Over-the-Counter Hearing Aids Will Help Millions of Older Adults

Good news for millions of older adults in the U.S. who suffer from hearing loss. The Food and Drug Administration (FDA) has just approved over-the-counter sale of basic hearing aids for people with mild to moderate hearing loss. This means that people will be able to buy these hearing aids in pharmacies, other retail stores, and online without a prescription. Allowing over-the-counter sale of these devices is expected to stimulate competition and bring down prices.

Previously, hearing aids could only be purchased through a hearing care professional’s office or in specialized stores. In anticipation of FDA’s decision, however, some manufacturers had already started to produce hearing aids for over-the-counter sale when permitted. FDA's final rule will be effective 60 days from the date of publication (August 16, 2022). Manufacturers will be able to sell hearing aids before that date but will have to revise any non-compliant devices to meet the new rule.

Hearing Loss: The Toll Among Older Adults

An estimated 44 million Americans ages 20 years and older, or 40 million ages 50 and over, suffer from hearing loss and the heavy social, emotional and health tolls that come with it. Although hearing loss can occur at all ages, the risk increases significantly as people grow older, doubling with every decade of life. In fact, roughly nine out of ten people with hearing loss are adults ages 50 and older. The highest prevalence of hearing loss is among those 80 years and older. Eighty percent of people in this age group have hearing loss compared to ten percent among those in their 50s. Other factors than age can also influence hearing loss risk. For instance, the likelihood of hearing loss is greater among men than women and lower among Black individuals than people from other racial and ethnic groups.

For older adults, hearing loss is usually permanent and progressive. Typically, it starts with difficulty hearing soft spoken people (mild hearing loss) and gradually worsens to not being able to perceive regular speech without hearing aids (severe hearing loss) or even hear very loud sounds (profound hearing loss).

When left untreated, hearing loss can have profound impacts on people’s lives. For many who experience it, hearing impairment can bring a sense of insecurity, lead to social isolation and reduce overall quality of life. It can also lead to serious health issues. Compared to people with normal hearing, older adults with hearing loss have a higher risk of developing dementia and other problems such as depression or functional disabilities. Falls, a serious health risk among older adults, are also strongly associated with untreated hearing loss.   

The Price: A Significant Barrier to Hearing Care

Yet, despite the negative impact on health, many older adults who have lost the ability to hear well do not get the care they need. Only 13 percent of Medicare beneficiaries who report having hearing troubles have a hearing aid. Use of hearing devices is especially low among women, racial and ethnic minorities, and low-income individuals.  

The high cost of hearing technologies and services is the biggest barrier to older adults with hearing loss seeking the care they need. The average cost of a hearing aid is about $2,300 per ear with the price ranging from $1,000 to $4,000. Some premium models cost as much as $6,000. These prices have imposed a heavy financial burden on many older adults who buy them and deter many people from seeking hearing care. Many people often face these high costs more than once because hearing aids must be adapted to the changing severity of hearing loss.

In general, insurance coverage of hearing care for older adults is limited. Many commercial health insurance plans do not cover hearing services or aids. Traditional Medicare does not cover hearing exams, except in limited circumstances. Nor does the program pay for hearing aids or fitting services. Some people with Medicare who opt for Medicare Advantage plans have limited coverage for hearing care but can still face large out-of-pocket costs.

Having the option to purchase over-the-counter hearing aids will lower barriers to access and increase competition in the hearing aid market. Under the new FDA rule, people with mild to moderate hearing loss will no longer be required to get a hearing exam, a prescription from a doctor for a hearing aid, and visit an audiologist to get a basic hearing aid. Now, consumers will be able to directly purchase basic hearing aids in pharmacies, retail stores and online, an option that was not previously available. Yet, for many older adults with severe or profound hearing loss, most of whom tend to be in their 70s and 80s, an over-the-counter solution isn’t enough. They will continue to need more sophisticated, expensive devices, as well as a prescription and professional assistance.

The ability to hear well is critical to each person and their family's well-being, regardless of the extent of their hearing loss. Older adults deserve nothing less.