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F.D.A. Approves Over the Counter Hearing Aids

August 19, 2022

(NYT) The FDA decided last Tuesday to allow hearing aids to be sold over the counter and without a prescription to adults, a long-sought wish of consumers frustrated by expensive devices.

The high cost of hearing aids, which are not covered by basic Medicare, has discouraged millions of Americans who have hearing loss from buying the devices. Health experts say that untreated hearing loss can contribute to cognitive decline and depression in older people.

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

The changes could upend the market, which is dominated by a relatively small number of manufacturers. Current costs for hearing aids range from about $1,400 at Costco to roughly $4,700 elsewhere.The F.D.A.’s rule takes effect in 60 days.

Dr. Robert Califf, the F.D.A. commissioner, said the move is meant to “unleash the power of American industry” in a way that could have global influence.

The White House also hailed the move as a signature accomplishment for President Biden, who signed the Inflation Reduction Act on Tuesday.

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

“This is going to make a really concrete 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 the barriers to getting hearing help have included costs that are not covered by Medicare. There is also stigma — such as appearing “old” — that comes with use.

The change has been percolating for years. In 2017, Senators Chuck Grassley, a Republican of Iowa, and Elizabeth Warren, a Democrat of Massachusetts, introduced a bill enabling 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 promote the wide availability of low-cost hearing aids” to be published.

Senators Warren and Grassley had released a joint report accusing the “dominant hearing aid” makers of engaging in an “astroturf lobbying” effort by flooding the F.D.A. with repetitive comments steering the agency toward a new generation of hearing aids that would be “less effective, protecting manufacturers’ existing market share and locking in their competitive advantage.”

“The logic is simple: The less effective an O.T.C. hearing aid is, the more likely consumers will be forced to abandon these options and instead opt for more expensive, prescription devices sold by the manufacturers that dominate this line of business,” the senators’ investigative report said.

The F.D.A. reviewed more than 1,000 comments submitted about the rule and made a handful of changes in the final version released on 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 that the hearing aids have a user-adjustable volume control and simplified wording on the product label.