The FDA greenlights Apple’s Hearing Aid feature for AirPods Pro

The Food and Drug Administration has approved Apple’s over-the-counter Hearing Aid feature. Designed for people with mild to moderate hearing loss, it transforms the second-gen AirPods Pro into OTC hearing aids. This follows the FDA’s 2022 decision to allow adults with less-than-severe impairment to use corrective consumer hearing devices without a professional test, prescription or fitting.

The FDA says Apple’s software-based Hearing Test feature for AirPods Pro showed similar benefits to those who received a professional fitting of the wireless earbuds. “Results also showed comparable performance for tests measuring levels of amplification in the ear canal, as well as a measure of speech understanding in noise,” the FDA wrote in its announcement. The agency adds that it didn’t observe any “adverse events” from using the device as an OTC hearing aid.

Apple’s Hearing Aid feature, coming in iOS 18, starts with a hearing test on your paired iPhone or iPad. As the image above shows, the test begins by ensuring your earbuds have a good seal. After that, it activates active noise cancellation (ANC) and asks you to tap the screen when you hear tones in the left and right ears.

Once you finish, your results will live in the iOS Health app, where you can see how your results change (or not) over time. You can download your results and give them to an audiologist anytime. (If the test determines you have severe hearing loss, it will recommend you seek a professional assessment since the AirPods feature is only approved for those with mild to moderate impairment.)

Engadget’s Billy Steele got an early preview of the feature after Apple’s big iPhone 16 event earlier this week. “It seems to be as quick and easy as Apple describes,” our audio expert wrote. Although the demo was a simulation, it covered each step of the process, adding up to only about five minutes.

Apple developed the feature using 150,000 real-world audiograms and millions of simulations. The company’s FDA application was reviewed under the agency’s De Novo premarket pathway, which provides a runway for novel devices that don’t carry serious risk.

Apple’s Hearing Aid and Hearing Test features will arrive no earlier than when iOS 18 launches to the public on September 16. The AirPods Pro (second-gen) is required to use the feature.

This article originally appeared on Engadget at https://www.engadget.com/audio/headphones/the-fda-greenlights-apples-hearing-aid-feature-for-airpods-pro-164912484.html?src=rss

Meta and the Mental Health Coalition launch a data-sharing program to reduce violating suicidal content

September marks Suicide Prevention Month, a time to recognize the people impacted by suicide and suicidal thoughts, as well as the importance of working together to raise awareness and take preventive steps. A new collaboration aims to fulfill the latter, with Meta teaming up with the Mental Health Coalition to create Thrive, a signal-sharing program. Thrive should allow participating companies to send signals about content focused on self-harm or suicide to each other, thus locating and investigating the same or similar posts more easily. Snap and TikTok join Meta as founding members.

Thrive will initially work through companies providing hashes (codes corresponding to the violating content). Each one will only provide information about the image or video and shouldn't include specific information about users or the account. Meta says it will prioritize content that is graphic or depicting or promoting viral challenges around suicide or self-harm.  

Meta announced the news in a statement and shared it's providing Thrive's technical infrastructure. The company, which has been far from a shining example in preventing harm on its site, also acknowledged the need for cross-platform collaboration. "Unfortunately this content isn't limited to any one platform — especially when it comes to viral challenges — and it's imperative that the technology industry works together to help prevent it from spreading," said Antigone Davis, vice president of Global Safety at Meta. 

Thrive's director, Dr. Dan Reidenberg, will oversee the program, stating, "The integration of signal sharing, coupled with cross-industry collaboration and moderated by an independent and neutral intermediary, represents a major breakthrough in industry collaboration and public protection on the global, public health crisis of suicide and ultimately save lives."

In the US, the National Suicide Prevention Lifeline is 1-800-273-8255 or you can simply dial 988. Crisis Text Line can be reached by texting HOME to 741741 (US), 686868 (Canada), or 85258 (UK). Wikipedia maintains a list of crisis lines for people outside of those countries.

