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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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Food and Beverage
Dirty Birds Expands to Downtown Long Beach, Signaling Continued Urban Revival
San Diego’s Dirty Birds sports bar is opening a new location in Downtown Long Beach, highlighting the city’s ongoing revitalization and growth ahead of the 2028 Olympics.
Downtown Long Beach is getting a flavorful new addition as The Bascom Group announces a lease agreement bringing San Diego’s popular sports bar chain Dirty Birds to a prime retail space at 200 Pine Avenue.
The deal marks another milestone in the ongoing revitalization of Long Beach, particularly within its bustling downtown entertainment corridor.
A Prime Location in the Heart of Downtown
The newly leased space spans 3,039 square feet on the ground floor of 200 Pine Avenue, a six-story office tower that has undergone significant renovations in recent years. The building, a recognizable fixture in the downtown skyline, includes:
- Class “A” upgraded common areas
- A 123-stall parking structure
- Strong tenant retention history
- Existing retail neighbors like Agaves Kitchen & Tequila and Agaves Ultra Lounge
An additional 4,923-square-foot lower-level space remains available and is already attracting interest for a potential speakeasy-style nightclub concept.
Dirty Birds Brings Its Signature Energy North
Founded in San Diego, Dirty Birds has built a loyal following as a high-energy sports bar known for:
- Award-winning chicken wings with unique flavors like Dirty Blue and Apple Bourbon Chipotle
- A lively, fan-focused atmosphere filled with sports memorabilia
- A diverse menu including burgers, sandwiches, salads, and craft beer
With multiple locations across San Diego neighborhoods like Pacific Beach, Ocean Beach, and near San Diego State University, the brand has established itself as a go-to destination for sports fans.
Its expansion into Long Beach represents a strategic move into a rapidly growing urban market.
Downtown Long Beach’s Ongoing Transformation
The arrival of Dirty Birds reflects broader momentum in downtown Long Beach, fueled by public and private investment. According to Bascom leadership, the area is experiencing a surge in activity driven by:
- Community events like the DTLB Live! series
- Streetscape and public space improvements
- Increased residential and mixed-use development
Nearby landmarks include:
- Billie Jean King Main Library
- Long Beach City Hall
- Long Beach Convention & Entertainment Center
The location also benefits from excellent transit access, including proximity to the Metro A Line.
Olympic Spotlight and Future Growth
Looking ahead, Long Beach is poised for global attention as a key venue city for the 2028 Summer Olympics. The city is expected to host 11 sporting events, making it one of the most active Olympic hubs outside Los Angeles itself.
This global spotlight is accelerating over $1.7 billion in development projects, including:
- Waterfront transformations
- Expanded residential housing
- Infrastructure upgrades through the Elevate 28 program
What This Means for Long Beach
The addition of Dirty Birds is more than just a new restaurant—it’s another indicator of a city on the rise. As downtown Long Beach continues to evolve into a vibrant live-work-play destination, high-profile tenants like Dirty Birds help:
- Strengthen the local economy
- Enhance nightlife and dining options
- Attract both residents and visitors
With an anticipated opening later this year, Dirty Birds is set to become a new hotspot for sports fans and food lovers alike.
Related Links
- 200 Pine Avenue Property Details
- LoopNet Listing for 200 Pine Avenue
- The Bascom Group Official Website
- Downtown Long Beach Plan
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Last Updated on April 2, 2026 by Daily News Staff
🕒 [UPDATE] Orion Performs Translunar Injection Burn
The spacecraft has completed its critical engine burn, sending Artemis II on a trajectory toward the Moon. This marks the official start of its deep space journey.
Artemis II Successfully Launches
CAPE CANAVERAL, Fla. — NASA has successfully launched its Artemis II mission, marking the first crewed journey toward the Moon in more than 50 years.
The powerful Space Launch System (SLS) rocket lifted off from Kennedy Space Center on April 1, carrying four astronauts on a 10-day mission around the Moon and back.
On board are Commander Reid Wiseman, Pilot Victor Glover, Mission Specialist Christina Koch, and Canadian astronaut Jeremy Hansen. The mission is already being hailed as a major milestone in NASA’s effort to return humans to deep space.
Shortly after liftoff, the Orion spacecraft successfully reached orbit and deployed its solar arrays, beginning its journey that will eventually send the crew on a translunar trajectory toward the Moon. 
Artemis II is a lunar flyby mission, meaning astronauts will not land but will travel farther from Earth than any human mission in decades while testing critical systems needed for future landings.
