Aug. 3, 2023 – Ashley Bundy realized that not everyone around her could be mumbling and there must be another reason she was having trouble hearing them. 

At 31, Bundy is now among those U.S. adults who have taken advantage of the availability of over-the-counter hearing aids. When she was diagnosed earlier this year with mild to moderate hearing loss, she was told she may have to spend upwards of $10,000 on hearing aids. After extensive research, she bought a pair over the counter for $1,300 that she controls with an app on her phone.

“Ten thousand dollars is the price of a car,” said Bundy, who lives in Minnesota. “We shouldn’t be punished for not being able to hear.”

Now that she has them, Bundy realized how many things she couldn’t hear before, down to the buzzing overhead lights at the hardware store where she works.

But for some – particularly those with more complex hearing loss – the option to bypass an audiologist makes the process more overwhelming and confusing.

The FDA estimates that close to 30 million adults in the U.S. have some degree of hearing loss, but only about 20% seek help. Many people still aren’t familiar with the products and often are unsure whether they should try them.  

Though it is too early to know any solid data, anecdotally audiologists are reporting increased appointments related to hearing testing and discussion of options, said Catherine Palmer, PhD, past president of the American Academy of Audiology and director of audiology at the University of Pittsburgh Medical Center.

Palmer said the sheer volume of available products might be a barrier in itself. There is compelling data, Palmer said, that shows “people become overwhelmed with too many choices and therefore make no choice,” she said. “Basically, people want choices, but not this many.”

She added that audiologists are reporting more people coming in with hearing aids that they have purchased but are not sure how to use.

“I consider this really still day one of the market,” Kelley said. “I think it’s consumer confusion of who these are for. It’s another pathway to care, but the market needs to play out. We’re just at the beginning.”

A randomized trial of almost 1,000 adults aged 70-84 with untreated hearing loss – who also had dementia-related risk factors like diabetes and high blood pressure – found that hearing aids could cut the risk of Alzheimer’s and other dementias by half. It is the largest study on the subject to date. 

The results, presented at the Alzheimer’s Association International Conference (AAIC) 2023 and published online July 17 in The Lancet, are bolstering a recent push from advocates and hearing experts for more awareness of hearing loss as a public health issue – one that is often neglected. 

“Typically, we see it takes people about 5 years after experiencing hearing loss to take a step,” Kelly said. “Hearing health is so much a part of overall health. We need to protect it, screen for it, be aware of it.”

The best candidates are adults with mild to moderate hearing loss whose devices don’t need to be programmed or fitted and are comfortable making any adjustments on phone apps. 

According to the American Academy of Audiology, proposed regulations from the FDA do not require that that hearing aids be returnable but do require that device packages state the return policy. For those who have not had a hearing test or are unsure about whether over-the-counter hearing aids are right for them, it is important to select hearing aids that can be returned. 

The academy says if you have any of these conditions, you should not get over-the-counter hearing aids: 

• Malformed or misshapen ear since birth or due to trauma.
• History of drainage from the ear within the previous 90 days.
• History of sudden or rapidly progressive hearing loss within the previous 90 days.
• Dizziness just experienced or experienced over a long time.
• Hearing loss in only one ear or sudden or recent onset of hearing loss within the previous 90 days.
• Significant ear wax accumulation or a foreign body in the ear canal.
• Pain or discomfort in the ear.

Despite customer confusion, Palmer said having hearing aids easily available, at the very least, leads to more interest from consumers in their own hearing health.

“Some may start to look at over-the-counter hearing aids and become overwhelmed and therefore seek professional assistance,” Palmer said. “Others may see all of this advertising and be motivated to have a hearing test to start the process.”