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(NEW YORK) — Hearing aids can be sold over the counter in an effort to increase access and lower costs, the U.S. Food and Drug Administration announced on Tuesday. The move will allow those with mild to moderate hearing loss to directly purchase hearing aids from retailers.

Previously, those with mild to moderate hearing loss needed a prescription to receive a hearing aid, which required a medical exam, possibly by a specialist such as an audiologist.

Not only can this process be costly, but it can also take time, depending on provider availability, experts said.

The news was celebrated by the Hearing Industries Association, a group representing hearing aid manufacturers and other industry stakeholders, which said in a statement the “change will expand access to hearing aids among the estimated 38 million Americans who have perceived mild to moderate hearing loss.”

“In the United States, we see wealthier individuals being able to access hearing aids and individuals who are living at or below federal poverty level struggling to access hearing aids,” Dr. Nicholas Reed, assistant professor at Johns Hopkins University Bloomberg School of Public Health, told ABC News.

This ruling came just prior to President Joe Biden signing the Inflation Reduction Act on Tuesday, which proponents claim will further reduce drug prices and keep health insurance affordable for millions of Americans.

When will they be available?

“Americans could see over-the-counter hearing aids available as early as mid-October,” FDA Commissioner Robert Califf said at an FDA briefing Tuesday.

Califf said the ruling will clarify the regulatory requirements for hearing aids and personal sound devices, also referred to as PSAPs. He said it will take time for manufacturers to ensure that they are meeting these new requirements.

“These actions reflect the FDA’s commitment to safely lowering barriers to access, providing consumers with greater choices to lower prices, and helping to facilitate innovation in hearing aid technology,” Califf said.

Who can use them?

“The new over-the-counter category applies to certain air conduction hearing aids, intended for adults aged 18 and older who have perceived mild to moderate hearing loss,” Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health, said at an FDA briefing Tuesday.

Air conduction hearing aids are worn inside the ear or on the ear, with an inside the ear component and amplified sound into the ear canal. In an effort to prevent further hearing loss, these devices will have sound limits.

“Hearing aids for severe hearing loss or for users younger than age 18 will be prescription devices, to assure patient safety as well as effectiveness,” Shuren said.

What are the implications?

“The FDA estimates this rule will save consumers on the order of about $1,400 per individual hearing aid, or almost, or over $2,800 per pair. And that’s the direct savings,” Brian Deese, White House Director of National Economic Council, said at the FDA briefing Tuesday.

While these are just estimates in savings, Deese also believes this ruling will increase innovation and competition in the market.

“The requirement to see a doctor or a hearing specialist was an example of what economists call a barrier to entry. It was a regulation that kept more companies or more innovators from entering the market to compete,” Deese said.

Emma Egan is an MPH candidate at Brown University and a contributor to the ABC Medical Unit.

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(NEW YORK) — Monkeypox and related viruses are known for their ability to transmit between humans and animals, but with increasing global spread, the Centers for Disease Control and Prevention said that household pets may be at risk after a dog in France apparently contracted monkeypox from its owners in July, according to a report published in The Lancet journal.

This is the first reported case of human-to-pet transmission of monkeypox.

“We are still learning what different animal species may be susceptible to infection, and this new case report is important because it shows that dogs are able to get the disease,” Dr. Meghan Davis, associate professor of environmental health and engineering at Johns Hopkins Bloomberg School of Public Health, told ABC News. The CDC says it’s not clear if other animals, like cats, can develop monkeypox, but recommends that people sick with monkeypox take precautions around all animals to be safe.

Monkeypox cases continue to climb across the globe and in the United States, where more than 12,000 Americans have been diagnosed.

For anyone recovering at home, the CDC said it’s important to stay away from other household members — including pets — or take steps to reduce the risk of household transmission if isolating away isn’t possible.

Isolate away from pets if possible

Monkeypox transmission happens during close contact. With pets, this could be through cuddling, hugging, kissing, licking and sharing sleeping areas or food.

If you are diagnosed with monkeypox and have not yet exposed your pet — meaning you haven’t been in contact with the pet since your symptoms developed — try to find a friend or a neighbor to care for your pet. Your isolation period may last two to four weeks. Once your skin lesions are healed, clean and disinfect your home, including washing your bedding, before bringing your pet back home.

