SUBSCRIBE TO OUR FREE NEWSLETTER
Daily news & progressive opinion—funded by the people, not the corporations—delivered straight to your inbox.
5
#000000
#FFFFFF
5
#000000
#FFFFFF
A specialist places a hearing aid on a patient on October 20, 2021 in Fort Lauderdale, Florida. (Photo: Joe Raedle/Getty Images)
'Terrific Win for Consumers': Biden FDA Clears Way for Over-the-Counter Hearing Aids
"This is such an important move that will change lives," said the Congressional Progressive Caucus.
Aug 16, 2022
The Food and Drug Administration finalized a rule Tuesday to allow U.S. consumers to purchase hearing aids over the counter beginning as early as October, a years-in-the-making change that could benefit millions of people who have forgone assistance due to onerous regulatory and cost barriers.
"We need to go further by expanding Medicare to cover hearing (and visual and dental)."
"I've been fighting for this for five-plus years and this is a terrific win for consumers," said Sen. Elizabeth Warren (D-Mass.), who teamed up with Sen. Chuck Grassley (R-Iowa) in 2017 to introduce legislation requiring the FDA to allow lower-cost hearing aids to be sold over the counter (OTC) to people with mild to moderate hearing loss.
The bill ultimately passed that same year as part of the FDA Reauthorization Act. The FDA's final rule is set to take effect in 60 days.
In a joint statement on Tuesday, Warren and Grassley said that "we've pressed the FDA to take action every step of the way--holding both Republican and Democratic administrations accountable--and fought back against entrenched special interests."
"We are thrilled that the FDA has finalized these guidelines and that safe, effective, accessible, and affordable hearing aids will now be available over-the-counter for millions of Americans," the senators added.
The Congressional Progressive Caucus also applauded the step:
An estimated 37.5 million adults in the U.S. report some level of hearing difficulty but just a fraction have tried hearing aids, a discrepancy that reform advocates have attributed to costs and other obstacles, including the need for a prescription.
On average, hearing aids cost around $2,000 per device in the U.S.--and most people with hearing problems need an aid for both ears.
Making matters worse, traditional Medicare and many private insurance plans don't cover hearing aids or exams for fitting them, leaving patients to foot the entire bill.
David Segal, a progressive candidate for U.S. Congress in Rhode Island's 2nd Congressional District, applauded the FDA's final rule, saying it would make "life easier and more affordable for more people."
"We need to go further by expanding Medicare to cover hearing (and visual and dental)--and then by expanding Medicare to cover everybody!" Segal added.
During the new rule's public comment period, the FDA faced fierce pushback from the handful of giant hearing aid manufacturers that dominate the market, concentration that has helped push prices higher.
An investigative report released by Warren and Grassley in June found that hearing aid manufacturers such as Starkey used "astroturf lobbying tactics to influence FDA's rulemaking process and weaken the agency's OTC hearing aid rule."
"Almost immediately after FDA issued the proposed rule, stakeholders benefiting from the status quo launched letter-writing campaigns that
generated over 400 comments which--in whole or in part--appeared to be form letters rather than the independent views of those that sent them," the report notes. "These comment letters were ostensibly written by individuals, but in reality reflect industry talking points."
An Urgent Message From Our Co-Founder
Dear Common Dreams reader, It’s been nearly 30 years since I co-founded Common Dreams with my late wife, Lina Newhouser. We had the radical notion that journalism should serve the public good, not corporate profits. It was clear to us from the outset what it would take to build such a project. No paid advertisements. No corporate sponsors. No millionaire publisher telling us what to think or do. Many people said we wouldn't last a year, but we proved those doubters wrong. Together with a tremendous team of journalists and dedicated staff, we built an independent media outlet free from the constraints of profits and corporate control. Our mission has always been simple: To inform. To inspire. To ignite change for the common good. Building Common Dreams was not easy. Our survival was never guaranteed. When you take on the most powerful forces—Wall Street greed, fossil fuel industry destruction, Big Tech lobbyists, and uber-rich oligarchs who have spent billions upon billions rigging the economy and democracy in their favor—the only bulwark you have is supporters who believe in your work. But here’s the urgent message from me today. It's never been this bad out there. And it's never been this hard to keep us going. At the very moment Common Dreams is most needed, the threats we face are intensifying. We need your support now more than ever. We don't accept corporate advertising and never will. We don't have a paywall because we don't think people should be blocked from critical news based on their ability to pay. Everything we do is funded by the donations of readers like you. When everyone does the little they can afford, we are strong. But if that support retreats or dries up, so do we. Will you donate now to make sure Common Dreams not only survives but thrives? —Craig Brown, Co-founder |
Our work is licensed under Creative Commons (CC BY-NC-ND 3.0). Feel free to republish and share widely.
The Food and Drug Administration finalized a rule Tuesday to allow U.S. consumers to purchase hearing aids over the counter beginning as early as October, a years-in-the-making change that could benefit millions of people who have forgone assistance due to onerous regulatory and cost barriers.
"We need to go further by expanding Medicare to cover hearing (and visual and dental)."
"I've been fighting for this for five-plus years and this is a terrific win for consumers," said Sen. Elizabeth Warren (D-Mass.), who teamed up with Sen. Chuck Grassley (R-Iowa) in 2017 to introduce legislation requiring the FDA to allow lower-cost hearing aids to be sold over the counter (OTC) to people with mild to moderate hearing loss.
