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F.D.A. Clears Path for Hearing Aids to be Sold Over the Counter

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F.D.A. Clears Path for Hearing Aids to be Sold Over the Counter

The Meals and Drug Administration selected Tuesday to permit listening to aids to be offered over-the-counter and with no prescription to adults, a long-sought want of customers pissed off by costly exams and units.

The excessive value of listening to aids, which aren’t lined by fundamental Medicare, has discouraged thousands and thousands of Individuals who’ve listening to loss from shopping for the units. Well being consultants say that untreated listening to loss can contribute to cognitive decline and melancholy in older folks.

Underneath the brand new rule, folks with delicate to reasonable listening to loss ought to be capable to purchase listening to aids on-line and in retail shops as quickly as October, with out being required to see a physician for an examination to get a prescription.

The F.D.A. cited research estimating that about 30 million Individuals expertise listening to loss, however solely about one-fifth of them get assist. The adjustments may upend the market, which is dominated by a comparatively small variety of producers, and make it a broader subject with less expensive, and maybe, extra modern designs. Present prices for listening to aids, which have a tendency to incorporate visits with an audiologist, vary from about $1,400 at Costco to roughly $4,700 elsewhere.

“This might basically change expertise,” mentioned Nicholas Reed, an audiologist on the Division of Epidemiology at Johns Hopkins Bloomberg College of Public Well being. “We don’t know what these firms would possibly give you. We could actually see new methods listening to aids work, how they give the impression of being.”

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The F.D.A.’s ultimate rule takes impact in 60 days. Business representatives say machine makers are largely able to launch new merchandise, although some may have time to replace labeling and packaging or to adjust to technical particulars within the rule.

Dr. Robert Califf, the F.D.A. commissioner, mentioned the transfer is supposed to “unleash the facility of American business” in a manner that might have international affect.

“Listening to loss has a profound influence on day by day communication, social interplay and the general well being and high quality of life for thousands and thousands of Individuals,” Dr. Califf mentioned throughout a Tuesday press briefing. “It is a great worldwide drawback the place I believe American ingenuity could make an enormous distinction.”

The White Home additionally hailed the transfer as a signature accomplishment for President Biden, who can also be anticipated to signal the Inflation Discount Act on Tuesday. The change eliminates the requirement to see an audiologist for a listening to examination and becoming, a course of hardly ever lined by insurance coverage.

Federal officers estimated $2,800 in financial savings on the price of a pair of listening to aids. Brian Deese, White Home director of the Nationwide Financial Council, mentioned making the change was a “high precedence” for the president.

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“That is going to make a very concrete distinction within the lives of thousands and thousands of Individuals,” Mr. Deese mentioned.

Listening to loss is related to cognitive decline, melancholy, isolation and different well being issues in older adults. But the boundaries to getting listening to assist have included prices that aren’t lined by Medicare. There’s additionally stigma — reminiscent of showing “previous” — that comes with use.

Appreciation for the significance of sharp listening to for adults can also be off-kilter: A latest survey discovered that individuals aged 50 to 80 had been twice as prone to plan on taking their pet to the veterinarian within the coming 12 months than to get their listening to checked.

“It breaks my coronary heart just a little bit,” mentioned Sarah Sydlowski, affiliate chief enchancment officer of the Cleveland Clinic Head and Neck Institute and lead creator of the examine. “I believe our largest problem as a occupation and as a well being care system is to be sure that folks perceive that listening to is extremely necessary. It deserves their consideration, it deserves their motion.”

The transfer has rankled a few of the nation’s audiologists, the professionals who information folks by the method of selecting one of the best listening to help, adjusting the settings and attaining the best match. The brand new transfer eliminates the longstanding requirement that customers begin the method of getting a listening to help with them. However some within the occupation see alternative.

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“The listening to well being care skilled isn’t going to go manner,” mentioned Barbara Kelley, government director of the Listening to Loss Affiliation of America, which represents audiologists and customers. “The over-the-counter rule opens a brand new avenue that’s enormous for adults with delicate to reasonable listening to loss to take that step before later. And that’s what we’re actually enthusiastic about.”

The change has been percolating for years. In 2016, a proposal for the F.D.A. to approve over-the-counter listening to aids for adults with delicate to reasonable listening to loss got here out in a Nationwide Academies report. The next 12 months, Senators Chuck Grassley, a Republican of Iowa, and Elizabeth Warren, a Democrat of Massachusetts, launched a invoice enabling the company to make the change that was signed into legislation.