This article originally appeared on Engadget at https://www.engadget.com/social-media/meta-and-the-mental-health-coalition-launch-a-data-sharing-program-to-reduce-violating-suicidal-content-124446825.html?src=rss

How Apple’s Hearing Aid and Hearing Test will work on AirPods Pro

The second-generation AirPods Pro have had hearing health features for a while now. However, those tools are being expanded in iOS 18 with Hearing Test, Hearing Aid and Hearing Protection that will soon be available on the earbuds. Apple's three-prong approach to hearing health now covers awareness, assistance and prevention, but it all starts with the "clinically validated" hearing test you can take on your own. 

Apple has created its version of the hearing test we all probably took as kids. The one where you sit in a booth and raise your hand when you hear a sound. The company offers an alternative to the booth, bulky equipment and trip to the doctor with AirPods Pro and the iPhone. In any quiet environment, the earbuds and the phone can now offer a similar test to what you'd get in a physician's office. Here's how it works. 

From the Settings menu on your iPhone, you'll tap into the AirPods Pro settings to find the Hearing Health section. First, the software will check to make sure the fit of your AirPods provides a good seal for the test and that your location is quiet enough for the tech to offer reliable results. Once Hearing Test begins, active noise cancellation (ANC) will be enabled and you'll tap your iPhone screen when you hear tones on both the left and right sides. Apple employed 150,000 real-world audiograms and millions of simulations to develop a test that's quick and easy. But most importantly, the company says, it created one that's accurate. 

Once the test is completed, you'll get immediate results on your phone, telling you the level of hearing loss (if any) in each ear. If you have minimal hearing loss but could maybe benefit from help in certain frequencies, the software will recommend some tweaks in the Media Assist settings for entertainment audio and calls. If you have mild to moderate hearing loss, Hearing Test may suggest you use the AirPods Pro Hearing Aid feature to improve every day life. 

AirPods Pro will soon be able to tell you if you have some degree of hearing loss.
Apple

I got a brief walkthrough of Hearing Test following the iPhone 16 event, and it seems to be as quick and easy as Apple describes. To be clear, I didn't actually take a real test, just a simulated version with fake results, but every step in the process was accounted for in my abbreviated session. All told, you should be able to complete Hearing Test in about five minutes. 

Hearing Test results will be stored in the Health app, allowing you to see changes over time. You can retake the test as often as you want, with access to hearing health articles and the ability to download results just a tap away. I should also note that Hearing Aid is designed for people with mild to moderate hearing loss. If Hearing Test determines that you have severe hearing loss, the software will recommend that you visit an audiologist for further guidance. 

Hearing Aid is a software-based solution that boosts certain frequencies so certain sounds are enhanced on AirPods Pro. It's a first of its kind submission to the FDA, and a tool that allows you to customize the amplification, balance and tone at any time in the settings. The feature should help people with mild to moderate hearing loss better hear conversations and environmental sounds, but also improve what they hear in music, videos and calls. 

Both Hearing Aid and Hearing Test should be available this fall, pending FDA approval, as part of an iOS 18 update

Catch up on all the news from Apple’s iPhone 16 event!

This article originally appeared on Engadget at https://www.engadget.com/audio/headphones/how-apples-hearing-aid-and-hearing-test-will-work-on-airpods-pro-154814439.html?src=rss

Apple’s AirPods Pro update turns them into a clinical grade hearing aid

Apple was very busy when it came to AirPods announcements this week. Alongside new fourth-generation AirPods (and an ANC option) and updated AirPods Max, it's also giving attention to the AirPods Pro, with a focus on hearing health. This leans heavily on hearing loss prevention, with noise levels limited by default, and an app to measure exactly how noisy your surroundings are. Apple notes that one in three people are regularly exposed to environments that can damage hearing, even with in-ear buds like AirPods Pro and noise cancellation.

The company is now introducing a clinically-validated hearing test on your iPhone. The test taps into large-scale data studies that Apple used to develop its hearing loss features, and it only takes five minutes. It'll ask you to tap the screen when you hear a series of tones at different frequencies. Your hearing profile will also be automatically applied to audio content across music, movies and phone calls.

