Dr. Rebecca Blaha, lead audiologist at the Pennsylvania Ear Institute (PEI) and assistant professor at the Salus University Osborne College of Audiology (OCA), with Dr. Aaron Roman, a clinical audiologist at PEI and assistant professor in OCA, discuss over-the-counter hearing aids.in a new podcast.
Blaha: The FDA ruling is officially in effect as of this month, so we're here to talk about what that means to you as a potential consumer. What exactly is an over-the-counter hearing aid?

Roman: An over-the-counter hearing aid, just like over-the-counter glasses or pretty much anything over-the-counter, is something that you can buy pretty much anywhere so these are hearing aids that you can purchase from your local pharmacy (Walgreens, CVS, anything like that). You could also very likely buy these online. They're going to be sold through many streams, such as Bose. You'll also see them from generic online companies. You do not need a hearing test ahead of time to get them. If you decide that, "Hey, I need hearing aids. I'm really struggling," you can buy these over-the-counter, as the name implies.

Blaha: According to the ruling, they are targeting patients who have mild to moderate hearing loss, or at least they perceive it to be mild to moderate. How would you know if you have that type of hearing loss?

Roman: What we should do first is step back and think about what are the exact rules that you need to follow to get these over-the-counter devices. Because they're over-the-counter, really the only rule that we need to think about is that these are intended for adults. If you are under 18, these devices are not for you.

The next recommended feature that we would think about is whether or not you perceive a hearing loss. The FDA rule says that over-the-counter hearing aids are designed for people who perceive a mild to moderate hearing loss. What that means for you can vary from person to person. Generally, people with mild to moderate hearing losses, they tend to do pretty well on one-on-one conversation when in a quiet room. However, when placed in background noise, they really tend to struggle [and] it's really hard to hear the person sitting next to you or across from you.

Additionally, oftentimes with a mild or moderate hearing loss, people will tend to say they struggle to hear their grandchildren speak, or that high voices are hard to understand, or that sometimes people are mumbling. If that is describing your situation, you might be a good candidate for over-the-counter hearing aids. However, one thing I would advocate for, and this is me putting on my audiologist hat, is that if you don't know, you should get a hearing test. Because these are over-the-counter devices, you don't need a hearing test to get them. But, it's always recommended to know where you fall and if you have a hearing loss that's worse than that moderate recommendation, you might need something a little bit stronger or a little bit more personalized to your needs and an over-the-counter device really won't do the job.

hearing aid
It's also been shown in studies that your perception of your level of difficulty does not necessarily always relate to your level of hearing changes. We might see patients that have more severe degrees of hearing loss but they are compensating in other ways and therefore don't perceive their level of handicap to be as severe as their hearing loss. You may find some patients that even would be, what we would classify as audiometrically normal, but they perceive greater degrees of hearing difficulty and challenge and therefore would pursue amplification, even when it wouldn't be required.

So, your subjective performance doesn't always relate to the level of hearing and having your hearing tested before knowing if this device is appropriate for you would always be recommended.

Roman: It's important to note, legally speaking, it is not required. So, you do not need to get a hearing test before purchasing over-the-counter hearing aids.

Blaha: Now, with traditional hearing aids, one of the goals to make over-the-counter a new designation is to improve access so that more people will address hearing loss sooner. It does tend to take the average patient between seven to 10 years to address their hearing loss after first noticing symptoms. The goal would be with this new classification that is easier to obtain, that patients would address their hearing concerns more quickly. So, we do see that as a potential benefit.

There are several direct-to-consumer devices already on the market but they cannot be called an over-the-counter hearing aid. They would be classified as something referred to as a personal sound amplification product. The FDA has a classification for these devices that provide amplification but are not intended for the correction of a hearing loss and are to be used for recreational purposes by individuals that have normal hearing.

So, these can be deceptive. When you look online, you can find many of these devices available on websites such as eBay, Amazon, and other direct-to-consumer outlets. They look like hearing aids. They produce amplification like hearing aids. But, they are, in fact, not classified as an FDA hearing aid. So, you may see some of these personal sound amplification products transition to the new OTC guidelines.

What exactly do these [OTC] devices have to be capable of producing?

Roman: They essentially have to produce a certain amount of what we call gain. Gain is another word that you might hear to reference amplification. These hearing aids are producing an appropriate amount of amplification, again, for someone with a mild to moderate hearing loss. But that amount is going to change, depending on your needs.

