Skip to main content

Hearing aids to be available without prescription after FDA rule

Hearing aids to be available without prescription after FDA rule

The U.S. Food and Drug Administration issued a rule Tuesday to allow certain types of hearing aids to be made available over the counter without the need for a prescription or medical examination.

The FDA said the rule, which will create a new regulatory category for over-the-counter hearing aids, applies to those “with perceived mild to moderate hearing impairment. “

“In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health,” the rule says.

The FDA claims that the rule will lower the costs of hearing aids as well. It follows President Biden’s July 2021 Executive Order on Promoting Competition in the American Economy, which specifically said that the Secretary of Health and Human Services should publish “a proposed rule on over-the-counter hearing aids.”

“It’s the latest action we are taking to make our economy more competitive and less concentrated,” Biden said in a statement on Tuesday. “When too few companies dominate, American consumers pay higher costs. We’re finally building an economy that works for working families.”

FDA ISSUES PROPOSAL TO CREATE NEW CATEGORY OF OVER-THE-COUNTER-HEARING AIDS

SMART HEARING AIDS FOR SENIORS

Kim M. Smith, leader of the Utah Deaf Hospital Rights movement and president of the Utah Association of the Deaf, brushes her hair away from her hearing aid as she poses for a portrait Monday, Jan. 20, 2020, at Alta View Hospital in Sandy, Utah. (Isaac Hale/The Daily Herald via AP)

The final version of the rule came after a notice-and-comment period that yielded more than 1,000 public comments from hearing aid manufacturers and consumers, as well as professional associations, lawmakers, and state agencies, the FDA said. This resulted in changes to the proposed rule, such as lowering the maximum sound output for OTC hearing aids and requiring an adjustable volume control.

The FDA said that the rule will go into effect in mid-October and that Americans will be able to find over-the-counter hearing aids in drug stores and other retail stores – including online – at that time.

DEMS CLAIM WINS ON CLIMATE AND PRESCRIPTIONS AFTER PARLIAMENTARIAN REVIEWS SOCIAL TAX AND SPENDING BILL

The Food and Drug Administration issued a proposal Tuesday in an effort to provide over-the-counter hearing aids.

The Food and Drug Administration issued a proposal Tuesday in an effort to provide over-the-counter hearing aids. (iStock)

“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,” Health and Human Services Secretary Xavier Becerra said in a statement. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”



Comments

Popular posts from this blog

Kamala Harris Is Far From An Enigma

Kamala Harris Is Far From An Enigma By Ben Emos and Tony Bruce | Wednesday, September  25 , 2024 | 7 min read Recently, critics have argued that Vice President Kamala Harris hasn’t fully fleshed out her policies, raising concerns about the clarity of her agenda. Interestingly, this critique mirrors rhetoric often used by former President Donald Trump, who is known for diverting attention from more controversial issues. In this case, it could be seen as a way to shift the spotlight away from growing unease around the GOP’s Project 2025 and the more symbolic “eating of cats and dogs” controversy in Springfield, Ohio. Project 2025, the Republican-backed policy framework, has stirred concern due to its extreme deregulation measures and rollbacks on protections for vulnerable communities. Critics of the plan argue that it represents a significant threat to public health, environmental safety, and economic equality. The “eating of cats and dogs” metaphor, while not literal, encapsulates ...

The Truth Behind Trump’s Tale of a Harrowing Helicopter Ride and Emergency Landing That Never Happened

The Truth Behind Trump’s Tale of a Harrowing Helicopter Ride and Emergency Landing That Never Happened. By Mary Jones and Ben Emos | Thursday, August  15 , 2024 | 6 min read During Donald Trump’s political campaigns, particularly in 2016 and 2020, he often  employed personal attacks and misinformation to undermine his opponents. In 2016, Trump targeted Hillary Clinton by focusing on her husband’s extramarital affairs, hoping to tarnish her public image. By 2020, his strategy shifted to Hunter Biden’s business ventures, with Trump attempting to discredit Joe Biden by associating him with his son’s dealings. In both cases, the goal was clear: damage the opponent’s reputation through a blend of accusations, half-truths, and outright falsehoods. In yet another one of his colorful anecdotes, former President Donald Trump claimed he experienced an emergency helicopter landing alongside former San Francisco Mayor Willie Brown. Trump described the situation as a tense moment, suggesti...

Donald Trump Sentenced in Hush Money Trial Involving Porn Star Stormy Daniels

Donald Trump Sentenced in Hush Money Trial Involving Porn Star Stormy Daniels. By Don Terry | Tuesday, January 14, 2025 | 2 min read In a landmark case that has captivated the nation, former President Donald Trump has been sentenced after being convicted on 34 felony counts of falsifying business records. The charges stemmed from a hush money payment made to adult film star Stormy Daniels during the 2016 presidential campaign. Despite the guilty verdict, the court handed down an unconditional discharge, meaning Trump will face no further penalties, including imprisonment or community service. The allegations centered on claims that Trump orchestrated the payment to Daniels to silence her allegations of an affair. Prosecutors argued that the payment was fraudulently recorded in business ledgers, violating state law. The jury ultimately sided with the prosecution, but the sentencing judge issued a rare and controversial ruling, granting unconditional discharge. Legal analysts have n...