News
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
Science
October Meteor Showers Give Phoenix Skywatchers a Reason to Look Up
Phoenix skywatchers have several chances to catch October’s meteor showers. Here’s when to watch the Taurids and Orionids—and how moonlight affects the view.
Last Updated on October 10, 2026 by Daily News Staff
PHOENIX — October is bringing several opportunities to spot shooting stars over the Valley, with the Draconids reaching their October 8–9 peak and more meteor activity ahead.
The Draconids remain active through October 10, although viewers should expect a light display as the peak passes. Under favorable conditions, the shower typically produces only a handful of meteors per hour. timeanddate.com
Next, the Southern Taurids have an annual activity peak around October 14. Known for occasional bright fireballs, the shower continues into November. The stronger Orionids peak on the night of October 21 into the morning of October 22, typically producing 10–20 meteors per hour under dark skies. A bright Moon will interfere with this year’s display. American Meteor Society
The Orionids originate from debris left by Halley’s Comet. For Phoenix viewers, the best opportunity will be after moonset and before dawn, weather permitting. City lights will further reduce the number visible. amsmeteors.org
NASA recommends finding a viewing area away from streetlights, allowing about 30 minutes for eyes to adjust, and watching a broad stretch of sky. No telescope is needed—just a comfortable chair and patience. NASA Science
ECurious about what’s happening above us? Explore more space stories and science explainers in The Knowledge at STM Daily News.xplore more space, science and everyday
Local News
Maricopa Boil Water Advisory Lifted After Negative E. Coli Tests
Maricopa boil water advisory lifted: Global Water–Santa Cruz Water Company customers in Maricopa can resume normal tap water use after follow-up testing found no E. coli.
MARICOPA, Ariz. — A precautionary boil water advisory for Global Water–Santa Cruz Water Company customers in the city of Maricopa was lifted Thursday, October 8, after repeat testing found no E. coli in water samples. The utility announced the cancellation at approximately 2 p.m. Arizona time.
The advisory was issued October 7 after two preliminary tests indicated possible contamination. Customers were temporarily instructed to use bottled water or boil tap water for at least one minute before drinking it or using it for food preparation.
With follow-up results negative, affected customers no longer need to boil water for drinking, cooking, making ice, brushing teeth or washing dishes, according to the utility.
The advisory affected the utility’s customers in the city of Maricopa, located in Pinal County. It was not a countywide warning for Maricopa County or Phoenix.
Residents can visit Global Water Resources’ official notice page for updates or call 866-940-1102 with questions.
Automotive
Hyundai Unveils All-New Tucson With Bold New Look, Smarter Hybrid Tech
Hyundai has unveiled the all-new Tucson, bringing bolder styling, a next-generation hybrid targeting up to 42 mpg, AI-powered infotainment and the rugged new XRT PRO.
Hyundai’s popular compact SUV gets a major makeover with a targeted 42 mpg hybrid, AI-powered infotainment and a more adventurous XRT PRO model.
Hyundai is preparing the Tucson for its next chapter, unveiling an all-new version of its popular SUV with a dramatically revised design, next-generation hybrid technology and a new digital experience built around artificial intelligence.
Hyundai Motor Company introduced the all-new Tucson in New York City against the Manhattan skyline, calling the redesigned model its “boldest SUV” yet.
For buyers, however, the bigger story may be what lies beneath the new styling. Hyundai is combining improved hybrid efficiency, more advanced infotainment and additional off-road capability in an effort to make the Tucson equally comfortable handling weekday commuting, family duty and weekend adventures.
A Bolder Tucson Takes Shape
The new Tucson adopts Hyundai’s “Art of Steel” design philosophy, giving the SUV a more muscular and purposeful appearance.
Rather than simply updating the outgoing Tucson, Hyundai appears to be pushing the model toward a stronger SUV identity while maintaining the everyday practicality that has helped make the Tucson one of the company’s most important global vehicles.
The new exterior is complemented by a redesigned cabin emphasizing space, storage and easier-to-use controls. Hyundai says the interior includes flexible storage solutions and available relaxation features designed to make longer trips more comfortable.
That combination could be important in a compact SUV segment where shoppers increasingly expect vehicles to serve several roles at once — commuter, family vehicle, road-trip machine and recreational vehicle.
Hybrid Targets Up to 42 MPG
One of the most significant changes is Hyundai’s Next-generation Hybrid System.
Hyundai says the new system is targeting fuel economy of up to 42 mpg, while also attempting to preserve responsive driving performance.
If that target carries through to production specifications and official fuel-economy testing, it could make the Tucson Hybrid particularly attractive to drivers who want SUV practicality without moving to a fully electric vehicle.