The mission also marks several historic firsts, including the first woman and the first person of color—Victor Glover—to travel into lunar space.
NASA says the mission is a key step toward future lunar landings and long-term plans to establish a human presence on the Moon later this decade.
🛰️ Artemis II Mission Timeline
The 10-day Artemis II mission follows a carefully planned trajectory from Earth to the Moon and back:
- Day 1: Launch and Earth orbit
- Day 1–2: Translunar injection burn
- Days 2–4: Deep space travel
- Days 4–5: Lunar flyby
- Days 5–8: Return to Earth
- Days 9–10: Reentry and splashdown
For official updates and in-depth mission details, visit the following trusted sources:
- NASA: Artemis II Mission Overview
- NASA Artemis Program (Return to the Moon)
- Orion Spacecraft – Mission Details
- Space Launch System (SLS) Rocket Overview
- Kennedy Space Center – Launch Operations
- Watch NASA Live Coverage and Replays
🧾 Sources
- NASA official launch coverage and mission updates
- NASA Artemis II press materials and briefings
- NASA Kennedy Space Center launch operations updates
Stay with STM Daily News for live updates on Artemis II.
Travel Advisory
Traveling to Mexico this spring? Here’s what to know about current advisories
Traveling to Mexico this spring? Visitors should be aware of state-specific travel advisories, as safety concerns in one region do not affect major resort areas like Cancun and Los Cabos, currently rated Level 2, which encourages increased caution. Monitoring official updates is essential for informed travel decisions amidst evolving conditions.
Last Updated on March 30, 2026 by Daily News Staff
Traveling to Mexico this spring? Here’s what to know about current advisories
(Tiffany Miller for ALG Vacations) For some travelers counting down to spring break, recent headlines about violence in parts of Mexico have sparked a new question: Should I cancel my trip? Travel advisors say they are seeing a surge in calls and emails from clients trying to determine whether developments in one region affect major resort areas elsewhere.
The questions follow several days of unrest in parts of Mexico after security operations targeting organized crime leaders prompted temporary flight disruptions and shelter-in-place guidance for U.S. government personnel in areas including Puerto Vallarta and Guadalajara. In this article, ALG Vacations explains what current travel advisories mean for spring break travelers heading to Mexico.
The U.S. State Department evaluates Mexico state by state, not as a single destination, and advisory levels vary by region. Many major beach destinations, including Cancun, Riviera Maya, Tulum and Los Cabos, are currently under a Level 2 advisory, which encourages travelers to exercise increased caution. It does not discourage travel.
Part of the confusion stems from geography. Puerto Vallarta, on the Pacific coast, is roughly 1,300 miles from Cancun and the Riviera Maya on the Caribbean side, about the distance between New York and Miami. Because advisories are assigned state by state, developments in one region do not automatically alter another.
In recent days, that uncertainty has translated into additional inquiries about whether specific resort areas are experiencing disruptions. U.S. Embassy security alerts issued this week indicate that temporary shelter-in-place guidance affecting Puerto Vallarta was lifted and that flight operations resumed. The advisory level for the Mexican state of Quintana Roo remains unchanged.
Some clients are asking about alternatives, advisors say, but many are continuing with their plans after reviewing official updates. Travel patterns often shift in response to breaking headlines, they add, before stabilizing as clearer information becomes available.
The State Department assigns travel advisories on a four-tier scale ranging from Level 1, exercise normal precautions, to Level 4, do not travel. While Level 2 encourages increased awareness, Level 3 and Level 4 carry stronger language discouraging or restricting travel.
Advisories are reviewed regularly and can be updated as conditions evolve. The State Department’s Mexico advisory page breaks down conditions by state, reflecting the country’s federal structure rather than issuing a single national designation. Travelers can also enroll in the State Department’s Smart Traveler Enrollment Program, which provides real-time security updates and allows U.S. officials to contact citizens in an emergency.
Embassy notices state that airports, hotels and tourism services in Quintana Roo are operating normally. Security conditions across Mexico vary widely by state, with some regions carrying higher advisories and others designated Level 1. Most destinations popular with U.S. travelers are currently classified as Level 2.
As spring break approaches, advisors say informed decision-making depends on reviewing the advisories assigned to a specific destination and monitoring official updates, rather than reacting to national headlines alone. Travel decisions ultimately depend on individual comfort levels, they add, but advisory levels are assigned regionally and should be evaluated accordingly.
Photo courtesy of Shutterstock
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