After a long delay, the Food and Drug Administration issued final regulations Aug. 16, 2022, for over-the-counter 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 new class of hearing aids
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.
In 2017, the FDA Reauthorization Act designated a new class of hearing aids available over the counter to increase the accessibility and affordability of hearing aids for U.S. adults who believe they have mild to moderate hearing loss. These OTC hearing aids could be purchased without a medical evaluation by a physician or a fitting by an audiologist.
Before publishing the final rule, the FDA reviewed over 1,000 public opinions during the open comment period. The final ruling takes into account 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% of Americans live within 5 miles 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.