After a long delay, the Food and Drug Administration issued final regulations for over-the-counter hearing aids on August 16, 2022. The final rule will be in effect 60 days after publication, meaning consumers will be able to see OTC hearing aids on the shelves of community pharmacies across the country by October 2022.
We are a pharmacist and audiologist studying the potential ways Americans with hearing loss can get OTC hearing aids. In a market dominated by only a handful of manufacturers, hearing aids now available over the counter will expand access to the estimated 28.8 million American adults who could benefit from their use.
A new class of hearing aids
A hearing aid is a device that is worn around the ear and that makes the desired sounds more audible to people with hearing loss. Hearing aids contain a microphone, amplifier and miniature speaker to make sounds louder. Traditionally, hearing aids are only accessible 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 can be purchased without a medical evaluation by a physician or an adjustment by an audiologist.
Before publishing the final rule, the FDA reviewed more than 1,000 public opinions during the open comment period. The final ruling takes into account a variety of comments regarding maximum sound output, product labels and user controls. The implementation of these regulations is a year late, largely because of the COVID-19 pandemic.
Pharmacists will play a key role in the sale of OTC hearing aids. First, pharmacies are more accessible to Americans than audiology practices. Audiologists are usually located in metropolitan areas with higher incomes, younger populations, and greater insurance coverage, along with a smaller proportion of people who need hearing aids the most, namely older adults. By contrast, nearly 90% of Americans live within a 5-mile radius of one of the more than 61,000 community pharmacies nationwide.
The ruling will also help hearing aids get into patients’ ears more quickly. It typically takes an average of four to five years after people recognize their hearing loss to see a healthcare provider, and sometimes another six years to purchase a hearing aid. This new law allows people to purchase OTC hearing aids as soon as they become aware of their hearing problems.
OTC hearing aids offer a do-it-yourself approach to addressing hearing loss. For example, people can use a smartphone app to measure and adjust the hearing aid to their hearing needs. Traditional hearing aids require a professionally performed hearing test and technical features that allow for more individual tuning.
Better access at a lower cost
The use of hearing aids among people who could benefit from them remains low. The federal law of 2017 can help remove barriers to owning hearing aids by making them not only more accessible, but also more affordable.
Prescription hearing aids cost more than US$5,000 per pair on average, while the American Academy of Audiology predicts that OTC hearing aids will cost $300 to $600 per device. The costs and services associated with prescription hearing aids, which require an average of two to three audiology visits, are typically not covered by Medicare, Medicaid, or private insurers. At prices comparable to monthly car loans, hearing care services are often exclusive to those who have the means to afford high out-of-pocket expenses. Some hearing aids may be eligible for reimbursement through a flexible spending account.
There are also racial differences in hearing aid use that can be mitigated by OTC hearing aids. While black Americans are more likely to have a recent hearing test, they are less likely than white older adults to use hearing aids on a regular basis. Such differences can potentially have negative impacts on health and quality of life, including a higher risk of cognitive impairment, dementia and falls, as well as social isolation, loneliness and depression.
The pharmacist’s role in OTC hearing aids
While OTC hearing aids do not require consultation with a medical professional or a hearing test, pharmacists will play an important role in ensuring safe and effective use.
Public pharmacists, one of the most accessible healthcare providers, are trained to identify, prevent and solve medication problems. In addition, pharmacists have long helped patients buy medical devices and equipment without a prescription, such as glucometers for diabetes testing and blood pressure monitors for hypertension.
Public pharmacists are preparing to help patients select and purchase OTC hearing aids. In certain cases, pharmacists will refer some patients to audiologists and physicians for additional evaluation, treatment, and care. They may also contact patients to ensure the device is working as expected. To prepare pharmacists for this new role, the University of Pittsburgh has developed an online program to teach pharmacists and pharmacy assistants how to help patients choose OTC hearing aids safely.
By providing a cheaper and more readily available option, OTC hearing aids have the potential to remove significant barriers to hearing aid adoption and use.
This is an updated version of an article originally published on September 21, 2021.