But Apple took it even further and has developed an over-the-counter, professional-grade hearing aid feature. It'll boost the specific kinds of sounds you need help with. It's a big move from Apple, as existing OTC hearing aids can cost between $1,000 and $1,500. The second-gen AirPods Pro are just $250 by comparison.

The company is still awaiting FTC approval, but expects to launch these hearing features later in the fall. It'll join new sleep apnea detection coming to Apple Watch.  

Catch up on all the news from Apple’s iPhone 16 event!

This article originally appeared on Engadget at https://www.engadget.com/audio/headphones/apples-airpods-pro-update-turns-them-into-a-clinical-grade-hearing-aid-174919818.html?src=rss

Abbott’s OTC glucose monitor is now available in the US

Health tech company Abbott has been working on a number of biometric wearables for regular consumers. Now, we can get our hands on one. The company just released the Lingo continuous glucose monitor. 

This is an over-the-counter device, so you can just order it without prior approval. However, it’s not intended for diabetics, as it isn't designed for insulin pumps or serious medical alerts. Rather, it’s for curious people who want to keep an eye on their glucose levels. 

Here’s how it works. The biosensor gets stuck to the back of the arm and can stay there for up to 14 days straight. During that time, the device continuously streams glucose data to the affiliated smartphone app. This should, in theory, translate the “body’s reaction to food, exercise and life’s daily stressors.”

The app in action.
Abbott

The app looks particularly robust, providing access to all kinds of related health metrics. There are glucose graphs that update in real time and something called Lingo Count, which displays data related to glucose spikes.

There’s even a place for food and activity logging and the app syncs with Apple Health to automatically track workouts. Once there’s enough information in the system, it’ll provide tailored recommendations and create challenges to encourage healthy habits.

Each Lingo biosensor costs $49, but they only work for two weeks and aren’t reusable. The company is offering combo packs, with two sensors available for $89 and six for $249.

Abbott’s Lingo device isn’t the first over-the-counter continuous glucose monitor on the market. A company called Dexcom received FDA approval for a similar sensor earlier this year. The company’s Stelo Glucose Biosensor is also $89 for two units, each working for two weeks. 

It's worth noting that there's little evidence to suggest that this type of glucose monitor is actually useful. Additionally, there isn't much to suggest that there's even a meaningful way to "optimize" blood sugar.  

This article originally appeared on Engadget at https://www.engadget.com/wearables/abbotts-otc-glucose-monitor-is-now-available-in-the-us-170036887.html?src=rss

WHO-backed study finds no link between mobile phone use and brain cancer

By the early 2000s, it seemed everyone had two things: a cell phone and the certainty its radio waves could give them cancer. The first is arguably more true than ever, but a new World Health Organization-backed systematic review found no link between mobile phone use and brain cancer. These findings included no association with use for more than a decade, number of calls or length of time spent talking on the phone.

The review analyzed over 5,000 studies, eventually including 63 published between 1994 and 2022, which, together, included participants from 22 countries. The research, led by the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA), also found no link to other head and neck cancers. This data comes ahead of the WHO's publication of an Environmental Health Criterion Monograph looking at radio wave exposure's impact on human health.

In 2011, the International Agency for Research on Cancer (IARC) classified radio waves as "possibly carcinogenic," meaning it couldn't rule out or confirm the link. This list also includes aloe vera, coffee and working as a firefighter — among over 1,000 other entries. "This systematic review of human observational studies is based on a much larger dataset compared to that examined by the IARC, that also includes more recent and more comprehensive studies, so we can be more confident that exposure to radio waves from wireless technology is not a human health hazard," Ken Karipidis, ARPANSA's health impact assessment assistant director and the lead author, said in a statement. Karipidis and his team are if mobile phones have links to other cancers, such as leukemia.

