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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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Last Updated on May 16, 2026 by Daily News Staff
National Small Business Month
Every May, communities across the United States recognize Small Business Month, a time dedicated to celebrating the entrepreneurs, family-owned companies, startups, and local shops that help drive the American economy. From neighborhood restaurants to innovative tech startups, small businesses continue to play a vital role in creating jobs, supporting communities, and inspiring innovation.
According to the U.S. Small Business Administration, small businesses account for millions of jobs nationwide and represent the backbone of local economies. Throughout May, organizations, chambers of commerce, and business leaders host networking events, educational workshops, and promotional campaigns to support entrepreneurs and encourage consumers to shop locally.
One of the highlights of the month is National Small Business Week, which honors outstanding entrepreneurs and business owners making a difference in their communities.
For consumers, Small Business Month is also a reminder that supporting local businesses helps strengthen neighborhoods and keeps communities thriving. Whether it’s dining at a local café, shopping at an independent store, or hiring a local service provider, every purchase can make an impact.
Learn more about Small Business Month and related events through the official U.S. Small Business Administrationwebsite.
Related External Links
- U.S. Small Business Administration (SBA)
- National Small Business Week – SBA
- SCORE – Mentoring and Resources for Small Businesses
- U.S. Chamber of Commerce – Small Business Resources
- Forbes Small Business News and Insights
Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
News Brief
Earthquake Swarm Shakes Southern California Near Salton Sea
Earthquake Swarm: A swarm of earthquakes near California’s Salton Sea and Brawley area has prompted increased monitoring by seismologists as hundreds of tremors shake the region.
A swarm of earthquakes has been rattling Southern California near the Salton Sea, drawing attention from residents and seismologists across the region.
Salton Sea earthquake swarm?
The activity is centered near Brawley in Imperial County, an area known for frequent seismic movement due to its location within the Brawley Seismic Zone. According to the U.S. Geological Survey, hundreds of small earthquakes have been recorded over the past several days, with the strongest reaching a magnitude of approximately 4.7.
Residents throughout Imperial Valley, parts of Riverside County, and even portions of Arizona reported feeling shaking from several of the larger quakes. Minor incidents such as falling objects and brief power disruptions were also reported, though no major injuries or widespread structural damage have been confirmed at this time.
The region sits near the southern end of the San Andreas Fault and is considered one of California’s most geologically active areas. Scientists say earthquake swarms are relatively common near the Salton Sea because of the interaction between tectonic fault systems and geothermal activity beneath the surface.
While experts continue to monitor the situation closely, they emphasize that earthquake swarms do not necessarily indicate that a larger earthquake is imminent. However, officials encourage residents to review emergency preparedness plans, secure heavy furniture, and keep emergency supplies ready.
The Salton Sea region has experienced similar seismic swarms in the past, making it an important area of study for earthquake researchers and emergency management agencies.
For continued updates on this developing story and other regional news, visit STM Daily News.
Related External Links
- U.S. Geological Survey (USGS) – Earthquake Monitoring
- California Institute of Technology (Caltech)
- California Earthquake Preparedness Guide
- Ready.gov – Earthquake Safety Tips
- USGS – Salton Trough and Seismic Activity
Stay informed with the latest breaking news, trending stories, and real-time updates from around the world on STM Daily News. Visit our Stories This Moment page for continuously updated coverage on major events, technology, transportation, science, entertainment, and more.
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Consumer Corner
Frustration at the Pump: Why Americans are Exploring Electric Vehicles
Exploring Electric Vehicles: For more than one-third of Americans, one simple number is leading them to research electric vehicles: the final tally at a recent gas station fill-up. The pump is no longer just the close of a sale; for a growing number of drivers, it’s where questions begin.
Frustration at the Pump: Why Americans are Exploring Electric Vehicles
(Feature Impact) For more than one-third of Americans, one simple number is leading them to research electric vehicles: the final tally at a recent gas station fill-up.
This, according to new research from Hyundai Motor America, isn’t a hypothetical situation. In fact, 23% of respondents reported it’s happened to them more than once. For nearly half of Americans, pulling up to the pump now brings frustration or outright dread.
Many drivers have a number in mind where the math begins shifting, and once the shift happens, it rarely goes away. The pump is no longer just the close of a sale; for a growing number of drivers, it’s where questions begin.
For 23% of those surveyed, $5 per gallon is where they would start considering alternatives to a gas-powered vehicle. While some say they wouldn’t consider alternatives based on gas costs at all, this meaningful share of Americans points toward a specific tipping point.
Some begin by comparing models or brands while others find themselves on an automaker’s website, further along in the process than they initially expected to be. Most don’t act on this impulse right away, but drivers are increasingly caught somewhere between curious and committed – and 46% of those surveyed said they’d be likely to seriously research an EV.
The desire to leave the pump behind, which an EV would allow for, is a deal nearly half of respondents said they would take. However, the transition isn’t frictionless as charging access and range anxiety remain the top concerns for 28% of potential buyers.
While the move toward electric vehicles is often framed as a long-term decision made with spreadsheets and financial planning, for many Americans, it’s beginning somewhere smaller: a routine fuel stop and an eye-opening receipt.
If you’ve found yourself dismayed at the pump, find more information on electric vehicles at HyundaiUSA.com.
Photo courtesy of Shutterstock
eSOURCE:
Hyundai
Welcome to the Consumer Corner section of STM Daily News, your ultimate destination for savvy shopping and informed decision-making! Dive into a treasure trove of insights and reviews covering everything from the hottest toys that spark joy in your little ones to the latest electronic gadgets that simplify your life. Explore our comprehensive guides on stylish home furnishings, discover smart tips for buying a home or enhancing your living space with creative improvement ideas, and get the lowdown on the best cars through our detailed auto reviews. Whether you’re making a major purchase or simply seeking inspiration, the Consumer Corner is here to empower you every step of the way—unlock the keys to becoming a smarter consumer today!
