As a result of FDA regulation, hearing aids will no longer need a prescription 

As a result of FDA regulation, hearing aids will no longer need a prescription –  Tuesday, the U.S. Food and Drug Administration published a regulation allowing some kinds of hearing aids to be sold over-the-counter and without a prescription or medical assessment. The FDA said that the regulation, which would establish a new regulatory classification for over-the-counter hearing aids, applies to persons “with perceived mild to moderate hearing impairment.”

The rule states, “By establishing a regulatory category for over-the-counter (OTC) hearing aids and amending existing regulations, we intend to provide reasonable assurance of safety and effectiveness for these devices, as well as promote access to and innovation in hearing aid technology, thereby protecting and promoting public health.”

The FDA asserts that the regulation will also reduce the price of hearing aids. It follows President Biden’s Executive Order on Promoting Competition in the American Economy from July 2021, which required the Secretary of Health and Human Services to issue a draught regulation on over-the-counter hearing aids.

Kim M. Smith, leader of the Utah Deaf Hospital Rights campaign and president of the Utah Association of the Deaf, pushes her hair away from her hearing aid while posing for a photo at Alta View Hospital in Sandy, Utah, on Monday, January 20, 2020. As of this autumn, millions of Americans may be able to purchase hearing aids without a prescription, per a long-awaited regulation adopted on Tuesday, August 16, 2022, that aims to make hearing aides more accessible to persons with hearing loss.

Following a notice-and-comment phase that garnered more than 1,000 public comments from hearing aid manufacturers, consumers, professional groups, politicians, and state agencies, the FDA issued the final version of the rule. This led in modifications to the proposed regulation, such as decreasing the maximum sound output for over-the-counter hearing aids and mandating a volume control that is adjustable. At mid-October, Americans will be able to find over-the-counter hearing aids in pharmacy shops and other retail establishments, including internet retailers, according to the FDA.

As a result of FDA regulation, hearing aids will no longer need a prescription 
As a result of FDA regulation, hearing aids will no longer need a prescription 

 

Health and Human Services Secretary Xavier Becerra said in a statement, “Reducing health care costs in America has been a focus of my since day one, and this rule is anticipated to help us achieve excellent, affordable health care access for millions of Americans in need.” The FDA’s move today signals a key milestone in the effort to make hearing aids more affordable and accessible.

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The FDA clarified that the new category of over-the-counter (OTC) devices “applies to certain air-conduction hearing aids designed for individuals 18 and older with perceived mild to moderate hearing impairment.” Anything other, whether it be a different sort of assistance or one intended for a younger individual, would still need a prescription.

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