The Food and Drug Administration (FDA) recently issued a rule that allows hearing aids to be available over-the-counter (OTC). This rule enables consumers who perceive themselves to have mild to moderate hearing loss to buy hearing aids from stores or online retailers without a medical exam or prescription.
This rule, which took effect October 17, is expected to make hearing aids more accessible to the public, but many questions remain unanswered: what does it mean to have perceived mild to moderate hearing loss; what can we expect from this new category of hearing aids; and how can audiologists and hearing specialists help even when there isn’t a need for a hearing exam to obtain these devices? Enrique Perez, MD, Assistant Professor of Otolaryngology at the New York Eye and Ear Infirmary of Mount Sinai, shares his thoughts on the FDA rule and the benefit OTC hearing aids can bring to consumers.
Who might benefit most from this new rule?
Older adults who have noticed they are struggling somewhat with hearing in their day-to-day activities would likely benefit the most. The rule applies to people age 18 and older with perceived mild to moderate hearing loss, which can be subjective to quantify without an exam. The OTC devices would likely be suitable for people without serious otologic (ear) disease, frequent discomfort in the ear, or ear infections.
What devices are covered under the rule?
The rule covers air conduction hearing aids, which mimic the way we naturally hear but deliver amplified sound to the inner ear. This is opposed to bone-anchored hearing aids, which require surgical implantation, or personal sound amplification products, which are not mean for impaired hearing but are intended for people with normal hearing to amplify sounds in certain situations.
It remains to be seen how OTC hearing aids will eventually be labeled, but it is important that the labels are comprehensive, to ensure that individuals are not misled. For example, an OTC label could point out that the product is different from a prescription hearing aid and that if you are not seeing a benefit, you should be evaluated by a specialist.
How might an audiologist help?
Hearing aids becoming available over the counter doesn’t necessarily mean there is no longer any need for an audiologist. As more people have access to hearing aids, we might start to see a big chunk of these people we might not ordinarily see in clinic.
Enrique Perez, MD
How can I tell if I might have mild to moderate hearing loss?
There are clearly defined levels of hearing loss, which are determined through hearing exams, known as audiograms, on the decibels individuals are able to hear. But without an actual audiogram, you would have to rely on subjective cues, Dr. Perez said.
Someone with mild hearing loss might be struggling to hear low rumbling sounds or people whispering or speaking in another room.
Moderate hearing loss could look like someone with difficulty hearing people talking at a low tone, or struggling to understand conversation in a quiet office.
People with mild or moderate hearing loss might also struggle to hear conversations in a noisy environment, like a busy restaurant.
A key takeaway: If you’re struggling to hear in your daily activities, you might have some form of hearing loss, and hearing aids could be suitable for you.
For example, someone might try an OTC hearing aid and notice it is not amplifying sounds the way it needs to. An audiologist in this situation might be able to classify the degree of hearing loss and point the patient to the right kind of device they need.
Audiologists specialize in managing prescription devices, adjusting to each patient’s condition. Hearing loss can be complex: some people have very good hearing in the low frequencies but poor hearing in high frequencies, and a specialist can account for those nuances.
A possible limiting factor of an OTC hearing aid could be comfort. Everyone’s opening of the ear canal can be quite different. Audiologists work with making ear molds to make the fit more secure and comfortable. However, it is not clear how billing would work for mold services at this point, especially regarding OTC devices.
What might the future of hearing aid access look like?
In the long term, I hope to see that as more OTC hearing devices enter the market, competition will drive down the price of the technology in general. Perhaps it could even reduce the prices of prescription hearing aids.
It’s sad to tell a patient that they could benefit from hearing aids, but because most insurances do not cover these devices, they are shut out. These devices are pretty expensive, even at wholesale prices. The cheapest ones could run around $800, and expensive ones could easily run north of $5,000. This is not pocket change for a retiree on fixed income.
There also has to be a system for consumers to try out and return OTC hearing aids, just as they can try on reading glasses at the pharmacy. Some dispensers of prescription hearing aids do 30- to 90-day trials; perhaps there’s some way OTC devices can have a similar return policy. Finally, as a physician, I want to see OTC hearing aids rolled out in a safe manner, with adequate patient education and labeling to ensure people don’t end up getting hurt. There needs to be proper education of when these devices are suitable and for what kind of patient.