3D printing of body parts is coming fast – but regulations are not ready

In the last few years, the use of 3D printing has exploded in medicine. Engineers and medical professionals now routinely 3D print prosthetic hands and surgical tools. But 3D printing has only just begun to transform the field.

Today, a quickly emerging set of technologies known as bioprinting is poised to push the boundaries further. Bioprinting uses 3D printers and techniques to fabricate the three-dimensional structures of biological materials, from cells to biochemicals, through precise layer-by-layer positioning. The ultimate goal is to replicate functioning tissue and material, such as organs, which can then be transplanted into human beings.

We have been mapping the adoption of 3D printing technologies in the field of health care, and particularly bioprinting, in a collaboration between the law schools of Bournemouth University in the United Kingdom and Saint Louis University in the United States. While the future looks promising from a technical and scientific perspective, it’s far from clear how bioprinting and its products will be regulated. Such uncertainty can be problematic for manufacturers and patients alike, and could prevent bioprinting from living up to its promise.

From 3D printing to bioprinting

Bioprinting has its origins in 3D printing. Generally, 3D printing refers to all technologies that use a process of joining materials, usually layer upon layer, to make objects from data described in a digital 3D model. Though the technology initially had limited applications, it is now a widely recognized manufacturing system that is used across a broad range of industrial sectors. Companies are now 3D printing car parts, education tools like frog dissection kits and even 3D-printed houses. Both the United States Air Force and British Airways are developing ways of 3D printing airplane parts.

The NIH in the U.S. has a program to develop bioprinted tissue that’s similar to human tissue to speed up drug screening. Paige Derr and Kristy Derr, National Center for Advancing Translational Sciences

In medicine, doctors and researchers use 3D printing for several purposes. It can be used to generate accurate replicas of a patient’s body part. In reconstructive and plastic surgeries, implants can be specifically customized for patients using “biomodels” made possible by special software tools. Human heart valves, for instance, are now being 3D printed through several different processes although none have been transplanted into people yet. And there have been significant advances in 3D print methods in areas like dentistry over the past few years.

Bioprinting’s rapid emergence is built on recent advances in 3D printing techniques to engineer different types of products involving biological components, including human tissue and, more recently, vaccines.

While bioprinting is not entirely a new field because it is derived from general 3D printing principles, it is a novel concept for legal and regulatory purposes. And that is where the field could get tripped up if regulators cannot decide how to approach it.

State of the art in bioprinting

Scientists are still far from accomplishing 3D-printed organs because it’s incredibly difficult to connect printed structures to the vascular systems that carry life-sustaining blood and lymph throughout our bodies. But they have been successful in printing nonvascularized tissue like certain types of cartilage. They have also been able to produce ceramic and metal scaffolds that support bone tissue by using different types of bioprintable materials, such as gels and certain nanomaterials. A number of promising animal studies, some involving cardiac tissue, blood vessels and skin, suggest that the field is getting closer to its ultimate goal of transplantable organs.

Researchers explain ongoing work to make 3d-printed tissue that could one day be transplanted into a human body.

We expect that advancements in bioprinting will increase at a steady pace, even with current technological limitations, potentially improving the lives of many patients. In 2019 alone, several research teams reported a number of breakthroughs. Bioengineers at Rice and Washington Universities, for example, used hydrogels to successfully print the first series of complex vascular networks. Scientists at Tel Aviv University managed to produce the first 3D-printed heart. It included “cells, blood vessels, ventricles and chambers” and used cells and biological materials from a human patient. In the United Kingdom, a team from Swansea University developed a bioprinting process to create an artificial bone matrix, using durable, regenerative biomaterial.

‘Cloneprinting’

Though the future looks promising from a technical and scientific perspective, current regulations around bioprinting pose some hurdles. From a conceptual point of view, it is hard to determine what bioprinting effectively is.

Consider the case of a 3D-printed heart: Is it best described as an organ or a product? Or should regulators look at it more like a medical device?

Regulators have a number of questions to answer. To begin with, they need to decide whether bioprinting should be regulated under new or existing frameworks, and if the latter, which ones. For instance, should they apply regulations for biologics, a class of complex pharmaceuticals that includes treatments for cancer and rheumatoid arthritis, because biologic materials are involved, as is the case with 3D-printed vaccines? Or should there be a regulatory framework for medical devices better suited to the task of customizing 3D-printed products like splints for newborns suffering from life-threatening medical conditions?

