It’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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  • After spending over $12,000 for my last two sets of hearing aids I have to wonder at the cost and why it hasn’t decreased over the years. My latest TV cost a quarter of my last one and is about ten times better. Why no technology savings in hearing aids? I have to suspect it is to do with the fee structure of audiologists being tied with the purchase price of devices. All of which is very confusing and I am sure that the consumer pays for it. Let’s get Apple and Google to make hearing aids and pay the audiologists for their services separately and save a lot without sacrificing anything!

  • I am a Board Certified Otolaryngologist. I see the goal, to get more hearing impaired people hearing at an affordable cost. This is not the means to that goal. This is a false equivalent to loss of vision. Fitting a hearing aid properly is not the same as picking up a pair of reading glasses. The ear is a very complex system of outer, middle and inner ear disease. Even hearing loss related to aging is not the same between individuals. A better system would still require a medical evaluation of hearing by an audiologist at the minimum, before recommending an over the counter hearing aid AS AN OPTION, before they purchase one. Medical conditions will be missed and will progressively get worse. The solution is to force the health insurance companies to cover them, not to find a cheap, dangerous way around the problem.

  • I can see this working like buying glasses online. Some will be crap, some will be great and it’ll be the reviews that helps us find what we need. I’ve been buying glasses online for my family for several years and once I was able to use reviews to find legitimate sites we’ve saved a ton of money while keeping our eyes in great shape. I can see OTC hearing aids running the same way. You don’t HAVE to get a doc to look at you, but once you do you can find what you need for much cheaper and adjust it for you. Heck, audiologists could even offer a cheaper service to help program those aids if they wanted to (if the market doesn’t come up with a better answer, though I think it will).

    I haven’t been able to get hearing aids because of the expense and this will be great for those of us that can’t shell out that kind of money.

  • Insurance needs to cover the cost of quality hearing aids, as well as exams by qualified audiologists. Period. is is serious stuff, people.

  • I know quite a few people who have tried the OTC hearing aids. All have stated they are a waste of money. Just making everything louder is a far cry from having adjustments for specific deficiencies. I will gladly pay for aids that do the job correctly.

  • This is very ill advised and business driven and not in the best interest of hearing impaired people like myself. Prescription hearing instruments and the programs that adjust them are incredibly personalized to the measured hearing disabilities of each individual and only Doctors of Audiology are trained and licenced to test hearing and program the hearing instruments.

  • These over the counter amplification devices may not be the answer for everybody that has a hearing loss, but they will help many people. We often see a “one size must fit all” mentality in this country that demands that if something doesn’t fix everybody’s problem, then it is worthless. Stop thinking like that. Just stop it! I have 20/20 far vision, but have to wear reading glasses for close up work. I buy them at Walmart for less than $10, and they work just fine. I know from using variable volume head phones that my hearing is greatly improved without the high cost of programmable hearing aids.
    Get these PSAPs on the market, and the sooner the better.

    • Being able to buy a good OTC hearing aid will surely help those who will never be able to afford the hearing aids pushed by audiologists.

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