph.D., is currently Distinguished Professor of Speech and Hearing Sciences at Indiana University. Professor Humes has been actively engaged in the field of audiology for 40 years; since 1977. Judy R. Dubno, Ph.D., is a Professor and Director of the Hearing Research Program in the Department of Otolaryngology–Head and Neck Surgery at the Medical University of South Carolina in Charleston. Her research focuses on auditory perception and speech recognition and how perception changes with age, hearing loss, hearing aids, and training.

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