Sally Pipes InsideSources.com
It’s been five years since Congress directed federal regulators to develop regulations that will allow the sale of over-the-counter hearing aids. Yet people today still cannot buy them.
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 require the Food and Drug Administration to finalize its rules on over-the-counter hearing aids within 30 days.
It is high time for the agency to pull itself together. Millions of Americans would benefit from better access to hearing aids. Authorizing their over-the-counter sale would energize a market that needs it and would lead to lower prices.
Thirteen percent of American adults – 38 million people – suffer from hearing loss. Hearing aids could dramatically improve their ability to communicate and lead productive and satisfying 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 use a hearing aid.
This is often because hearing aids are expensive. These days, they rarely cost less than $1,000. They can sometimes cost over $6,000.
People can’t get much help with these costs. Hearing aids are not covered by Medicare or many private health insurance plans.
And since hearing aids require a prescription, patients who need them must also deal with the cost and inconvenience of visiting an audiologist, care that may not be covered by insurance.
Allowing the devices to be sold without a prescription could expand access and reduce their cost.
People are much more likely to seek out hearing aids if they can pick them up without an intermediary, as with other essential medical treatments and technologies.
A larger potential market will attract more manufacturers offering more products. This competition will put downward pressure on prices and lead to the availability of a wider variety of hearing aids that cater to different market segments.
The result will be more widespread adoption of hearing aids and lower overall costs.
This line of thinking inspired Senators Grassley and Warren, among others, to sponsor the Over-the-Counter Hearing Aids Act in 2017. The FDA was supposed to finalize regulations that would have implemented the law in 2020. The agency has missed that deadline in over a year. Public comments on the proposed rule did not close until January of this year.
Hence the new series of laws of Grassley and Warren.
Opponents of over-the-counter hearing aids — like audiologists and others who benefit from the current system — point out that hearing loss can signal a more serious problem. If people don’t have to see a health care provider to get hearing aids, it’s thought that these health conditions might go undiagnosed.
Many audiologists also claim that getting over-the-counter hearing aids without a prescriptive fit will compromise their effectiveness and lead people to conclude that the hearing aids won’t work for them.
Healthcare providers have long made arguments like these to try to control the supply of medical care – and keep the price high. Optometrists still complain about letting consumers order contact lenses online. Physician organizations are lobbying state legislators across the country to restrict the ability of nurse practitioners 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.
Additionally, people will always have the option of seeking professional help from an audiologist. They just won’t have to.
Today, consumers are buying even more advanced technology than the latest hearing aids without the help of a professional. It is infantilizing to believe that they will not be able to manage the purchase of the devices themselves.
Selling over-the-counter hearing aids will make them more accessible to millions of people. Consumers have waited five years for better access. They shouldn’t wait any longer.
Sally C. Pipes is President and CEO and Thomas W. Smith Fellow in Health Policy at the Pacific Research Institute.