FDA moves to make hearing aids available over the counter

FDA moves to provide over-the-counter hearing aids to millions

The Food and Drug Administration on Tuesday moved to make hearing aids available for consumers to buy over the counter without a prescription or medical exam, a long-awaited goal for nearly 30 million consumers.

“By mid-October, Americans will be able to purchase more affordable hearing aids over the counter at pharmacies and stores across the country,” President Biden said in a statement on Tuesday. “This action builds on my commitment to lower costs for American families, providing American families with nearly $3,000 in savings for a pair of hearing aids and giving people more options to improve their health and well-being. gives.”

The president called on the FDA to make hearing aids available over the counter last year in his promotional contest in the US Economy executive order to help lower costs and increase competition in certain industries.

The devices will be available to individuals 18 years of age and older who have mild to moderate hearing loss. They can be purchased at pharmacies, stores and online.

The move comes more than four years after Congress ordered the FDA to draft rules for over-the-counter devices. The new rules would create a new class of hearing aids that would reverse state-level rules that required patients to visit a physician or audiologist to obtain prescriptions and fittings.
Health and Human Services Secretary Javier Becerra said on Tuesday that the decision was the fulfillment of a long-term goal.

“Reducing the cost of health care in America has been a priority for me from day one and we hope to help this rule achieve quality, affordable health care access for millions of Americans,” he said. “Today’s action by the FDA represents an important milestone in making hearing aids more cost-effective and accessible.”

Hearing aids currently cost an average of more than $5,000 per pair and are generally not covered by traditional Medicare or other insurers. Vice President Harris said the new proposal would reduce the cost of hearing aids by hundreds or even thousands of dollars.

“Every American has a right to access to affordable health care,” she said in a statement Tuesday. “Today our administration has taken another step forward in our fight to protect that right.”

The change is expected to significantly benefit older adults – individuals most likely to experience hearing loss and be on a fixed income – as well as those in poorer and rural communities who have fewer audiologists.

A 2019 study published in Social Science and Medicine found that the counties with the greatest numbers of older adults with hearing loss often had fewer available audiologists, as doctors practice in smaller, affluent urban areas.

Barbara Kelly, executive director of the Hearing Loss Association of America, said stigma, lack of access and confusion about how to get the best health care often prevents people — especially older Americans — from taking care of their hearing health. . He said the option would benefit countless Americans who may need a situational hearing aid at restaurants or large family gatherings, perhaps without the need for a hearing professional.

“For years, we have worked to make hearing health care affordable and accessible, and this is a huge step in getting people to pay attention to their hearing health as quickly as possible,” Kelly told The Post. “And it provides just one more opportunity — a new avenue really — for adults with mild to moderate hearing loss who can take a step themselves.”

Although approximately 38 million adults in the United States report hearing loss, few have tried the devices. In adults over 70 with hearing loss, only one in three has ever worn one, according to data collected in the National Health Interview Survey.

The FDA’s move follows years of federal efforts to remove barriers between patients and over-the-counter hearing aids. In 2015, the President’s Advisory Council on Science and Technology under Barack Obama recommended that the FDA create a new class of “basic” hearing aids that can be purchased without a prescription or a doctor’s visit. Two years later, President Donald Trump signed the Over-the-Counter Hearing Aid Act of 2017, which gave the FDA three years to implement the new rules.

The FDA missed that 2020 deadline, but President Biden stepped up the pressure in July 2021 when he signed an executive order that set a November deadline for a new proposed rule from the federal agency.

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