In Europe and the U.S., scholars and commentators have questioned whether bioprinted materials should enjoy patent protection because of the moral issues they raise. An analogy can be drawn from the famed Dolly the sheep over 20 years ago. In this case, it was held by the U.S. Court of Appeals for the Federal Circuit that cloned sheep cannot be patented because they were identical copies of naturally occurring sheep. This is a clear example of the parallels that exist between cloning and bioprinting. Some people speculate in the future there will be ‘cloneprinting,’ which has the potential for reviving extinct species or solving the organ transplant shortage.

Dolly the sheep’s example illustrates the court’s reluctance to traverse this path. Therefore, if, at some point in the future, bioprinters or indeed cloneprinters can be used to replicate not simply organs but also human beings using cloning technologies, a patent application of this nature could potentially fail, based on the current law. A study funded by the European Commission, led by Bournemouth University and due for completion in early 2020 aims to provide legal guidance on the various intellectual property and regulatory issues surrounding such issues, among others.

On the other hand, if European regulators classify the product of bioprinting as a medical device, there will be at least some degree of legal clarity, as a regulatory regime for medical devices has long been in place. In the United States, the FDA has issued guidance on 3D-printed medical devices, but not on the specifics of bioprinting. More important, such guidance is not binding and only represents the thinking of a particular agency at a point in time.

Cloudy regulatory outlook

Those are not the only uncertainties that are racking the field. Consider the recent progress surrounding 3D-printed organs, particularly the example of a 3D-printed heart. If a functioning 3D-printed heart becomes available, which body of law should apply beyond the realm of FDA regulations? In the United States, should the National Organ Transplant Act, which was written with human organs in mind, apply? Or do we need to amend the law, or even create a separate set of rules for 3D-printed organs?

We have no doubt that 3D printing in general, and bioprinting specifically, will advance rapidly in the coming years. Policymakers should be paying closer attention to the field to ensure that its progress does not outstrip their capacity to safely and effectively regulate it. If they succeed, it could usher in a new era in medicine that could improve the lives of countless patients.

https://theconversation.com/3d-printing-of-body-parts-is-coming-fast-but-regulations-are-not-ready-128691

No shield from X-rays: Rethinking lead aprons

Patients have come to expect a technician to drape their torsos with a heavy lead apron when they get an X-ray, but new thinking among radiologists and medical physicists is upending the decades-old practice of shielding patients from radiation.

Some hospitals are ditching the ritual of covering reproductive organs and fetuses during imaging exams after prominent medical and scientific groups have said it’s a feel-good measure that can impair the quality of diagnostic tests and sometimes inadvertently increase a patient’s radiation exposure.

The about-face is intended to improve care, but it will require a major effort to reassure regulators, health care workers and the public that it’s better not to shield.

Fear of radiation is entrenched in the collective psyche, and many people are surprised to learn that shielding can cause problems. The movement also has yet to gain much traction among dentists, whose offices perform more than half of all X-rays.

“There’s this big psychological component, not only with patients but with staff,” said Rebecca Marsh, a medical physicist at the University of Colorado Anschutz Medical Campus in Aurora, Colorado, who spoke about shielding at a December forum here at the annual meeting of the Radiological Society of North America. “How do you approach something that is so deeply ingrained in the minds of the health care community and the minds of patients?”

Covering testicles and ovaries during X-rays has been recommended since the 1950s, when studies in fruit flies prompted concern that radiation might damage human DNA and cause birth defects. Only in the past decade did radiology professionals start to reassess the practice, based on changes in imaging technology and a better understanding of radiation’s effects.

Lead shields are difficult to position accurately, so they often miss the target area they are supposed to protect. Even when in the right place, they can inadvertently obscure areas of the body a doctor needs to see—the location of a swallowed object, say—resulting in a need to repeat the imaging process, according to the American Association of Physicists in Medicine, which represents physicists who work in hospitals.

Shields can also cause automatic exposure controls on an X-ray machine to increase radiation to all parts of the body being examined in an effort to “see through” the lead.

Moreover, shielding doesn’t protect against the greatest radiation effect: “scatter,” which occurs when radiation ricochets inside the body, including under the shield, and eventually deposits its energy in tissues.

Still, Dr. Cynthia Rigsby, a radiologist at Chicago’s Ann & Robert H. Lurie Children’s Hospital, called the move away from shielding a “pretty substantial” change. “I don’t think it’s going to happen overnight,” she added.

In April, the physicists’ association recommended that shielding of patients be “discontinued as routine practice.” Its statement was endorsed by several groups, including the American College of Radiology and the Image Gently Alliance, which promotes safe pediatric imaging.

