FDA Finalizes Rule For Availability of OTC Hearing Aids

The FDA has issued a rule that will grant millions of Americans access to OTC hearing aids in pharmacies or online without a prescription or medical exam required.

The FDA issued a final rule to establish a new category of OTC hearing aids, which could save consumers millions of dollars while greatly improving access to these devices.

This ruling, which will be implemented in mid-October, will allow patients with mild to moderate hearing impairment to buy hearing aids directly from pharmacies, other retail settings, or online, while eliminating the need for a medical exam, prescription, or audiologist-directed fitting adjustment.

“Reducing health care costs in America has been a priority of mine since day one and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Secretary of the US Department of Health and Human Services, Xavier Becerra, in a press release. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”

Nearly 30 million US adults could benefit and communicate better with hearing aids, but they can be expensive and inaccessible. The action seeks to stimulate competition in the hearing aid technology marketplace by allowing for the sale of OTC hearing aids, according to an FDA press release.

The original rule was proposed on Oct. 20, 2021. Following the FDA’s proposition, more than 1000 public comments were made by consumers, professionals, hearing aid manufacturers, public health organizations, advocacy groups, members of Congress, and other stakeholders.

The FDA responded by advocating for the safety and effectiveness of hearing aids, and concurrently amended the original proposed rule. These changes included lowering the maximum sound output to prevent over-amplification, revising the aid’s insertion depth, adding user-adjustable volume control, simplifying the phrasing, and specifying performance and device design requirements for hearing aids.

The new ruling will repeal certain conditions from the state-regulated hearing aids so that the OTC version can be sold. The FDA will also issue the Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs), to clarify the difference between hearing aids and PSAPs, which amplify sound for consumers with normal hearing.

Finally, the rule establishes certain guidelines for OTC air-conducting hearing aids. These products can be used by adults 18 years of age and older with mild to moderate hearing impairment. However, prescription devices, especially those for severely impaired individuals or those younger than 18 years of age, will not be sold in this category.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Robert M. Califf, MD, in a press release. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”

Reference

U.S. Food and Drug Association. FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans. FDA website. August 16, 2022. Accessed on August 16, 2022. https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans