The FDA Reauthorization Act of 2017 designated a new class of OTC hearing aids. They will become available in early October 2022. Maica/E+Getty Images
After a long delay, the U.S. Food and Drug Administration (FDA) issued final regulations Aug. 16, 2022, for over-the-counter (OTC) hearing aids. The final rule is effective 60 days from its publication, meaning that consumers could see OTC hearing aids hitting the shelves of community pharmacies nationwide by October 2022.
We are a pharmacist and audiologist who study the potential ways Americans with hearing loss can obtain OTC hearing aids. In a market dominated by only a handful of manufacturers, hearing aids that are now available without a prescription will expand access to the estimated 28.8 million U.S. adults who could benefit from their use.
A hearing aid is a device worn around the ear that makes desired sounds more audible for people with hearing loss. Hearing aid devices include a microphone, amplifier and miniature loudspeaker to make sounds louder. Traditionally, hearing aids have been accessible only with professional services provided by a licensed hearing aid dispenser or audiologist.
Before publishing the final rule, the FDA reviewed more than 1,000 public opinions during the open comment period. The final ruling considers a variety of comments related to maximum sound output, product labeling and user controls. Implementation of these regulations is a year overdue, largely because of the COVID-19 pandemic.
Pharmacists will play a key role in OTC hearing aid sales. For one, pharmacies are more accessible to Americans than audiology practices. Audiologists tend to be located in metropolitan areas with higher incomes, younger populations and greater insurance coverage, along with a smaller proportion of people who need hearing aids most — namely, older adults. In contrast, nearly 90 percent of Americans live within 5 miles (8 kilometers) of one of the more than 61,000 community pharmacies nationwide.
The ruling will also help get hearing aids into patients' ears more quickly. It typically takes an average of four to five years after people recognize their hearing loss before they see a health care provider, and sometimes an additional six years to obtain a hearing aid device. With this new law, people will be able to purchase OTC hearing aids as soon as they become aware of their hearing difficulties.
OTC hearing aids will offer a do-it-yourself approach to addressing hearing loss. For example, people might be able to use a smartphone app to measure and adjust the hearing aid to best fit their hearing needs. Traditional hearing aids require a professionally administered hearing test and technical features that may allow more customized fine-tuning.
Prohibitive costs and appointment hurdles have discouraged patients from obtaining hearing aids.
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Increased Access at Lower Costs
Hearing aid use among people who could benefit from their use remains low. The 2017 federal law may help remove barriers to hearing aid ownership by making them not only more accessible, but also more affordable.
At prices similar to monthly car loan payments, hearing health care services are often exclusive to people who have the means to pay high out-of-pocket expenses. Some hearing aids may be eligible for reimbursement using a flexible spending account.
There are also racial disparities in hearing aid use that could be mitigated by OTC hearing aids. Although Black Americans are more likely to have had a recent hearing test, they are less likely than white older adults to regularly use hearing aids. Such disparities can have potential negative consequences for health and quality of life, including a higher risk of cognitive impairment, dementia and falling, as well as social isolation, loneliness and depression.
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The Pharmacist's Role in OTC Hearing Aid Adoption
While OTC hearing aids won't require consultation with a medical professional or a hearing test, pharmacists will play an important role in ensuring their safe and effective use.
By providing a lower-cost and more readily available option, OTC hearing aids have the potential to address significant barriers to hearing aid adoption and use.
Community pharmacists may soon be able to help patients pick out a hearing aid at their local pharmacy.
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Lucas Berenbrokis an associate professor of pharmacy and therapeutics at the University of Pittsburgh, and Elaine Mormer is a professor of audiology at the University of Pittsburgh. Berenbrok and Mormer's article is republished from The Conversation under a Creative Commons license. You can find the original article here.
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Originally Published: Sep 21, 2021
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