Around the same time, the Food and Drug Administration proposed removing from the federal code a 1970s recommendation to use shielding. A final rule is expected in September.

In the coming year, the National Council on Radiation Protection and Measurements, which gives guidance to regulatory bodies, is expected to release a statement supporting a halt to patient shielding.

However, experts continue to recommend that health care workers in the imaging area protect themselves with leaded barriers as a matter of occupational safety.

Groups in Canada and Australia have endorsed the change, and a movement to abandon lead shields is underway in Great Britain, according to Marsh.

Marsh, who’s helping direct the educational effort, said perhaps a dozen U.S. hospitals have changed their official policies, but “most hospitals are starting to have the conversation.”

Chicago’s Lurie hospital is launching an “Abandon the Shield” campaign to educate staff, patients and caregivers before it stops shielding across the organization this spring, Rigsby said. Shielding is used for most of the 70,000 X-ray procedures performed annually at Lurie in a variety of settings, from orthopedics to the emergency department.

A few miles away, at the University of Chicago Medicine hospitals, the recommendation to stop shielding “came as kind of a shock,” said Dr. Kate Feinstein, chief of pediatric radiology.

Feinstein said it seems contrary to what radiology professionals are taught, and she’s uncertain how it applies to her department, which already takes steps to reduce the chance that a shield will interfere with an exam. “We apply our shields correctly, and our technologists are incredibly well trained,” she said.

Nevertheless, Feinstein said, her department is weighing a halt to routine shielding.

Some hospitals are concerned about violating state regulations. As of last spring, at least 46 states, including Illinois, required shielding of reproductive organs if they are close to the area being examined, unless shielding would interfere with the diagnostic quality of the exam, according to the medical physicists’ association.

Some states are revising their regulations. In some cases, hospitals have applied for waivers or sidestepped state rules by taking the stance that a shield has the potential to affect diagnostic quality anytime it is used, Marsh said.

The amount of radiation needed for an X-ray is about one-twentieth of what it was in the 1950s, and scientists have found no measurable harm to ovaries and testicles of patients from radiation exposure that comes from diagnostic imaging after decades of looking at data.

“What we know now is that there is likely no (hereditary) risk at all,” said Dr. Donald Frush, a radiologist at Lucile Packard Children’s Hospital Stanford in Palo Alto, California, who chairs the Image Gently Alliance.

There’s also no evidence that fetuses are harmed by even a relatively high amount of radiation exposure, such as that from a CT scan of the abdomen, Marsh said.

Nevertheless, some patients may insist on shielding. The physicists’ group suggested that when hospitals craft their policies they consider that shielding may “calm and comfort.”

“I don’t think any of us are advocating to never use it,” Frush said.

Public confusion might develop if dentists continue to shield while hospitals don’t. An estimated 275 million medical X-ray exams were performed in the U.S. in 2016, but 320 million dental X-rays were done.

Mahadevappa Mahesh, the chief physicist at Johns Hopkins Hospital, said there’s been less outreach to dentists on the topic. “It’s high time we bring them into the discussion,” he said.

The American Dental Association states abdominal shielding “may not be necessary” but has continued to recommend using lead collars to shield the thyroid “whenever possible.”

But Mahesh, who’s on the board of the physicists’ association, cautioned that lead collars to protect the thyroid may not be helpful and could obscure images taken by newer 3-D dental imaging machines.

Contacted for a response, the dental association said its guidance on shielding is under review.

Technologists especially will need support in educating patients and families “so they are not feeling like they are walking into a disastrous conversation,” said Marsh, the medical physicist.

She is doing her part. At the radiology conference, Marsh strummed a banjo and sang her version of the Woody Guthrie ballad “So Long, It’s Been Good to Know Yuh,” with lyrics like: “To get rid of shielding at first may seem strange, but the time is upon us to embrace this change.”

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Patient shielding provides negligible benefits while increasing risks

https://medicalxpress.com/news/2020-01-shield-x-rays-science-rethinking-aprons.html

China reports 17 new cases of mystery virus

China reported 17 new cases of the mysterious SARS-like virus on Sunday, including three people in serious condition, heightening fears ahead of China’s Lunar New Year holiday when hundreds of millions of people move around the country.

The new coronavirus strain has caused alarm because of its connection to Severe Acute Respiratory Syndrome, which killed nearly 650 people across mainland China and Hong Kong in 2002-2003.

Of the 17 new cases in the central city of Wuhan—believed to be the epicentre of the outbreak—three were described as “severe”, of which two patients were too critical to be moved, authorities said.

