FDA Approves Sale Of OTC Hearing Aids, Furthering Biden Administration's Goal Of Expanded Healthcare Access
The FDA approved the sale of over-the-counter hearing aids, allowing millions of Americans to buy hearing aids without seeing an audiologist to improve access to hearing aids, which may lower costs for millions of Americans.
The rules, which take effect in mid-October, apply to hearing aids for people with mild to moderate hearing loss. The aids will be available directly from stores or online without medical exams, a prescription, or audiologist fitting adjustment.
White House National Economic Council director Brian Deese said the government estimated the rule would save consumers about $1,400 per individual hearing aid or over $2,800 per pair."
The FDA's final rules for the sale of over-the-counter hearing aids lower the maximum sound output to reduce the risk of hearing from over-amplification of sound, revise the insertion depth limit in the ear canal, and require user-adjustable volume control, performance specifications, and device design requirements.
The Hearing Industries Association, representing hearing aid manufacturers, suppliers, distributors, and hearing health professionals, says the new rule will "expand access to hearing aids among the estimated 38 million Americans who have perceived mild to moderate hearing loss."
Shares of Eargo Inc (NASDAQ: EAR), a California-based hearing aid manufacturer, are surging probably in response to the news.
Price Action: EAR shares are up 41.50% at $2.86 on the last check Wednesday.
Photo via Wikimedia Commons
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