It’s Wednesday.
Dear Blenders,
Signed,
If My Back is Better. It seems better…
When Biden Bits was posted for Tuesday, President Biden had tweeted 2 times. He added 11 tweets giving him a Tuesday Tweeting Total of 13 tweets and 0 retweets…
On Tuesday the FDA announced; Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans
Today, the U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist.
The rule is expected to lower the cost of hearings aids, furthering the Biden-Harris Administration’s goal of expanding access to high-quality health care and lowering health care costs for the American public. It is designed to assure the safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace.
Today’s action follows President Biden’s Executive Order on Promoting Competition in the American Economy, which called for the FDA to take steps to allow hearing aids to be sold over the counter and set a swift 120-day deadline for action, which the FDA met. In 2017, Congress passed bipartisan legislation requiring the FDA to create a category of OTC hearing aids, but it was not fully implemented until now. Consumers could see OTC hearing aids available in traditional retail and drug stores as soon as mid-October when the rule takes effect.
“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. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”
Close to 30 million adults in the U.S. could benefit from hearing aid use. Individuals with permanent hearing impairment can use hearing aids to help make speech and sounds louder, improving the ability to communicate effectively with others. Many hearing aids can be expensive. The final rule aims to stimulate competition and facilitate the sale of safe and effective OTC hearing aids in traditional retail stores or online nationwide, providing consumers with perceived mild to moderate hearing loss with improved access to devices that meet their needs and are less expensive than current options.
“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Robert M. Califf, M.D. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”
The OTC category established in this final rule applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing impairment. Hearing aids that do not meet the requirements for the OTC category (for example, because they are intended for severe hearing impairment or users younger than age 18) are prescription devices.
The FDA finalized the rule after receiving and reviewing more than 1,000 public comments on the proposed rule issued on Oct. 20, 2021. Comments submitted by consumers, professional associations, hearing aid manufacturers, public health organizations and advocacy groups, members of Congress, state agencies, and other stakeholders are summarized in the final rule, along with the FDA’s respective responses. In response to public comments and to assure the safety and effectiveness of OTC hearing aids, the final rule incorporates several changes from the proposed rule, including lowering the maximum sound output to reduce the risk to hearing from over-amplification of sound, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the phrasing throughout the required device labeling to ensure it is easily understood. The final rule also includes performance specifications and device design requirements specific to OTC hearing aids.
Furthermore, today’s action correspondingly amends existing rules that apply to prescription hearing aids for consistency with the new OTC category, it repeals the conditions for sale for hearing aids, and it includes provisions that address some of the effects of the FDA OTC hearing aid regulations on state regulation of hearing aids.
Concurrently with issuing the final rule, the FDA also issued the final guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs), to clarify the differences between hearing aids, which are medical devices, and PSAPs, consumer products that help people with normal hearing amplify sounds.
The effective date for the final rule is 60 days following publication in the Federal Register. Manufacturers of hearing aids sold prior to the effective date of the final rule will have 240 days after its publication to comply with the new or revised requirements. For hearing aids that have not been offered for sale prior to the effective date, compliance with the new or revised requirements must be achieved before marketing the device, including obtaining 510(k) clearance if applicable.
FDA. 08/16/2022.
President Biden’s full statement:
For millions of Americans, hearing aids and the doctor’s visit to get them prescribed are too expensive. In the executive order I issued last year to increase competition in key industries and lower costs, I called on the FDA to finally make hearing aids available over the counter.
Today, the FDA is doing just that. As early as mid-October, Americans will be able to purchase more affordable hearing aids over the counter at pharmacies and stores across the country. This action makes good on my commitment to lower costs for American families, delivering nearly $3,000 in savings to American families for a pair of hearing aids and giving people more choices to improve their health and wellbeing. And, it’s the latest action we are taking to make our economy more competitive and less concentrated. When too few companies dominate, American consumers pay higher costs. We’re finally building an economy that works for working families.
White House.gov. 08/16/2022.
His next 10 tweets all focus on the Inflation Reduction Act of 2022; which was signed into law on Tuesday.
President Biden: Look, give me a couple of minutes and I’m going to tell you why the climate provisions I’m about to sign into law are such a big, you know what deal. For the country it means jobs. Lot’s of jobs. Why? Well, because by 2030 we’ll have 950 million solar panels operating in the United States. 120,000 wind turbines operating. We’ll have 2,300 battery plants to store clean energy–and that’s just eight years from now. And to make that all in time, we’re going to be creating a whole lot of jobs–good paying union jobs. A lot of you are going to say to me, “Joe, I’m not getting a job building a wind turbine. What does it mean to me?” Well, let me tell you what it means to you. It means financial savings. And we’re going to make costs lower, make energy cheaper, create tons of good paying jobs and address the climate crisis. Finally. It’s a win–win–win situation.
The YouTube is 23 minutes and 20 seconds long. His full remarks can be found here.