This article originally appeared on Engadget at https://www.engadget.com/mobile/who-backed-study-finds-no-link-between-mobile-phone-use-and-brain-cancer-123032606.html?src=rss

Discover the RingConn Gen 2: The Thinnest, Lightest AI Smart Ring with 12-Day Battery Life

Forget bulky, pricey, and intrusive smartwatches! Smart rings are the new black, providing key insights into your health without weighing down your wrist or distracting you with notifications. Like David versus Goliath, RingConn boldly faced giants to bring an accessible smart ring to the masses and it continues to challenge the status quo even with the arrival of even bigger names in the market. Taking its game to the next level, RingConn is introducing its next-gen smart ring boasting not only a discreet, comfortable design and AI-powered comprehensive health tracking but also a battery life that will last you almost two weeks, ensuring that you will never miss a beat when it comes to taking control of your well-being, especially the all-important sleep that we often take for granted.

Designer: RingConn

Click Here to Buy Now: $209 $299 (30% off). Hurry, only 436/10,400 left! Raised over $3 million.

The original RingConn already delivered a more convenient way to keep track of your health and sleep quality 24/7. You only had to take it off after a few days to charge it briefly, and it didn’t get in your way or distract you with notifications. Best of all, it offered all the data and insights into your health without any subscription fees. It empowered everyone to take control of their health by giving them the tools and knowledge to create the path to healthier living.

The RingConn Gen 2 builds on that solid foundation and takes it up to eleven, improving not only the technology inside but also the design that will make you proud to show the ring off. At only 2g and only 2mm thick, it is the thinnest and lightest smart ring on the market. You might even forget that you’re wearing it, freeing you to go about your life without giving it a second thought. And with an IP68 dust and water protection rating, you don’t even have to worry when your hand gets wet, accidentally or intentionally. Wear it outdoors, in the shower, under the rain, or for a swim, the RingConn Gen 2 will be able to keep up with whatever lifestyle you live.

Its ultra-thin profile belies the amount of technology that the RingConn Gen 2 packs inside. From the basics like 3D accelerometers to advanced PPG (photoplethysmography) and temperature sensors, this discreet and lightweight smart ring has everything necessary to paint a complete picture of your body’s health. Unlike a smartwatch, the RingConn Gen 2 takes advantage of the finger’s thin skin and abundant blood vessels to provide precise tracking, taking note of key metrics like heart rate, heart rate variability, and blood oxygen levels. All of this data is fed into the RingConn app which presents a holistic view of your well-being, including stress levels and monthly cycles, without hiding anything behind subscription fees.

One of the biggest innovations that this next-gen smart ring brings to the table, or to the bed rather, is AI-powered sleep tracking. Sleep is easily overlooked and quickly sacrificed on the altar of productivity, but it is ironically one of the most important factors in living a healthy and productive life. Using next-gen sensors and advanced AI, the RingConn Gen 2 can evaluate your nighttime breathing, respiratory variations, sleep stages, and overall sleep efficiency, allowing you to detect critical sleep risk events and issues like sleep apnea so that you can take the right steps to improve your sleep quality and your overall well-being.

With all the features it provides, your mind will probably be blown away by the RingConn Gen 2’s 10-12 day uptime on a single charge. Add in the charging case and you can get an accumulative 150 days of use before you need to plug it in. That’s five months of continuous sleep and health tracking, generating a comprehensive picture of your health directly available on your phone. So ditch the smartwatch, put on your favorite timepiece, slip on the RingConn Gen 2, and live your healthiest life today!

Click Here to Buy Now: $209 $299 (30% off). Hurry, only 436/10,400 left! Raised over $3 million.

The post Discover the RingConn Gen 2: The Thinnest, Lightest AI Smart Ring with 12-Day Battery Life first appeared on Yanko Design.

Heal your gut and Calm your mind with this pair of innovative wearable devices

Our health is the single most important investment we can make, but most people tend to take it for granted or are at a loss for what to do. Some pay no attention to the discomfort in their gut, simply attributing it to indigestion, while others belittle the stress and anxiety they feel each day, deciding to just “tough it up.” Others do take the effort to address these concerns but end up with solutions that are costly, uncomfortable, and worse, ineffective. Fortunately, that doesn’t have to be the case, thanks to these innovative wearable devices that target the centers of physical and mental health, providing people with easy-to-use, portable, safe, and comfortable tools to enjoy a pain-free gut, a stress-free mind, and a happy, healthy life in j just weeks.

