FDA approves over-the-counter hearing aids

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August 19, 2022

(NYT) The FDA decided last Tuesday to allow over-the-counter and non-prescription hearing aids to be sold to adults, a wish long sought by consumers frustrated with expensive devices.

The high cost of hearing aids, which are not covered by basic health insurance, has discouraged millions of hearing-impaired Americans from purchasing these devices. Health experts say untreated hearing loss can contribute to cognitive decline and depression in older adults.

Under the new rule, people with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores from October.

The changes could disrupt the market, which is dominated by a relatively small number of manufacturers. Current costs for hearing aids range from around $1,400 at Costco to around $4,700 elsewhere. The FDA rule takes effect in 60 days.

FDA commissioner Dr. Robert Califf said the move was intended to “unleash the power of American industry” in a way that could have global influence.

The White House also hailed the move as a milestone achievement for President Biden, who signed the Cut Inflation Act into law on Tuesday.

The change eliminates the need to see an audiologist for a hearing test and fitting, a process rarely covered by insurance.

“This is going to make a very real difference in the lives of millions of Americans,” Mr. Califf said.

Hearing loss is associated with cognitive decline, depression, isolation and other health problems in older adults. Yet barriers to getting a hearing aid include costs that are not covered by Medicare. There’s also the stigma – like appearing “old” – that comes with use.

The change has been felt for years. In 2017, Senators Chuck Grassley, a Republican from Iowa, and Elizabeth Warren, a Democrat from Massachusetts, introduced a bill allowing the agency to make the change that was signed into law.

President Biden issued an executive order last July calling for greater competition in the economy, which included a call for the rule to be released “to promote the wide availability of low-cost hearing aids.”

Senators Warren and Grassley had released a joint report accusing ‘dominant hearing aid makers’ of engaging in an ‘astroturf lobbying’ effort by flooding the FDA with repetitive comments pointing the agency towards a new generation of devices hearing aids that would be “less efficient, protecting manufacturers’ existing market share and sealing their competitive advantage.

“The logic is simple: the less effective an over-the-counter hearing aid is, the more likely consumers will be forced to abandon those options and instead opt for more expensive prescription devices sold by manufacturers who dominate this industry. ‘activity,” the senators said. says the investigation report.

The FDA reviewed more than 1,000 comments submitted about the rule and made some changes to the final version released Tuesday. They include lowering the maximum sound output of the devices and revising the insertion depth limit in the ear canal. The rule also requires hearing aids to have a user-adjustable volume control and simplified wording on the product label.

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