t’s about to get a lot easier to get hearing aids.

The Food and Drug Administration launched an effort Wednesday to make the devices available over the counter, a move that could eventually save thousands of dollars for hearing-impaired Americans.

The agency said it will immediately stop enforcing a requirement that patients get a medical evaluation before obtaining  hearing aids and consider creating a new category of over-the-counter products, which will encourage new manufacturers to step into the market.


Those moves could quickly reduce costs for average buyers. Hearing aids cost about $4,600 a set, and Medicare generally doesn’t cover the cost of hearing aid exams or the devices themselves, so most consumers are forced to pay out of pocket.

The FDA said its decision applies to the class I and class II subset of air-conduction hearing aids, meaning “any wearable instrument or device designed for … impaired hearing.” It does not apply to bone-conduction hearing aids, or to prescription-use hearing aids that are inserted deep in the ear canal.

Given the aging of the population — about 10,000 Americans turn 65 every day — the effort to ease access to hearing aids could help tackle rising demand for the devices. About 30 million Americans are already estimated to suffer from mild to moderate hearing loss, which is often age-related.

Andrew Scholnick, a senior legislative representative for the AARP, said the FDA’s move “will greatly reduce the cost of hearing aids, increase their availability, and help remove the stigma associate with hearing loss.”

Currently, six companies manufacture nearly all the hearing aids sold in the US, and most are located abroad. In a blog post about the FDA’s move, an economic adviser to the Obama administration said making them available over the counter promises to open the market to new competitors.

The extent of that competition remains to be seen. But the FDA’s announcement will soon make hearing aids as easy to get as simple reading glasses, which have long been available over the counter.

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