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FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans
Last Updated on June 26, 2024 by Daily News Staff
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.
Related Information
- Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
- Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
- Hearing Aids and Personal Sound Amplification Products: What to Know
https://stmdailynews.com/category/lifestyle
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Former President Barack Obama recently sparked headlines, social media debates, and a fresh wave of UFO chatter after a brief remark during a podcast interview. The comment quickly ricocheted across news outlets, with many asking: Did Obama just confirm aliens exist? And just as quickly, Donald Trump weighed in.
Let’s unpack what was actually said — and what it means.
🎙️ The Comment That Ignited the Conversation
During a rapid-fire question segment on a podcast hosted by Brian Tyler Cohen, Obama was asked directly:
“Are aliens real?”
Obama’s response:
“They’re real, but I haven’t seen them.”
That short answer fueled immediate speculation. Clips spread online, often stripped of context, with some interpreting the statement as a bombshell confirmation of extraterrestrial life.
🧠 What Obama Meant
Soon after the comment gained traction, Obama clarified his meaning.
His explanation aligned with a position he’s expressed before:
✔ He was referring to the statistical likelihood of life elsewhere in the universe
✔ He was not claiming evidence of alien visitation
✔ He emphasized that during his presidency he saw no proof of extraterrestrial contact
In other words:
Obama was speaking philosophically and scientifically — not revealing classified information.
This interpretation matches mainstream scientific thinking: given the size of the universe, life beyond Earth is plausible, but confirmed evidence remains elusive.
🛸 Why the Comment Resonated
The remark landed in a cultural moment where:
• Interest in UAPs (Unidentified Aerial Phenomena) is high
• Government transparency around UFO reports has increased
• Space exploration discoveries (exoplanets, water worlds) dominate science news
Even a casual statement from a former president can ignite intense discussion.
🇺🇸 Trump’s Reaction
Former (and current political figure) Donald Trump responded critically.
Trump characterized Obama’s comment as:
• A “mistake”
• Potentially involving “classified information”
He also reiterated his own stance:
He does not know whether aliens are real.
Trump pivoted the conversation toward disclosure, suggesting he would support or consider declassifying UFO/UAP-related files — a theme that has periodically surfaced in political rhetoric.
⚖️ Politics vs Interpretation
Trump’s reaction highlights how statements about extraterrestrial life often become political flashpoints, even when the original comment is speculative or philosophical.
Key distinction:Obama’s Clarification Public Interpretation Life elsewhere is likely “Obama confirmed aliens” No evidence of contact “Government disclosure”
🔬 The Scientific Reality
Organizations like NASA and the broader research community maintain:
✅ Life beyond Earth → statistically plausible
❓ Intelligent civilizations → unknown
❌ Confirmed alien contact → no verified evidence
Investigations into UAPs consistently conclude:
• Most sightings have conventional explanations
• Some remain unresolved due to limited data
• None confirmed as extraterrestrial craft
🌌 Why These Stories Keep Captivating Us
Conversations about aliens sit at the intersection of:
✨ Science
🧠 Curiosity
🛸 Mystery
🎭 Pop culture
🏛️ Politics
When a former president comments, the intrigue multiplies.
📌 Bottom Line
Did Obama say aliens are real?
Yes — but in the sense that life elsewhere in the universe is likely, not that aliens are visiting Earth.
Did he claim evidence?
No.
Trump’s response?
Critical, skeptical, and framed around classification and disclosure.
If you’re fascinated by this topic, you might also enjoy exploring:
• How scientists search for alien life
• What counts as real “evidence”
• Why UFO sightings are so often misinterpreted
Want me to craft a follow-up article like “How Close Are We to Discovering Alien Life?” 🚀👽
Related Links & Further Reading
- NASA – Search for Life
- NASA – Exoplanet Exploration
- SETI Institute – Search for Extraterrestrial Intelligence
- U.S. Department of Defense – UAP Reports
- How Close Are We to Discovering Alien Life?
- What Are UAPs? Explained
- A Brief History of UFO Investigations
Dive into “The Knowledge,” where curiosity meets clarity. This playlist, in collaboration with STMDailyNews.com, is designed for viewers who value historical accuracy and insightful learning. Our short videos, ranging from 30 seconds to a minute and a half, make complex subjects easy to grasp in no time. Covering everything from historical events to contemporary processes and entertainment, “The Knowledge” bridges the past with the present. In a world where information is abundant yet often misused, our series aims to guide you through the noise, preserving vital knowledge and truths that shape our lives today. Perfect for curious minds eager to discover the ‘why’ and ‘how’ of everything around us. Subscribe and join in as we explore the facts that matter. https://stmdailynews.com/the-knowledge/
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The Long Track Back
Why Downtown Los Angeles Feels Small Compared to Other Cities
Downtown Los Angeles often feels “small” compared to other U.S. cities, but that’s only part of the story. With some of the tallest buildings west of the Mississippi and skyline clusters spread across the region, LA’s downtown reflects the city’s unique polycentric identity—one that, if combined, could form a true mega downtown.
Last Updated on February 18, 2026 by Daily News Staff
Panorama of Los Angeles from Mount Hollywood – California, United States
When people think of major American cities, they often imagine a bustling, concentrated downtown core filled with skyscrapers. New York has Manhattan, Chicago has the Loop, San Francisco has its Financial District. Los Angeles, by contrast, often leaves visitors surprised: “Is this really downtown?”
