Regulation, Innovation, and the Road to Fully Implantable Hearing Devices

Welcome to this Week in Hearing. I’m Shari Eberts, co author of Hear & Beyond Live Skillfully with Hearing Loss. And this week our guest is Brent Lucas, the CEO of Envoy Medical, which is a medical device company with two fully implantable hearing products. Both of them give people an interesting option that, unlike most hearing aids and cochlear implants, doesn’t need to be removed for sleeping or showering. So thank you, Brent for being here. It’s great to meet you and I’m looking forward to talking about why you’re so excited about the hearing care industry for this year. Yeah, thanks for having me. It’s very nice to meet you. I’ve seen you on LinkedIn and on the Internet, so it’s nice to actually get a chance to talk. Absolutely, I agree. So before we dive into our discussion though, I was hoping to learn a little bit more about you. What got you interested in hearing devices and how your career path has led you to your current role at Envoy Medical. Sure. Happy to. So I am at Envoy in large part because my family first invested in what was called, called St. Croix Medical back in 1995. So I was in middle school, going into high school, and my parents talked about this new investment they were going to make in a company called St. Croix Medical that was going to try to make the world’s first fully implanted hearing device. And then as I went through my high school, college and then law school careers, I just always was very interested in the company, started working there, and as I began to work there, I realized I could add a lot of value to what was going on. But also I became very interested in the ability to really change people’s lives with what you’re doing on a day to day basis. There’s not a lot of companies out there, not a lot of industries where you can have such an impact on individual human beings. And also, you know, have, have a career. So that, that’s kind of what got me in. And now I, now I’m stuck. Yeah. So now, now I’m in forever. Yeah, well, it’s kind of a lifelong passion for you. Actually. It’s really very unusual for someone to be at a company like this for their, really, you know, most of their life. Yeah. And I, you know, I, I think the hearing industry could use some more competition and innovation too. So I, and I’m, I’m a big fan in the underdog. You know, I like the underdog stories and Envoy Medical has been one for 29 years now. So we’re actually 29 years old at this year. So being able to now lead that company as it’s going to hopefully become a market leader and fully implantable technologies is really a very unique opportunity and one I’m very humbled to have. Yeah, well, thank you for sharing that. That’s always great to get people’s backstory, like their why, you know, I think it really changes the conversation. So let’s talk about 2025. It looks like it’s going to be another interesting year in the world of hearing devices, which I think is good news. And it just seems like every year there are more options for consumers with you know, me being a person with hearing loss. That always makes me very happy. Even Apple has, you know, finally gotten into the game. And I was just at the Consumer Electronics Show, I was able to try out these hearing glasses that, that are under FDA approval process at the moment. So curious what you see as some of the most exciting trends in the space for this year. So I think it’s very interesting. I noticed on LinkedIn too, a lot of folks that I follow are in the hearing space are now going to CES or the Consumer Electronics Show. That seems to now be where the latest and greatest or the, where the most interesting tech is being released for the hearing industry. So I think I, what I’m excited about or what I find interesting is that there’s more competition coming into the space from outside of the big sort of players who have been around for a long time. So you have Envoy Medical on the implant side now trying to push sort of the big three that are there. And then you have these other larger players. I mean, Apple’s not an underdog. … You have these other players coming into the hearing aid space with their technologies. And I think that’s just going to benefit the consumer at the end of the day. Lowering prices, more competition, lowers prices. And I just think that’s going to be a good thing. So that’s what I’m most excited for. I don’t have any particular technology other than ours that I’m very excited about, but I think the more competition comes in the better for the consumer, the more innovation. It’ll force all of us to try a little harder. And I think that’s, that’s what we should be excited about. Yeah, I absolutely agree. And I think when a name like Apple gets into the space, it just takes on. I don’t know if credibility is the right word, but like, an interest level just in the general population goes up. And so if we have more people focused on hearing and how to make things more accessible for people with hearing loss, we can only win. So I’m very excited about it as well. Absolutely agree. And I think, you know, you haven’t had, really, in this industry, you haven’t had your Medtronic or your Boston Scientific sort of anchoring and saying, you know, this is a real. This is a real medical device industry. And, and so I think it just brings a lot of, like you said, credibility that now we have, you know, the big consumer electronic brands saying, no, this is a. This is. This is important, and people can make good money, but we can also help a lot of people’s lives. I think that’s just. Yeah, well said. Absolutely. Fingers crossed. Right? Yeah. So I battled a lot of hearing loss stigma when I was in my 20s. I first noticed my hearing loss, and my father battled a lot of stigma. I’m curious what you think about stigma. Is it. It’s still an issue for hearing aid users, and is