National Consumers League weighs in on FDA’s OTC Hearing Aid Rule, encourages consumers to consult with medical professionals
August 17, 2022
Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832
Washington, DC – Today, the U.S. Food and Drug Administration (FDA) issued its final rule enabling access to over-the-counter hearing aids for consumers with perceived mild to moderate hearing loss. National Consumers League (NCL) strongly supports expanding access to and affordability of hearing aids. NCL is encouraged by the positive impact these policy changes will have on increasing access to life-altering hearing aids. “We hope this means that more people will proactively assess their hearing loss and seek the help they need for their hearing health needs” said Sally Greenberg, Executive Director of NCL.
At the same time, while OTC hearing aids are a promising first step in achieving that goal, NCL remains concerned about potential consumer safety issues surrounding the use of OTC hearing aids without consultation of a trained, medical professional. NCL strongly encourages consumers to first consult with a medical professional before treating their perceived hearing loss with a hearing aid, including those that will be sold OTC.
Safety is the cornerstone of NCL’s mission. This is why NCL, along with 90 leading healthcare and consumer organizations, weighed in during the public comment period and via a group letter to FDA urging the agency to adopt lower the maximum outputs for OTC devices and establish a limit on gain. This limit has been recommended by leading hearing health professional organizations to ensure consumer safety. FDA ultimately lowered the maximum outputs in the final rule but decided against establishing a gain limitation. While we are pleased that the FDA recognized the need to lower the maximum outputs, we believe these devices could have been safer by limiting the amount of gain, as recommended by hearing care professionals. The lack of a gain limit, coupled with excessive amplification of sound for prolonged periods of time, may put some consumers at risk of experiencing increased hearing loss.
Because hearing loss is a medical condition that is unique to each individual, it should be addressed in consultation with a hearing care professional. With OTC hearing aids expected to be in stores as early as mid-October, NCL encourages consumers to purchase hearing aids in consultation with a professional who can help them fully understand the nature of their hearing loss, if any exists at all, and ensure that the treatment plan is appropriate for their needs, including the potential use of OTC hearing aids.
If consumers experience any adverse events or complications related to the use of OTC hearing aids, including worsening hearing after using such a device, NCL encourages consumers to report these events to the FDA. Instructions for reporting adverse events, are available at https://www.fda.gov/safety/medwatch, or by calling (800) FDA-1088.
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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.