Those infected range from 30 to 79 years old.

The virus has now infected 62 people in Wuhan, city authorities said, with eight in a severe condition, 19 recovered and discharged from hospital, and the rest in isolation receiving treatment.

Two people have died so far from the virus, including a 69-year-old man on Wednesday after the disease caused pulmonary tuberculosis and damaged multiple organ functions.

Authorities said they had begun “optimised” testing of pneumonia cases across the city to identify those infected, and would begin “detection work… towards suspected cases in the city” as a next step, as well as carrying out “sampling tests”.

Scientists with the MRC Centre for Global Infectious Disease Analysis at Imperial College in London warned in a paper published Friday that the number of cases in the city was likely to be closer to 1,700, much higher than the number officially identified.

Authorities said Sunday that some of the cases had “no history of contact” with the seafood market believed to be the centre of the outbreak.

No human-to-human transmission has been confirmed so far, but Wuhan’s health commission has previously said the possibility “cannot be excluded”.

Three cases have also been reported overseas—two in Thailand and one in Japan.

-Rumour quashing-

Though China has not yet reported cases outside of Wuhan, discussion about the coronavirus spreading to other Chinese cities has swelled on social media.

On Sunday evening there were more than 400 million views of the hashtag “Shanghai pneumonia” on Weibo, China’s Twitter-like social media site, while “Shenzhen pneumonia” garnered at least 340 million views.

China’s centre for disease control moved to quash speculation about the mysterious disease on Saturday, publishing a flyer that dismissed “five big rumours”.

One of them included claims about the coronavirus spreading, which China’s disease control authority dismissed by saying all cases were being treated in Wuhan.

A hospital in Guangzhou, a city in southern China, also moved to dispel rumours about suspected cases of the Wuhan pneumonia, reported state-run Global Times on Sunday.

The original post, which was published through the hospital’s official Weibo account on Saturday, has since been deleted.

Screening measures

Although there has been no official announcement of screening measures on the mainland, Wuhan deputy mayor Chen Xiexin said on state broadcaster CCTV that infrared thermometers had been installed at airports, railway stations and coach stations across the city.

Chen said passengers with fevers were being registered, given masks and taken to medical institutions. Nearly 300,000 body temperature tests had been carried out, according to CCTV.

Authorities in Hong Kong have stepped up detection measures, including rigorous temperature checkpoints for inbound travellers from the Chinese mainland.

The US said from Friday it would begin screening direct flights arriving from Wuhan at San Francisco airport and New York’s JFK, as well as Los Angeles, where many flights connect.

Thailand said it was already screening passengers arriving in Bangkok, Chiang Mai and Phuket, and would soon introduce similar controls in the beach resort of Krabi.

Wuhan is a city of 11 million inhabitants that serves as a major transport hub, including during the annual Lunar New Year holiday when hundreds of millions of Chinese people travel across the country to visit family.

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Experts warn over scale of China virus as US airports start screening

https://medicalxpress.com/news/2020-01-china-cases-mystery-virus.html

Creating living robots out of stem cells

Scientists have created a new life form that’s something between a frog and a robot. Using stem cells scraped from frog embryos, researchers from the University of Vermont (UVM) and Tufts University assembled “xenobots.” The millimeter-wide blobs act like living, self-healing robots. They can walk, swim and work cooperatively. Refined, they could be used inside the human body to reprogram tumors, deliver drugs or scrape plaque out of arteries.

“These are novel living machines,” says Joshua Bongard, a computer scientist and robotics expert at UVM who co-led the new research. “They’re neither a traditional robot nor a known species of animal. It’s a new class of artifact: a living, programmable organism.”

To determine the best design for this new life form, researchers from UVM ran an evolutionary algorithm through a supercomputer. Then, the Tufts team assembled and tested the design using stem cells from the African frog species Xenopus laevis — the xenobot name comes from this frog, not the Greek prefix meaning other or stranger.

What the team created is a body form never seen in nature. The cells work together, allowing the robots to move on their own in watery environments. They even spontaneously cooperated to move around in circles, pushing pellets into a central location.

The researchers point to the advantages of these “biological machines.” Unlike robots made with steel or plastic, these would simply decompose after use. When sliced, they are able to regenerate and stitch themselves back together, something few other robots can do, and in addition to medical purposes, they could be put to use cleaning up radioactive waste or microplastics.

If you’re starting to panic at the idea of supercomputers designing living robots, you’re not alone. “That fear is not unreasonable,” Levin says. “When we start to mess around with complex systems that we don’t understand, we’re going to get unintended consequences.”