The method to finalize laws has moved slowly since then, with some battle over particulars, like how the federal rule would work together with state legal guidelines on listening to help returns or warrantee insurance policies and the way a lot the units ought to amplify sound.

President Biden issued an government order final July calling for larger competitors within the economic system, which included a name for the rule “to advertise the extensive availability of low-cost listening to aids” to be printed.

That rule got here out within the fall, adopted by a interval of public remark. The Listening to Industries Affiliation, an business group, submitted a 45-page remark letter warning the F.D.A. about firms that had come in the marketplace in 2018, after the preliminary legislation handed, promoting listening to aids that “had been ineffective, of poor high quality, and in some instances, harmful.” The group supplied detailed recommendation on keep away from a repeat situation.

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“We applaud the motion to extend entry to take care of individuals who’ve issue and encourage them to hunt knowledgeable,” to assist navigate their choices and the becoming course of, mentioned Kate Carr, president of the commerce group. Different organizations raised issues that the F.D.A. could be creating a security subject by permitting new listening to help makers to make units that permit customers to listen to loud sounds.

Senators Warren and Grassley had launched a joint report accusing the “dominant listening to help” makers of partaking in an “astroturf lobbying” effort by flooding the F.D.A. with repetitive feedback steering the company towards a brand new era of listening to aids that will be “much less efficient, defending producers’ present market share and locking of their aggressive benefit.”

The logic is easy: The much less efficient an O.T.C. listening to help is, the extra seemingly customers will probably be compelled to desert these choices and as a substitute go for costlier, prescription units offered by the producers that dominate this line of enterprise,” the senators’ investigative report mentioned.

The F.D.A. reviewed greater than 1,000 feedback submitted in regards to the rule and made a handful of adjustments within the ultimate model launched on Tuesday. They embody reducing the utmost sound output of the units and revising the insertion depth restrict within the ear canal. The rule additionally requires that the listening to aids have a user-adjustable quantity management and simplified wording on the product label.

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Are salmon sperm facials really good for your skin?

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Are salmon sperm facials really good for your skin?

Just when it seemed that the skincare industry had exhausted itself with absurd products and cyborgian procedures, Kim Kardashian brought a new one into the cultural consciousness. In the summer of 2024, Kim Kardashian announced on “The Kardashians” that she had salmon sperm injected into her face, spurring reactions of glee and intrigue that echoed from Rodeo Drive to TikTok.

Salmon sperm facials — which are sometimes called salmon DNA facials for civility’s sake — have become the latest addition to med spa menus across Los Angeles. Formula Fig in Culver City and West Hollywood recently added what is called “the longevity treatment,” which is its take on the popular facial, for $550. Done by Dorfman, a Beverly Hills-based med spa that boasts a celebrity client list, offers the procedure for $750. Kanodia Med Spa, also Beverly Hills-based, offers the facials starting at $1,000.

The procedure is performed through microneedling, which forms channels in the skin before the product is applied topically to the face. Using salmon DNA as an injectable is not yet FDA-approved, so doctors and med spas apply it in conjunction with microneedling and laser treatments. (The substance itself carries an orange-ish tint.) The procedure promises youthful, smooth skin and has been rapidly gaining popularity, thanks partly to endorsements on social media and by celebrities like Jennifer Aniston and Charli XCX.

The idea to use salmon sperm for regeneration is older than you might think. The study of salmon DNA for wound healing was originally pioneered in Italy in the 1980s, said Dr. Zakia Rahman, a clinical professor at Stanford’s School of Dermatology. In the last few years, there has been a resurgence of scientific interest in the substance as a beauty treatment in Korea.

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In fact, many doctors source salmon DNA from there. Dr. Donald Yoo, a facial plastic surgeon in Beverly Hills, uses a substance called Rejuran, which is procured from one ocean-side factory in a beachfront town in Gangneung, Korea. In October of last year, he visited the factory during the salmon spawning season to witness the extraction process, which kills the salmon as the DNA is removed.

“During the tour, they showed us the streams where the salmon were captured, the factory where they process the salmon DNA, and actually had us handle some of the live salmon prior to processing,” he says.

Dr. Yoo argues that the uncanniness of salmon sperm is what has made the procedure so popular. His office in Beverly Hills offers the treatment for a starting price of $850.

“There’s a little bit of that shock factor involved,” says Dr. Yoo. “The reason that it’s growing is the fact that science has given it a good, strong basis.”