there anything that manufacturers can do to sort of help people move past that stigma? Yeah, well, first, I’m sorry you had to go through that. Yeah. And. And we talked to you know, we’ve talked a lot of patients throughout the years and stigma is very much still there. I think, you know, one of the interesting things for a company that makes fully implanted devices, people sometimes suggest that we make stigma worse. And I don’t agree with that statement because to me, stigma is having to use something that you don’t necessarily want to, or you’re wearing a device that maybe is not the best device for you. So people go around and they complain about their hearing aid and they say, well, this thing doesn’t work for me anyway. Why am I wearing it? And they put it in a drawer. I think that’s how you get the stigma sometimes. So, again, I was going to sound like a broken record here, but competition, innovation, giving people more choices is really how I think the manufacturers can help with stigma to normalize that. You know, not everybody wears eyeglasses. Some people wear contacts, some people get Lasik, some people do other things. Like there’s. There’s other things you can do to solve a problem, but when you try to force, you know, a round peg into a triangle every single time, it’s. It’s not gonna have the result, and some people are gonna be dissatisfied. So I think that’s part of the Stigma is it comes from the dissatisfaction that’s out there. And I’m not saying that everybody’s dissatisfied with their hearing device, but clearly it’s not a hundred percent. And I think the stigma comes from Those, you know, 20% people that say they’re not happy, or the 40% that are somewhat happy. Those are the people that we really need to serve with other options so that they can feel like they’re treated and then. And then sort of give hearing therapies a better name across the board. You know, that’s a very interesting perspective. And I liked how you talked about, you know, some people get Lasik, some people have contacts, some people have big glasses, little glasses, you know, and I think that that’s great just to have that consumer choice. And so hopefully we’re moving in that direction for hearing care as well. I think hearing sometime is harder because people have all different degrees of hearing loss. And so the options available may be more limited if you have more severe or profound hearing loss. But there’s still that concept that there should be choices for everyone at every level. And I agree, and I would just echo on that a little bit or pull on that thread. I think one of the things I’m realizing as a public company, CEO now, we’re now a public company, and talking to the investor market, there’s not a lot of understanding about what hearing loss is. And you say, you know somebody, you say hearing loss, and it’s like, well, all hearing loss is the same. No, it’s not. And there’s, you know, 40 to 50 million people in this bucket just in the United States. They shouldn’t all be treated the same way. We shouldn’t think about them all the same way. And I really do think that adds to the stigma is not understanding that there’s differences, not on not educating people enough on it. And. And then it looks like a manufacturer is just pushing their own agenda or pushing their own product. And that’s not a good look either. Right. When you’re trying to sell an hearing aid to somebody who needs a cochlear implant, needs a BAHA, you know, you. That’s how you get a bad name. And so I think as. As there’s more options available, that’s going to help everybody across the board. Yeah, well, absolutely. Fingers crossed again. Right? Yeah. So I guess we’ve talked about a little bit how most people with hearing loss wear something external to hear better. Right. Even cochlear implants, they have, you know, part of the device obviously in the inner ear. But there’s an external component as well. But Envoy’s products are fully implantable. So why is this a good option for people with hearing loss? And is there a certain type of hearing loss that’s best suited for this type of product? Yes – yes, there are two products that we have. So we have the Esteem, which is a fully implanted active middle ear implant that. I know it’s a mouthful sometimes we call it a FI-ME, the fully implanted active middle ear implant. And it’s still the only one that’s FDA approved. Thats one product that’s for sensorineural hearing loss, moderate to severe. And then we have our investigational Acclaim device, which is a fully implanted cochlear implant. And that. That product has been in three patients at Mayo Clinic. And we’re now starting our pivotal study at seven sites. And that’ll actually be starting here in the next couple of weeks. So and that’s for Severe to Profound hearing loss. So we have two products sort of for. There’s a little bit of crossover in the severe range, but generally speaking, sort of two classes of patients. Both of these products, however, are for the people who have tried hearing aids and are not getting enough. So hearing aids work for the majority of folks. We think they’re great technologies. And we’re not suggesting that you just bypass hearing aids and go to our products. We prefer that you’ve tried hearing aids. And at some point a lot of people decide that they’re not getting enough for some. That for some reason. And then they need. That, we would argue, should consider implants, you know, starting with middle ear implants and then eventually going to a cochlear implant. So why do we think these work? Well, they’re with you all of the time. So there’s some data out there to suggest that if you hear all day, you get. Your brain sort of learns that signal better and you do better. Cochlear implant users, for example, that use their cochlear implant for longer periods of time every day generally do better than their peers who only use