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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
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News
Gregory Outreach Services Expands Food Access with Addition of Third Refrigerated Van
Gregory Outreach Services expands its mission to fight food insecurity with the addition of a third refrigerated van, doubling food access for low-income seniors and veterans in Phoenix.
Last Updated on January 8, 2026 by Daily News Staff
Gregory Outreach Services’ newest refrigerated delivery van expands food access for low-income seniors and veterans across Phoenix.
Phoenix, AZ — Gregory Outreach Services has taken a major step forward in its mission to fight food insecurity with the addition of a third refrigerated delivery van, significantly expanding its capacity to serve low-income seniors and veterans across the Phoenix area.
The new refrigerated van was made possible through the support of a generous anonymous donor. The expansion is further strengthened by the continued generosity of the BHHS Legacy Foundation, who donated fresh produce to support the organization’s growing distribution efforts.
As rising food costs and inflation continue to place pressure on individuals living on fixed incomes, the need for reliable access to nutritious food has never been greater. This latest addition to the organization’s mobile fleet allows Gregory Outreach Services to double the number of individuals served, while maintaining strict food safety and quality standards.
“As the cost of living continues to rise, more seniors and veterans are struggling to afford nutritious food,” said Diana Gregory, Founder and CEO of Gregory Outreach Services. “This van allows us to bridge a widening gap for individuals living on fixed incomes, many of whom face mobility challenges and limited access to fresh food options.”
Meeting a Growing Community Need
Gregory Outreach Services works directly with seniors and veterans who are disproportionately affected by inflation, medical expenses, and transportation barriers. For many, simply reaching a grocery store can be a challenge. Refrigerated vehicles are essential to ensuring that fresh fruits and vegetables arrive safely and consistently at senior housing communities, veteran shelters, and community distribution sites.
“This third van complements the two already in operation and represents a critical milestone in our growth,” Gregory added. “We are deeply grateful to our anonymous donor for investing in our mission, and to BHHS Legacy Foundation’s Board of Directors and its CEO, Jerry Wissink for Legacy’s generosity in donating fresh produce. Together, this support allows us to scale our impact and respond to the increasing needs of our community.”
Expanding Impact While Preserving Dignity
With an expanded fleet and increased food supply, Gregory Outreach Services is better positioned to address food insecurity, promote healthier outcomes, and serve seniors and veterans with dignity, respect, and care. The organization’s mobile delivery model ensures help reaches those who need it most — directly and reliably.
About Gregory Outreach Services
Gregory Outreach Services is a nonprofit organization dedicated to improving health outcomes for low-income seniors and veterans through mobile produce delivery, nutrition education, and community-based wellness programs. By bringing fresh food directly to those most in need, the organization works to reduce food insecurity and strengthen community wellness.
For more information, visit dianagregory.com.
Stories of Change: People Making a Difference
Discover inspiring stories of changemakers making a positive impact. Explore videos and articles of people tackling today’s biggest challenges with action and hope. Visit: https://stmdailynews.com/stories-of-change/
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/ Get The Knowledge. Read more community news and local stories at STM Daily News.
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Economy
How Bird Flu Upended the U.S. Egg Market — and Why Prices Are Finally Beginning to Stabilize
Egg Market: Egg prices surged during the U.S. bird flu outbreak as laying hen inventories collapsed. Here’s how flock recovery is helping stabilize egg prices today.
How Bird Flu Upended the U.S. Egg Market — and Why Prices Are Finally Beginning to Stabilize
Few grocery items frustrated American consumers over the past two years quite like eggs. Once an inexpensive staple, egg prices surged to historic highs following a prolonged outbreak of highly pathogenic avian influenza (HPAI), commonly known as bird flu. Today, however, prices appear to be stabilizing. Here’s how the crisis unfolded — and why relief is finally showing up at the checkout line.The Bird Flu Crisis and Its Impact on Egg Supply
Beginning in 2022, the United States experienced one of the most severe bird flu outbreaks in modern history. The virus spread rapidly through poultry farms, forcing producers to cull millions of birds to prevent further transmission. Egg-laying hens were hit especially hard, leading to a sharp drop in egg production nationwide. By 2024 and into early 2025, the cumulative losses totaled well over one hundred million birds. With fewer hens producing eggs, supply tightened dramatically, and prices soared. At the peak of the crisis, consumers in some regions saw egg prices climb above six dollars per dozen.Why Egg Prices Stayed High for So Long
Unlike other agricultural products, egg production cannot rebound quickly after a disruption. When laying hens are lost, they must be replaced with young birds known as pullets. These pullets require approximately four to six months to mature before they begin producing eggs. Even after farms were cleared to restock, producers faced additional challenges. Strict biosecurity measures, concerns about reinfection, and the logistical complexity of rebuilding flocks slowed the recovery process. As a result, egg supplies remained tight long after the initial outbreaks subsided.Laying Hen Inventory Recovery Takes Shape
By mid to late 2025, signs of recovery became more apparent. Producers gradually increased pullet placements, and national laying hen inventories began to grow. While the total number of hens had not yet returned to pre-outbreak levels, the upward trend marked an important turning point. This steady rebuilding of flocks meant more eggs entering the supply chain. Wholesale markets responded first, with prices easing as inventories improved. Retail prices soon followed, signaling that the worst of the supply shock was beginning to fade.Egg Prices Begin to Stabilize
