Friday, March 29

Analysis | Americans can soon buy hearing aids over the counter


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Today’s edition: Inside the Biden administration’s struggle to stop the record monkeypox outbreak. The Biden administration will stop buying some vaccines, treatments and tests in the months ahead. But first … 

Hear, hear: The FDA is allowing over-the-counter purchase of hearing aids

The Food and Drug Administration cleared the way for millions of Americans to buy hearing aids over the counter — a move aimed at increasing competition, spurring innovation and driving down the cost of the pricey medical devices. 

“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,” Biden said in a statement, adding that patients could save nearly $3,000 for a pair of hearing aids.

But it’s not so simple. It’s difficult to predict just how quickly a wide swath of manufacturers will begin selling devices over the counter and how much money Americans will save. 

Yet Biden officials and a key pair of bipartisan senators are touting the long-awaited measure as a major win for consumers. Hearing aids can cost several thousand dollars and typically aren’t covered by traditional Medicare or other insurers, leaving them unaffordable to many Americans. The federal government estimates that nearly 30 million people could benefit from hearing aids, yet only about one-fifth actually use the devices. 

The final regulation released yesterday was years in the making, The Post’s Eugene Scott and Katie Shepherd note.

  • In 2015, outside advisers to the Obama administration made a recommendation: The FDA should create a new category of “basic” hearing aids that could be bought over the counter.
  • In 2017, Congress passed legislation giving the FDA three years to propose such rules.
  • But the agency failed to meet its deadlines. Biden ramped up pressure on the FDA in an executive order signed in July 2021 — and it took another year before the rules were finalized.

Specifically … The change allows adults with mild to moderate hearing loss to buy the devices in stores and online without having a prescription or a medical examination. Such a change is expected to particularly help older adults, poor Americans and those living in rural areas where access to audiologists may be limited.

“The downside — if there’s a downside — is that people may choose to purchase a hearing aid without going to see a hearing professional,” said Tricia Neuman, a senior vice president at the Kaiser Family Foundation. “And they may not be able to get a hearing aid that fits them well, that can be adjusted over time.”

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Sen. Chuck Grassley (R-Iowa):

Here’s the big idea: A small number of hearing aid manufacturers dominate the space. Allowing devices to be sold over the counter could infuse more competition into the market and potentially spark new companies to create more innovative hearing aids.

“We would never see like an Apple try to enter hearing care in the current state of things, but they certainly might be considering it now,” said Nicholas Reed, an assistant professor at Johns Hopkins Bloomberg School of Public Health.

But whether that will happen — and how fast a technological shift could come — is an open question. Reed said he believes over-the-counter hearing aids will come on the market in a “relatively rapid period” of less than six months, but that it could take three to five years before the market is fully fleshed out. 

He’s confident such devices will become cheaper. In a news briefing, Brian Deese, the director of the National Economic Council, said such savings could amount to $2,800 for a pair of hearing aids, though FDA officials toed a more cautious line. 

  • “Those amounts will vary,” said Jeffrey Shuren, the head of the FDA’s Center for Devices and Radiological Health. “A lot of it is just hard to predict, and important to see what happens in the marketplace, but we do know with competition we can see reduction in costs.”

Inside the 100-day struggle to stop monkeypox

It’s been 100 days since the record monkeypox outbreak was first detected in Europe — and no country has more cases than the United States. The federal response has struggled to keep up, beset by turf wars, ongoing surprises and muddled messaging.

The Post’s Dan Diamond, Fenit Nirappil and Lena H. Sun are out with a deep dive this morning into what went wrong, as some public health experts warn the virus is on the verge of potentially becoming entrenched in the United States. 

“For two months, the Biden administration has been chased by headlines about its failure to order enough vaccines, speed treatments and make tests available to head off an outbreak that has grown from one case in Massachusetts on May 17 to more than 12,600 this week, overwhelmingly among gay and bisexual men,” our colleagues write. 

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The defense: Biden officials maintain the response is at a turning point. They touted the newly created White House monkeypox team, the decision to declare the virus a public health emergency and a new plan to increase vaccine doses by as much as fivefold.

