If you're one of the 30 million Americans experiencing hearing loss, here's some exciting news. OTC hearing aids are now available nationwide. It's a totally new way for consumers to care for their own hearing health, and an interesting look at how public health and digital technology can intersect.
- HP Hearing PRO
- Hearing Aids and Personal Sound Amplification Products: What to Know
- Digital Health Center of Excellence
- Consumer Technology Association
- Episode Transcript
Speaker 1: Welcome to CHPA Chat, conversations in the consumer healthcare industry with Anita Brikman.
Anita Brikman: On today's CHPA Chat, a totally new way for consumers to take control of their hearing health and a look at how public health and digital technology intersect. Today, we're talking about over-the-counter hearing aids and the number of adults who could potentially benefit. That's coming up.
Listeners. Hello, hello. Can you hear me? Well, if you're one of the 30 million Americans experiencing hearing loss, here's some exciting news. OTC hearing aids are now available nationwide thanks to long-term efforts by Congress, the White House, FDA and the consumer healthcare industry. It's a totally new way for consumers to care for their own hearing health, and an interesting look at how public health and digital technology can intersect.
Joining me in diving into this topic today is John Luna, CEO of Nuheara and chair of CHPA's Consumer Medical Devices Committee. He also serves on the Consumer Technology Association's Board of Industry Leaders, and is chair of their Over-the-Counter Hearing Aids Standards Committee. Welcome, John.
John Luna: Thanks, Anita. Happy to be here.
Anita Brikman: And we are also joined by Dr. Marcia Howard, who is CHPA's Vice President for Regulatory & Scientific Affairs and the staff lead on CHPA's Consumer Medical Devices Committee. Marcia, great to have you on as well.
Marcia Howard: Thank you. Happy to be here.
Anita Brikman: John, let's start with you. How big of a problem is hearing loss in the US? I know I kind of made a joke at the beginning, but it's really not a joking matter.
John Luna: No, hearing loss continues to grow in the US population and globally. We've got about 48 million Americans in the US who have hearing loss that can benefit from the use of hearing aids. About 10 million have done something about it and currently wearing devices to help themselves in different environments with their hearing loss, and there's 38 million Americans or so that actually have a need in the mild to moderate category. And this new change in regulation opens up access and affordability for that population for both personal sound amplifier products and hearing aids.
Anita Brikman: And what is the difference there? What are the different options? Because you mentioned the amplification versus a hearing aid. What is the difference?
John Luna: So personal amplification products basically just enhance sound. They're not necessarily personalized to a person's actual hearing loss or needs, and they're unregulated by the FDA. The OTC Hearing Aid Act and prescriptive hearing aids are regulated hearing aids by the FDA under FDA classifications and rules, and so those are intended to treat hearing loss and mitigate the challenges of someone's hearing loss specifically to the hearing loss needs to the individual.
Anita Brikman: And are there different ways the hearing aids actually fit in or around the ear?
John Luna: Yeah, there are a lot of different styles of hearing aids, right? Everybody thinks of the traditional hearing aid, the type that go over the ear, and those have been popular for many, many years. And now, we're seeing products like the Nuheara, HP Hearing PRO and other products that have an earbud form factor or an in-the-ear form factor that are now made available to the public over the counter.
Anita Brikman: Marcia, what about before 2021, before over-the-counter hearing aids were available? What did a person have to do to get fitted with one of these devices?
Marcia Howard: Well, first you had to actually recognize that you had hearing loss. And once you figured out, "Maybe I needed to see someone," then you would have to schedule an appointment with a doctor, usually an ear, nose, and throat or an ENT physician, or you might also visit an audiologist who is also a licensed healthcare professional. So this meant the person had to schedule an appointment, perhaps take time off from work and then go and take their prescription to a place where they can get a prescription hearing aid. And that might cost a couple of thousand dollars or more just to get the hearing aids that you need to hopefully improve your hearing. Now, we have the OTC hearing aid, which is hopefully going to be a game-changer for this particular sector of the self-care market.
Anita Brikman: You mentioned the cost there. John, what is the cost range now in the OTC marketplace?
John Luna: Yeah. To pick up on what Marcia was saying, the average purchase for a pair of hearing aids in the US is about $4,600. So $4,600 out of pocket.
Anita Brikman: Wow.
John Luna: And the OTC Hearing Act that, so that was part of the affordability. Not all of Americans can afford that, and not all of them had access to healthcare. And so now, we see products in the OTC market from $199 a pair all the way to $3,000 a pair. So there's a big range between the OTC products. Our product, the HP Hearing PRO, is selling for $699 a pair.
