Regulatory Focus
Posted 09 December 2019 | By
In a letter to Acting US Food and Drug Administration (FDA) Commissioner Brett Giroir last week, Senators Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) raised questions about the agency’s plans to issue rules to regulate over-the-counter (OTC) hearing aids.
“Hearing aids can greatly assist those with hearing loss to lead normal lives. Sadly, although hearing aids are considered prescription products, they are not generally covered by health insurance or Medicare and can cost thousands of dollars,” Grassley and Warren wrote, noting that many Americans with age-related hearing loss are unable to afford hearing aids.
