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Hearing Devices to be Sold Over the Counter as FDA Regulations Change

Hearing Aid
Hearing devices to be sold over the counter, as FDA regulations change. Credit: Michael Sauers CC BY-NC 2.0 / Flickr

This week, the U.S. Food and Drug Administration (FDA) passed new regulations allowing hearing devices to be sold over the counter, a move aimed at making the devices easily accessible.

On Wednesday, the regulations prompted many businesses to announce the availability of hearing products in thousands of stores across the United States this fall. Some electronic product retailers already started offering online hearing assessment tools.

The FDA said it will allow people with mild to moderate hearing loss to buy devices from retailers without requiring a medical exam, prescription, or fitting adjustment, but it will continue to regulate the quality of OTC devices.

The federal agency also noted that OTC devices could be available as early as mid-October when the new policy takes effect. People with severe hearing impairment and those younger than eighteen will still require prescriptions.

The new category of OTC devices opens the door for new products to be sold, yet, many retail stores have been already selling hearing devices such as personal sound amplification products, TV amplifiers, and hearing protection devices.


FDA Regulation to lower cost of hearing devices

According to the FDA, the new regulation is expected to make hearing aids more affordable, benefiting nearly thirty million people in the United States, mostly older adults, who suffer from hearing loss.

According to the National Council on Aging, an advocacy group, the price of standard hearing aids, which often includes a consultation with an audiologist and a fitting, can be up to as much as $7,000 per pair without insurance.

The high cost of the devices discourages people from seeking help, Health and Human Services Secretary Xavier Becerra told reporters on Tuesday.

Becerra said that “today’s action should help make hearing aids not only more accessible but truly more affordable.”

As per the new rule, the agency estimates consumers will save about $1,400 per individual hearing aid or more than $2,800 per pair, Brian Deese, director of the White House National Economic Council, said during a briefing.

In some stores, customers will be able to purchase the devices using health savings accounts and flexible spending accounts, yet, some insurance providers cover the costs of the device.

Consumer advocates in the US have for years complained that the cost of hearing devices is too high in the U.S., calling on regulators to implement new rules that allow for over-the-counter devices.

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