Hearing aids expected to cost less as FDA allows over-the-counter sales. What to know

·2 min read
Isaac Hale/The Daily Herald via AP

Hearing aids may soon be more accessible to millions of people in the United States under a new rule, officials say.

The ruling, finalized by the Food and Drug Administration on Aug. 16, would create a new type of hearing aids that can be sold over the counter without a prescription, according to a news release. In addition to making hearing aids more accessible, the rule is expected to make them cheaper.

“My last pair of hearing aids cost over $4k out of pocket. I haven’t been able to get one fixed because they’re six years old and the technology is obsolete, but I can’t yet afford new ones, so I’m relying on an even older pair. This decision will literally change my life. Wow,” one person shared on Twitter in response to the ruling.

The new hearing aids would be available to people age 18 and older with mild to moderate hearing impairment, the release says. Consumers would be able to purchase aids directly from a retailer without any medical exams, prescriptions or fittings from an audiologist. Hearing aids that fall outside of this category will still require a prescription.

Over-the-counter aids could be rolled out in retailers as soon as mid-October when the rule is set to go into effect.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” FDA Commissioner Dr. Robert M. Califf said in the release. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”

Lawmakers have been pushing for greater access to hearing aids for years.

In 2017, Congress passed bipartisan legislation requiring the FDA to establish over-the-counter hearing aids. The legislation is just now being enforced, the FDA said.

The finalized rule was first proposed Oct. 19, 2021. Since October, the FDA received and reviewed more than 1,000 public comments about the rule. Based on the comments, the FDA has incorporated a number of changes in the finalized rule from the initial proposal.

Changes to the proposal include “lowering the maximum sound output to reduce the risk to hearing from over-amplification of sound, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the phrasing throughout the required device labeling to ensure it is easily understood,” according to the release. The finalized rule also has performance and design specifications for over-the-counter aids.

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