Imagine if getting a hearing aid were as simple as picking out a pair of reading glasses at the drugstore. Sounds like music to your ears, right? This scenario may not be such a pipe dream.

Latest development: The FDA is being urged to create a new category of “over-the-counter (OTC) hearing devices” for adults with mild-to-moderate hearing loss. This recommendation comes from a recent report released by a committee convened by the National Academies of Sciences, Engineering, and Medicine, an independent, nonpartisan body of experts who advise the federal government on matters related to science, technology and health policy.


Statistics show that 86% of people who would benefit from hearing aids do not get them. The main deterrent is cost. Since the average retail price for a pair of hearing aids is almost $5,000, hearing aids are a big purchase for most people—especially since they are not covered by Medicare or most private insurers. (Hearing aids may be eligible for reimbursement from health savings accounts or flexible spending accounts.)

OTC hearing devices, on the other hand, are expected to be much more affordable than traditional hearing aids. They will likely come in a range of prices but will probably be closer to several hundred dollars per pair…not several thousand. There will also be easier access to the OTC devices (in drugstores and online, for example).

And OTC hearing devices are likely to be just as unobtrusive as the latest high-end traditional devices.

An important distinction: OTC hearing devices are not to be confused with personal sound amplification products (PSAPs), also OTC products, which are approved by the FDA for people with normal hearing who may need sound amplification in certain situations. PSAPs are commonly used, for example, by bird-watchers and hunters to hear animal calls. The FDA prohibits these devices from claiming to actually improve hearing.


Hearing aids are not just expensive. They also require going to an audiologist or a hearing aid dispenser to get advice on the right model for you, fittings and instructions on their use. It typically takes one to two visits until a new hearing aid user is tested, fitted and fully set to go.

Because OTC devices are expected to be easier to access, those with hearing loss will likely treat their problem much sooner. Hastening this process could reap real health benefits, since research shows that untreated hearing loss—even if mild—is socially isolating and is linked to increased risk for serious conditions such as depression and dementia.

OTC hearing devices remove barriers—without sacrificing hearing improvement. In a double-blind, placebo-controlled, randomized clinical trial published in the American Journal of Audiology, researchers analyzed data from 154 adults ages 55 to 79 with mild-to-moderate hearing loss. One group received preprogrammed hearing aids with the help of an audiologist, while the other group followed an OTC-style process by choosing a similar high-end set without a professional fitting and instructions.

Both groups reported that the devices had similar levels of effectiveness, as measured by self–report surveys of hearing aid benefits. Those in the OTC group, however, were somewhat less likely to say that they would purchase the -devices—perhaps because they lacked confidence in their own choices compared with those whose hearing aids were chosen for them by professionals.


It’s important to note that no standard definition or design has yet been established when it comes to OTC hearing devices. So you should be clear-eyed when it comes to expectations.

Among the most significant pros and cons…

Pro: Easily accessible. In a best-case scenario, you will try on a few versions of OTC hearing devices at your local drugstore and go home with your choice the same day. For some people, these devices may be an entry-level product—and a way to bridge the gap before having a professional fitting for traditional hearing aids later.

Con: That choice might be trickier than you think. Choosing OTC hearing aids essentially requires a self-diagnosis of your hearing ability, which could be more complicated than it seems. It’s possible that a consumer would be able to see an audiologist and take his/her test results to a retailer to then purchase OTC hearing devices. There are also online hearing tests now available, including the FDA-cleared at-home hearing test iHEAR, available for $69 at

Also: Varying levels of hearing loss may affect each ear, confounding the process. However, many OTC models will likely have a volume control (manual or automatic) that will enable different volumes for each ear.

Important: Medical clearance is not required or recommended for OTC hearing devices. In fact, the FDA recently removed this requirement for adults with mild-to-moderate hearing loss who are purchasing hearing aids because the evidence does not support a need to consult a doctor first.


Bipartisan bills have been introduced in Congress to pass legislation so that OTC hearing devices can be made available to Americans. The Senate and House are expected to vote on these bills before the end of the year.

How to voice your opinion: If you think that OTC hearing devices should be made available (or you oppose this proposal), log on to the Hearing Loss Association of America’s web page for instructions on writing to your US senator and/or representative:

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