The answer is yes—and no.
Downtown LA in Context
Compared to other major cities, Downtown Los Angeles (DTLA) is relatively small as a central business district. For much of the 20th century, strict height restrictions capped most buildings under 150 feet, while cities like Chicago and New York were erecting early skyscrapers. LA’s skyline didn’t really begin to climb until the late 1960s.
But history alone doesn’t explain why DTLA feels different. The real story lies in how Los Angeles grew: not as one unified city center, but as a collection of many hubs.
Downtown Los Angeles
A Polycentric City
Los Angeles is famously decentralized. Hollywood developed around the film industry. Century City rose on former studio land as a business hub. Burbank became a studio and aerospace center. Long Beach grew around the port. The Wilshire Corridor filled with office towers and condos.
Unlike other cities where downtown is the place for work, culture, and finance, Los Angeles spread its energy outward. Freeways and car culture made it easy for businesses and residents to operate outside of downtown. The result is a polycentric metropolis, with multiple “downtowns” rather than one dominant core.
A Resident’s Perspective
As someone who lived in Los Angeles for 28 years, I see DTLA differently. While some outsiders describe it as “small,” the reality is that Downtown Los Angeles is still significant. It has some of the tallest buildings west of the Mississippi River, including the Wilshire Grand Center and the U.S. Bank Tower. Over the last two decades, adaptive reuse projects have transformed old office buildings into lofts, while developments like LA Live, Crypto.com Arena, and the Broad Museum have revitalized the area.
In other words, DTLA is large enough—it just plays a different role than downtowns in other American cities.
View of Westwood, Century City, Beverly Hills, and the Wilshire Corridor.
The “Mega Downtown” That Isn’t
A friend once put it to me with a bit of imagination: “If you could magically pick up all of LA’s skyline clusters—Downtown, Century City, Hollywood, the Wilshire Corridor—and drop them together in one spot, you’d have a mega downtown.”
He’s right. Los Angeles doesn’t lack tall buildings or urban energy—it just spreads them out over a vast area, reflecting the city’s unique history, geography, and culture.
A Downtown That Fits Its City
So, is Downtown LA “small”? Compared to Manhattan or Chicago’s Loop, yes. But judged on its own terms, DTLA is a vibrant hub within a much larger, decentralized metropolis. It’s a downtown that reflects Los Angeles itself: sprawling, diverse, and impossible to fit neatly into the mold of other American cities.
🔗 Related Links
Dive into “The Knowledge,” where curiosity meets clarity. This playlist, in collaboration with STMDailyNews.com, is designed for viewers who value historical accuracy and insightful learning. Our short videos, ranging from 30 seconds to a minute and a half, make complex subjects easy to grasp in no time. Covering everything from historical events to contemporary processes and entertainment, “The Knowledge” bridges the past with the present. In a world where information is abundant yet often misused, our series aims to guide you through the noise, preserving vital knowledge and truths that shape our lives today. Perfect for curious minds eager to discover the ‘why’ and ‘how’ of everything around us. Subscribe and join in as we explore the facts that matter. https://stmdailynews.com/the-knowledge/
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The Knowledge
Century City: From Hollywood Backlot to Business Hub
Century City, originally part of 20th Century Fox’s backlot, transformed into a prominent business district in Los Angeles during the 1950s amid the decline of cinema. Developer William Zeckendorf envisioned a mixed-use urban center, leading to iconic skyscrapers and establishing the area as a hub for law, finance, and media, blending Hollywood history with modern business.
Before Century City became one of Los Angeles’ premier business districts, it was part of 20th Century Fox’s sprawling backlot, used for filming movies and housing studio operations. By the 1950s, as television rose and movie attendance declined, 20th Century Fox faced financial challenges and decided to sell a portion of its land.
Developer William Zeckendorf envisioned a “city within a city”—a modern, mixed-use urban center with office towers, hotels, and entertainment facilities. Branded Century City, the name paid homage to its studio roots while symbolizing LA’s vision for the future.
The first skyscrapers, including the Gateway West Building, set the tone for the district’s sleek, futuristic skyline. Architects like Welton Becket and Minoru Yamasaki helped shape Century City’s iconic look. Over time, it evolved from Hollywood’s backlot to a corporate and legal hub, attracting law firms, financial institutions, and media companies.
Today, Century City stands as a testament to Los Angeles’ postwar optimism, westward expansion, and multi-centered urban growth—a unique blend of Hollywood history and modern business.
Related STM Daily News Links:
- The Evolution of Los Angeles Public Transportation
- Why Los Angeles Grew Into a Sprawling City
- Downtown Los Angeles: Past, Present, and Future
Dive into “The Knowledge,” where curiosity meets clarity. This playlist, in collaboration with STMDailyNews.com, is designed for viewers who value historical accuracy and insightful learning. Our short videos, ranging from 30 seconds to a minute and a half, make complex subjects easy to grasp in no time. Covering everything from historical events to contemporary processes and entertainment, “The Knowledge” bridges the past with the present. In a world where information is abundant yet often misused, our series aims to guide you through the noise, preserving vital knowledge and truths that shape our lives today. Perfect for curious minds eager to discover the ‘why’ and ‘how’ of everything around us. Subscribe and join in as we explore the facts that matter. https://stmdailynews.com/the-knowledge/
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