What basis is that? It begins with polynucleotides, which are fragments of DNA derived from salmon sperm. They were previously used in wound healing after clinical studies showed that they accelerated the tissue repair process. Salmon DNA, as it turns out, shares striking similarities with human DNA, causing it to stimulate collagen production, according to a 2022 peer-reviewed study in the journal Marine Drugs.

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“It decreases inflammation,” says Dr. Yoo. “It promotes cell proliferation and blood vessel proliferation.”

When applied to the face, it can result in a soft, radiant, even-toned complexion. For years, scientists in Europe and South Korea have performed clinical studies of salmon DNA on skin to investigate its effect on collagen reproduction. One study conducted on wound healing in mice showed that administering polynucleotides expedited healing and collagen density.

However, despite the growing interest in this treatment, Dr. Rahman is not convinced of its efficacy.

“You have to be careful before jumping on a trend to see if it’s scientifically valid,” said Dr. Rahman.

After reviewing the scientific research, she explains that because of how the nucleotides function on the cell level, they can potentially be harmful to patients with rosacea and can actually cause some inflammation within the cells.

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She notes that, when it comes to absorption, polynucleotides are also relatively large, as opposed to more commonly used skin treatment ingredients like retinoids and vitamin C.

“The reason why retinoids and vitamin C work so well is that they’re very small and they can penetrate the skin,” says Dr. Rahman. “So this, if you were just to apply it topically, probably wouldn’t get absorbed.”

From a scientific perspective, it’s not clear that salmon DNA has the potential benefits that are advertised, she said, adding that established methods still yield the best results.

“If you’re using a topical retinoid or topical vitamin C, they’re much less expensive,” she says. “A lot of the laser treatments that we do, which are FDA-cleared for things like collagen stimulation and resurfacing of the skin, are actually much more cost-effective.”

“Do we really want to kill more salmon for their gonads?”

— Dr. Zakia Rahman, Stanford School of Dermatology clinical professor

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She also has sustainability concerns. After all, salmon sperm is finite.

“Do we really want to kill more salmon for their gonads?” she asks.

Nevertheless, the trend has become widespread in Europe and South Korea, and in the last year, it has developed a loyal fan base in the U.S. On Instagram, the hashtag #salmonspermfacial has over 5,000 posts featuring before-and-after photos. On TikTok, viral testimonials about salmon DNA facials rack up hundreds of thousands of likes.

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Jorian Palos discovered salmon DNA facials after searching for a way to lessen her eye bags and discoloration. She tried the treatment at a med spa chain called Skin Station in Orange County. She said the process was slightly disquieting.

“It was painful, just because it’s salmon semen essentially going under your eye.”

Though she was happy with her results, the recovery was also intense.

“My face was bruised under my eyes for about a week,” she said. “It turned purple, and then it turned yellow.”

Shirel Swissa did not have as an intense recovery. She routinely microneedles and vouches for the treatment.

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“Right now, my skin is the smoothest and clearest it’s been in forever,” she says. “There’s no texture. It also helps with my active acne.”

As for the sperm element, Swissa is unbothered: “It smells a tiny bit fishy. It’s not overpowering, but it’s tolerable.”

Dr. Yoo says it’s good to be skeptical of the latest health trend, but predicts that, based on the results he’s seen, salmon sperm facials will stick around.

“It’s an exploding field,” he said.

No pun intended.

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Behind a Museum Door, These Beetles Are Eating Flesh for Science

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Behind a Museum Door, These Beetles Are Eating Flesh for Science

Deep in the labyrinth of the American Museum of Natural History, past the giant suspended blue whale and the first floor’s Alaska brown bears, is an unobtrusive locked door. On it, there is a small sign.

“Bug Colony.”

Behind the door, accessible only to a handful of museum employees, thousands of flesh-eating dermestid beetles toil around the clock handling a task of specimen preparation that even the museum’s best trained specialists cannot.

They eat the meat off animal skeletons, leaving only clean bones behind.

Since many skeletons are too fine to be cleaned by human hands, the museum’s osteological preparation team turns to the six-legged staffers to prepare them for research and display.

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The work is carried out in three gray wooden boxes the size of footlockers that house the colony. They are lined with stainless steel and their flip-up tops reveal beetles swarming the earthly remains of various small animals, mostly birds. They feast upon the gobbets of flesh clinging to the carcasses.

The room is pervaded by the soft, crackling sound of gnawing. “It sounds like something frying, or Rice Krispies when you add milk,” said Rob Pascocello, the colony’s tender.