The researchers hope that the more we understand this technology and capability, the better off we’ll be. Plus, the xenobots come preloaded with their own food source, which should run out in about a week, unless they’re in a nutrient-rich environment. Don’t worry though, these little guys can’t reproduce or evolve — at least not yet.

https://www.engadget.com/2020/01/15/uvm-tufts-living-robots-xenobots/

2020 brings new ways to upgrade your hearing

If your peepers are letting you down, you have an endless choice of ways to frame that physical defect as a style statement. If you have hearing loss, not so much. Even the term “cool hearing aid” feels like an oxymoron. It’s not for lack of trying; companies have attempted to deviate from the “pink plastic blob” for years now — the result is usually something like a silver, or black plastic blob instead.

Why does that matter? Because for whatever reason, there’s still a stigma attached to wearing a hearing aid. If companies start making products that are as stylish as they are functional we all win. Fortunately, that’s starting to happen, and here are four new ways to upgrade your hearing without it feeling like a penance.

Olive Union Smart Ear $249

If you have mild hearing loss in just one ear, a pair of hearing aids might not make sense (or fit your budget). Olive’s Smart Ear aims to bring consumer headphone style to an assisted hearing device. It’s not a “hearing aid” instead it’s an amplifier (think reading glasses, but for ears). It’s primarily a solution for those who find themselves only speaking to the person on their “good side” at dinner parties, but has a few other tricks up its sleeve.

The bud looks just like any of the (many) TWS headphones on the market today. Rightly or wrongly, some people still feel self-conscious wearing a “classic” hearing aid, so the Olive’s design might make you feel more like you’re sporting a funky wearable than a miniature ear trumpet. Most hearing amplifiers simply mimic the design of a hearing aid, and rarely the smaller, sleeker ones. More and more companies are taking the bud-like approach, but Olive Union is going all in.

The Smart Ear’s focus is on boosting your one bad ear when you need it most: during a conversation. I’ll admit, I’ve used my own one-sided hearing loss to my strategic advantage at the dinner table (“sorry, this is my bad side, I can’t really hear you”), but the Olive would definitely help me out when I actually do want to converse with the person to my left. It’s comfortable, tailored to your hearing through a simple hearing test, and offers up to seven hours of listening time.

Unlike many TWS headphones, the Olive doesn’t come with a charging case. Instead, there’s a simple cradle that connects to any microUSB power source. I also found that if you don’t get a good fit, the bud can gently work its way out of your ear and start creating feedback. The companion app has an option to reduce this, but it still comes and goes.

As for the actual hearing assistance, I found it to be adequate for my level of (conductive) hearing loss, but it tends to amplify most sounds equally, like the clink of plates or the clatter of cutlery in a restaurant as well as your table mate’s retelling of their recent meditation retreat in Peru.

While the Olive isn’t quite right for me, I can see it being an inexpensive solution for those who need a bit of a boost from time to time. It’s certainly small enough and durable enough to live in your bag or pocket for those times you need it. The fact it looks more like a headphone makes it less discreet, but also less drab.

Lively ($1,650)

Technically, Lively doesn’t “make” hearing aids, instead, it’s an all-in-one audiologist for the modern age. Instead of traipsing to get a hearing test in some dated, dusty high street store, simply take the company’s online test and they’ll ship your hearing aids directly to you.

The experience brings shopping for a hearing aid more in line with well, anything else you’d want to buy online. Of course, you can still speak with an audiologist about your personal needs, or visit one of their premises if you prefer.

With Lively, it’s more about streamlining the whole experience so that it feels like a convenient service, rather than a dreaded trip to the docs. The hearing aids Lively sells are of the same quality you’d expect from your regular provider, but the savings of being online mean they don’t cost as much. Lively’s hearing aids cost $1,650 a pair which is lower than many rivals of similar quality.

I visited their New York office for the “in-person” experience, and it was about as nice as any visit to the hearing specialist as I could have hoped for. The hearing aids are small, discreet and — for my hearing loss — worked remarkably well. The sound enhancement was more natural than some rival products I’ve tried, and the companion app makes customizing your settings a breeze. There’s music streaming here too, but only for iOS users.

One issue I tend to find with hearing aids is that the volume isn’t quite set loud enough, something that only becomes apparent once you’ve left the clinic and had a chance to use them in the real world. Typically, this would mean booking a return visit for an adjustment. With Lively, you can request assistance via the company’s app. Simply tell them the problem your experiencing, and receive help remotely. For me, that was an update sent to my phone, which boosted the volume of my hearing aid to a far more satisfactory level. All of this without moving from my chair.

