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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, audiologists might start to see a big chunk of these people we might not ordinarily see in clinic.

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