Understandably, this may not be possible for everyone.

Hand hygiene and physical distancing can still help

If your pet stays with you while you are isolated, you can still take steps to reduce their risk of transmitting monkeypox.

“Keep your pets, just keep your distance — and don’t let your pet share your bed — if you are diagnosed with or suspect you have monkeypox,” Davis said.

Echoing guidance given when isolating at home with COVID-19, wash your hands every time you touch your pet, wear a mask and try to keep your skin lesions covered. Maintain your distance and don’t let your pet get into contaminated clothes, towels or sheets.

“Pets that had close contact with a symptomatic person with monkeypox should be kept at home and away from other animals and people for 21 days after the most recent contact,” according to CDC guidance.

Call your vet and try to get your pet tested for monkeypox if your pet shows signs of monkeypox infection after exposure

Though we don’t understand all the symptoms of monkeypox in animals, symptoms could look like lethargy, lack of appetite, coughing, runny nose, fever and pimple-like or blister-like rashes.

If one pet gets sick, try to keep them separate from other pets or people at home — especially from anyone in the household who is pregnant, immune compromised or a child.

Keep caring for your pet, do not abandon or euthanize your pet

Monkeypox exposure or diagnosis is not a reason to consider abandoning or euthanizing your pet, the CDC said.

The CDC also recommends that people should not put a mask on their pets, or clean or bathe their pets with chemical disinfectants such as alcohol, hydrogen peroxide or hand sanitizer. Wash your hands often and clean any contaminated bedding or other pet materials following CDC guidance if your pet gets monkeypox.

Quickly dispose of the pet’s waste — do not just leave it on the ground or in the backyard — using a sealed, dedicated trash can, and contact your local public health department for further details on how to handle the contaminated waste.

Dr. Jade A Cobern, board-eligible in pediatrics, is a part of the ABC News Medical Unit and a general preventive medicine resident at Johns Hopkins.

ABC News’ Sony Salzman and Arielle Mitropoulos contributed to this report.

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(WASHINGTON) — Newly updated COVID-19 boosters tailored to target a dominant strain of the virus will be available in the next three weeks or so, assuming the Food and Drug Administration and Centers for Disease Control and Prevention work through their processes for authorization as expected.

That was White House COVID coordinator Dr. Ashish Jha’s prediction Tuesday at an event hosted by the U.S. Chamber of Commerce Foundation.

In late June, the FDA directed Moderna and Pfizer to make vaccines for the upcoming winter that targeted the more contagious BA.5 omicron subvariant, along with the original COVID strain. That work has been underway and the next step is for the FDA and CDC to review data from the companies, once they’ve received it.

Neither the FDA nor the CDC has announced a timeline.

The rollout was expected sometime in September, but Jha’s estimate on Tuesday was the most specific to date.

“We’re going to know more about this in the upcoming weeks and these vaccines will become available by early to mid-September,” he said, again including the caveat that FDA and CDC need to act before anything can be official.

“But the big picture, bottom line, is these are substantial upgrades in our vaccines,” Jha said. “And those vaccines are coming very, very soon.”

Jha also said that he was hopeful there will eventually be enough vaccine supply for any adult who wants a new booster to be able to get one, despite funding squabbles that forced the federal government to order only enough for the most vulnerable Americans.

“We’re still working on trying to pull more resources from other places. I would like to get to a point where every adult in America who wants a vaccine can get one. I’m hopeful we will be there. We’re not quite there yet in terms of how many vaccine doses we’ve been able to buy,” Jha said.

“What’s really limited us is a lack of resources, but we are pulling from other high-priority items. So my hope is that we’re gonna be able to have this for every single adult in America. We will know more about that in the upcoming weeks I think,” he added.

So far the U.S. has contracted for 105 million doses of the newly-updated boosters from Pfizer and 66 million doses from Moderna, the two leading COVID vaccine manufacturers for the country. Both contracts with Pfizer and Moderna include an option for hundreds of millions of more doses down the line, should the U.S. secure the money.

Between Pfizer and Moderna, if both companies were able to complete their orders, the U.S. would have about 171 million doses of the new shots. But more than 260 million Americans have had at least one vaccine dose already and would theoretically consider getting a booster.

