“President Biden’s recent, sweeping, and historic Executive Order (EO), includes a provision that is an encouraging sign the Administration is committed to expanding self-care to improve public health: allowing hearing aids to be sold over-the-counter (OTC). Biden’s EO comes just in time for International Self-Care Day — July 24th — which is an annual reminder that personal healthcare occurs 7 days a week, 24 hours a day, and is a critical part of global public health.
“Approximately 48 million Americans have hearing loss and medical devices such as hearing aids could help them overcome mild to moderate hearing impairment. However, these devices are currently only available by prescription, and data show that fewer than one-out-of-five people who have hearing loss actually use them. The consumer healthcare industry — and more importantly consumers — have been waiting for an FDA-proposed rule mandated by the OTC Hearing Aid Act of 2017. Among other actions, Biden’s EO calls on the U.S. Department of Health & Human Services (HHS) to issue this long-awaited proposed rule within the next 120 days to allow hearing aids to be sold OTC.
“CHPA and our members strongly encourage FDA to act swiftly. Consumer medical devices and other OTC products provide Americans with accessible, affordable, and trustworthy personal healthcare products which are more important now than ever.”