Hearing aids now available over the counter: Here's what you should know

A new Food and Drug Administration rule went into effect Monday creating a category of over-the-counter hearing aids, effectively allowing the sale of the devices at retailers and pharmacies, as opposed to solely from audiologists.

The rule is intended to increase accessibility and provide an affordable alternative to hearing aids from audiologists, which can be expensive and require a medical examination, a fitting, and a prescription, according to the FDA.

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“I wrote the law that gives people access to safe, effective, and affordable hearing aids over-the-counter — and today, 30 million Americans with mild to moderate hearing loss can buy hearing aids right off the shelf or online,” U.S. Sen. Elizabeth Warren, D-Massachusetts, said in an email to the Times. “This is a life-changing win for millions of Americans — expanding access to hearing aids and lowering costs by thousands of dollars.”

U.S. Sen. Elizabeth Warren, D-Massachusetts, speaks during an August visit to Wellfleet.
U.S. Sen. Elizabeth Warren, D-Massachusetts, speaks during an August visit to Wellfleet.

Who should get an over-the-counter hearing aid?

Over-the-counter hearing aids are intended for adults over the age of 18 with mild to moderate hearing loss, according to Shauna Nelson, press officer at the FDA.

The hearing aids are customizable and controlled by the user, Nelson said in an email to the Times. They can include self-assessment hearing tests and wireless technology, she said.

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"An individual who truly has mild hearing loss and needs assistance in specific listening situations and who can manage the self-fitting may find that an OTC (over-the-counter) Hearing Aid meets their needs," said Catherine Palmer, past president of the American Academy of Audiology in an email correspondence with the Times.

Why buy an over-the-counter hearing aid?

Over-the-counter hearing aids are less expensive than traditional devices. According to the American Academy of Audiology, the current cost estimate for over-the-counter hearing aids is between $300 and $600.

Untreated hearing loss can be linked to depression and cognitive decline, according to the academy. Only one in four adults who could benefit from hearing aids has ever used them, according to the National Institute on Deafness and Other Communication Disorders.

The FDA expects over-the-counter hearing aids to improve accessibility to hearing aids, Nelson said.

How do I know if I have mild/moderate hearing loss or severe hearing loss?

One way to determine the severity of your hearing loss is to get a hearing test done by an audiologist.

However, there are some characteristics of mild to moderate hearing loss you can identify, according to the National Institute on Deafness and Other Communication Disorders. The characteristics include when speech sounds muffled, when you have trouble hearing when in a group, when you turn up the TV volume higher than others and when you ask others to speak more slowly or repeat what they said.

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More severe hearing loss should be checked out by a hearing health professional. Severe hearing loss indications include difficulty hearing conversations even in quiet settings and trouble hearing loud sounds like car horns or loud music.

How do I find the right over-the-counter hearing aid for me?

According to the FDA, consumers can find over-the-counter hearing aids available in retail and drug stores starting mid-October.

One way to pick out the right one for you is to get a test done by an audiologist and discuss over the counter options with them, according to the American Academy of Audiology.

However, if a test by an audiologist is not possible, the customer should read product reviews and research, and then consider what they want from the over-the-counter hearing aid.

Leanne Fletcher, an audiologist at Advanced Audiology Associates Inc. in Marstons Mills, said customers should make sure they are able to return the over-the-counter hearing aid if it doesn’t fit.

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The effectiveness of an over-the-counter hearing aid will depend on an individual's self-fitting, Palmer said. People in general cannot accurately determine their own level of hearing loss or the effectiveness of a device, she said.

The brain will likely take several weeks to adjust to any returned audibility, since the brain had previously adapted to the hearing loss, she said.

Are there any risks to using an over-the-counter hearing aid?

Over-the counter hearing aids do not require a customer to take a hearing test. However, all patients should take hearing tests before considering buying a hearing aid, according to Fletcher.

Some hearing loss may be medically treatable, while people with severe hearing loss should not buy over-the-counter hearing aids, she said.

“If people don’t have a hearing test they don’t know if they’re a candidate, or if they need medical intervention, or they may not benefit from an over-the-counter hearing aid,” Fletcher said.

Additionally, over-the-counter hearing aids are not customized for the patient like prescription hearing aids are, she said.

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Fletcher said buying an over-the-counter hearing aid without getting a medical examination runs the risk of not addressing a treatable condition that affects hearing.

Over-the-counter hearing aids can also achieve noise levels that may be damaging over time, Palmer said.

Over-the-counter hearing aids must be FDA approved, Nelson said.

Contact Asad Jung at ajung@capecodonline.com. Follow him on Twitter @asadjungcct

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This article originally appeared on Cape Cod Times: What you should know about over-the-counter hearing aids