Eargo Neo HiFI ($2,950)

Despite the name (and the marketing images), the Neo HiFi isn’t a music streaming device. Instead, it’s an incredibly small hearing aid, by far the smallest on this list. Its diminutive form means it’s practically invisible once you’ve placed it in your ear (don’t worry, there’s a small tab for removing it easily). This makes it a great choice for those who really don’t want people to know they’re wearing a hearing aid.

Beyond its tiny size, another selling point for the Eargo, is the whole user experience. Unlike most hearing aids that maybe have a carry case for the device and spare batteries, Eargo’s products all have the battery built-in. The case for the Neo HiFi not only stores the buds, but charges them at the same time (you then charge the case once a week or so).

As the Neo HiFi is so small, there’s no Bluetooth onboard, but once again, that case comes to the rescue. Place the buds in that, and you can connect to them via the companion app to adjust settings and more.

Another factor to consider is also related to its size. As discreet as they are, the more space a hearing aid has, the louder and clearer the audio tends to be. This means the Eargo might not be quite as impactful, sonically, as other options on this list. The company has engineered the Neo HiFi to get the most out of the real-estate is does have, and the clever tip design does mean there’s a good amount of isolation, but I found them to be less suitable for my hearing loss than other options on this list.

The Eargo Neo HiFi is the middle ground between form and function. They are easily the “coolest” hearing aids on this list, with a product that really feels like it was designed for the young as well as the more senior user. The trade-off might be the audio, which is no small thing for a hearing gadget, obviously. But it still delivers a solid boost for its size, you just need to make sure it’s appropriate for your hearing first.

Phonak Virto Black ($6,000 and up)

Unlike the other companies we’ve discussed so far, Phonak is a classic hearing aid manufacturer, not a disruptive newcomer. That means its new Virto Black device has decades of experience behind it, and it shows.

The Virto Black is, in many ways, the yin to the Eargo’s yang. It’s a more traditional company that’s trying to appeal to a broader audience with a few slick tricks. But first and foremost it’s a very capable hearing aid. For me, it’s the device that helped most with my conductive hearing loss, to the point where I almost felt like I had “normal” hearing again, no small feat.

When it comes to sensors and software, the Virto Black is a powerhouse. According to the company, it 16 different hearing performance features, five different wireless technologies and will analyze 1,600 data points to calibrate the sound to your needs. All you need to know is that it’s smart enough to adapt its sound on the fly depending on your surroundings, though there are presets (which you can manually configure) too, if you want a little more control.

As the name suggests, the hearing aids are black, and they sit in the ear, rather than behind it. This might seem like an unusual color choice at first, but it actually makes them look more like wireless headphones than your grandpa’s beige hearing aid. It’s a weird world where we’re more okay with black buds in the ear rather than something discreet behind it, but here we are.

Where the Phonak gets more interesting are the additional features. For one, there’s Bluetooth music streaming. This might seem like an obvious addition, but it’s not as common as you think. And for a variety of reasons, when it is present, it’s often iOS only. The Virto Black will stream music from any Bluetooth source, be it your phone, laptop or even a television. This connectivity also means you can take calls through the hearing aids too. For calls, the sound is fine, but don’t expect the buds to sound anywhere near as good as dedicated headphones. This is a bonus feature more than a headliner.

Perhaps my favorite thing about the Virto Black, after its solid performance at helping me hear, is the “Roger” accessory. It’s a small disc laden with microphones. Place Roger anywhere (within about 30 feet of you) and it’ll beam whatever it hears right into the Virto Black. You can even control which direction it “listens” and there’s a lanyard mount so you can have one person in a crowded room have a direct line to your ears. It feels like having hearing superpowers and makes the Virto Black feel a lot more versatile. Note, your audiologist might charge extra for Roger, but it’s both good fun and actually useful.

All this technology doesn’t come cheap. At around $6,000 the Virto Black is pitched as a premium option. Unfortunately, the economics of hearing aids hasn’t benefited from masses of competition, so prices remain high if you want the good stuff. If you don’t need any of the bells and whistles and don’t mind a behind-the-ear device, you don’t need to spend this much, but if you like the style, and some of the more gadgety features, paying up for good hearing shouldn’t feel frivolous.

https://www.engadget.com/2020/01/15/upgrade-your-hearing-with-technology/

Joe Biden’s Obamacare Retread

Watching the Democratic Presidential candidates debate the best way to fix health care, it’s difficult to escape the impression that they suffer from collective amnesia. Their party had its shot at reforming the system a decade ago and blew it by passing a slapdash “reform” program that clashed so violently with the laws of economics that it became a symbol of big government overreach, bureaucratic ineptitude, and broken campaign promises. Ten years on, two of the top contenders for the Democratic presidential nomination have tacitly admitted this by pledging to replace it with some version of single-payer. The leading candidate in that contest, however, wants to retread Obamacare.