A few nuggets from the story:

  • Bavarian Nordic CEO Paul Chaplin was so incensed by federal officials’ decision to split vaccine doses that he threatened to cancel all future vaccine orders from the United States
  • In June, White House coordinator Ashish Jha and the top infectious disease expert Anthony Fauci began to believe that the number of cases were far more than reported. They pressed Raj Panjabi, who leads the National Security Council’s pandemic office, to move faster to expand testing.
  • In July, White House Chief of Staff Ron Klain exhorted federal health officials to expedite vaccine doses that were stuck in Denmark and treatments that had been difficult to remove from the national stockpile.

Biden administration eyes next phase of the pandemic

In a bid to usher the country into the next era of the coronavirus pandemic, the Biden administration will stop buying some vaccines, treatments and tests in the weeks to months ahead, White House coronavirus response coordinator Ashish Jha said yesterday. 

The administration is currently ironing out the wrinkles of transitioning the products to the regular health-care system, a complicated process set to begin this fall that involves regulatory, market dynamic and equity issues. “My hope is that in 2023, you’re going to see the commercialization of almost all of these products,” Jha said at an event sponsored by the U.S. Chamber of Commerce Foundation.

Jha also encouraged all Americans to get new boosters designed to protect against new variants once they become available in anticipation of the comeback of the common flu — which has been largely stymied over the last two years because of covid-19 control measures like masking that have fallen to the wayside nationwide. 

  • Under normal non-pandemic times, flu really stretches our health-care system,” he said. “Throw in covid-19 on top of that, our health-care system is going to get into serious trouble unless we are very proactive about preventing it.”

The White House expects the retooled shots to be ready by early to mid-September, but Jha admitted that the administration hasn’t been able to purchase enough doses for every American adult to receive one because of a lack of pandemic funding.

The U.S. Chamber of Commerce Foundation: 

First lady Jill Biden tests positive for covid-19

First lady Jill Biden has tested positive for the coronavirus and will begin a course of the antiviral treatment Paxlovid, The Post’s Amy B Wang reports. 

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Biden, 71, is double vaccinated, twice boosted and experiencing mild symptoms, her spokeswoman Elizabeth Alexander said. She will isolate at a private residence in South Carolina until she produces two consecutive negative coronavirus tests. 

President Biden tested negative for the coronavirus yesterday morning, but will mask for 10 days when indoors and in proximity to others because he is considered a close contact of the first lady, according to White House press secretary Karine Jean-Pierre.

White House prescriptions

First in The Health 202: New ad campaign highlights Democrats recent health-care achievements

Democratic-aligned advocacy group Protect Our Care is launching a new TV ad campaign highlighting Democrats’ spending bill to address health care and climate change that Biden signed into law yesterday.

The four-figure ad buy, which will run nationally, promotes a new rallying cry for the party: Democrats got it done. For years, Democratic lawmakers have pledged to allow Medicare to negotiate the price of prescription drugs, a key policy included in the Inflation Reduction Act. 

The ad comes as Biden prepares to hit the road to sell his recent string of successes to voters in anticipation of November’s midterm elections, where Democrats are at risk of losing their majority in one or both chambers of Congress. The administration is also planning to hold “influencer briefings” to amplify its message, and is set to kick off the fall midterms push with a rally in Maryland next week, The Post’s Yasmeen Abutaleb reports.

  • Polio may have been circulating undetected for up to a year and may have been present in New York’s wastewater since as early as April, the Centers for Disease Control and Prevention said in a report released yesterday.
  • The FDA received more than 48,000 reports of faulty ventilators and respiratory devices made by Dutch medical equipment maker Philips between May and July, which included 44 deaths, Reuters reports.
  • At least eight children in the United States have tested positive for monkeypox, ABC News reports. A majority of the cases in the United States have been among men who have sex with men, though health officials have said anyone can contract the virus.
  • A federal appeals court ruled yesterday that the Americans With Disabilities Act covers individuals with “gender dysphoria,” handing a win to transgender people in a case concerning a former inmate who alleged discrimination at a Virginia prison, CNN reports.

Why a Century-Old Vaccine Offers New Hope Against Pathogens (By Roni Caryn Rabin | The New York Times)

Buy and Bust: Collapse of Private Equity-Backed Rural Hospitals Mired Employees in Medical Bills (By Sarah Jane Tribble | Kaiser Health News)

Pregnancy tests are routine before many surgical procedures. But Dobbs has raised the stakes of a positive result (By Trisha Pasricha | Stat)

Thanks for reading! See y’all tomorrow.



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