The beetles are tiny enough — just a few millimeters long — to crawl into the recesses of the smallest animals and nibble away without affecting delicate skeletal structures, said Scott Schaefer, who oversees the museum’s collection of more than 30 million specimens and objects.

“They do the fine, detailed work that cannot be done by hand, because it’s so delicate,” Mr. Schaefer said. “It’s gentler than boiling a specimen or soaking it in chemicals or acid.”

Museum officials say the ravenous colony has processed most of the bird collections’ more than 30,000 skeleton specimens over the decades, plus countless other forms of carrion. “They get into the small crevices and, if left unchecked, keep eating until there’s nothing left to eat,” Mr. Schaefer said.

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On a recent weekday, Paul Sweet, collection manager for the ornithology department, stood in the Bug Room, and in the interest of scientific precision pointed out that its name was imprecise.

True bugs, known to their fans as the Hemiptera order, have mouthparts that pierce and suck. Beetles — Coleoptera — are typically cylindrical and have mouthparts that chew.

The colony had gone to town with those mouthparts to reduce a once-lustrous pink flamingo to a humble bone bundle. A regal snowy owl was similarly picked clean. Then there was the small skeleton in a canister, with bones tinier than toothpicks.

“That’s a songbird,” said Mr. Pascocello.

Dermestid beetles are scavengers often found in the wild on animal carcasses, and in the nests, webs and burrows of animals.

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Museum officials told The New York Times in 1979 that their dermestid colony had remained self-sustaining since being brought over from Africa in the 1930s. Mr. Sweet said the current group has been around for his entire 35 years at the museum, but could not say for sure if they were the original colony’s descendants.

Either way, since a beetle’s life is only about six months, “they’re all kissing cousins,” said Mr. Pascocello. He said that while the museum was closed during the coronavirus pandemic, he “kept a backup colony in my bedroom.”

On this day, Mr. Sweet was looking to skeletonize a northern gannet, a sea bird recovered from Midland Beach on Staten Island. It had been skinned, dried, and trimmed of most of its flesh by researchers before it was handed over to the colony for finishing work.

Within minutes, the carcass was swarmed. The beetles can pick clean a small bird within a couple of days, but may need two weeks for larger skeletons like the gannet.

Mr. Pascocello once served the beetles an orangutan; Mr. Sweet once gave them an emu. But the size of the beetles’ boxes is a factor. Larger specimens must be served piecemeal, like the carcass of a feisty Cuban crocodile known as Fidel, obtained from the Bronx Zoo in 2005.

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Before the pristine skeletons are boxed and cataloged, they are soaked in water and frozen for days to kill remaining beetles or eggs.

The beetles are not a threat to humans, but an infestation of the museum’s specimen collection would be disastrous. Keeping the beetles well fed discourages them from wandering away, as does a strip of Vaseline toward the top of their boxes and a sticky floor section across the room’s doorway.

If the supply of specimens should stall, Mr. Pascocello keeps some chicken around as emergency food. Mr. Sweet said he offered the colony pigs’ feet during the pandemic because it was the cheapest bone meat at the supermarket.

The gourmandising of the beetles is a reminder that important science is not always conducted in gleaming, hygienic laboratories. On the door, under the “Bug Colony” sign, is a handwritten addendum:

“Bad odors emanating from behind this door is normal.”

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Researchers find drinking water is safe in Eaton, Palisades burn areas as utilities lift last 'do not drink' order

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Researchers find drinking water is safe in Eaton, Palisades burn areas as utilities lift last 'do not drink' order

Scientists have released some of the first independent test results confirming that drinking water in fire-affected areas around Altadena and the Pacific Palisades is largely free of harmful contaminants, as an Altadena utility lifted the last “do not drink” notice left in the burn zones.

Researchers with the LA Fire HEALTH Study released results on Friday from 53 homes spread across the burn areas and the more than three miles surrounding them. They found only one with a toxic substance at dangerous levels: at one home, the water contained benzene, a known carcinogen, at concentrations slightly above the state’s allowable level of 1 part per billion.

The findings add to mounting evidence that the affected area’s drinking water is safe. In March, Caltech professor Francois Tissot’s team found no lead levels above the U.S. Environmental Protection Agency’s limit in the tap water of the 43 homes they tested in Altadena and surrounding communities. Separately, UCLA professor Sanjay Mohanty’s group found no concerning levels of heavy metals or potentially harmful “forever” chemicals in 45 homes tested in the Palisades.