Former Vice President Joe Biden describes this plan as “moderate” because it doesn’t call for the immediate introduction of “Medicare for All,” as does Senator Bernie Sanders, or the two-phase transition to single payer favored by Senator Elizabeth Warren. Yet his plan to “build on the progress” of the “Affordable Care Act” includes a variety of false claims about its achievements. In a recent opinion piece in the Concord Monitor, one of New Hampshire’s most influential newspapers, Biden wrote: “Obamacare protected more than 100 million people with preexisting conditions.” This is a wild exaggeration according to a report issued by the Democrats themselves after PPACA was signed into law:

From 2007 through 2009, the four largest for-profit health insurance companies, Aetna, Humana, UnitedHealth Group, and WellPoint, refused to issue health insurance coverage to more than 651,000 people based on their prior medical history.… From 2007 through 2009, Aetna, Humana, UnitedHealth Group, and WellPoint refused to pay 212,800 claims for medical treatment due to pre-existing conditions.

During the period discussed, an average of 217,000 individuals were denied coverage annually, while an average of 70,933 claims per year were denied. No honest extrapolation of these figures across the insurance industry will get you to 100 million. But where Biden really insults our intelligence is his claim that Obamacare will save us money with a combination of new subsidies and price controls. If this doesn’t set off your BS detector, consider the last time we were told the “Affordable Care Act” would to save us money. Precisely the reverse occurred. During the first three years the law was in effect, insurance premiums doubled across the entire health insurance market, including employer-based plans.

Yet Biden would have us believe Obamacare was an unqualified success, and he’s not content to merely perpetuate it. He wants to expand it to include an exceptionally bad idea that even the Democrats rejected during the 2009 health care reform debate — the public option. This is how he describes it in his column for the Concord Monitor: “We cannot rest until every American can access quality, affordable care.… That’s why my plan starts by giving Americans a choice to either stick with their private plan or get covered by a Medicare-like public option.” Biden claims this will keep insurers honest by forcing them to compete for the first time. This is nonsense, as the editors of the Wall Street Journal explain:

Mr. Biden supports a new government insurance plan that would “compete” with private insurance. We use quotation marks since a government insurer with zero cost of capital and political backing starts with an unbeatable advantage. The public option would undercut competitors on price, stiff providers with low reimbursement rates, and crowd out private insurance over time.

Despite Biden’s claim that he objects to the elimination of private insurance, a stated goal of “Medicare for All,” the addition of a public option to Obamacare would inevitably drive private insurers out of the health care market. Biden, however, claims it would merely offer more choice for consumers and wouldn’t force a change on folks who are happy with their insurance. He has even taken to repeating the most infamous whopper told by his former boss about Obamacare. In late October Biden actually pledged, “Under my plan, if you negotiated an agreement for health care with your employer, union, or otherwise, and you like it because you’ve given up wages to get it, you can keep it.”

That whopper is no truer today than it was in 2013, when it earned erstwhile President Obama the “Lie of Year Award” from PolitiFact. When the public option obliterates private health insurance, it won’t matter whether you like your current coverage or not. Unlike the federal government, an insurer can’t operate at a loss and remain viable. Faced with that situation, they will simply exit the health coverage market and invest their resources in a line of business that promises a decent return on investment. Eventually, this will also drive up the cost of providing care. Sally Pipes, the Thomas W. Smith fellow in healthcare policy at the Pacific Research Institute, puts it as follows:

If a public option’s artificially low premiums entice the privately insured away, then [health care] providers will have to raise rates for those remaining on private insurance. That would drive yet more privately insured to the public option. The cycle would continue until there were no private insurers left.… Joe Biden wants voters to believe his health proposal offers choice. It doesn’t.

Former Vice President Biden’s health plan isn’t a moderate proposal. It’s just as radical as anything proposed by Bernie Sanders or Elizabeth Warren — only less honest. As Seema Verma, the administrator of the Centers for Medicare & Medicaid Services, wrote last July in the Washington Post, “Whether conceived as an expansion of Medicare or the creation of a government health care option, the public option is a Trojan horse with single-payer hiding inside.” “Good Ole Joe” knows that, of course. Even if he can’t always figure out exactly which state he’s in, he’s still sentient enough to know a retread of Obamacare will sell better than single payer, even if the end result will be identical.

