Yahoo Movies Over-the-counter hearing aids are available now—what to know before buying, according to Reviewed experts
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A new regulation passed by the FDA means over-the-counter hearing aids are now more accessible for millions of Americans. As of October 17, instead of being forced to visit an audiologist and shelling out thousands of dollars for the added expense, consumers can buy hearing aids that are FDA-certified from any major retailer like Amazon, Walmart or Best Buy without needing a prescription.
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►Hearing aids: Here's everything you need to know
What this means for hearing aid users
The new regulations remove barriers, and potentially reduce costs, for those seeking medical-grade hearing aids. Instead of having to pay for a specialist and get a prescription, anyone can purchase tested hearing aids from any retailer at which they are sold.
"When my husband got his first set of hearing aids in his late 20s, we (laughably) thought they would be the silver bullet that solved our communication problems," says Sarah Kovac, Accessibility Editor at Reviewed. "They made a huge difference, but it never ceased to surprise me how many issues we’ve had with them despite their thousands-strong price tag. 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."
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 (as opposed to bone conduction) hearing aids, the most common type of hearing aid. That guidance was officially released in 2018.
The most recent change is that the FDA has formalized these guidelines by establishing some basic rules. Over-the-counter aids are still 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.
Under these new rules it is technically possible for manufacturers of any kind to make and sell an FDA-licensed hearing aid provided the product passes a rigorous testing procedure. That testing, however, still figures greatly into how expensive that new pair of hearing aids will be.
► Related: FDA allows over-the-counter sales of hearing aids without doctor exam or referral
► More: Are OTC hearing aids available yet? What to know about when (and where) you can get them.
Will this make hearing aids cost less?
Not necessarily. On average, a pair of prescription 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.
You also can’t rely on your health insurance to pick up the costs either. There is no hearing aid coverage through Medicare parts A or B. Private health insurance may also require additional costs to buy hearing aids 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.
Even though these new guidelines establish a process by which over-the-counter hearing aids can be sold, the need for an audiologist and prescription is the only part of the process being removed. Testing for these products must still happen to an intense degree for full FDA approval, and those tests don’t come cheap. So, while hearing aid costs may decrease somewhat with these new laws in place, users shouldn’t expect a night-and-day difference now that the changes have gone into effect.
What to know before buying over-the-counter hearing aids
Even as we wait for the FDA’s new hearing aid regulations to affect the market as a whole, some hearing aids are already available for purchase over the counter. This only applies to air conduction hearing aids, and only to users over 18 years of age.
Some popular FDA-certified brands include:
Through the purchase process you may also see a wide range of phrases relating to the FDA, like “FDA-registered” or “FDA-approved.” 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. The FDA also doesn’t issue direct approvals of products; they set rules for quality control and performance and check these are met.
If a hearing aid manufacturer jumped through all the hoops needed to get an FDA medical device classification, that means certain standards are expected. These include accurate labeling, quality control, checks that the device functions as promised and basic safety tests.
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.
For that step, we suggest consulting the FDA’s own 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.
While it’s possible you may see hearing aids cost as little as $100 at some retailers, these haven’t passed through any serious medical muster. As great as the price may look, it’s probably too good to be true. It's likely these are simple amplifiers and lack the capabilities of real hearing aids. But if you follow these simple checks, you’ll find the safest hearing aids available in this brave new world of over-the-counter options.
Where to buy over-the-counter hearing aids today
With the new FDA over-the-counter hearing aid regulations officially in effect, there are a few major retailers beginning to sell hearing aids and amplifiers. We recommend searching within the above-linked FDA databases to ensure you’re getting the best quality products, but here are some options.
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Prices were accurate at the time this article was published but may change over time.
This article originally appeared on Reviewed: FDA over-the-counter hearing aids: What new laws mean and where to buy
