Over-the-counter hearing aids are coming - what does that mean for you?

Devices soon will be available without a doctor’s visit or prescription.
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Come fall, hearing aids will be as easy to buy as earbuds.

The U.S. Food and Drug Administration will make hearing aids available over-the-counter beginning Oct. 17 — a move President Joe Biden says will make the devices more affordable and give Americans “more choices to improve their health and well-being.”

According to the National Institute on Deafness and Other Communication Disorders, about 28.8 million American adults could benefit from using hearing aids. Only about one-fifth of the people who could benefit from the devices actually seek them, however, according to the FDA.

But not everyone with hearing loss should run to the local pharmacy or electronics store and pick up a pair of hearing aids, UCLA Health experts say.

“The fact that over-the-counter hearing aids could expand access for those who have hearing loss is definitely a good thing. We encourage people to pay attention to their hearing health,” says Narine Oganyan, director of Audiology and Speech Pathology at UCLA Health. “We want to make sure that patients and consumers make informed decisions — over-the-counter hearing aids are appropriate for certain patients and are not appropriate for others.”

Over-the-counter hearing aids are intended for mild to moderate hearing loss in adults 18 and older, according to the new FDA rules. No doctor visit is needed.

What’s the typical hearing-aid process?

Traditionally, hearing aids are fitted and prescribed by a hearing specialist, such as an audiologist or a licensed hearing-aid dispenser. An individual who suspects that they have hearing loss, or has been told by loved ones that they appear to have difficulty hearing, should undergo a hearing test to determine whether a hearing aid is recommended, says Gina Gracia, AuD, Audiology Manager at UCLA Health.

Based on the individual’s test results, lifestyle, hearing needs and budget, the specialist will recommend an appropriate hearing aid, which would then be programmed specifically for the patient’s hearing deficiencies.

Patients have 45 days to trial these new hearing devices, and per state-mandate, it is permissible to return these devices for a full refund within this period, Gracia says. This trial period only applies to prescription hearing aids.

“Hearing aids are not like eyeglasses, where you put them on and everything is immediately clear,” Gracia says.

It takes a while for the brain to get used to the volume and diversity of sounds hearing aids restore, she says.

"We want to make sure that patients and consumers make informed decisions - over-the-counter hearing aids are appropriate for certain patients and are not appropriate for others."

narine oganyan, director of audiology and speech pathology at ucla health

“It’s almost counterintuitive, but you have to wear the hearing aids daily so that your brain can adjust to these ‘new’ sounds and can relearn how to filter unwanted noise in order to focus on what you need to hear, such as conversation,” Gracia says. “So it’s a learning process. It’s not an instant, overnight solution.”

Hearing aids at the UCLA Audiology clinic range from $650 to $3,250 per device.

The over-the-counter hearing aid process

Though FDA rules are still being finalized for over-the-counter hearing aids, it appears these devices will be available at various price points and with differing levels of customization. Some will come with “presets” a user can choose from to help the device best fit their needs. Others will include a smartphone app to administer a hearing test that helps customize the hearing aids based on test results.

It’s unlikely that audiologists will be allowed to adjust over-the-counter hearing aids, Gracia says, so it’s important for consumers to understand what modifications are available in the model they choose, what kind of tech support exists and return-policy details.

The starting price for over-the-counter hearing aids is lower than those available through an audiologist. One company offering hearing aids approved for over-the-counter sale will retail for $899 a pair.

The accessibility of over-the-counter hearing aids may encourage more people to address their hearing loss, Oganyan says.

“Another benefit of over-the-counter hearing aids is that they can provide an option for those who would otherwise disregard or postpone addressing their hearing problems. This may be because they don’t want to reveal their hearing difficulties or don’t want to deal with intervention. In this case, they have the option of walking into a store, purchasing a pair and discovering that they are getting some benefit from using these over-the-counter hearing aids,” she says.

That initial success could lead them into an Audiology or Hearing Aid Dispensing office for more customized help.

“This may be a pathway for consumers to actually do something about a hearing problem that they may have been ignoring for years,” Oganyan says.

Stigma of hearing loss

People often delay seeking hearing help or deny there’s a problem because of negative associations with hearing loss and hearing aids. Age is the strongest predictor of hearing loss among adults, especially those 60 and older.

“There’s a stigma against having hearing aids because most associate hearing aids as a sign of aging,” Gracia says. “I tell my patients: What’s more embarrassing is answering a question wrong because you mishear it, not being able to participate in a conversation, or taking missteps because of not hearing or inaccurate hearing.”

The earlier someone with hearing loss begins using a hearing aid, the better, she says, because the period of adjustment to amplified sound is typically quicker and easier.

Who should not use over-the-counter hearing aids?

Over-the-counter hearing aids are not for everyone, Oganyan notes. They should not be used by:

  • Children younger than 18.
  • People with moderately-severe to profound hearing loss.
  • People with sudden hearing loss.
  • People who have fluid or blood coming from ear(s).
  • People with hearing loss or tinnitus in one ear.
  • People experiencing severe dizziness.
  • People with abnormal ear anatomy.

People experiencing sudden hearing loss, severe dizziness or those who have fluid or blood coming from their ears should seek medical attention right away, Oganyan says.

Anyone who has concerns about their hearing, she adds, could also speak to their primary care physician, who can then refer them for a hearing test.

Learn more about UCLA Health Audiology Services.

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