Anita Brikman: Wow, that is a big savings. Why the big cost continuum in the OTC space? Is it how strong these are, the way they work? I mean, you're talking about a couple hundred dollars up to a couple thousand. What, I guess, decides the cost?
John Luna: So there's two types of OTC hearing aids, those that are exempt, meaning they have the basic ability to meet the standard and the rule, and then there's those that are self-fitting. And so ours is a 510(k) cleared, FDA-cleared product for self-fitting, and we're the first company to receive the OTC classification based on the labeling guidelines and the rules around it. So self-fitting means that it has the ability to test your ears independently by frequency and actually is substantially equivalent to a clinically-fit hearing aid.
Anita Brikman: Thank you for that clarification. Marcia, how did we get here? What was behind the effort to switch from prescription to OTC in the hearing aid space? I know you can't just snap your fingers and make this happen.
Marcia Howard: That is very true. And believe it or not, this journey started back in 2017 when Congress actually passed bipartisan legislation that required FDA to establish a category for OTC hearing aids. And then shortly after President Biden took office in 2021, he issued an executive order and asked, or required, the Health and Human Services Department to issue this proposed rule that led to where we are today. He asked that FDA issue that proposed rule within four months of the executive order being issued. FDA actually issued it in October of 2021 as a proposed regulation. There was a time period for stakeholder input, including CHPA's comments were submitted to the docket based on this proposed regulation, and FDA finalized the regulations in August of 2022.
Anita Brikman: So that was the journey.
Marcia Howard: That was the journey. So from Capitol Hill to, I guess you would say, White Oak where FDA is home based and the stakeholders around the country, and now we find ourselves in October of 2022 the first opportunity for manufacturers to actually market OTC hearing aids.
Anita Brikman: That is fantastic. Now, let's take it back to the people. How does someone know if they have hearing loss other than the obvious? I know when I talk to my mom sometimes on the phone, I have to repeat things a few times because she doesn't hear as well. Can a person self-diagnose when it's time to seek a hearing aid?
Marcia Howard: I think for all of us, we have those periods where, and experiences, where we maybe miss a couple of words. We don't quite hear all of the conversation that's taking place and we wonder, "Is it just me?" And I just recently had that happen at a conference I was attending. And so thankfully, that time I found out that I wasn't the only one that wasn't quite hearing what was being said. But we also know that there are self-assessment tests that are out there. You want to find one from reputable organization that will help you understand if you have mild to moderate hearing loss.
OTC hearing aids are for adults with mild to moderate hearing loss only. If you have a child who is younger than 18 that has any level of hearing loss or you have severe hearing loss as an adult, then you really need to speak to a healthcare professional and seek the prescription version of these devices. But certainly, even if you are an adult and you don't feel comfortable, you can always reach out to your healthcare professional. But the way that they're marketed now, that roadblock of having to take that time to see your doctor or visit an audiologist is removed.
Anita Brikman: I'm so glad you really clarified that there's... those prescription hearing aids are going to stay on the market. Sometimes when we have a switch, the prescription version goes away. But that's not going to happen here.
Marcia Howard: No, absolutely. As John mentioned earlier, we actually now have three different types of hearing devices that you can now purchase. So you can have the personal sound amplification hearing devices. Those, as he rightfully stated, are not regulated by FDA. They are not considered hearing aids, but they are out there for those situations where maybe you need to enhance your ability to hear.
Maybe you're at a concert or at a conference like the one I just attended. But we now have OTC hearing aids that you can use and purchase at your retail store online without the need to visit a healthcare professional. And certainly, as we mentioned, there's always the option to speak to a doctor, to speak to an audiologist. And certainly, for anyone that has children that has hearing loss or someone who thinks that they might have more severe hearing loss, you should certainly speak to a professional.
Anita Brikman: Great advice. John, what about try before you buy or return policy or some sort of a warranty? If I'm going into this for the first time and I'm faced with an array of choices in the store, what kind of guarantees do I have as a consumer? What should I look for?
John Luna: That's a great question, and I think that that's probably the most important question for consumers. The two things you should look for, one is that return privilege, right? Because these are medical devices and because they're personal and because they have to be personalized to your own hearing loss, it's important that that self-fit and that self-care takes place in the home and in a quiet environment. You've got to download an app in many cases, like ours, and then go through that physical and then acoustic fitting process. Once that's completed, you want to make sure that you're using it in your lifestyle as much as 30 to 60 days, so you want to make sure you have a return privilege with whatever online retailer or store that you're purchasing it from.