President Biden: And today — today offers further proof that the soul of America is vibrant, the future of America is bright, and the promise of America is real and just beginning. (Applause.) Look, the bill I’m about to sign is not just about today, it’s about tomorrow. It’s about delivering progress and prosperity to American families. It’s about showing the American and the American people that democracy still works in America — notwithstanding all the — all the talk of its demise — not just for the privileged few, but for all of us.
President Biden: That’s what’s happening now. From the American Rescue Plan that helped create nearly 10 million new jobs, to a once-in-a-generation infrastructure law that will rebuild America’s roads, bridges, ports; deliver clean water, high-speed Internet to every American; to the first meaningful gun safety law in 30 years — and if I have anything to do with it, we’re still going to have an assault weapons ban, but that’s another story. And to get significant veterans’ healthcare law in decades, for the first time; to a groundbreaking CHIPS and Science Law that’s going to ensure that technologies and jobs of the future are made here in America — in America. (Applause.)
“Democracy” appears three times in his remarks…
President Biden: We’re in a session of — for a while, people doubted whether any of that was going to happen. But we are in a season of substance. This administration began amid a dark time in America — as Jim said, “a once-in-a-century pandemic” — devastating joblessness, clear and present threats to democracy and the rule of law, doubts about America’s future itself.
President Biden: It’s about showing the American and the American people that democracy still works in America — notwithstanding all the — all the talk of its demise — not just for the privileged few, but for all of us.
President Biden: Everything is going to make sure that democracy delivers for your generation. Because I think that’s at stake.
President Biden: But guess what? We’re giving Medicare the power to negotiate those prices now, on some drugs.
President Biden: We’re cutting deficit to fight inflation by having the wealthy and big corporations finally begin to pay part of their fair share.
President Biden: This bill is the biggest step forward on climate ever — ever — and it’s going to allow — it’s going to allow us to boldly take additional steps toward meeting all of my climate goals — the ones we set out when we ran.
President Biden: My fellow Americans, that’s the choice we face: We can protect the already-powerful or show the courage to build a future where everybody has an even shot. That’s the America I believe in. (Applause.) That’s what I believe in. And today — and today, we’ve come a step closer to making that America real.
What former President Obama says was a BFD…
BFD =’s big fucking deal.
I wasn’t gonna talk about that time then-Vice President Biden whispered to then-President Obama “this is a big fucking deal.”
But then decided to explain since both Former President and the current President made reference to the hot mic captured forever F-bomb dropped in 2010.
The Yahoo.com article is an op-ed written by President Biden…
Today, I signed the Inflation Reduction Act into law — one of the most significant laws in recent history. With this law, the American people won and special interests lost. The Inflation Reduction Act does so many things that so many of us have fought to make happen for years and years.
There are three things everyone should know about the Inflation Reduction Act.
President Biden via Yahoo.com. 08/16/2022.
The Three things:
First, we are lowering costs for working families.
Second, in this historic moment, Democrats sided with the American people and Republicans sided with the special interests.
Third, we demonstrated that government can work for working families.
President Biden via Yahoo.com. 08/16/2022.
President Biden’s Public Schedule for Wednesday, August 17th 2022:
| Official Schedule | The President has no public events scheduled. Biden Residence, Wilmington, DEOut-of-Town Pool |
| 10:00 AM | Out-of-Town Pool Call Time Biden Residence, Wilmington, DEOut-of-Town Pool |
President Biden has tweeted…
It’s 2 tweets so far for Wednesday…
President Biden: Look, the bill I’m about to sign is not just about today, it’s about tomorrow. It’s about delivering progress and prosperity to American families. It’s about showing the American and the American people that democracy still works in America — notwithstanding all the — all the talk of its demise — not just for the privileged few, but for all of us.
From the White House:
State Fact-sheet; How the Inflation Reduction Act Lowers Energy Costs, Creates Jobs, and Tackles Climate Change Across America
Today, the White House released state fact sheets highlighting how the Inflation Reduction Act tackles the climate crisis in states across the country and how families and communities can benefit from a clean energy future. The fact sheet outlines how families can save on their utility bills, get tax credits for electric vehicles and energy-saving appliances, and access the economic opportunities of the clean energy future.
President Biden and Congressional Democrats beat back special interests to pass this historic legislation, delivering the most significant action in U.S. history to tackle the climate crisis and strengthen U.S. energy security. By signing the Inflation Reduction Act, President Biden is delivering on his promise to lower energy costs, create good-paying jobs, and deliver a clean, secure, and healthy future for families across America.
White House.gov. 08/17/2022.
It lists each state with a link to see what that state will receive.
Fact-sheet; How the Inflation Reduction Act Builds a Better Future for Young Americans
Fact-sheet; How the Inflation Reduction Act Helps Black Communities
Fact-sheet; How the Inflation Reduction Act Helps Latino Communities
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