March 10, 2022
Washington, DC – Today, National Consumers League (NCL), along with 29 not-for-profit, public health organizations from across the country, sent a letter to the U.S. Food and Drug Administration (FDA) regarding the agency’s ongoing process to establish regulations that will soon allow hearing aids intended for adults with perceived mild to moderate hearing loss to be sold over-the-counter (OTC) without any involvement of a medical professional. As the FDA finishes developing its final OTC hearing aid regulation, we urge the agency to include stronger measures to better protect consumers affected by this new category of medical devices.
We applaud the FDA for its efforts to provide increased access and affordability through the creation of this new category of hearing aids. At the same time, the FDA must ensure these devices are safe, particularly given that many consumers will purchase OTC hearing aids without knowing their clinical level of hearing loss and not having any support from a medical professional. In addition to hearing loss, many OTC hearing aid users may also have other medical challenges impeding their ability to recognize and/or react to loud or uncomfortable sounds produced by these hearing aids. Under such circumstances, the need to ensure OTC hearing aids fulfill their intended purpose without risking unintended harm cannot be understated.
The letter states: “To ensure the safety of consumers, we believe the FDA should implement the recommendations of the nation’s leading associations of hearing care professionals, including the American Academy of Otolaryngology-Head and Neck Surgery, American Academy of Audiology, American Speech-Language-Hearing Association, and International Hearing Society. These associations are urging the FDA to lower the maximum sound output to 110 decibels and establish an amplification (or gain) limit of 25 decibels. These associations, as well as respected entities like the World Health Organization and the Centers for Disease Control and Prevention, have made clear that allowing sounds to enter the ears of consumers at the proposed levels can cause serious and permanent hearing damage within mere seconds.”
Importantly, these recommendations will not have any impact on the FDA’s goal of providing increased access to affordable hearing devices, compromise the effectiveness of OTC hearing aids, or discourage innovation—they will only make them sufficiently safe for consumers with mild to moderate hearing loss.
About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.