The strategy also reflects a broader automotive trend. Hybrids have increasingly become an important middle ground for consumers looking to reduce fuel consumption without changing their driving and charging habits.
Final EPA fuel-economy figures and U.S.-market specifications will ultimately determine how the new Tucson compares with its competitors.
Pleos Connect Brings AI Into the Cabin
Technology is another major focus of the redesign.
The Tucson introduces Hyundai’s Pleos Connect next-generation infotainment platform, which incorporates Gleo AI, an expanding app marketplace and a redesigned user interface.
Hyundai describes Pleos Connect as an evolving digital platform rather than simply a conventional infotainment system.
That could allow the Tucson’s capabilities to expand over time as software, applications and connected services develop.
The important question for drivers will be whether all that technology actually makes everyday tasks easier. Automakers continue adding increasingly sophisticated screens and software to their vehicles, but intuitive controls and minimal driver distraction remain just as important as the number of available features.
Tucson XRT PRO Heads Further Off the Pavement
Hyundai is also expanding the Tucson’s adventurous side with the introduction of the Tucson XRT PRO.
The more rugged model adds enhanced off-road technologies, including Hyundai’s first Smart Terrain Assist, or STA.
The system is designed to help the vehicle adapt to changing terrain and provide drivers with additional confidence when leaving paved roads.
The XRT PRO could broaden the Tucson’s appeal among buyers who like the practicality of a compact crossover but want more capability for camping, outdoor recreation and light off-road travel.
More detailed specifications will help determine just how far the XRT PRO moves beyond the appearance-oriented adventure packages commonly offered in the compact SUV market.
A Major Vehicle in Hyundai’s Bigger Product Push
The importance of the new Tucson extends beyond a single model.
“Millions of families around the world count on the Hyundai TUCSON, and this is the best one we have ever built,” Hyundai Motor Company President and CEO José Muñoz said during the announcement.
Muñoz also said the Tucson begins what Hyundai describes as the most ambitious product offensive in its history.
The automaker plans to introduce more than 100 new or refreshed vehicles globally by 2030, including 58 in North America.
That makes the Tucson something of an opening act for Hyundai’s next generation of vehicles.
The Tucson Enters Its Next Era
Compact SUVs remain some of the most versatile vehicles on the market, and Hyundai appears determined to keep the Tucson competitive by improving several areas simultaneously rather than relying on styling alone.
A targeted 42-mpg hybrid powertrain could appeal to fuel-conscious drivers. Pleos Connect and Gleo AI represent Hyundai’s push toward increasingly software-driven vehicles. Meanwhile, the new XRT PRO gives the Tucson lineup a more adventurous option.
There are still important details to come, including complete U.S. specifications, EPA-certified fuel economy, trim levels, pricing and availability.
But Hyundai’s message is already clear: the next Tucson is intended to be more than a routine redesign.
It is being positioned as a showcase for where Hyundai believes the modern SUV is headed — bolder in appearance, smarter inside and more efficient underneath.
Source: Hyundai Motor Company. Specifications and fuel-economy figures discussed by Hyundai are preliminary and may vary by market. Final U.S. specifications and EPA ratings may differ.
Sources & Related Links
- Hyundai Motor Company — Official All-New Tucson Announcement
Hyundai’s original newsroom announcement covering the redesign, next-generation hybrid system, Pleos Connect, Gleo AI and Tucson XRT PRO. Hyundai
Hyundai Motor: All-New Tucson Official Announcement - Hyundai — All-New Tucson Highlights
Official product page with more detail on the “Art of Steel” design, Pleos Connect, 17-inch display, app marketplace, hybrid technology and XRT PRO. Hyundai
Explore the All-New Tucson - Hyundai USA — Tucson
Hyundai’s U.S. consumer page for Tucson information, specifications, trims and future model updates.
Hyundai USA: Tucson - PR Newswire — All-New Hyundai Tucson Press Release
The syndicated release announcing the new Tucson and Hyundai’s target of up to 42 mpg for its next-generation hybrid system. PR Newswire
Read the Original PR Newswire Release - Car and Driver — 2027 Hyundai Tucson
Independent coverage with additional U.S.-market specifications, including powertrain, interior, cargo and XRT Pro information. Car and Driver
Car and Driver: 2027 Hyundai Tucson Details - Road & Track — 2027 Hyundai Tucson
Additional independent coverage of the Tucson redesign, hybrid powertrain, Pleos Connect and XRT Pro off-road features. Road & Track
Road & Track: New Hyundai Tucson Details
