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.
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.
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.