FDA Makes Hearing Aids More Accessible

Regulatory NewsRegulatory News
| 07 December 2016 | By Michael Mezher 

In a move intended to improve patient access to hearing aids, the US Food and Drug Administration (FDA) on Wednesday issued an immediately effective guidance that reduces the regulatory requirements for selling certain hearing aids.

"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," FDA says.

FDA announced that it does not intend to enforce the requirement for American adults to get a medical evaluation before obtaining most hearing aids. The White House praised the move on Wednesday, saying it "could start a movement toward over-the-counter hearing aids that will cost a fraction of the $2,300 apiece of current products, helping more of the 30 million Americans who need assistance."


Under CFR 21 Sec. 801.421, hearing aid dispensers are prohibited from selling hearing aids to adult patients without a physician signed medical evaluation, or a waiver signed by the patient. Additionally, dispensers are required to retain a copy of these documents for three years after dispensing a hearing aid to a patient.

However, in its new guidance, FDA says it will no longer enforce those requirements for Class I and Class II non-prescription air-conduction hearing aids sold to adult patients.

According to FDA, the move is in line with recommendations made in two recent reports on hearing aid innovation, affordability and access.

The first report, released by the President's Council of Advisors on Science and Technology (PCAST) in October 2015, called for FDA to remove the medical evaluation requirement, as it "provides little patient benefit, while acting as a barrier to access for the millions of Americans needing hearing assistance."

The second report, which was commissioned by FDA and other federal agencies and conducted by the National Academies of Sciences, Engineering and Medicine (NAS), concurred, while noting that "the health risk of missed diagnoses of treatable causes of hearing loss is low."

FDA adds that other reports signal that "a majority of consumers today are signing the waiver in lieu of a medical evaluation," making the benefit of such a requirement even more questionable.

However, FDA says it will still enforce two other provisions of CFR 21 Sec. 801.421, which require dispensers to give potential customers copies of the instructional brochure upon request, and to give them an opportunity to review the brochure before a purchase.

The PCAST report also went a step further, calling on FDA to "approve [a] class of hearing aids for over-the-counter (OTC) sale, without the requirement for consultation with a credentialed dispenser."

Going forward, FDA says it will consider that and other recommendations, but notes that it would seek public comment before taking such actions.



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Tags: Hearing Aids

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