And so as an example, we have a 60-day money back guarantee. One of our largest retailers, Best Buy, has a 60-day money back trial period so that they want the consumer to be successful with the product and also wear it in their everyday life. And if it's a situational use product, they may not use it every day or every hour of the day, but there might be two, three hours a day over a period of a month or two that they need to get adjusted to hearing sounds again.
The second is a warranty. Once you're successful with the product, you want to make sure that you've got support from the manufacturer. And so we offer a two-year warranty on our product to make sure that consumer is satisfied and has a working hearing aid, or hearing aids I should say, system for the two-year period that we have it under warranty.
Anita Brikman: Okay, great advice for consumers. All right. Now let's talk about CES, the Consumer Electronic Show which pretty much takes over a Las Vegas. Marcia, John, you guys were both there, and OTC hearing aids made a big splash. Tell me more about that.
Marcia Howard: Well, actually, John was the star of this show, or one of the stars of the show, for a session that was devoted strictly to OTC hearing aids. I think for me, the standout thing that I learned was that hearing loss begins as early as age 20, which was surprising to me because I thought it was something that maybe happened in middle age. But to hear that there may be hearing deficits starting that at such a young age, I think that's going to make it important because younger people may not always either believe that they have hearing loss or want to accept or take that time to go see their doctor to say that "Oh, I think I'm losing my hearing at such a young age." And so being able to go and self-diagnose and have a device that can give you that assistant for improved hearing is, I think, going to be really critical.
John Luna: We've seen prevalence of hearing loss at a much younger age. So that juvenile population under 18, if they have an experience, they should have their hearing tested professionally, right? See a physician first.
Anita Brikman: Okay.
John Luna: The prevalence of gaming, two years of lockdown and COVID for a lot of people and a lot of headphone wearing has changed the hearing landscape, and I think it's important to understand what your hearing baseline is today because it doesn't get better, right? Over time, hearing typically gets poorer as you age.
And the average hearing aid purchaser in the US is 72 years old historically. The average purchaser of our products are 52 years old. So we're seeing people come in at a much younger age because of the form factor, because of the cost, because it does more than just augments or treats their hearing loss. It actually can be used for calls like this, video calls. It can be used for listening to music, telephone calls. So you can use it in your everyday environment, working out, listening to music and so on, streaming Bluetooth, and then also have it fit your hearing loss or hearing needs in different
Anita Brikman: Marcia, how will digital health increase access to OTCs, or how could it if there are these digital assists available down the road even further along than hearing aids?
Marcia Howard: Right. And thankfully, digital health isn't really new in the consumer space. I mean, we all know that there are digital pregnancy tests and digital ovulation predictors, so it's not that digital health is new to the self-care side. But with FDA recently putting out a proposed regulation that would allow for an additional condition of use for non-prescription products there's an opportunity perhaps to switch over-the-counter medicines that would use some sort of technology, to either aid in self-selection or in actual use of these products for more chronic conditions or long-term conditions that we haven't been able to do because the labeling alone wasn't sufficient to provide the consumer what they needed to know to use these drugs properly and effectively. So I think this sets the stage for what might be some really new and novel ways to bring self-care to the forefront.
Anita Brikman: An exciting new world. Before we sign off, John, first you and then Marcia, where can consumers go for more information about OTC hearing aids, and where can members of our industry go for more information about digital health?
John Luna: For our products, you can go to hphearingpro.com and you'll find out more information. And there's a FAQ section at the bottom of that page that can answer any questions.
Anita Brikman: Marcia?
Marcia Howard: Well, of course FDA has some wonderful information. They have a webpage that's dedicated to OTC hearing aids, as well as provides information on prescription hearing aids. They also have an entire team that's focused on digital health within its Digital Health Center of Excellence. And of course, as we talked about, CES is hosted by CTA, or the Consumer Technology Association, and they also have a website that has good information and serves as a good resource to consumers. And then I will be remiss if I didn't mention CHPA as we continue to expand our representation in consumer medical devices. And our communication team has been adding new content to our website on medical devices, including digital health, and I'm sure you will see information on OTC hearing aids soon.
Anita Brikman: Marcia, John, thank you for joining me and enlightening myself and our listeners about the new access to hearing aid help because it is over the counter.
Speaker 1: Thank you for joining us here at CHPA Chat. For more information and to hear our entire catalog of shows, please visit chpa.org.
The views expressed in this podcast are solely those of the speaker and do not necessarily represent the opinions of the Consumer Healthcare Products Association.