As laying hen inventories recovered, egg prices moved away from their record highs. By late 2025 and into early 2026, prices at many grocery stores had fallen noticeably compared to peak levels. While costs remain somewhat higher than pre-pandemic norms, the extreme volatility seen during the height of the bird flu crisis has largely subsided. Additional factors also helped stabilize the market. Federal and state efforts to strengthen biosecurity, limited egg imports to supplement domestic supply, and improved disease monitoring all contributed to a more balanced egg market.What This Means for Consumers
For consumers, the stabilization of egg prices offers a welcome sense of normalcy. Shoppers are less likely to encounter sudden price spikes, and eggs are once again becoming a predictable part of grocery budgets. While prices may not return to the ultra-low levels seen years ago, the recovery of laying hen inventories suggests that the egg market is on firmer footing. Continued vigilance against future outbreaks will be critical, but for now, the outlook is far more stable than it was during the height of the bird flu crisis.Looking Ahead
The bird flu outbreak served as a reminder of how vulnerable food systems can be to disease disruptions. Thanks to gradual flock rebuilding and improved supply conditions, egg prices are stabilizing — a sign that recovery, while slow, is real. If current trends continue, consumers and producers alike may finally be moving past one of the most turbulent chapters in the modern egg market.Further Reading & Sources
- USDA – Avian Influenza Updates and Poultry Industry Impact
- USDA Economic Research Service – Egg Prices and Food Inflation Data
- U.S. Bureau of Labor Statistics – Consumer Price Index (Egg Prices)
- Associated Press – Coverage of the U.S. Bird Flu Outbreak
- USDA Agricultural Marketing Service – Egg Market and Wholesale Reports
- CDC – Avian Influenza Information and Monitorin
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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Stories of Change
Senior Assist Day Marks Four Years of Supporting Seniors in South Phoenix
Senior Assist Day celebrates four years of serving seniors at Tanner Gardens in South Phoenix, led by Assistory Outreach Services and founder Jon Taylor.
Senior Assist Day Marks Four Years of Supporting Seniors in South Phoenix
PHOENIX, AZ — Senior Assist Day reached a meaningful milestone this year, marking four years of service to seniors living at Tanner Gardens in South Phoenix. Hosted by Assistory Outreach Services, the annual event continues to provide dignity, connection, and practical support to an often-overlooked population.A Personal Beginning
The origins of Senior Assist Day are deeply personal for Assistory Outreach Services founder and CEO Jon Taylor.“The origin of me going to Tanner Gardens was when I was with the 100 Black Men of Phoenix. We used to do a luncheon for seniors around December.”That early connection took on new meaning as Taylor’s mother began showing signs of dementia, inspiring him to create an event rooted in empathy and care.
“I got a great feeling from being around those senior citizens. Senior Assist Day is roughly based on my mother.”
An Event That Continues to Grow
What began as a small gathering has grown into a full community experience. Seniors now enjoy catered meals, live music, personal care services, and gifts tailored to their needs. This year’s event included authentic Mexican food, live holiday music, haircuts provided by AJ’s Barbershop, and the donation of new shoes — a moment that stood out for many attendees.“Seeing the excitement and how they were reacting to the new shoes was incredible,” Taylor said.
Beyond a Single Day
Senior Assist Day also helps build trust between Assistory Outreach Services and the residents of Tanner Gardens, opening the door to additional programs throughout the year. Through initiatives like the Digital Access Program for Seniors (DAPs), the organization helps seniors develop basic phone and computer skills, empowering them to stay connected and informed.Challenges and Purpose
Keeping the event going year after year requires dedication and resources. Taylor personally raises funds and helps purchase gifts for more than 130 residents annually. Despite the challenges, his motivation remains strong.“I do feel as though this is my ministry. I’m providing services, and I’m being fulfilled at the same time.”
Looking Ahead
Looking to the future, Taylor envisions Senior Assist Day becoming an all-day celebration, offering expanded services, entertainment, and meals — all focused exclusively on the residents of Tanner Gardens. As the event enters its fifth year, Senior Assist Day stands as a testament to what consistent community engagement and compassion can achieve. About Assistory Outreach Services Assistory Outreach Services is a community-based nonprofit organization dedicated to empowering seniors, low-income residents, and individuals experiencing homelessness. Assistory helps senior citizens embrace technology by teaching basic cell phone and computer skills, using a formula rooted in education, love, and patience to remove fear and build confidence. In addition to senior programming, the organization focuses on serving low-income and homeless populations by providing food boxes, holiday meals, and homeless care packages known as Assist Packs. This year, Assistory Outreach Services is expanding its impact by partnering with other nonprofits and religious organizations to coordinate food distribution through its community food pantry. Coverage by STM Daily News.STM Daily News is a multifaceted podcast that explores a wide range of topics, from life and consumer issues to the latest in food and beverage trends. Our discussions dive into the realms of science, covering everything from space and Earth to nature, artificial intelligence, and astronomy. We also celebrate the amateur sports scene, highlighting local athletes and events, including our special segment on senior Pickleball, where we report on the latest happenings in this exciting community. With our diverse content, STM Daily News aims to inform, entertain, and engage listeners, providing a comprehensive look at the issues that matter most in our daily lives. https://stories-this-moment.castos.com/
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