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FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans

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More Affordable Hearing Aids Could Be in Stores as Soon as Mid-October

Today, the U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist. 

The rule is expected to lower the cost of hearings aids, furthering the Biden-Harris Administration’s goal of expanding access to high-quality health care and lowering health care costs for the American public. It is designed to assure the safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace. 

Today’s action follows President Biden’s Executive Order on Promoting Competition in the American Economy, which called for the FDA to take steps to allow hearing aids to be sold over the counter and set a swift 120-day deadline for action, which the FDA met. In 2017, Congress passed bipartisan legislation requiring the FDA to create a category of OTC hearing aids, but it was not fully implemented until now. Consumers could see OTC hearing aids available in traditional retail and drug stores as soon as mid-October when the rule takes effect.

“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”

Close to 30 million adults in the U.S. could benefit from hearing aid use. Individuals with permanent hearing impairment can use hearing aids to help make speech and sounds louder, improving the ability to communicate effectively with others. Many hearing aids can be expensive. The final rule aims to stimulate competition and facilitate the sale of safe and effective OTC hearing aids in traditional retail stores or online nationwide, providing consumers with perceived mild to moderate hearing loss with improved access to devices that meet their needs and are less expensive than current options. 

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Robert M. Califf, M.D. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”   

The OTC category established in this final rule applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing impairment. Hearing aids that do not meet the requirements for the OTC category (for example, because they are intended for severe hearing impairment or users younger than age 18) are prescription devices. 

The FDA finalized the rule after receiving and reviewing more than 1,000 public comments on the proposed rule issued on Oct. 20, 2021. Comments submitted by consumers, professional associations, hearing aid manufacturers, public health organizations and advocacy groups, members of Congress, state agencies, and other stakeholders are summarized in the final rule, along with the FDA’s respective responses. In response to public comments and to assure the safety and effectiveness of OTC hearing aids, the final rule incorporates several changes from the proposed rule, including lowering the maximum sound output to reduce the risk to hearing from over-amplification of sound, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the phrasing throughout the required device labeling to ensure it is easily understood. The final rule also includes performance specifications and device design requirements specific to OTC hearing aids.

Furthermore, today’s action correspondingly amends existing rules that apply to prescription hearing aids for consistency with the new OTC category, it repeals the conditions for sale for hearing aids, and it includes provisions that address some of the effects of the FDA OTC hearing aid regulations on state regulation of hearing aids.

Concurrently with issuing the final rule, the FDA also issued the final guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs), to clarify the differences between hearing aids, which are medical devices, and PSAPs, consumer products that help people with normal hearing amplify sounds.  

The effective date for the final rule is 60 days following publication in the Federal Register. Manufacturers of hearing aids sold prior to the effective date of the final rule will have 240 days after its publication to comply with the new or revised requirements. For hearing aids that have not been offered for sale prior to the effective date, compliance with the new or revised requirements must be achieved before marketing the device, including obtaining 510(k) clearance if applicable.

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https://stmdailynews.com/category/lifestyle

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    Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.

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Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.

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Enterobacter bugandensis: A Superbug from the Stars and Its Implications for Space Exploration

NASA has discovered *Enterobacter bugandensis*, a multidrug-resistant superbug aboard the ISS, posing significant health risks to astronauts.

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space fire galaxy universe. Enterobacter bugandensis
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Enterobacter bugandensis

In a discovery that sounds straight out of a sci-fi horror film, NASA recently announced the identification of a new multidrug-resistant bacterium aboard the International Space Station (ISS). Dubbed Enterobacter bugandensis, this superbug not only raises eyebrows but also presents significant health risks for astronauts venturing into the great unknown.

The Discovery: An Unsettling Find

The identification of E. bugandensis is a chilling reminder of the unexpected challenges that come with space exploration. This bacterium has mutated in the isolated, unique environment of outer space, rendering it genetically distinct from its Earth-bound relatives. The result? A formidable adversary for human health, capable of resisting common antibiotics that would typically combat its terrestrial counterparts.

Collaborative research conducted by IIT Madras and NASA revealed a wealth of information about this superbug, encompassing its prevalence, distribution, and colonization patterns in the microgravity environment of the ISS. The results are not just startling; they compel us to rethink our approach to microbial management in space.

Sci-Fi or Reality? The Horror Unfolds

Imagine a creature lurking within the confines of the ISS, much like an antagonist from a John Carpenter film or the ominous Hunter Seeker robo-wasp from Dune: Part One. E. bugandensis has thrived in the station’s isolated systems, benefiting from the absence of natural competition. The bacterium’s ability to acquire iron and its interactions with other microorganisms have facilitated its extraordinary resilience.

Scientists have uncovered remarkable genomic adaptations that bolster the superbug’s ability to withstand the extreme conditions of space. These adaptations diverge significantly from those found in the more benign strains of bacteria typically encountered on Earth, emphasizing the unique challenges posed by microgravity.

