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Hearing loss can increase your risk for a variety of health conditions. Getting a hearing aid can help. Getty Images
  • Hearing loss affects millions of Americans, but high costs prevent many from purchasing hearing aids.
  • Later this year, the FDA is expected to release requirements for over-the-counter (OTC) hearing aids meant for people with mild to moderate hearing loss.
  • Experts recommend that you visit an audiologist to help you choose the best option before purchasing an OTC device.

When you think about improving your health or quality of life, do your ears come to mind? Probably not.

But hearing loss affects 48 million Americans. That number is expected to rise to 73 million by 2060.

Trouble hearing often has a larger impact on lives than just missing out on conversations. Hearing loss is associated with increased risk of falling, depression, and dementia.

Yet, only about 1 in 5 people who could benefit from hearing aids wears one.

“The majority of people with untreated hearing loss are the people who don’t actually recognize they have a problem and therefore are not seeking help,” explains Catherine Palmer, PhD, president of the American Academy of Audiology and director of audiology for the Integrated UPMC Health System.

The rest of the untreated group realize they have hearing loss but don’t pursue hearing aids for various reasons, be it stigma or cost.

Historically, hearing aids have been rarely covered by private health insurance, Medicare, or Medicaid — keeping them financially out of reach for many who could benefit from them.

The Over-the-Counter Hearing Aid Act, a law sponsored by Senator Elizabeth Warren and passed in 2017, is set to change that by increasing accessibility for people with mild or moderate hearing loss by encouraging over-the-counter (OTC) hearing aid options.

While the average cost of prescription hearing aids is about $4700 for a set, they can range from about $1600 to $8000, depending on the model, technology, and options. New OTC options could be as low as $200, but Palmer believes are likely to range from about $600 to $1000 per set.

While these less expensive OTC hearing aid options will remove barriers to buying a hearing aid, there are also several expected challenges that consumers and the audiologist community will have to navigate.

Currently, there are several OTC hearing devices available, including personal sound amplification products (PSAPs) and hearing aids approved by the Food and Drug Administration (FDA). But these current products marketed as OTC hearing aids haven’t gone through review under the new OTC hearing aid law requirements.

Right now, the language used to market OTC devices can be confusing for consumers to navigate because there’s no set terms as to what each term — from PSAP to hearing aid — means, according to Dr. Ana Kim, an otolaryngologist at Columbia Doctors and associate professor of otolaryngology at Columbia University Medical Center.

The FDA is expected to provide initial language around OTC hearing aid requirements no later than this fall, going into effect no later than spring 2021, according to Palmer.

Specifically they may include guidance on how loud they can be, labeling, tuning capabilities, and technical support. Most current OTC hearing devices don’t have fine-tuning controls, although it’s unknown what future requirements will be.

As some of these devices are expected to be pre-programmed and come with apps to help consumers adjust them, the level of required support will be a key component of the new regulation.

“It is most important that these individuals can access audiologists when they need help navigating a myriad of choices of devices or when they need help using these devices. We know that the amplification device is only part of a hearing solution. The services/support that is needed is just as important,” Palmer says.

Adjusting for hearing is much more complicated than for vision, making it challenging for people to finely tune their own hearing devices.

“With vision, you’re looking at one variable: Is vision clear or blurry? When we test [hearing], we test every frequency, from 125 hertz to 8 kilohertz, that allows us to appreciate everything from music to speech,” Kim explains.

When fitting someone for a hearing aid, you then have to set each frequency’s maximum comfort level and maximum threshold level — and fine-tune it for each individual’s hearing loss patterns and even ear canal shape.

Beyond the complex tuning process, the process of hearing loss is typically so gradual that the brain adapts to a new reduced input. Living with this new normal means that adjusting a hearing aid to proper levels can be nearly impossible for individuals to do on their own.

“When we do a good job bringing back sound across frequency and across input levels, the person will not like the sound for a week or so until the brain adapts to this ‘new normal,’” Palmer says.

“If you had the person do this themselves or asked them how things sounded, you would slowly tune the hearing aid to mimic the hearing loss because this is what the person considers normal until they are exposed to the correct levels of sound,” Palmer states.

Difficulties self-tuning are problematic in part because individuals might think that hearing aids just aren’t helpful for them and stop seeking additional medical care, Kim expresses.

“Over-the-counter options open the floodgates in terms of accessibility, but they may increase discouraged thinking if patients try one kind of hearing aid [have a bad experience] and then stop using them altogether,” says Kim.

When you have an audiologist, they can troubleshoot for you. But Kim worries that people who purchase OTC hearing aids won’t have that option.

Palmer believes that it would be ideal for audiology clinics to have OTC hearing aids options available, since it would provide them with the go-to support they’ll need in the future.

Both Kim and Palmer agree that OTC options make the most sense for individuals with mild to moderate, situation-specific hearing loss.

Still, both strongly encourage individuals to visit an audiologist before purchasing an OTC option, once they’re available.

“Over-the-counter hearing aids shouldn’t replace getting a baseline hearing test. Then, your doctor can educate you on whether there’s a good OTC option for you,” Kim says.