it for a couple. Couple hours a day. So we’re very excited to study what is it going to look like when a cochlear implant user actually gets to wear their device all day long. Also for those folks that do want a discreet option, they can now choose it. They can, they have an option to pick something that’s not visible to the rest of the world. And for some people, that’s. That is a choice that’s important. Fully implanted devices have longer battery. Well, so with our Esteem patient, for example, the one that’s been FDA approved for, for since 2010, actually, we have patients, once they get implanted, they don’t even touch the remote. They, they forget where they put their remote, and then they need a battery change. They, five years later, they say, oh, I need my. I need my I need my remote. So they can really live their life without thinking about it is kind of how I say it. So again, it’s not for everybody. Right, but it’s important that you have these options. I like to point to sleep apnea sometimes to people. So there’s a device called the Inspire, which is a sleep. Fully implanted sleep apnea device. Well, CPAPs work very well for some people, and that’s the right choice for them. But some people want a fully implanted surgical option. So it’s really quality of life mixed with, with, you know, what do you want for your existence? Maybe you have dexterity issues or bad eyesight, where changing the battery is on your hearing aid is very hard. Then an implant makes sense. So there’s a lot of nuances and a lot of opportunities there for people. But again, the key is that patients have a choice. And I think that’s what I want to keep hammering home is it’s more important that they have a choice. It’s not necessarily one size fits all. And I think the hearing industry has made that mistake for the last 40 or 50 years. No, that’s very interesting. I mean, I guess as consumers are sort of considering this type of device what are the risks that they should be aware of? Right. So if the device breaks or if there’s a new advancement that comes up, can it be swapped out with another model? And you talked about the chaining of the battery. What is that process like as well? So always risk with surgery. So both of our devices have to be implanted under general anesthetic, and there’s risk with general anesthetic. Theres you know, infection risk when you make an incision so there’s risk to surgery and that would apply to both of our devices. The other reality is that if you implant something doesn’t always go perfectly this for the first time. So sometimes there’s a need for a, we call it an enhancement or a revision surgery. Sometimes. In our clinical trial for the first product we had some taste disturbance. So that’s common in cochlear implants as well. If you go in through the mastoid, you have a nerve that runs through there, the corda tympani. Sometimes that’s sacrificed or touched and that can cause temporary ache disturbance. So there are surgical risks and that is something you need to factor in when you’re considering, considering an implant. On the upgrade side however, so for these devices, they’ve been our devices, they’ve been designed in a way where they can either be swapped out. So in our Esteem there’s a battery that sits behind your ear that can be taken out with a pretty simple 30 to 45 minute procedure and you could get updated electronics. So we have a next generation that we’re planning for that device and the people, when they get their next battery change will be able to get that. It’ll be backwards compatible for the Acclaim which is a fully implanted cochlear implant. You’ll be able to get either firmware updates or again the battery pack update which is, is in the chest now. Interestingly and importantly, one of the sort of ways that the existing cochlear implant manufacturers make most of their money is by selling the external cochlear implant part. So that’s about, you know, some people that’s about a 7 to $10,000 piece. It can break, it falls off easily. For some folks you don’t have that with ours. Also if you have like the Phonak just released their very cool hearing aid that I hear very, very nice things about. For our device because we use the ear, you could put the Phonak in if you wanted and have connectivity to your phone. You could use an AirPod with our devices because we use the ear to pick up sound. You can use the latest and greatest consumer electronic. So you actually have more flexibility I would argue with our device than you do with some of the interesting. So if you wanted to connect to your phone via Bluetooth or something like that, would you be able to do that directly? Or you would need to use sort of like an AirPod or something like that. Right now our design is such where you would need to use an AirPod or a hearing aid. You know, if you still have your hearing aid, you can use that. And I think that’s actually going to benefit our patients. It takes a second to think through my reasoning here, but I think it’s actually gonna be a benefit for our patients because to upgrade implanted technology is a multi year cycle. So if we have the foundation of the device that uses the ear, then let the patient use the ear for the latest and greatest consumer electronics. As AI progresses, I’m sure things are gonna be moving very quickly. So let them use the latest and greatest AirPod, for example, and we’ll provide the ability to hear through your ear and then they can work together. Interesting. Okay, awesome. So just shifting gears a little bit, I know that there’s something called the Hearing Device Coverage Clarification act that is very important to your company. So can you talk a little bit about what that is and why is that important for people with hearing loss to understand? Sure. It’s a very important bill for Envoy Medical. But also, I think, just generally speaking, the hearing industry