Over the Counter Hearing Aids

Over the counter hearing aids have been in the news lately with bi-partisan Over the Counter Hearing Aid act getting signed in to law. The new law directs the Food and Drug Administration (FDA) to regulate the sale of hearing devices that can be sold off the shelf without the assistance of an audiologist.  The goal of the legislation is to make hearing aids more accessible as more than 50 million people in the US have hearing loss, yet 80% goes untreated.


First off,  OTC hearing devices have been available for many years, they are known as Personal Sound Amplification Products or PSAPs. Perhaps you’ve seen ads on late night TV or offers for low priced “hearing devices” available online. These devices are currently not regulated nor can they be called a hearing aid. Prices are very low, ranging from $15 -$300 or more a piece. They are amplifiers that simply make all sounds louder, where a hearing aid can be programmed by a professional (like us) to meet the unique hearing loss of the patient. If you have a high frequency hearing loss (like the pitch of a woman or child’s voice) it makes no sense to make the lower frequencies louder too. It will only make it more difficult to hear what a person is trying to say, especially if other noise is present.

Who are they for? OTC hearing aids are for people with mild to moderate hearing loss only; they have limits on how loud they can be turned up and they are not made for people with more severe hearing losses or complicated ear conditions.

How are they fitted? Many OTC hearing aids are “self-fit”, which means you can set them up through a program or smartphone app, or they have preset settings that you can choose. Traditional hearing aids are programed by an audiologist to help with your specific hearing loss and are tested to make sure they are amplifying sound in the way that is needed for your ears.

How are they maintained? There is no set regulation on OTC hearing aids regarding coverage if something happens to the device or if it stops working. Plus, if you are having trouble with the device there may be limited help from the manufacturer. Traditional hearing aids come with a warranty from the manufacturer that covers not only damage but also in many cases loss replacement. Traditional hearing aids are fit by an audiologist who performs regular maintenance to keep the hearing aids working and updates the software. Without regular maintenance most hearing aids will stop working within several months.


Like many people, we’re a bit skeptical about the motives of legislators. Since hearing loss is associated with aging and noise exposure, there is a huge number of potential patients as the tail end of baby boomers are now well in to their fifties. Seeing this potential market, companies are looking to cash in without the enormous research and development that the leading hearing aid manufacturers have incurred. These amplifier companies have helped to gain credibility by getting their devices “regulated” by the FDA.  Whether or not this legislation will improve the lives of millions of Americans is to be seen as the devil will be in the details that the FDA creates. Many studies have shown that hearing aids fit without follow up care will result in more hearing aids in the dresser drawer.  A study done in Britain where hearing aids are no cost in their healthcare system showed that 60% of patients who were given hearing aids without follow up care discontinued using them.

Check out this opinion column published in The Hill.

Many Medicare supplement plans that currently offer hearing aid coverage will probably stop now that insurance companies can direct people to buy hearing aids OTC paying out of pocket.

What about costs? Cost-wise OTC hearing aids will likely be less expensive than traditional hearing aids. Audiologists are the healthcare providers who specialize in hearing so regardless of whether OTC or traditional hearing aids are right for you, an audiologist can help you make the best decision. We strongly recommend a baseline hearing test even if you would like to buy OTC hearing aids to ensure your ears are healthy and that OTCs are the best option for you.


It’s valuable advice we received from our parents. Something that has more features and higher quality will generally cost more. A Cadillac Escalade and Chevy Spark are both cars made by General Motors. The Cadillac is considerably more in price because it has more space, a more powerful engine, a high end sound system, heated and cooled seats, etc. If you are six adults traveling through 8 inches of snow, you can’t get the job done with a Chevy Spark. Hearing aids are the same way…not all devices will get the job done. That’s where an audiologist comes in. Without first knowing the degree of hearing loss, it is difficult to get the right level of performance. The USA Today recently published a story about over the counter hearing aids which you can find here.