Hearing Aids Will Soon Be Available Without a Prescription

You will now be able to buy hearing aids over-the-counter, both in-store and online.

In a historic move, the FDA finalized a motion that is said to improve access to hearing aids for millions of Americans by creating a new class of over-the-counter (OTC) products.

The final rule is expected to lower the cost of hearing aids—which would expand access to the health care devices—by "fostering innovation and competition" within the product's marketplace.

According to a recent press release, the action also repealed the conditions for the sale of hearing aids, issued guidance on what differentiates a prescription hearing aid from its OTC counterpart, and outlined specific performance and design requirements for OTC hearing aid devices.

Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” FDA Commissioner Robert M. Califf, M.D. stated in the release. 

He continued: “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 new class of over-the-counter consumer products is said to only apply to certain air-conduction hearing aids, or Personal Sound Amplification Products (PSAPs), that are intended for people 18 and older who have perceived mild to moderate hearing impairment.

To clarify, hearing aids will still be considered medical devices.

Hearing aids that do not meet the requirements for the OTC category of PSAPs will remain as prescription devices. These include hearing aids intended for severe hearing impairment or those for children and anyone younger than the age of 18.

The new rule establishing PSAPs as FDA registered products could benefit close to 30 million adults living in the U.S. when it takes effect in October, according to research from the National Institute on Deafness and Other Communication Disorders.

Hearing aids, traditionally, have not been cheap—as many deaf or hard of hearing people and their families can already attest.

A recent Consumer Affairs report cited that on average, the price of a single hearing aid came in at somewhere around $2,300. The report continued, explaining that overall costs commonly range from $1,000 to $4,000 per ear, while premium hearing aids, which may be necessary for individuals with severe hearing loss, can cost upwards of $6,000 per ear.

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 the release. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible," he added.

Some may recall previous attempts by the government to cut consumer costs on the product. Back 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.

This new motion, however, follows President Biden's Executive Order that sought to promote competition in the American economy and called for the FDA to take steps to allow hearing aids to be sold over-the-counter.

According to the official statement, the new administration set a swift 120-day deadline for action, which the agency met. As a result, consumers could see OTC hearing aids available online and in traditional retail and drug stores as soon as mid-October, when the ruling officially goes into effect.

To read the ruling in its entirety, click here.

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