Sally Pipes InsideSources.com
It’s been five years since Congress directed federal regulators to develop regulations allowing over-the-counter sales of hearing aids. However, you cannot buy them today.
A bipartisan group of senators wants to change that. In April, a quartet led by Chuck Grassley, R-Iowa, and Elizabeth Warren, D-Mass., introduced legislation that would force the Food and Drug Administration to finalize its regulations for OTC hearing aids within 30 days.
It’s high time for the agency to pull itself together. Millions of Americans would benefit from increased access to hearing aids. Allowing over-the-counter sales would add momentum to a market that needs it — and lead to lower prices.
Thirteen percent of American adults — 38 million people — have hearing loss. Hearing aids could dramatically improve their ability to communicate and lead productive and fulfilling lives. Yet only a fifth of Americans who would benefit from such devices use them.
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Only about one in 20 people in their 50s with hearing loss uses a hearing aid.
This is often because hearing aids are expensive. Currently, they rarely cost less than $1,000. They can sometimes cost upwards of $6,000.
At this cost, people cannot get much help. Hearing aids are not covered by Medicare or many private health plans.
And because hearing aids require a prescription, patients who need them must also pay the cost and inconvenience of seeing an audiologist — a treatment that insurance may not cover.
Selling the devices over the counter could expand access and lower their costs.
People are much more likely to shop for hearing aids when they can pick them up without a middleman, as with other major medical treatments and technologies.
A larger potential market will attract more manufacturers offering more products. This competition will drive prices down – and result in a wider selection of hearing aids that appeal to different market segments.
The result will be wider hearing aid adoption and lower overall costs.
This mindset inspired Senators Grassley and Warren, among others, to sponsor the Over-the-Counter Hearing Aid Act back in 2017. The FDA was supposed to finalize the regulations that would have implemented the law in 2020. The authority has missed this deadline more than a year. Public comments on the proposed rule were not closed until January of this year.
Hence the new legislative round by Grassley and Warren.
Opponents of OTC hearing aids – such as audiologists and others who benefit from the current system – point out that hearing loss may signal a larger problem. If people don’t have to go to a health care provider to get hearing aids, it’s assumed that these health problems could go undiagnosed.
Many audiologists also argue that buying hearing aids without a prescription fitting undermines their effectiveness—leading people to conclude hearing aids aren’t working for them.
Health care providers have long made arguments like this to try to control the supply of medical care — and keep its price high. Optometrists still grumble about letting consumers order contact lenses online. Physician organizations are lobbying state legislatures across the country to limit the ability of nurses and physician assistants to treat patients independently.
Obstacles like these can benefit incumbents. But they increase costs for patients and the rest of the healthcare system.
In addition, people still have the opportunity to seek the professional help of an audiologist. You are just not obligated to do so.
Consumers today are buying even more advanced technology than the latest hearing aids without professional assistance. It’s infantilizing to think that they can’t handle the purchase of the devices on their own.
Selling hearing aids over the counter will make them more accessible to millions of people. Consumers have waited five years for improved access. You shouldn’t have to wait any longer.
Sally C. Pipes is President, CEO and Thomas W. Smith Fellow in Health Policy at the Pacific Research Institute.
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