US Regulatory Agency Proposes New Rule Allowing Sale Of Over-The-Counter Hearing Aids

WASHINGTON (UrduPoint News / Sputnik - 19th October, 2021) The US food and Drug Administration (FDA) issued a proposal for a new rule that would allow the sale of over-the-counter hearing aids to consumers, the FDA said on Tuesday in a press release.

"Today, the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans. The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist," the FDA said.

The proposal follows an Executive Order from President Joe Biden in July on promoting competition in the US economy, which called for the FDA to allow the sale of over-the-counter hearing aids.

Although about 15% of US adults report trouble hearing, only about one-fifth of those people who could benefit from a hearing aid use one, the FDA said. The proposed rule aims to address barriers to use, including cost, access, and social stigma related to hearing loss.

The rule is intended to promote innovation and competition among hearing aid manufacturers and will likely give consumers greater choice at lower prices, the FDA added.