is in general at the end of the day, Envoy Medical’s first product, the Esteem, struggled. It’s commercially struggled because it was called a hearing aid. And because it’s called a hearing aid by CMS, it’s not a covered benefit. So it’s cash pay. Right now you can still get one cash pay. But for a medical device, it’s pretty hard to make a viable product that’s not, not covered by insurance. And we kept going up against this until, you know, recently we were able to get these bills introduced, one in the House and one in the Senate, and they’re both called the same thing, the Hearing Device Coverage Clarification Act. Now, because there’s a new Congress and every two years when a new Congress starts, you have to get bills reintroduced. So we will go through the process of getting this reintroduced. But if you’re somebody who cares about hearing loans and you’re somebody who cares about patient access to new technologies, you should absolutely want to support bills like this because it allows patients to get access these devices, our, our devices, the, the Esteem, the middle ear device, and the devices of our competitors that also have products like this, but they’ve not brought them to this country because it’s not covered by insurance. These should not be called hearing aids. And they should get coverage. Absolutely should get coverage. And so if you care about hearing loss, you should be supportive of bills like this because it ultimately Means more things for more patients. Interesting. Yeah. And I wish that they would insurance would also cover hearing aids. Of course. Yeah. In general, like, this is one of our you know, most important senses. And the fact that all of these devices is not, are not covered is just crazy to me. But I understand your point. You know, this is more. This can be singled out as a different type of device, and so why not take advantage of making that available as well? Right. And the hearing aid. the hearing aid discussion you know, we would agree, and we also agree that audiologists should get paid for their services. And we think there just needs to be more coverage around this in general. But Envoy Medical sort of had, you know, there’s only so many hours in the day. So we picked, like, this is a very important thing to us. And as I remind people in Congress when I talk to them, you know, our largest competitor, Cochlear Corporation, also has a fully implanted active middle ear implant, the Carina. So if we are able to get this change, we will be benefiting our largest competitor. But we think it is just very important that devices like this are not considered an hearing aid and then therefore automatically not covered. Again, if you just took the whole hearing aid exclusion out of Medicare, that would do the same thing. But honestly, I think that’s going to be a little bit harder. And I think there’s a lot of industry folks that might not agree on the same thing. So we’re picking our battles. But yes, I think this is a very important bill. I don’t know where the new administration stands on this type of thing, but I’m hoping that we can get a chance to explain ourselves and why this is very antiquated for CMS to not cover today. No, well, good luck with that fight. I mean, I think that it will benefit many, many people. So I wish you lots of luck with that. Thank you. So, as we wrap up here, I guess just a final question. If there’s anything else that consumers should be thinking about when they’re looking for the right device for them or any final thoughts that you want to share with consumers who are watching today. I think consumers need to be an advocate for themselves. You know, they really need to educate themselves and they need to do that by just going into an audiologist’s office, which is important, but they also need to do the research online so they have an idea of what they’re looking for before they get in there. I mean, the hearing industry does have this sort of business model problem right now, I would argue where, you know, you go into a certain audiologist’s office, they may have a closer connection to one manufacturer than they do to others. That doesn’t mean that they’re the only, the only game in town. So I think what I would argue is be an advocate for yourself, educate yourself and then, you know, really seek out who’s out there and get the best, the best care. We have a lot of people that still contact us that say, I didn’t even know fully implanted hearing device. I didn’t even know that was a thing. And part of that is because, you know, we’re not being talked about in retail audiologists offices. And so you need to do a little bit more to educate yourself. And we’re trying to build our website, by the way, in a way that’s more general, to educate on a lot of different things. So it’s not just Envoy. Envoy. Envoy. It’s really more about hearing loss in general. And I think we’re trying to help people become advocates for themselves. Excellent. I love that yeah, I love that self advocacy message. It’s so important that we, we realize that we actually, the people with hearing loss, we are the most important factor in our success. And so it’s that self advocacy that, that’s such an important but sometimes hard lesson to learn. Right. But it’s definitely an important message. So thank you for that. Yeah, absolutely. I mean the reality too is primary care physicians and those folks are just not well educated on hearing loss. So you really do need, from the very beginning, you need to be your own advocate, you need to do your own education. Absolutely. Well, thank you, Brent, for being on the podcast today. I’m talking about these updates and various topics. Really enjoyed getting to know you better and to learn more about your products. And if people are interested in learning more, they can visit envoy medical.com so thanks so much. Take care. Yep. Thank you. Appreciate.