Joe Biden’s Obamacare Retread

Health Insurers Level More Blows To Medicare For All

Health insurance companies are already reporting unprecedented growth in signing up seniors to their Medicare plans for 2020, which is bad news for certain Democrats pushing single payer versions of “Medicare for All.”

The nation’s largest health insurer, UnitedHealth Group, last week reported its best growth ever for enrollment in individual Medicare Advantage, the private coverage sold by health plans via contracts with the federal government. UnitedHealth’s UnitedHealthcare health insurance unit was the first of the big health insurers to report quarterly earnings and updated 2020 projections for what is expected to be a record year of growth for Medicare Advantage. Other insurers including the Aetna unit of CVS Health, Anthem, Cigna and Humana will be reporting their quarterly earnings in the next two months.

“Within our Medicare Advantage offerings including dual eligible growth, we expect to serve nearly 700,000 more people in 2020,” UnitedHealth Group chief executive David Wichmann told analysts on the company’s fourth quarter earnings call last week.

Wichmann described the most recent open enrollment period, which ended in early December for seniors to choose their Medicare health and drug coverage for 2020, as UnitedHealth’s “strongest ever” for individual Medicare Advantage.

UnitedHealth’s record Medicare Advantage enrollment comes as most Democrats running for their party’s nomination for the Presidency back off a single payer version of Medicare for All that would uproot the private insurance industry. And that would in effect end a Medicare Advantage program that has already signed up more than one in three Medicare eligible seniors and growing.

But more seniors signing up for private Medicare Advantage means it will be politically harder for it to be taken away and replaced with a government-run single-payer version of Medicare for All pushed most notably by Sen. Bernie Sanders of Vermont.

Sanders continues to push single payer Medicare and last week during a debate in Des Moines reiterated that his plan has no copayments or deductibles. Meanwhile, Democrats that include former Vice President Joe Biden and most others still in the race are touting an effort to build on existing coverage under the Affordable Care Act. Sen. Elizabeth Warren, historically a supporter of Sanders plan, has backed off moving all Americans to a government-run healthcare system in favor of first bolstering the ACA and introducing a public option.

As more baby boomers turn 65 and become eligible for Medicare, insurers and the federal government are seeing more of them sign up for private Medicare Advantage than the government-run traditional fee-for-service Medicare.

This year, Medicare Advantage plans are offering more supplement health benefits under new rules established by the Centers for Medicare & Medicaid Services, which has seen  a record number of health plans selling coverage that offers seniors the same benefits as traditional Medicare plus extras like preventative care and outpatient healthcare services.

“We are bullish obviously overall on the outlook for both Medicare Advantage, but also the dual special needs marketplace as well,” UnitedHealth’s Wichmann said. “They are both very larger today and growing in markets. MA is clearly outperforming fee-for-service in terms of overall benefit coverages and the quality of outcomes and the returns that people are getting in terms of their overall satisfaction and so no surprise that it is performing as well and seems to be gaining some momentum.”

The lack of momentum for a single payer version of Medicare for All among Democrats vying to challenge President Donald Trump should Republicans re-nominate him to run for a second term isn’t lost on health plans signing up seniors to Medicare Advantage.

The health insurance industry and its supporters say Medicare Advantage is more about “modernizing” Medicare with the help of the private sector and seniors are increasingly recognizing the difference.

“Despite the lower costs, better outcomes, and high satisfaction that defines Medicare Advantage, some would argue for policies that threaten the success of Medicare Advantage and turn back the clock on innovative care models that enable seniors to live healthier lives,” Allyson Schwartz, a former Democratic Congresswoman and president and CEO of Better Medicare Alliance wrote in an opinion column in the Jan. 7^th issue of the journal Health Affairs.

“From my time leading a women’s health center, to my work as Commissioner of Health and Human Services in Philadelphia, to my service in Congress crafting health policy on the Ways and Means Committee, to my role today, I believe health care is a basic human right,” Schwartz wrote. “As we seek to address Americans’ very real concerns, we should fix what is broken in our health care system, while strengthening that which works to ensure coverage and quality at a cost we can all afford.”

https://www.forbes.com/sites/brucejapsen/2020/01/19/insurers-level-more-blows-to-medicare-for-all/#724529a53912