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Over-the-counter hearing aids in the U.S. are officially becoming a reality. On Tuesday, the Food and Drug Administration finalized the regulations needed for hearing aids to become widely available without a prescription. These OTC aids may save money for millions of Americans with poor hearing and are expected to reach retail shelves in as little as two months.
The arrival of OTC hearing aids has been a long time coming. Five years ago, as part of the FDA Reauthorization Act of 2017, the FDA was tasked with developing regulations that would create a new category of hearing aids that could be sold in traditional retail or online outlets. In July 2021, President Biden signed an executive order that, among many other things, pushed the FDA to speed along its regulatory process. By late October 2021, the FDA released its proposed rules for these products, and on Tuesday, the agency issued its final language on them.
About 15% of Americans over the age of 18, or almost 40 million people, are thought to be affected by hearing loss, while about 28 million Americans could benefit from hearing aids, according to the National Institute on Deafness and Other Communication Disorders. But relatively few people take advantage of them, with less than a third of those over 70 and an even smaller percentage of adults between 20 and 69 (16%) having ever used a hearing aid.
Some major reasons for this disparity have been money and accessibility. Today’s hearing aids either require a visit to a doctor or hearing loss specialist as well as a prescription, or have to be purchased through specialty stores. And the entire process can cost upwards of $2,000, costs that often aren’t covered by insurance. While the exact prices of OTC aids aren’t clear yet, they’re certain to be cheaper in general and easier to obtain.
“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra in a statement. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”
gizmodo.com
The arrival of OTC hearing aids has been a long time coming. Five years ago, as part of the FDA Reauthorization Act of 2017, the FDA was tasked with developing regulations that would create a new category of hearing aids that could be sold in traditional retail or online outlets. In July 2021, President Biden signed an executive order that, among many other things, pushed the FDA to speed along its regulatory process. By late October 2021, the FDA released its proposed rules for these products, and on Tuesday, the agency issued its final language on them.
About 15% of Americans over the age of 18, or almost 40 million people, are thought to be affected by hearing loss, while about 28 million Americans could benefit from hearing aids, according to the National Institute on Deafness and Other Communication Disorders. But relatively few people take advantage of them, with less than a third of those over 70 and an even smaller percentage of adults between 20 and 69 (16%) having ever used a hearing aid.
Some major reasons for this disparity have been money and accessibility. Today’s hearing aids either require a visit to a doctor or hearing loss specialist as well as a prescription, or have to be purchased through specialty stores. And the entire process can cost upwards of $2,000, costs that often aren’t covered by insurance. While the exact prices of OTC aids aren’t clear yet, they’re certain to be cheaper in general and easier to obtain.
“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra in a statement. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”
Over-the-Counter Hearing Aids Are Finally on the Way
The FDA's finalized regulations will allow hearing aids to be sold without a prescription in U.S. stores as early as mid-October.
gizmodo.com
