May 4, 2024

Senators press FDA to finalize OTC hearing aids, accuse industry of ‘astroturf’ campaigns – MedTech Dive

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Senators Elizabeth Warren, D-Mass., and Chuck Grassley, R-Iowa, are doubling down on their campaign to get the Food and Drug Administration to swiftly approve rules allowing retail sales of inexpensive hear…….

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Senators Elizabeth Warren, D-Mass., and Chuck Grassley, R-Iowa, are doubling down on their campaign to get the Food and Drug Administration to swiftly approve rules allowing retail sales of inexpensive hearing aids.

A report compiled by the cross-aisle pair accuses large hearing-aid manufacturers of undermining a proposed FDA rule to create a class of over-the-counter hearing aids.

In a June 29 letter sent to FDA commissioner Robert Califf, the senators accused hearing-aid manufacturers of launching “astroturf campaigns,” citing form letters found in submitted comments to the FDA’s proposed rule. The two said form letters accounted for about 40% of the comments received by the agency.

“Powerful stakeholders, including dominant manufacturers in the highly-concentrated hearing aid industry, are using astroturf lobbying tactics to weaken the FDA’s proposed rule,” Warren and Grassley wrote in a joint statement. The senators want to “expand access, reduce costs, and ensure a robust new market for safe and effective OTC hearing aids.” 

At the same time, they accused the manufacturing lobby of “harming American consumers.”

According to the senators’ report, while nearly 38 million Americans experience hearing loss, the high cost of hearing aids mean only one in five people who would benefit from a device use one. 

Since January, the senators have been urging the FDA to adopt a final rule, after the agency issued a proposed …….

Source: https://www.medtechdive.com/news/senators-warren-grassley-otc-hearing-aids-accuse-industry/626662/