These devices will have the ability to sort of self-fit, or some of them will at least. Self-fit means that you can say, "Okay, I feel like I need more of a boost in my low pitches. I need more of a boost in my high pitches." There are going to be these devices that allow you to do that.
I would say, as someone who works with people with hearing loss, that's a really hard task to figure out. A lot of times when I ask individuals to describe their hearing loss, they tend to struggle to say, "Oh, it's only in the lows," or, "It's only in the highs." The nice thing with the over-the-counter devices, if it doesn't work for you, you can always change it, right? So, if you accidentally turn up the gain, or the amplification in the low pitches and you say, "Oh, now sounds sound bad," you can always reset that. The same thing can go for the highs. But, because the onus is on you, the person wearing the hearing aids, that's a lot of pressure and a lot of customization that you have to do.

You have to ask yourself when you're evaluating, "Do I want to pursue these over-the-counter devices," is that something that you feel comfortable doing. Again, there's absolutely no problem in doing that and in many cases, even with traditional hearing aids we allow patients the ability to customize the volume that they get. But this amount of customization, it gives the user a lot of power behind it which is a double-edged sword, right? It's a good thing and it can be a bit complicated at times which can be a challenge.

patient being fitted for hearing aid
Some of these devices will be adjustable using Bluetooth and contain several features that would be traditionally relegated to a more prescribed device. So, what would technically be a prescribed device?

A prescribed device we usually think of as coming from a hearing aid healthcare professional, either an audiologist or a hearing instrument specialist, where they have taken your test results and they are designing the device to provide the exact amount of amplification required to overcome the hearing loss that was determined during testing.

So, we are going in and very carefully manipulating the settings. If it's left up to you, you may have very general settings that you can adjust, if any, and some may say, "Okay, you have just a volume control," and therefore it's going to either possibly be too much bass and sound a little bit underwater or noisy, or you may have too much treble, which a lot of people complain sounds tinny. You may not have too much adjustment available to you because these are meant to be very basic and easy to use.

Roman: One of the questions we should ask is what are the pros and cons of over-the-counter hearing aids. I see a lot of news articles that try to outline them, I see a lot of people in my conversations with patients and providers alike say, "Okay, what are the good things, what are the bad things?" So, let's talk about some of the pros first.

The first thing is with over-the-counter hearing aids in general, they may be less expensive than more traditional hearing aids. That might not always be the case, because depending on your insurance coverage, depending on sort of the level of technology with a traditional hearing aid, that price can come in pretty close. But, I have seen over-the-counter devices priced as low as $300 per device. I've also seen them as high as $2,000 per device. So, you can be more in charge of your budget when purchasing these over-the-counter hearing aids. I can't really say that as a blanket statement, they're overall cheaper. You will likely be paying less than you would for traditional amplification, but not always.

As we already talked about, the customization aspect is very nice. It gives you a lot of control over what is comfortable to you, so that's definitely another pro.

One final pro is how easy it would be to get these. Currently, you have to go through either a physician to go to an audiologist, or you can go straight to an audiologist, and then from there you have to get a hearing test. Then you have order the hearing aids, and be fit [with the hearing aids]. In this scenario, it would be no more different than doing any sort of online shopping where if you find something you like online, you order it and then you receive the product.

Now, let's think about some of those cons. The first con that I can think of, as a healthcare provider, is that you are guessing what your hearing looks like without a hearing test. Again, legally you absolutely don't need a hearing test to get these over-the-counter devices. But, I still find that people want to know, just so that they can say, "Hey, is this device right for me?" I would always advocate, putting on my audiology hat once again, for you to get a hearing test.

Another con in these devices is what you buy might not be fully appropriate for what you're actually perceiving. You might be getting something that is too strong for you, or, honestly, this might be more likely, you are going to get something that's just not giving you the power that you need. This can have some absolute negative consequences. Not so much that it would damage your hearing, but of course, if you're not getting the power you need, you're really not being able to explore all the sound that you require to functionally communicate. And in the worst case scenario, if you're not getting enough power, you're effectively wearing ear plugs, so that's really not helping you in the long run at all. You have to be very confident in your perception of your hearing ability to pursue this.

Again, I am actively encouraging patients to do this if this is something that they feel is appropriate for them, but I would always encourage a hearing test.

hearing test
Blaha: You're buying this as a consumer device and so it is up to you to understand how to manipulate the settings and follow the instructions. But what kind of aftercare would you have if you were ordering this from a catalog or a website? If there is a problem with this device, would it require you to mail it back to the manufacturer for any services or would you be able to go to a provider? Again, once you go to the provider, there would be a fee associated with having an expert look at your devices to troubleshoot and help you to learn how to use them effectively.
So, would there be a cost savings? You purchased the product without going through the professional but ultimately needed their assistance in order to use it correctly and effectively. In some ways, it may seem like cost savings initially, but you do need the services of a professional to get the best benefit.