Designer: Kineon

Click Here to Buy Now: $359 $998 (64% off). Hurry, only 20 left! Raised over $200,000.

It’s almost too easy to take the discomfort that we feel in our guts for granted, but that can actually affect not only our physical health but our mental state as well. If the brain is the control center of the body, the gut or gastrointestinal tract is the health hub and reflects the general state of the body. Gut problems are often a symptom of or lead to more serious health disorders, and these, in turn, also affect our mental well-being.

Revitalize Gut Health With Red Light Laser Therapy

HEAL+ is a non-invasive solution that makes sure that your gut is working properly in order to improve your overall health. The science behind HEAL+ is laser therapy, specifically low-level laser therapy or LLLT to reduce inflammation and pain that commonly occurs with gut-related disorders such as IBS, colitis, Crohn’s disease, and more. It also assists in recovery from long-COVID by boosting your immune system and improving your overall health. This non-invasive method regulates microbial balance in the gut which is necessary for proper digestion and enhanced immune functions. Going beyond your gut, HEAL+ also supercharges nitric oxide for improved blood circulation and enhances dopamine signaling in the brain to improve your mood, giving credence to the saying “A Happy Gut Means a Happy Mind.”

Best of all, HEAL+ is not some complicated machine or nauseating drug but a wearable device you simply wrap around your waist. Attach the removable laser modules to the front of the waistband and you’re good to go, enjoying the relief that HEAL+ brings to gut issues. It’s easy to use and comfortable to wear, allowing you to bring this health-promoting device anywhere with you.

Calm+ is a neck-worn device, easy to use and helps stack with daily habits. Ease the ‘fight or flight’ state triggered by daily stress within just 15 minutes. Calm+ stimulates the Vagus nerve that’s responsible for signaling the brain to release calming neurotransmitters like acetylcholine and serotonin, chemicals that are associated with calmness and relaxation. The device includes built-in sensors that will integrate optical heart measurements, allowing you to personalize the dosage to your own optimal outcomes.

Together, HEAL+ and CALM+ help improve your physical and mental well-being through a combination of red light therapy and vagus nerve stimulation. Thanks to its compact and portable design, it can keep your gut healthy and your mind happy whenever and wherever you are. The Kineon App is your ultimate guide to wellness. Seamlessly schedule, track your progress, customize your programs, and get access to expert insights, anywhere, anytime. Say goodbye to gut ouchies and stress-induced headaches and live your healthiest and happiest life with the innovative HEAL+ and CALM+ wearables. Together with the wealth of information and community assistance through Kineon’s Pain to Possible Program, you can quickly embark on a journey to wellness and calm right now!

Click Here to Buy Now: $359 $998 (64% off). Hurry, only 20 left! Raised over $200,000.

The post Heal your gut and Calm your mind with this pair of innovative wearable devices first appeared on Yanko Design.

Neuralink successfully implants its chip into a second patient’s brain

Neuralink's brain chip has been implanted into a second patient as part of early human trials, Elon Musk told podcast host Lex Fridman on Saturday. The company hasn't disclosed when the surgery took place or the name of the recipient, according to Reuters.

Musk said 400 of the electrodes on the second patient's brain are working out of 1,024 implanted. "I don't want to jinx it but it seems to have gone extremely well," he said. "There's a lot of signal, a lot of electrodes. It's working very well." 

The device allows patients with spinal cord injuries to play video games, use the internet and control electronic devices using their thoughts alone. In May, the company announced that it was "accepting applications for the second participant" in trials following FDA approval. 

The original Neuralink implant patient, Nolan Arbaugh, described the surgery as "super easy." In a demo, the company showed how Arbaugh was able to move a cursor around the screen of a laptop, pause an on-screen music device and play chess and Civilization VI.

Arbaugh himself participated in the marathon podcast with Musk and Fridman. He said that the device allows him to make anything happen on a computer screen just by thinking it, helping reduce his reliance on caregivers. 

