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At Long Last, the FDA Allows Over-the-Counter Purchases of Hearing Aids – Yet Many Questions Remain Unanswered

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Here at AgingOptions, we like to keep an eye (or should we say an ear) on certain developing stories of interest to aging adults – and this particular one has been developing in slow motion! Since 2017 the experts at the Food and Drug Administration have supposedly been working on new regulations to allow consumers to buy hearing aids over the counter, supposedly at a far lower cost and without referral from an audiologist.

Finally, according to this article from USA Todaythe big debut of the new law is just about here. By October, your new hearing aid could be as close as your nearest Costco, Walmart, or Amazon delivery van. But will the new devices work as advertised? Will consumers really save money? And will your insurance cover the cost? The USA Today article has some answers for eager but confused consumers.

Barriers Coming Down – and Cost as Well

Thanks to a new regulation passed by the FDA, easily accessible over-the-counter hearing aids may become a reality for millions of Americans for the first time. The article explains, “Come October, instead of being forced to visit an audiologist and shelling out thousands of dollars for the added expense, hearing aid users will be able to purchase FDA-certified hearing aids from any major retailer like AmazonWalmart or Best Buy without needing a prescription.”

The new regulations “remove barriers, and potentially reduce costs,” for those in need of medical-grade hearing aids, without the need to pay extra for a specialist and prescription.

High Cost, Technical Challenges Plague Users

Sarah Kovac, Accessibility Editor at Reviewed, explained her own experience with hearing aids, through her husband. “When my husband got his first set of hearing aids in his late 20s, we thought they would be the silver bullet that solved our communication problems,” Kovac writes. “They made a huge difference.”

Still, the experience was frustrating. “It never ceased to surprise me how many issues we’ve had with them despite their thousands-strong price tag,” she adds. “Parts need to be replaced, audio settings need to be recalibrated by the audiologist and there are periods of nearly constant squealing from feedback. These shortcomings persist despite being told he had the best hearing aids on the market.”

Changes in the Law Began in 2017

This change to allow OTC purchases of hearing aids has been a long time coming. The USA Today article states, “In 2017, a law was passed requiring the FDA to come up with guidelines for supplying hearing aids directly to the consumer without needing a prescription or medical fitting. The law would only apply to air conduction hearing aids, the most common type of hearing aid. That guidance was officially released in 2018.”

In this most recent change, the FDA has formalized the implementation of these guidelines by laying down some rules: “Over-the-counter aids will still be restricted to air conduction hearing aids (both behind and in-ear). The central additional requirements are that the volume level must be able to be adjusted by the user, and the amplification level be limited to prevent accidental ear damage,” the article explains.

According to these rules, technically any manufacturer can make and sell an FDA-licensed hearing aid, as long as they pass a rigorous testing procedure for the product. This testing “figures greatly” into the product’s eventual price, according to USA Today.

Driving Costs Down – Or Not?

“Will the new rules drive down costs? Not necessarily,” the article cautions. “The average cost of a pair of hearing aids costs over $4,000. For good quality hearing aids, a large part of this cost comes from the components and required research and development. Another large slice is associated with obtaining the hearing aids from, and having them fitted by, an audiologist.”

Moreover, your insurance isn’t always a help in covering hearing aid costs. “There is no hearing aid coverage through Medicare parts A or B,” the article explains. “Private health insurance may also require additional costs to cover hearing loss or set limits on coverage. Check your state regulations, though, as some require coverage but have spending limits and may be restricted to specific age groups.”

In reality, the need for an audiologist and prescription is the only part of the current process being formally suspended under the new regulations. “Testing for these products must still happen to an intense degree for full FDA approval, and those tests don’t come cheap,” the article states. “So, while hearing aid costs may decrease somewhat with these new laws in place, users shouldn’t expect a night-and-day difference once the changes go into effect.”

Important Tips Before You Buy

The changes are already happening, though they’re small ones for now. Some air conduction hearing aids for users over 18 years of age are already available from brands including Bose, Phonak, and Lively. All are FDA-certified.

But that FDA verbiage comes with a caution. “Through the purchase process you may also see a wide range of phrases relating to the FDA, like ‘FDA-registered,’ or ‘FDA-approved,’” the article warns. “These words don’t really mean anything as far as certified scientific testing is concerned. FDA registration just means the FDA is aware the manufacturer exists.”

What’s more, the feds will never formally endorse a product. “The FDA also doesn’t issue direct approvals of products,” says USA Today; instead, “they set rules for quality control and performance and check [that] these are met.”

You Can Check for Proper FDA Clearance

The good news is that if a manufacturer does their due diligence to get the FDA certification, you can assume a certain high level of quality, including “accurate labeling, quality control, checks that the device functions as promised and basic safety tests,” according to the article.

But homework is required: “The only way to be certain a device has been through the FDA clearance process is to check whether the device or manufacturer shows up in official FDA databases.” The article suggests consulting the FDA’s Establishment Registration & Device Listing page.

“Type the brand name into the ‘Establishment or Trade Name’ field, and see if the listing for the product exists. If it doesn’t, you’re not dealing with a brand that’s been given proper FDA clearance,” the article explains. And be aware of prices that seem too good to be true. “While it’s possible you may see hearing aids for as low as $100 at some retailers, these haven’t passed through any serious medical muster.”

Many over-the-counter options already exist, so it’s worth looking around. You’ll find an extensive selection at retailers like Amazon, Walmart, and Best Buy. The article also includes other national retailers you may wish to investigate.

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Photo Credit: Flickr/Creative Commons  (by Eknath Gomphotherium)

(originally reported at www.usatoday.com)

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