• Slug: BC-CNS Over the Counter Hearing Aids, 715 words.

By Jenna Sauter
Cronkite News

PHOENIX – Before Cliff Mills, 75, began wearing hearing aids 15 years ago, he couldn’t have expected to spend $5,000 on his first pair. But asked whether the cost was worth it, he responded: “I would have paid more.”

“On wearing my first pair of aids on the first day, I could hear birds and so many other long forgotten sounds. … It took time to get used to hearing them all,” said Mills, a retired event planner who lives in Montrose, Colorado.

About 15% of adults in the U.S. have some trouble hearing, according to federal statistics, and nearly 30 million people 18 or older could benefit from using hearing aids.

Nevertheless, even among older adults, those 70 or older, only 30% of those who would benefit from a hearing aid use one. Among younger adults, the number is 16%.

Why the low rates? Comfort and stigma are two reasons – some people don’t want to admit they need help hearing. But the biggest barrier may be what Mills encountered, which is lack of insurance coverage and the exorbitant costs.

“When I first thought about wearing hearing aids, there was a stigma,” Mills said. “Embarrassment was part of my issue; cost was also an issue.”

Hearing aids can cost $1,000 to $5,000 or more per device, and insurance usually does not cover the cost.

Efforts have been underway for years to make hearing aids available over the counter in stores and online, without an exam or professional fitting. The aim is to spur competition, lower costs and increase availability, especially for those who can’t afford the devices now.

In 2017, Congress passed legislation directing the Food and Drug Administration to develop regulations establishing over-the-counter hearing aids. Last fall, the agency issued proposed regulations, but a final rule, which must be decided by mid-July, still is pending.

“Given the complexity of the issues and the number of interested stakeholders, finalizing the rule for over-the-counter hearing aids will take time,” FDA spokeswoman Shirley Simson told Cronkite News in an email. “The FDA is continuing to prioritize this rulemaking and will work expeditiously to issue the final rule.”

The over-the-counter devices would be available for adults 18 and older who have mild to moderate hearing loss. The proposed rule includes volume limits to help prevent injuries, and aids for severe hearing loss or for users younger than 18 still would require a prescription.

The FDA proposal garnered more than 1,000 public comments, both for and against.

The American Academy of Audiology, representing about 14,000 audiologists in the U.S., wrote in opposition, saying the proposal “does not offer any assurance of reasonable safety measures. Rather than ‘protecting the public health,’ these regulations as drafted may instead put at risk the very people they are supposed to benefit.”

The Federal Trade Commission, on the other hand, is among the groups supporting the proposed guidelines. “Enhanced competition and innovation will make lower-priced hearing aids available to the millions of American health care consumers who live with untreated hearing loss,” FTC officials said.

While the final rule is pending, the Chicago hearing aid company Beltone is one getting ahead of the curve, teaming with audio equipment manufacturer Jabra to develop a pair of self-fit hearing aids that look like earbuds.

Users with mild to moderate hearing loss can calibrate and customize sound enhancement using their iPhones. A pair starts at $799, although an in-person consultation is necessary before purchase.

“The person is essentially programming it themselves just by listening to sounds play out and then hitting a button on their phone on an app,” said Kory Castro, a hearing aid specialist and a co-owner of Beltone clinics in Arizona.

“If you’re at a restaurant or at the bar, or in a meeting, and you just need a little bit of help understanding conversations, you can pop them out of the case and put them in your ear and just get help when you need it,” Castro said.

Whether a person requires hearing help in certain environments or all the time, Castro and other hearing specialists emphasized the importance of regular checkups.

“The thing that I really hound people on is just to have your hearing tested,” Castro said. “If they feel like they might have an issue … most hearing care centers will do a free hearing test.”

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