Intimidating Adaptations for Survival

The incredible adaptability of microorganisms is well-documented; however, E. bugandensis takes this to a new level. While most microbes aboard the ISS exist in a state of relative stability, this superbug has undergone genomic changes that allow it to thrive in a microgravity environment. Such transformations are not merely survival tactics; they underscore the bacterium’s unique evolutionary path, setting it apart from any counterparts on our home planet.

As scientists delve deeper into the genetic nuances of E. bugandensis, they reveal a complex web of interactions with other microbial inhabitants of the ISS. This interplay not only ensures the bug’s survival but also raises alarms about the potential health risks it poses to astronauts, particularly concerning respiratory infections.

Astronaut Immunity: A Critical Concern

One of the most pressing issues surrounding E. bugandensis is the compromised immune systems of astronauts during long-duration missions. The microgravity environment induces various physiological changes that may leave astronauts more vulnerable to infections. With the presence of this resilient superbug aboard the ISS, the danger of illness becomes an even greater concern, especially given the limited access to medical facilities in space.

To mitigate these risks, NASA is prioritizing ongoing studies of E. bugandensis and other microorganisms aboard the ISS. Understanding the behavior and adaptations of these space-dwelling microbes is crucial for ensuring the health and safety of astronauts on future missions to the Moon, Mars, and beyond.

Earthbound Implications: A Cautionary Tale

While the immediate focus is on the health risks posed to astronauts, the existence of E. bugandensis also raises questions about potential implications for Earth. Could a superbug adapted to the harsh realities of space somehow find its way back to our planet? While this scenario may sound like the plot of a science fiction thriller, it underscores the need for vigilance in monitoring microbial life in extraterrestrial environments.

Dr. Kasthuri Venkateswaran of NASA’s Jet Propulsion Laboratory, along with a collaborative team from IIT Madras, has been at the forefront of this research. Their work not only highlights the challenges of microbial management in space but also emphasizes the need for robust biosecurity measures to protect both astronauts and life on Earth.

Conclusion: A New Chapter in Space Exploration

The discovery of Enterobacter bugandensis serves as a stark reminder of the complexities and unforeseen challenges of space exploration. As we journey further into the cosmos, understanding and managing the microbial life we encounter will be paramount for the health and safety of astronauts. In this new frontier, every unexpected finding—be it a superbug or a new form of life—requires careful consideration and proactive measures to ensure a safe return to Earth.

As we look to the stars, we must also remain grounded in our commitment to understanding the intricate web of life that exists, even in the most unwelcoming environments. The future of space exploration may depend on it.

Learn more about Enterobacter bugandensis in the peer-reviewed article published in Nature. https://www.nature.com/articles/s41598-018-23069-z

The science section of our news blog STM Daily News provides readers with captivating and up-to-date information on the latest scientific discoveries, breakthroughs, and innovations across various fields. We offer engaging and accessible content, ensuring that readers with different levels of scientific knowledge can stay informed. Whether it’s exploring advancements in medicine, astronomy, technology, or environmental sciences, our science section strives to shed light on the intriguing world of scientific exploration and its profound impact on our daily lives. From thought-provoking articles to informative interviews with experts in the field, STM Daily News Science offers a harmonious blend of factual reporting, analysis, and exploration, making it a go-to source for science enthusiasts and curious minds alike. https://stmdailynews.com/category/science/

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The Return of Supersonic Travel: A Nostalgic Pilot’s First Look at the Future

Mike Bannister, former Concorde pilot, tests the futuristic flight deck of Boom Supersonic Overture.

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In the heart of the summer, at the bustling Farnborough International Airshow, a significant piece of aviation history intertwined with the future of supersonic travel. Mike Bannister, the former chief Concorde pilot renowned for his extensive experience with the iconic supersonic jet, took a remarkable step into the cockpit of the future. He had the unique opportunity to test the Overture flight deck simulator—introduced by Boom Supersonic—which promises to redefine high-speed commercial flight.


Bridging Generations of Aviation

The Concorde, retired two decades ago, was a symbol of speed and luxury, though encumbered with a complex cockpit crowded with knobs and gauges. Step into the era of Boom’s Overture, and the surroundings transform into something from a sci-fi film. The cockpit unveiled at the airshow, showcased sleek touchscreen interfaces replacing the myriad buttons of the past. The new design, according to Boom, centers around pilot convenience and a stark emphasis on safety.

“For someone who’s spent years flying a plane as iconic as the Concorde, seeing and experiencing the Overture’s advanced controls—it’s exhilarating,” Bannister shared after his simulation ride. “It’s not just about reliving the past speeds but stepping into a future where flying is not just faster but also significantly simpler.”

Simplicity and Safety in Design

The Overture’s designers have not simply focused on speed but brought forward a vision to streamline and enhance the flight experience. Incorporating feedback from real-world pilots, the cockpit is designed with an intuitive layout. Features like force-feedback sidesticks—a modern alternative to traditional yokes—offer pilots tactile feedback, mimicking the real-life responses of the aircraft.

“This new stick, it’s surprisingly intuitive,” remarked Brian Oliver, another former Concorde captain, echoing Bannister’s sentiments. “For someone who flew with yokes, adapting was a breeze, and the pressure feedback feels right.”