On the other hand, demand for boosters has dropped with each campaign for people to get another shot. About 108 million people have received their first booster shot, for example.

The White House said it had pulled $5 billion to cover the cost of vaccines for this fall and winter. Between the $3.2 billion awarded to Pfizer and the $1.74 billion awarded to Moderna so far, the government has hit that ceiling.

Because fall and winter usually bring a high volume of flu cases, Jha also urged the public to get both their flu shots and updated COVID boosters as soon as they could — or else risk a harsh winter of disease with far looser mitigation efforts than each winter of the pandemic so far.

“Our health care system is going to get into serious trouble unless we are very proactive about preventing it — so if we do nothing and just sort of hope for the best, I think we could end up getting into a lot of trouble this fall and winter,” Jha said.

People can get their flu and COVID shot on the same day, Jha noted, and he said he hopes that next year technology will have improved to the point that there’s a two-in-one combination booster available for both the flu and COVID.

He also emphasized the importance of improving ventilation in businesses and schools, which was also prioritized in the latest CDC guidance issued last week.

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(NEW YORK) — At least eight children in the U.S. have now tested positive for monkeypox, after health officials in Harris County, Texas, confirmed to ABC News that a presumptive case had been identified in a child under the age of 2.

Officials reported the child has been completely asymptomatic, according to the child’s parents, with no other symptoms other than a residual rash. The child is expected to make a full recovery, and is doing “very, very well,” Harris County Judge Lina Hidalgo said during a press conference on Tuesday.

“I understand that it’s a very scary thing, and parents have concerns, and what we need to make sure is to be vigilant and understand the risks, not assume the worst. But this reminds us that this is very real,” Hidalgo said.

The family has also been fully cooperative, and is assisting with contact tracing, though the child has not been in any day care or school settings. Thus far, no one else in the child’s circle has been identified as positive for monkeypox, according to officials.

How this child contracted monkeypox is still unknown, Hidalgo said.

“I understand this is a very, very worrisome for parents, especially as school is starting back up knowing that a child in our community has now contracted or as a presumptive positive for the monkey pox virus. It opens up a lot of questions about how this is spread. It makes people very worried. It makes things very tangible,” Hidalgo added.

Although this is indeed a “rare” case, Hidalgo noted that “we always knew that any person in this community can contract monkeypox. We knew that it was possible for a child to be exposed. Anyone can get this virus, so this isn’t entirely unexpected.”

The news of the positive pediatric case in Texas comes after a child in Martin County, Florida, has tested positive for monkeypox, according to state health data. The child in Florida is between the ages of 0 and 4 years old, according to the state health data.

Officials in Maine also announced Friday that they, too, had confirmed a positive monkeypox case in a child. No further information about the case has been released due to concerns over patient privacy, officials said.

“Maine CDC [Center for Disease Control and Prevention] is working to identify any others who may have been exposed and make vaccination available to close contacts,” officials wrote in a press release.

In addition to the cases in children reported in Maine and Florida, two cases have been confirmed in California, as well another two in Indiana, and a case in a non-U.S. resident reported in Washington, D.C.

The majority of cases in the current monkeypox outbreak have been detected in gay, bisexual or other men who have sex with men. However, health officials have repeatedly stressed that anyone can contract the virus.

The Centers for Disease Control and Prevention has previously warned that there has been some preliminary evidence to suggest that children younger than 8 years old are at risk of developing more severe illness if infected, alongside pregnant people and those who are immunocompromised.

However, last week, in an effort to protect the youngest Americans, the Food and Drug Administration issued an emergency use authorization that allows health care for children under 18 who are at high risk of monkeypox to be vaccinated.

Across the globe, nearly 32,000 cases of monkeypox have now been reported, including nearly 12,000 cases in the U.S. — the most of any country, according to the CDC. All but one U.S. state — Wyoming — have now confirmed at least one positive monkeypox case.

Monkeypox primarily spreads through prolonged skin-to-skin contact with infected people’s lesions or bodily fluids, according to the CDC. In addition to lesions, which can appear like pimples or blisters, the most common symptoms associated with monkeypox are swollen lymph nodes, fever, headache, fatigue and muscle aches.

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