However, problems cropped up shortly after his surgery when some of electrodes retracted from his brain. The issue was partly rectified later on by modifying the algorithm to make the implants more sensitive. Neuralink told the FDA that in a second procedure, it would place the implant’s threads deeper into the patient’s brain to prevent them from moving as much as they did in Arbaugh’s case.

Neuralink previously tested its implant in animals, including chimps, and some of those testing practices have been the subject of federal investigations

Despite those issues, the company said it had over 1,000 volunteers for its second surgical trial. Musk said he expects Neuralink to implant its chips in up to eight more patients by the end of 2024.  

This article originally appeared on Engadget at https://www.engadget.com/neuralink-successfully-implants-its-chip-into-a-second-patients-brain-123013864.html?src=rss

Breakthrough Titanium Heart Design Successfully Implanted in a Human

In a significant medical breakthrough, the Texas Heart Institute and BiVACOR have successfully implanted the BiVACOR Total Artificial Heart (TAH) in a human patient at Baylor St. Luke’s Medical Center. This development marks a substantial advancement in treating severe heart conditions, particularly for patients with biventricular and univentricular heart failure, who are unsuitable candidates for traditional devices like left ventricular assist devices.

Designer: BiVACOR

The BiVACOR TAH features a titanium rotary blood pump utilizing magnetic levitation technology. This innovation minimizes the wear and tear commonly seen in traditional artificial hearts. With only one moving part, the TAH emulates the human heart’s function by efficiently pumping blood while reducing damage to blood cells.

The maglev technology allows the rotor inside the heart to operate without contacting other parts, reducing friction and extending the device’s lifespan. Inspired by high-speed trains, this technology enables the artificial heart to function quietly and smoothly, enhancing patient comfort. The TAH is designed to sustain patients until a suitable donor heart is available for transplant.

This successful implantation is part of a U.S. Food and Drug Administration study to assess the TAH’s safety and effectiveness in real-world conditions. Daniel Timms, founder and CTO of BiVACOR, noted that this technology brings us closer to providing more options for patients ineligible for traditional heart transplants.

Heart failure is a leading cause of death worldwide, affecting millions. In the U.S. alone, about 6.2 million adults suffer from heart failure. The National Institutes of Health estimate that up to 100,000 U.S. patients could immediately benefit from mechanical heart support like the TAH.

Dr. Joseph Rogers, president and CEO of the Texas Heart Institute, emphasized the importance of this new technology. Collaborating with BiVACOR and Baylor College of Medicine, they aim to revolutionize heart failure treatment and offer new hope to patients in need.

Comparing the Titanium Maglev Heart and the Biological Heart

The titanium maglev heart looks and functions quite differently from a natural human heart. Constructed from titanium, this heart implant features a strong, metallic design, which stands in stark contrast to the soft muscle tissue of a biological heart. The maglev heart’s sleek design includes various ports and connectors that allow it to work seamlessly with medical devices. Meanwhile, a biological heart has a more organic look, with textures and colors that highlight its living nature, without the industrial elements present in the titanium heart.

BiVACOR: The Total Artificial Heart, made of titanium

Design-wise, the maglev heart appears more mechanical, with visible joints and parts tailored for specific functions, resembling a machine more than an organ. Conversely, the biological heart is smooth and compact, with chambers and valves seamlessly flowing together without sharp edges or mechanical parts.

Functionally, the maglev heart includes technology for monitoring and control, allowing for potential remote adjustments. Its ports and cables are designed to connect to external devices. In contrast, the natural heart’s connections are biological, including arteries and veins, without external interfaces.

Size-wise, the titanium maglev heart may be larger than a biological heart due to the space required for mechanical components like motors and the magnetic levitation system. A biological heart is typically more compact, fitting efficiently within the chest cavity.

The titanium maglev heart shows how science and engineering can merge to provide new solutions for patients who cannot receive a biological heart transplant. Its design and features highlight advancements in medical devices, offering a promising option for those in need.

The post Breakthrough Titanium Heart Design Successfully Implanted in a Human first appeared on Yanko Design.