Today, U.S. President Biden issued an executive order that directs the U.S. Department of Health and Human Services (HHS) to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter.
HLAA applauds the Biden Administration for taking action on this important matter. Since the passage of the Over-the-Counter Hearing Aid Act of 2017, the Food and Drug Administration (FDA), the agency under HHS responsible for the rulemaking, has been working to create regulations regarding this new category of hearing devices intended for adults with mild to moderate hearing loss. However, the FDA has yet to release the rules that were due August 2020.
HLAA has been eagerly awaiting the rulemaking expected from FDA, almost a year overdue. We are pleased to see that President Biden also understands the importance of issuing these rules which will make available affordable hearing aids for millions of Americans.
This is a huge victory for the many adults with mild to moderate hearing loss who need to treat their hearing loss sooner rather than later, many of whom struggle to afford the cost of hearing aids which are often not covered by insurance.
It is time that we make hearing health a priority and make it accessible to get devices. If you are struggling with your hearing, get it checked. HLAA is here to help as your information source and advocate. We also encourage you to connect with your local HLAA Chapter for support.
Over-the-Counter (OTC) Hearing Devices
HLAA’s Externally-Led Patient-Focused Drug Development Meeting on Sensorineural Hearing Loss
Questions? Email HLAA Director of Communications Carrie Johnson.