In Major Shift, Hearing Aids May Soon Be Sold Without A Prescription
For decades, the FDA has regulated hearing aids as medical devices, which adds to the cost and effort of getting fitted for one. The FDA's draft rule, which still faces a 90-day comment period before it's finalized, would allow hearing aids to be sold over the counter.
Roll Call:
FDA Announces ‘Landmark’ Action To Make Hearing Aids Cheaper
The Food and Drug Administration on Tuesday took a major step toward bringing down the cost of hearing aids by making them available over the counter. The freedom to buy hearing aids without a fitting or test by a specialist is likely to make them cheaper and the market more competitive. The cost of hearing aids can run into the thousands. They often are not covered by insurance companies or traditional Medicare, the federal health program for people over 65, although private Medicare Advantage plans sometimes cover them. (Kopp, 10/19)
NPR:
FDA Moves To Allow Hearing Aids To Be Sold Over The Counter
People with mild or moderate hearing loss could soon be able to buy hearing aids without a medical exam or special fitting, under a new rule being proposed by the Food and Drug Administration. The agency says 37.5 million American adults have difficulty hearing. "Today's move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss," Health and Human Services Secretary Xavier Becerra said as he announced the proposed rule on Tuesday. There is no timeline yet for when consumers might be able to buy an FDA-regulated over-the-counter (OTC) hearing aid. The proposed rule is now up for 90 days of public comment. (Chappell, 10/19)
CBS News:
Cheaper, Sleeker Over-The-Counter Hearing Aids May Hit Shelves Next Year
Millions of Americans with mild-to-moderate hearing loss may soon be able to buy high-quality — and cheaper — hearing aids at their local drugstore. That's because the Food and Drug Administration on Tuesday issued long-awaited draft rules for selling such hearing aid devices over the counter, in addition to what the agency calls "sound amplification" products. Now that the proposed rules are out, it could take about a year for new hearing aids to hit the market, according to experts. (Layne, 10/19)
Stat:
Sen. Warren On Over-The-Counter Hearing Aids And FDA’s Independence
The move was mandated by a 2017 law written by Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa). ... Warren told STAT in an interview that she’s “celebrating” the new regulations, but that they were long overdue. “The only people who were benefiting by that delay were the manufacturers, who were still scooping up huge profits while consumers were overpaying for hearing aids or not getting those aids at all — and that is about to change,” she added. (Florko, 10/19)
