A bipartisan team of lawmakers wants the Food and Drug Administration to stop dragging its feet on making over-the-counter hearing aids available to consumers. Last Friday Sen. Chuck Grassley (R-IA) and Sen. Elizabeth Warren (D-MA) introduced a bill that orders the FDA to issue a final rule on the devices, four years after the passage of legislation for the sale of over-the-counter hearing aids.
“This rule is long overdue, and the FDA needs to act with urgency — not buckle to the pressure of corporate interests — to finalize a strong rule that will increase competition, lower costs for consumers and ensure that people can finally buy hearing aids right off the shelf,” Warren said in a statement.
A four-year wait
In 2017, Congress passed the FDA Reauthorization Act, which included the Over-the-Counter Hearing Aid Act, requiring the FDA to issue regulations on the sale of the over-the-counter devices no later than three years from the date of enactment. The agency did so last fall but has yet to issue a final rule. The public comment period for the rule ended in late January.
An estimated 38 million Americans suffer from some form of hearing loss. According to the National Institute on Aging, 1 in 3 people between the ages of 64 and 75 have trouble hearing. Hearing loss is the largest modifiable risk factor against dementia, according to a study in the Lancet. The study also found that treating hearing loss could eliminate 1 in 10 cases of dementia.
Related stories:
FDA moves to discard hearing aid prescription rule in favor of OTC devices
Docs haven’t asked about hearing in years, most older adults say