Experts noted that LA Fire HEALTH Study’s elevated benzene level — at 1.6 ppb — remains below the federal limit of 5 ppb and would likely drop below 1 ppb once the homeowner follows the utilities’ recommendation to run all faucets in the entire house for at least five minutes to flush contaminants out of the lines before using the tap water.

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The state’s limit of 1 ppb equates to no more than a two-in-one-million chance of a resident developing cancer from a lifetime exposure to the contaminant at that level, according to the State Water Resources Control Board. For higher, short-term exposures to benzene, the U.S. EPA says exposure to over 200 ppb for more than a day could have negative, non-cancer health consequences for children.

“I’m optimistic from these results,” said Chris Olivares, a professor of civil and environmental engineering at the University of California, Irvine, who has led the tap water-testing part of the LA Fire HEALTH Study. “The major takeaway, I think, is the importance of flushing.”

Andrew Whelton — a professor of civil and environmental engineering at Purdue University and a pioneer in the field of post-fire water contamination and remediation — attributes the quick and successful restoration of safe drinking water to the hard work of local utilities and state regulators, which followed a post-fire playbook Whelton and others developed in the wake of the 2017 Tubbs fire in Santa Rosa, 2018 Camp fire in Paradise, and subsequent fires throughout Colorado in 2021 and Hawaii in 2023.

The way dangerous volatile organic compounds, like benzene, could contaminate water supplies after a wildfire wasn’t well known or studied until a Santa Rosa resident reported a strong smell of gasoline — a signature indicator of benzene — when turning on their kitchen faucet for the first time after the 2017 fire.

Scientists and public health officials raced to understand and solve the problem. They found benzene levels as high as 40,000 ppb, and it took a year to restore safe water.

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After the Camp fire, scientists found levels over 900 ppb, which took eight months to remediate.

After the L.A. County fires, the Los Angeles Department of Water and Power found one instance of benzene at 71.3 ppb. The utility worked around the clock to restore safe water, first by closing roughly 4,800 open connections at fire hydrants and destroyed homes to restore water pressure, then continuously flushing water out of the system to push out contaminants. As they went, they tested and retested until benzene levels dropped to near-zero.

LADWP — with the approval of the State Water Resources Control Board — lifted its “do not drink” notice on March 7, exactly two months after the Palisades fire broke out. Two of the three smaller customer-owned utilities in Altadena, Lincoln Avenue Water Co. and Rubio Cañon Land and Water Assn. — which also detected benzene in their systems after the fires — quickly followed. The third, Las Flores Water Co., lifted the last “do not drink” notice on May 9.

Las Flores had registered the highest benzene levels of all the utilities: 440 ppb from a sample collected on April 10.

The LA Fire HEALTH Study team tested roughly eight homes within each burn area and over a dozen in adjacent communities between February and April while the testing and flushing process was ongoing.

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The results are some of the first from the LA Fire HEALTH Study’s broad-ranging, privately funded effort between nearly a dozen academic and medical institutions, to understand the health consequences of the L.A. County fires over the course of 10 years.

Outside the burn areas, no homes the team sampled exceeded the state’s allowable limit for benzene or any of the other two dozen volatile organic compounds for which the group tested. And inside the burn areas, benzene was the only contaminant that exceeded the state’s allowable limits.

Although the utilities have worked for months to flush contaminants out of the labyrinth of pipes shuttling water from reservoirs to private properties, it’s homeowners who are responsible for finishing out the job and flushing the pipes on their own properties.

The researchers stressed that the one benzene exceedance — found in Lincoln Avenue’s service area one week after the utility’s “do not drink” notice was lifted — is a reminder that residents should follow the utilities’ guidance for safe water use once returning home.

“Lincoln Avenue Water Company’s top priority is to provide safe and reliable drinking water to the community. Through extensive testing, we have established that our system is in compliance with all state and federal water quality standards,” said Lincoln Avenue general manager Jennifer Betancourt Torres, in a statement to The Times.

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“It’s important to emphasize that samples taken from inside the home are considered a representation of the residential plumbing and not the water being delivered,” she said.

The utilities and water safety experts say residents should first flush all of their lines — every faucet and spigot, both hot and cold, for at least five minutes. They should also run all appliances and fixtures, like dishwashers and washing machines, once with hot water before using. Two batches of ice from a fridge icemaker should be discarded.

Each utility is providing detailed, up-to-date guidance for their customers on their respective websites, including LADWP, Rubio Cañon, Lincoln Avenue and Las Flores.

Staff writer Ian James contributed to this report.

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