OTC hearing aids - who can benefit?

There are some new changes coming to hearing aids in the near future. In short, the Over the Counter Hearing Aid Act of 2017 has made it a requirement that people who need hearing aids be able to purchase them without having to do so through a hearing loss center. This law mostly impacts those with mild to moderate hearing loss. Congress passed the law in the hopes of helping to make hearing aids more accessible to people and in the hopes of reducing the cost of getting these entry level hearing aids.

If you are one of the many people who are considering the use of over the counter hearing aids, it is very important that you know what they are and what they do. They are not the same as what you would expect to find from other providers. Here’s what you need to know.

What Is the Rule?

While Congress passed the hearing aid rule in 2017, there has been a long delay in implementing it. In October of 2021, the FDA finally issued what it considered draft guidance on these over the counter hearing aids. This guidance was designed to make it possible for hearing aids to be sold to consumers online and through physical stores without the need to have a medical exam or to have a fitting completed by a professional audiologist. The goal there was to help to increase competition in the market and, as a result, make it more affordable and accessible to those who need it. Recently, the FDA published the new OTC hearing rules. If you are considering the use of these devices, you should know more about them.

What Makes OTC Hearing Aids Different?

To determine if you should purchase OTC hearing aids, it helps to know how they will be different from the models that are used and readily available today. For many people, there will be a number of concerns, including in the following areas.

How they are fitted

One key factor is how these hearing aids will be fitted. A proper hearing aid fitting influences the functionality and maximizes the benefits the hearing aid offers. It also plays a role in the comfort the patient has with using the device. With the new over the counter hearing aids, the process will likely involve some type of self fit design. Support will most likely be provided virtually — however in many cases, there is unlikely to be much support.

By comparison, prescription hearing aids are much different. A licensed audiologist is necessary to prescribe as well as fit these hearing aids. Verification tests like Real Ear Measurement are used to verify the proper programming. The goal here is to provide a much higher level of comfort and functionality as a result.


One of the primary goals of the over the counter hearing aids is to reduce cost. By increasing competition of these products, there may be some additional options for buyers. Today's prescription hearing aids typically cost between $1500 and $3500 each. It is not fully known how much hearing aids sold over the counter will cost but most expect that these hearing aids will cost between $500 and $1500 each.

Key to remember here is that hearing aids are not inexpensive tools. They are expensive because they have a much higher level of technology and functionality today than they used to have. Pricing will be set by the manufacturers, and a race to the bottom in pricing is likely. Yet there is no insight yet on what to expect in this way.

The design

Another key area that may differ significantly is the overall design of these hearing aids. Because the focus will be on providing a low-cost product, most of the over the counter hearing aids will likely strip down some of the features to reduce overall costs. One of the ways this may be done is by reducing the overall fit options. It is expected that some products will become a one-size-fits-all style with very little flexibility in terms of the shape or the design as a whole. There may be some manufacturers that offer several options or may offer some limited design solutions to entice buyers.

By comparison, over the counter hearing aids are not likely to live up to the quality and customization options that are present in many of today’s prescription hearing aids. Today, manufacturers are using a wide range of different methods to create highly customized designs to fit just about any need.

One area of focus could be on whether or not over the counter hearing aids will be designed to be concealed or discrete. Some of the most modern hearing aids today do a very good job of being hard to see once they are placed. Many are very discrete and hard to tell. Some even look like earbuds which is sure to confuse some people. It is unlikely that OTC models will include a discrete option like this.

Treatment levels

It’s important to note that those who have more severe forms of hearing loss may not benefit from these hearing aids at all. These are often the people that benefit from the application of hearing aids the most. Also, without testing, it will be up to the consumer to determine what type and level of hearing loss they have. That could create concerns and limit some people from obtaining the more effective forms of hearing aids to fit their needs.

Who Is Likely to be a Candidate for an OTC Hearing Aid?

There are a wide range of people who may benefit from an OTC hearing aid. For those who have mild hearing loss that may not be using a hearing aid just yet because of the cost associated with them, the use of OTC hearing aids could provide an opportunity to start getting help. It could provide a way for people to learn more about hearing aids and to get a taste of the benefits that they could offer by improving hearing.

If you have some of the initial signs of hearing loss, you may wish to consider this. For example:

  • Your friends and family may be telling you that you are not responding to them as they would expect. They may complain that you need to have your hearing checked.
  • You may find that you are asking people to repeat themselves often in various settings. That could include in noisy rooms as well as in everyday situations.
  • You may be turning the volume up on the TV more often or struggling to hear in a restaurant even though it does not seem like anyone else is having that type of problem.

In these situations, OTC hearing aids may be a good starting point. They may give you an idea of what hearing aids are like and how they may work for you.

Who is Not a Candidate for an OTC Hearing Aid?

There are some people that may not benefit from this type of hearing aid. While it may be better than not having any type of hearing device, it may not provide the best level of care and may not even offer help to some people who have significant hearing loss.

If you are unable to hear conversations in quiet settings or you cannot hear loud sounds – such as a loud sound that does not startle you as it does others – that may indicate a more significant loss of hearing. You may find that things like driving are no longer safe to do because you cannot hear the traffic or other sounds around you.

In these situations, OTC hearing aids are less likely to be helpful. They also may not be helpful ins situations where a person is suddenly suffering from hearing loss. If you have hearing loss that is unexplained or you have tinnitus (a ringing in the ears), you may not benefit from the simplistic design of most over the counter hearing aids.

What Should You Do Now?

If you are unsure what type of hearing aid is right for you, set up an appointment with an audiologist to learn more about your options. It may seem like waiting for an OTC hearing aid to become available is a good idea, but there is not a lot of indication of when these may be available. Until then, you may struggle with significant hearing loss and a drop in your overall quality of life as a result.

Further reading:

Prescription or OTC Hearing Aids: Which are right for me?

OTC Hearing aids are finally here!

Dr. Cliff's Pros and Cons for



Leslie Balderas

Dr. Leslie Balderas is an Audiologist at Applied Hearing Solutions in Phoenix, Arizona. An Arizona native, she earned her doctorate in Audiology from Arizona State University. Dr. Balderas is passionate about educating her patients about Best Practice audiologic care to help them achieve their optimal hearing treatment outcomes. Outside of the office, you can find her volunteering and giving back to her community.


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