Over-the-counter hearing aids are now available

An order from Biden gave the FDA a deadline for over-the-counter hearing aids, but a bipartisan bill and law signed by Trump in 2017 paved the way.

Update: Americans can begin purchasing hearing aids over the counter starting October 17, 2022. This story has been updated to reflect the eligibility date.

On August 16, the Food and Drug Administration (FDA) completed final approval for people with mild to moderate hearing loss to purchase over-the-counter hearing aids from stores and pharmacies. nationwide. Americans are eligible to purchase October 17 and do not need a physical exam, prescription, or fit with an audiologist.

A tweet from the White House said providing over-the-counter hearing aids would “reduce the price of a pair of devices by nearly $3,000 – giving more breathing space to an estimated 30 million Americans.”

In August, following the FDA’s approval, some on social media said a law signed by former President Donald Trump paved the way for that to happen. Senator Elizabeth Warren (D-Mass.) also tweeted that rule She teamed up with Senator Chuck Grassley (R-Iowa) in 2017 to make that happen.

QUESTION

Does the 2017 signed law pave the way for over-the-counter hearing aids?

SOURCES

ANSWER

This is the truth.

That’s right, a law passed in 2017 paved the way for over-the-counter hearing aids. At the time, President Trump signed the Food and Drug Administration Reauthorization Act, which included language for over-the-counter hearing aids. But a number of politicians and government organizations have also stepped in to change the policy.

WHAT WE FIND

In August 2017, then-President Donald Trump signed the Food and Drug Administration (FDA) Reauthorization Act (FDARA) into law.

The law did a few things:

  • Allows the federal government to charge companies in the pharmaceutical, medical device, and other healthcare industries, providing some funding for the agency to review products.
  • Set standards for FDA to set and meet performance goals for the evaluation of medical products, with the goal of bringing therapies, medical devices, and other products to market faster.

The FDA works with Congress and holds public meetings to determine what should be included in the Reauthorization Act. Every five years, the Authorization Act is introduced to Congress and signed into law by the president.

One bill that was passed as part of the Relicensing Act of 2017 is the Over-the-Counter (OTC) Hearing Assistance Act, a bipartisan bill introduced by Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) Given. .

The OTC Hearing Aid Act requires the FDA to create a new class of over-the-counter hearing aids that meet high standards but also provide consumers with a lower-cost FDA-regulated device choice.

Under this new category, consumers can also purchase devices without a prescription or check through in person, by mail, or online.

In the FDA’s August 16, 2022 notice of approval, the administration said that although the 2017 law required the FDA to create an over-the-counter hearing aid, it had not been fully implemented for until President Joe Biden issued an executive. Ordered on July 9, 2022.

Biden’s executive order is written to “promote competition in the American economy, which will lower prices for families, raise wages for workers, spur innovation, and even economic growth.” faster.”

Part of that order directed the Secretary of the Department of Health and Human Services to provide lower-cost hearing aids over the counter, as required by section 709 of the FDA Reauthorization Act of 2017, within 120 days since the order is signed.

After the FDA announced the final approval of over-the-counter hearing aids, Warren and Grassley released a joint statement that said the Over-the-Counter Hearing Act.

“Five years after our bipartisan Over-the-Counter Hearing Aids Act became law, consumers with mild to moderate hearing loss will finally have access to over-the-counter hearing aids,” said Warren and Grassley. affordable unit price. The FDA has finalized these guidelines, and safe, effective, accessible, and affordable hearing aids will now be sold over-the-counter to millions of Americans.”

So we can CONFIRM that a bill signed into law in 2017 calls for the FDA to provide over-the-counter hearing aids, but with a joint effort from Congress, the FDA, and the two administrations. The new president can do it.

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Edmund DeMarche

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