The bill ultimately passed that same year as part of the FDA Reauthorization Act. The FDA's final rule is set to take effect in 60 days.
In a joint statement on Tuesday, Warren and Grassley said that "we've pressed the FDA to take action every step of the way--holding both Republican and Democratic administrations accountable--and fought back against entrenched special interests."
"We are thrilled that the FDA has finalized these guidelines and that safe, effective, accessible, and affordable hearing aids will now be available over-the-counter for millions of Americans," the senators added.
The Congressional Progressive Caucus also applauded the step:
An estimated 37.5 million adults in the U.S. report some level of hearing difficulty but just a fraction have tried hearing aids, a discrepancy that reform advocates have attributed to costs and other obstacles, including the need for a prescription.
On average, hearing aids cost around $2,000 per device in the U.S.--and most people with hearing problems need an aid for both ears.
Making matters worse, traditional Medicare and many private insurance plans don't cover hearing aids or exams for fitting them, leaving patients to foot the entire bill.
David Segal, a progressive candidate for U.S. Congress in Rhode Island's 2nd Congressional District, applauded the FDA's final rule, saying it would make "life easier and more affordable for more people."
"We need to go further by expanding Medicare to cover hearing (and visual and dental)--and then by expanding Medicare to cover everybody!" Segal added.
During the new rule's public comment period, the FDA faced fierce pushback from the handful of giant hearing aid manufacturers that dominate the market, concentration that has helped push prices higher.
An investigative report released by Warren and Grassley in June found that hearing aid manufacturers such as Starkey used "astroturf lobbying tactics to influence FDA's rulemaking process and weaken the agency's OTC hearing aid rule."
"Almost immediately after FDA issued the proposed rule, stakeholders benefiting from the status quo launched letter-writing campaigns that
generated over 400 comments which--in whole or in part--appeared to be form letters rather than the independent views of those that sent them," the report notes. "These comment letters were ostensibly written by individuals, but in reality reflect industry talking points."
The Food and Drug Administration finalized a rule Tuesday to allow U.S. consumers to purchase hearing aids over the counter beginning as early as October, a years-in-the-making change that could benefit millions of people who have forgone assistance due to onerous regulatory and cost barriers.
"We need to go further by expanding Medicare to cover hearing (and visual and dental)."
"I've been fighting for this for five-plus years and this is a terrific win for consumers," said Sen. Elizabeth Warren (D-Mass.), who teamed up with Sen. Chuck Grassley (R-Iowa) in 2017 to introduce legislation requiring the FDA to allow lower-cost hearing aids to be sold over the counter (OTC) to people with mild to moderate hearing loss.
The bill ultimately passed that same year as part of the FDA Reauthorization Act. The FDA's final rule is set to take effect in 60 days.
In a joint statement on Tuesday, Warren and Grassley said that "we've pressed the FDA to take action every step of the way--holding both Republican and Democratic administrations accountable--and fought back against entrenched special interests."
"We are thrilled that the FDA has finalized these guidelines and that safe, effective, accessible, and affordable hearing aids will now be available over-the-counter for millions of Americans," the senators added.
The Congressional Progressive Caucus also applauded the step:
An estimated 37.5 million adults in the U.S. report some level of hearing difficulty but just a fraction have tried hearing aids, a discrepancy that reform advocates have attributed to costs and other obstacles, including the need for a prescription.
On average, hearing aids cost around $2,000 per device in the U.S.--and most people with hearing problems need an aid for both ears.
Making matters worse, traditional Medicare and many private insurance plans don't cover hearing aids or exams for fitting them, leaving patients to foot the entire bill.
David Segal, a progressive candidate for U.S. Congress in Rhode Island's 2nd Congressional District, applauded the FDA's final rule, saying it would make "life easier and more affordable for more people."
"We need to go further by expanding Medicare to cover hearing (and visual and dental)--and then by expanding Medicare to cover everybody!" Segal added.
During the new rule's public comment period, the FDA faced fierce pushback from the handful of giant hearing aid manufacturers that dominate the market, concentration that has helped push prices higher.
An investigative report released by Warren and Grassley in June found that hearing aid manufacturers such as Starkey used "astroturf lobbying tactics to influence FDA's rulemaking process and weaken the agency's OTC hearing aid rule."
"Almost immediately after FDA issued the proposed rule, stakeholders benefiting from the status quo launched letter-writing campaigns that
generated over 400 comments which--in whole or in part--appeared to be form letters rather than the independent views of those that sent them," the report notes. "These comment letters were ostensibly written by individuals, but in reality reflect industry talking points."
We've had enough. The 1% own and operate the corporate media. They are doing everything they can to defend the status quo, squash dissent and protect the wealthy and the powerful. The Common Dreams media model is different. We cover the news that matters to the 99%. Our mission? To inform. To inspire. To ignite change for the common good. How? Nonprofit. Independent. Reader-supported. Free to read. Free to republish. Free to share. With no advertising. No paywalls. No selling of your data. Thousands of small donations fund our newsroom and allow us to continue publishing. Can you chip in? We can't do it without you. Thank you.