Roman: Oftentimes what you will do with a traditional hearing aid is you purchase some sort of warranty and that includes follow up visits, so on and so forth. When you do over-the-counter hearing aids, I would advise anyone considering this is to make sure that they investigate what is the return policy. Can you return it and, if so, what is that time window that you have to return it? And what is the method of returning it? Is it sending it back to its manufacturer wherever you purchased it online or in person? Is it going to a brick and mortar store?

These are all considerations that you as a consumer need to take into account, when you purchase any product, but specifically anything that has to do with your health you really want to make sure that you are the most knowledgeable about whatever you are putting your money into.

Now, let's look at the other side of the coin. I'm a consumer, I know I need some sort of amplification. Why would I go to an audiologist and why would I get a traditional hearing aid? Are there pros and cons associated with that?

Blaha: When I think about how an audiologist approaches the use of hearing aids, we consider one element of your rehabilitative plan. When you come in then for the assessment, we are looking to see how much residual hearing do you retain, because that will be what we need to optimize. We'll listen to your concerns and find out what is it that you're noticing with your communication that you feel needs to be improved. And then we'll establish goals so that we can measure your progress towards those goals with the use of the devices that we may recommend.

Once we have your hearing tested, then we go in and we prescribe the hearing aids to effectively correct for the changes in your hearing. It's all relative to the level of your hearing and what we still have to work with. We also consider, what is your lifestyle? What features does the device need to have in order to reach the goals that we have just set? And then we always want to track your progress through a trial period where we go in and we fine tune it based on your experiences.

The audiologist is there to help set your rehabilitative plan and work with you collaboratively to make sure that the reason you purchased the device we are actually getting you towards those goals and helping you use them effectively. With something over-the-counter, you're kind of going on your own. You're trying to do all of these things that a professional would assist you with all by yourself. The devices are meant to be simple to use as an over-the-counter device, but you're going to have to instruct yourself, follow all of the guidelines that the manufacturer of this device sends to you which may not always be clear in terms of setting it up and getting the settings to where you would like them to be. And then, of course, without someone there objectively verifying how the hearing device performs, you may not be optimizing how you're using it to get the benefit that you're looking for.

patient undergoing hearing test
The big pro with traditional hearing aids is because we know what your hearing loss looks like [and] because we know how severe your hearing loss is, we as an audiologist can sort of customize the amplification to your ear, the anatomy of your ear, and then also to your hearing loss. You don't get that exact level of customization in over-the-counter hearing aids, however, as we said before, that might not be for you.

The pro in this is that you're going to get a more customized and more appropriate amount of sound in a traditional hearing aid, so then what are the considerations related to traditional hearing aids that you might want to think about?

The big thing that I hear from patient after patient is the cost. Traditional amplification can be costly, although there are oftentimes some level of insurance coverage, but that insurance coverage can vary.

Another consideration is access. The whole point of these over-the-counter hearing aids is to allow more access to devices and so I absolutely love that. A lot of times with audiologists, we can be hours away from some of our patients, depending on where you live. These over-the-counter hearing aids are a good solution where you say, "Hey, I would love to go to an audiologist, but it's so far away or it's going to take so much of my time," so that's when you can absolutely consider, "Maybe I can just try these out and see will they work for me." And if they don't, as long as you have a good return policy and you're very aware of the return policy of the over-the-counter, then maybe that's not the right device for you and you have to go with something else.

Blaha: Whichever route you decide to pursue, remember that there is a training period both for you to learn to effectively use the product and also, it's brain training to regain some of your listening skills. Hearing loss is typically not a sudden change to your hearing abilities. It takes a gradual, long-term timeline for the development of any changes that you might start to notice. Over that time, we need to retrain and adapt your brain back to its new level of hearing through the use of the amplifier either over-the-counter or prescribed.

It's important to be patient with yourself and be willing to practice with any device. If you're noticing that things seem different, don't consider it to be bad different, consider it just to be different and that it's a learning process that you need to go through in order to retrain yourself in your listening skills and that would be appropriate for an over-the-counter or something that is professionally prescribed.

Roman: We want you to hear no matter what. If it's something where you say, "Hey, I want to try something over-the-counter," that's amazing and I hope it works for you. If it doesn't or if you want to try something more traditional, that's awesome too. I hope to see you in the clinic.
Either way, if you ever have a question, I would encourage you to reach out to either your local audiologist, your physician, or any hearing instrument specialist. Any hearing specialist is here to help you and to answer your questions so don't be afraid to reach out. Don't be afraid to look into support groups for hearing loss. Even if you don't know you yourself have a hearing loss, these support groups are invaluable resources to you. At the end of the day, your hearing health is so important to your overall wellbeing and whatever needs are necessary for you to achieve that health is absolutely the route to go.