Devices

FDA Moves to Improve Hearing Aid Accessibility

FDA says it will no longer require medical evaluations and signed waivers before consumers purchase a hearing aid. In addition, the agency is considering creating a special over-the-counter (OTC) category for certain hearing aids that will likely lower costs for consumers.

“Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,” FDA commissioner Robert Califf is quoted in a release as saying. A new guidance has been issued and it will “support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing,” Califf adds. FDA intends to seek additional comments from stakeholders as it moves the OTC approach along.

FDA estimates that about 30 million people in the U.S. have impaired hearing. “Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention,” it says.

Recent studies have faulted FDA regulations on conditions for sale as a potential barrier to availability and accessibility of hearing aids, and concluded that the regulation was providing little to no meaningful benefit to patients. They found that hearing aids often cost more than $2,000 a piece, and such barriers to distribution channels may limit new entrants who could achieve technological breakthroughs that could offer a greater variety of lower-cost hearing aid options to those suffering from hearing loss. The regulation requires that all prospective hearing aid users have a medical evaluation by a licensed physician to determine the cause of hearing loss and whether medical or surgical treatments would be more appropriate

Under the new guidance, the agency will continue to enforce the medical evaluation requirement for prospective hearing aid users under 18.

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