High-Tech Enhancements

Among the most futuristic aspects is the augmented reality system, replacing the old droop nose of the Concorde, which was mechanically lowered during takeoffs and landings to aid pilot visibility. Overture pilots will use augmented reality for enhanced situational awareness, benefiting from real-time digital overlays that guide safe landings and navigation.


Feedback from Wings of Experience

The transformation from analog to digital is stark, but former Consexual pilots find the transition smoother than anticipated. John Tye, another voice from Concorde’s past, commented on the ease with which he adapted to the controls: “It tells you something when you can jump into a simulator and almost immediately feel at home.”

Looking to the Skies

As we stand on the cusp of reviving commercial supersonic travel, the innovations in Overture’s cockpit represent a leap forward in making future air travel safer and more efficient. The advancements echo a shared sentiment among those who’ve commanded both Concorde and Overture: the spirit of supersonic travel is evolving, not just returning, and it’s coming with a promise of innovation crafted around the needs of those at the helm.

Boom Supersonic’s ambitions with Overture, reinforced by collaborations with leading aerospace technology experts, mark a committed step toward bringing the world closer, faster. As the prototypes transition into reality, both pilots and passengers may soon look forward to a new era where the allure of supersonic travel is commonplace, marrying nostalgia with groundbreaking advancements. Welcome back to the future of flying, where history meets innovation at mach speeds.

Read the story on the Boom Supersonic website: https://boomsupersonic.com/flyby/pilots-point-of-view-overtures-next-generation-flight-deck-mike-bannister

https://stmdailynews.com/boom-supersonic-announces-major-advances-in-overture-aircraft-and-symphony-engine-development/

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  • Rod Washington

    Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.

    View all posts
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Six Flags Removes Surcharge Fee on Food and Merchandise Following Customer Backlash

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In a move that underscores the power of consumer feedback, Six Flags has announced the elimination of the surcharge fee on food, beverages, and retail purchases at its Texas parks. This decision comes after months of criticism from park-goers who felt the additional cost was an unwelcome burden during their visits.

Six Flags Surcharge Fee

Initially implemented earlier this year, the surcharge of $1.30 was added to every transaction involving in-park food and merchandise, clearly itemized as a separate line on receipts. The fee was introduced in response to rising labor and supply costs, which had been exacerbated by the economic challenges posed by inflation. However, as many families and thrill-seekers flocked to Six Flags for a day of fun, the new surcharge quickly became a point of contention.

Guests at theme parks often budget for a day filled with rides, games, and meals, and the addition of any unexpected fees can significantly impact their experience. While some parks, such as Disney World, allow guests to bring in outside food to mitigate high dining costs, Six Flags maintains a strict policy against outside food and drinks unless a guest has a documented food allergy. This left many visitors with no choice but to purchase food within the park, which was further complicated by the surcharge.

Tim Fisher, the Chief Operating Officer of Six Flags, acknowledged the concerns raised by guests in a recent news release. “We always welcome feedback from our guests on how we can improve their experience at our parks,” he said. “The surcharge fee at the legacy Six Flags parks was a frequent target for criticism, and we are committed to listening to our customers.”

The decision to remove the surcharge fee is a clear indication that Six Flags is willing to adapt based on customer sentiment. In an era where consumers are increasingly vocal about their experiences, this reversal showcases the importance of listening to feedback and the impact it can have on business practices.

As the parks gear up for another busy season, the removal of the surcharge fee is expected to enhance the overall experience for visitors, allowing them to enjoy their favorite rides and attractions without the added concern of unexpected costs. It remains to be seen how this change will affect customer satisfaction and park attendance, but one thing is certain: Six Flags is taking steps to ensure that its guests feel valued and heard.

So for those planning a trip to one of Texas’ Six Flags parks, it’s time to celebrate the return of a more transparent pricing model—one that aims to make your day of fun just a little bit more enjoyable!

https://investors.sixflags.com/news/press-releases/press-release-details/2024/Six-Flags-Eliminates-Guest-Surcharge-Fee-at-Participating-Legacy-Six-Flags-Parks/default.aspx

Looking for an entertainment experience that transcends the ordinary? Look no further than STM Daily News Blog’s vibrant Entertainment section. Immerse yourself in the captivating world of indie films, streaming and podcasts, movie reviews, music, expos, venues, and theme and amusement parks. Discover hidden cinematic gems, binge-worthy series and addictive podcasts, gain insights into the latest releases with our movie reviews, explore the latest trends in music, dive into the vibrant atmosphere of expos, and embark on thrilling adventures in breathtaking venues and theme parks. Join us at Looking for an entertainment experience that transcends the ordinary? Look no further than STM Daily News Blog’s vibrant Entertainment section. Immerse yourself in the captivating world of indie films, streaming and podcasts, movie reviews, music, expos, venues, and theme and amusement parks. Discover hidden cinematic gems, binge-worthy series and addictive podcasts, gain insights into the latest releases with our movie reviews, explore the latest trends in music, dive into the vibrant atmosphere of expos, and embark on thrilling adventures in breathtaking venues and theme parks. Join us at [insert website URL] and let your entertainment journey begin! https://stmdailynews.com/category/entertainment/

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