Historic hearing aid ruling could help 'those four-out-of-five people' who go untreated

The Food and Drug Administration (FDA) recently issued the approval of over-the-counter (OTC) hearing aids, which will enable Americans with mild to moderate hearing to buy hearing aids without a prescription.

Given that about 38 million Americans experience some degree of hearing loss as of 2018, the momentous ruling will help address hearing loss for a massive group of people in need.

“As only one out of five people who have hearing loss actually wear hearing aids, we are always seeking ways to reach those not currently treating their hearing loss,” Michael Halloran, president of Beltone, a leading provider of hearing aids in the U.S., told Yahoo Finance. “Over-the-counter hearing aids will help us to reach those four-out-of-five people so they can start their hearing care journey sooner.”

Prior to the ruling, the average price for a new model of hearing aid in 2022 was approximately $3,000, according to the Hearing Tracker, and overall prices ranged between $1,500 to $6,000. Most insurance companies and traditional Medicare do not cover hearing aids, and only a medical examination with an audiologist could lead to the consumer using a hearing aid.

OTC hearing aids will now likely cost $250 to $1,000 per device while consumers could save nearly $2,800, according to the American Association of Retired Persons (AARP).

The FDA’s latest rule to allow hearing aids to be sold over the counter will make it easier for millions of Americans to receive the care they need.

Every American has a right to receive affordable health care, and we have taken another step forward to protect that right.

— Kamala Harris (@KamalaHarris) August 23, 2022

Recovery from pandemic losses

The U.S. imports most of its hearing aids from Vietnam, China, Mexico, and Poland, according to the U.S. Trade Census.

With the trade restrictions brought on by the coronavirus pandemic, however, monthly imports dropped to a third of the volume, the lowest level in over a decade.

In total, hearing aid sales fell by 18% in 2020, according to the Hearing Industries Association, thanks to shipping delays and roughly 100 new global trade concerns reported to the World Trade Organization (WTO).

The lack of supply has unintended financial consequences for those with hearing loss as well. According to the Hearing Loss Association of America, “those with unaided hearing loss earned on average $20,000 less annually than those who used hearing aids or cochlear implants.”

New players in the market

The new FDA ruling now opens the door for electronics companies to enter the OTC hearing aid market, which had already shown signs of innovation through bluetooth and app-controlled devices.

In early 2021, Bose launched a “direct-to-consumer” self-fitting hearing aid with sound control from an app, the first-ever approved by the FDA, priced at about $850. The product lasted about a year before Bose retracted it from the market in May 2022.

The buzz around hearing aids in tech companies has continued as Apple (AAPL) was reported to be researching the use of AirPods as a health device.

Keith Lind and Claire Noel-Miller from the Public Policy Institute at AARP said that the FDA ruling will “increase competition, decrease cost, increase the pace of innovation, and expand the market.”

“While increased competition is expected to drive down prices for hearing aids, expanded access through retail outlets is also expected to increase sales volume,” they told Yahoo Finance in a statement. “Overall, FDA estimates that consumers will save about $63 million per year due to increased hearing aid use, innovation, and reduced health risks. However, this estimate appears conservative. In the long run, consumers may save substantially more than this.”

Tanya is a data reporter for Yahoo Finance.

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