Nina Ordinario
Associate Editor
Loyola University Chicago School of Law, JD 2024

Thanks to a new FDA final rule, published in August of this year, Americans can soon purchase specific hearing aids over-the-counter (OTC) without a hearing exam, prescription, or fitting. Although this rule will improve access to hearing aid devices and lower the costs for those with hearing impairments, many critics are convinced the rule will do more harm than good.

Hearing loss in America

The National Institute of Health (NIH), relying on research from the National Institute on Deafness and Other Communication Disorders (NIDCD) Epidemiology and Statistics Program, estimates that about 28.8 million U.S. adults could benefit from using hearing aids. Unfortunately, however, research shows that only a portion of these adults has used hearing aids. Specifically, only 40% of adults aged 70 and older and 16% of adults aged 20-69, who may benefit from hearing aids, have tried one.

Although some Americans may not realize they could benefit from a hearing aid, there are also a few barriers to those seeking hearing devices. For example, Americans in rural communities may have less access to hearing specialists or audiologists and, thus, less access to hearing exams, treatments, and prescription hearing aids. In addition, many people fear the stigma of using a hearing aid and being perceived as debilitated. The most significant barrier is cost. On average, a single hearing aid costs $2,000, and most insurance carriers, including Medicare, do not cover the cost of hearing aids or exams for fitting hearing aids.

The new FDA rule

The push for OTC hearing aids began when Congress passed the OTC Hearing Aid Act, a bipartisan bill, as part of the 2017 FDA Reauthorization Act (FDARA). The Act directed the FDA to establish a new class of hearing aids eligible for OTC sale within three years. Although the FDA failed to accomplish this goal within three years, President Joe Biden brought refocus to the OTC Hearing Act during his 2021 “Executive Order on Promoting Competition in the American Economy.” In this Order, Biden directed the Secretary of Health and Human Services “to promote the wide availability of low-cost hearing aids” and propose an FDA rule. As a result, the FDA released its proposed rule in October 2021, and the rule became final on August 17, 2022.

The rule, which will become effective on October 17, 2022, creates a new regulatory category of hearing aids and amends existing hearing aid regulations. Specifically, the rule defines an “OTC hearing aid” as “an air-conduction hearing aid that does not require implantation or other surgical intervention, and is intended for use by a person age 18 or older to compensate for perceived mild to moderate hearing impairment.” The FDA requirements for OTC hearing aids vary by device type and classification. However, there are a few common requirements for all OTC hearing aids. Most notably, all OTC hearing aids must be user-controllable and customizable to the user’s needs. In addition, there are several labeling requirements that include warnings. Within these warnings are lists of symptoms that, if experienced by a user, may indicate that the user should seek help from a hearing healthcare professional or physician, such as an ENT doctor.

Opposition to the rule

As of 2018, four companies control 84% of the hearing aid market. According to President Biden, the new rule will allow more companies to introduce their hearing aid products in the market, promote competition, and decrease hearing aid prices for consumers. Experts estimate that OTC hearing aids will cost between $300 to $600 per device, which will help reduce the financial barrier to obtaining devices. In light of these potential benefits, however, many experts are concerned that the new rule will harm consumers.

Many hearing specialists have expressed criticism of the new rule. In particular, they challenge that the new rule damages the reputation of hearing specialists and discourages consumers from consulting with a specialist first. Consumers who purchase OTC hearing aids will also forego a hearing exam and hearing aid fitting. Undeniably, there is a benefit of having an exam and fitting so that the user’s hearing aid will be configured to meet the needs of their medical condition. In addition, hearing specialists argue that hearing loss can be caused by underlying medical conditions, and without a hearing exam, these conditions will go undiagnosed and untreated.

In response to this criticism, the FDA has stated that they are not discouraging consumers from seeking help from a hearing specialist. The FDA’s labeling requirements, as discussed above, are designed to encourage consumers to see a hearing specialist or physician, especially if they are experiencing atypical symptoms or the OTC device does not improve their hearing.

Critics also state that the new rule will allow lower quality and cheaply made hearing aids to enter the market. Although this effect is foreseeable, supporters of the new rule believe that low-quality hearing aids can be pushed out of the market by consumers. Specifically, supporters believe that the new rule will encourage competition amongst manufacturers to develop user-friendly and effective products that consumers can trust. In addition, the FDA states in the rule that it still requires OTC hearing aid manufacturers to adhere to quality standards.

Consumer empowerment

In light of these arguments, there appears to be strong approval of the new FDA rule. Ultimately, the rule was intended to de-regulate the hearing aid industry, promote fair competition, and increase accessibility to low-cost hearing aids. As described above, almost 30 million Americans could benefit from using a hearing aid, but less than 30% of specific age populations have ever used one. The new rule will not only make it easier for Americans to try using a hearing aid, but it will also help consumers be more proactive and empowered in their healthcare decisions. Although the new rule may give rise to potential risks, Americans needed a solution to improve accessibility to hearing aids, and the new rule will likely provide more benefits than it will harm.