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FDA Approves Over-The-Counter Sale of Hearing Aids

About 15% of American adults report some level of hearing loss

Americans may be able to purchase hearing aid without an exam or fitting as soon as this fall.

A new rule from the Food and Drug Administration created a new category for over-the-counter hearing aid. The announcement comes after almost a year of waiting. Pending final approval, the hearing aid could be available as soon as mid-October. 

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Dr. Robert M. Califf in an Aug. 16 statement. “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.” 

Congress approved legislation that opened the door to the sales of hearing aid without a prescription during President Donald Trump’s administration in 2017. The policy was proposed by Senator Chuck Grassley of Iowa and Senator Elizabeth Warren of Massachusetts. The senators released a report that indicated the hearing aid industry was dominated by five major companies.

Implementing the law proceeded slowly. In July of 2021, President Joe Biden issued an executive order mandating the Secretary of Health and Human Services to “promote the wide availability of low-cost hearing aids” and comment on the law within 120 days of his order.

The FDA estimates hearing aid could be needed by 30 million American adults with roughly 15% of the adult population reported to be experiencing some type of hearing loss. 

One hearing aid costs approximately $2,000 with a pair costing between $4,000 to $6,000. 

Opponents of the rule change have said hearing aids need to be regulated with limitations placed on their volume output as devices that are too loud could harm hearing.

Under the FDA’s new rules, OTC hearing aid volume would be permitted to be 111 decibels in general. While certain sound control features are activated, the devices could be as loud as 117 decibels. Both limits are slightly below the initially proposed limits. The agency also said people under the age of 18 would still need to consult with a doctor to obtain a hearing aid. 

“It’s unlikely a company would add a ridiculous over-amplification of sound because the consumer probably wouldn’t like it,” says Nicholas Reed, assistant professor of epidemiology and audiology with the Johns Hopkins Cochlear Center, told Consumer Report

According to The Verge, headphone companies may be among the first to bring OTC hearing aid to the market.

“The line between headphone and hearing aid has already been blurring for years. In 2018, Bose secured the first FDA clearance for a ‘self-fitting’ hearing aid that could be sold directly to consumers in some cases,” the outlet points out. 

Bose’s hearing aids were still subject to some state regulations. The company stopped selling the products when it closed its healthcare division in 2021.

The rule also does away with a loophole in the industry – direct-to-consumer hearing aids which were available online or via mail to consumers without prescriptions. 

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