How the Future of Auditory Implants Could Transform Patient Care and Expand Clinical Options

Hello and welcome back to another episode of This Week in Hearing. I’m your host, Brian Taylor. And this week we return to our topic of implantable hearing devices. And here to discuss this topic is Brent Lucas, who’s the CEO of Envoy Medical. Weve had you on before, Brent, and it’s great to see you again. Thanks for joining us. Yeah, it’s good to see you, Brian. Thanks for having us back. Well, there’s a couple of things we want to get an update from you on, but before we do that, I thought would be a good a good time to maybe remind our viewers what’s unique about the Envoy Medical implantable devices. Yeah, happy to do that. So Envoy Medical is a company that focuses on fully implanted hearing devices. And not only are devices fully implanted, but we also use the ear to pick up sound. So the big differentiator for Envoy Medical and our big investment thesis is that using the ear to pick up sound is very efficient and elegant way of going about things. So we have a piezoelectric sensor that sits on the incus and that picks up the vibrations, the sound vibrations, as they come through your ear. And that’s what we use to pick up sound. So we have that sensor in both our esteem device, which is a fully implanted active middle ear implant and still the only one that’s FDA approved. And then we have that sensor also in the Acclaim, which is a fully implanted cochlear implant. And that’s our investigational device that’s currently in FDA trial. Well, let’s talk about that next. The Acclaim device. I know, just not too long ago there was a press release around the pivotal clinical trial. If you could elaborate on what that trial is all about, that’d be great. Yeah, the. So we are in a what’s called a pivotal clinical study, and that is a study required to collect data prior to submitting for what’s called a PMA application. So these devices are Class 3 medical devices that require a PMA approval from the FDA. That stands for pre market application approval. It’s not a 510k device. It’s not a de novo device. These are a PMA product and they have to go through a full clinical trial. So the pivotal clinical study or pivotal clinical trial, however you want to talk about it, is that last step before we apply for FDA regulatory approvals. We are currently in what we are calling the first stage of that trial. And that first stage is 10 patients. And then we will kind of review those first 10 with the FDA before expanding into the final part of the study, which will be an additional 46. So there’ll be 56 total patients implanted. We are at seven sites as investigational sites in the United States. And if you anybody wants to learn more about where those sites are, they can go to our website and we have a special webpage just for the clinical trial. But we also you can go to clinicaltrials.gov and the trial is listed as well as site listed there. Understood. Could you give us a little bit of insight into the timeline around these pivotal trials or studies? How long do they take typically? What are some of the next steps involved in that? So in the, in the hearing implant space, historically they have been about 50 patients and about 12 months of follow up for each patient. So our study design is very similar to that. So we have 56 total patients and that will allow us to evaluate both safety and efficacy for those. And we’ve agreed on primary endpoints with the FDA around those topics. And then we will do 12 months of follow up. So those familiar with cochlear implants, and the acclaim is a cochlear implants, I’ll talk about that one. So those familiar with cochlear implants, usually the device is implanted, then you wait a certain period of time, you activate that device and then the 12 months of follow up starts from that activation visit. So for us, we wait right currently for the trial, we’re going to wait four weeks between implantation and activation. We will turn those patients on and then we will go from there and follow them at 1, 3, 6 and 12 months. And so far, of those first 10, at the time of this reporting, we are, we have seven of those 10 activated. By the time this airs, we will have all 10 activated. And the activations have gone really well from a cochlear implant standpoint. Those of us in the industry know that when you turn on a cochlear implant, it takes some time to adjust for a patient. So what we’re finding is that these are quote unquote, pretty typical or normal activations for a CI, which is a great step up from where we were with the early feasibility study, which was a three patient feasibility study that we did at Mayo Clinic. And when we activated those patients, we noticed a little bit of an electric noise that we had in our system that really wasn’t allowing us to turn the device up the way and program the device the way the clinician wanted. So we did some things between the early feasibility study, which started at the end of 2022 or end of 2023, I can’t remember off the top of my head. So we did something to mitigate that noise. And, and it appears that we did the right things because so far these first activations have gone, you know, “normal”, which is for a clinical study is what you want. You want things to be going normally. So I’m, I’m very, I’m very happy and very excited about where things stand right now. Obviously, we have to go through the rest of the trial and things, you know, monitor everything appropriately and take all the appropriate steps and make sure everybody, you know, agrees with our data and doesn’t second guess it later. So we want to make sure we’re doing everything appropriately, and then we’ll file with the FDA at the end of the trial and hopefully get FDA approval. And we’re thinking that would probably come assuming everything goes, you know, relatively well and there’s not another Covid or anything like that. End of 2027 or first part of 2028. That’s great. It sounds like it’s progressing, though, as expected. Yes. Right now I, you know, that’s kind of the way you design these trials and then you cross your fingers and hope things move the way that, that you want. But right now I’m feeling very comfortable with, you know, one of the other, one of the other differences between the early feasibility activations and, and the pivotal study activations has been that the patients in the early feasibility study, they used a hearing aid on top of the Acclaim as a way to sort of get an extra boost because the. Of the noise that we were having. The patients in these activations for these first 10 have, are not using a hearing aid. So that’s a, that’s been great. Now I will say I think it’s really cool that you can use a hearing aid on top of the Acclaim. And I think that’s going to be a differentiator for us in the field because the other cochlear implants, especially the other totally implanted cochlear implants, will not be able to do that, at least in their current design. So I think it’s a great thing. But we also wanted to prove, you know, you don’t need it, you can have the Acclaim by yourself. And right now I think we’re on, we’re on track to show that hopefully as the data comes in. Well, that’s great. So thanks for updating us on Acclaim. Let’s shift gears and talk about the esteem middle Ear implant. How long has that been available? And I guess we have a lot of viewers out there that probably aren’t all that familiar with middle ear implants. So maybe talk a little bit about the different types of conditions that would warrant a middle ear implant. So the esteem has been around since 2010. It was the first fully implanted active middle ear implant to go through FDA trials. In fact, the FDA had created a separate new category for us in that device because nothing like that had actually been approved yet. It’s not a hearing aid, and it is not a cochlear implant, but needed its own category. A middle ear implant, I believe, I personally believe, is a great option for patients who are, you know, have been wearing hearing aids for a long time and are either clinically not seeing enough benefit from them or have other issues with them. You know, an example would be for our device, fully implanted, maybe a patient who has dexterity issues or a patient who has bad eyesight. The maintenance of a traditional hearing aid makes it almost impossible for them to use it. These are the type of patients that I think could really benefit from a fully implanted acute implant. So these are products that I would say are in that transition point between not no longer being able to use a hearing aid and getting a cochlear implant. But the patient doesn’t want to get a cochlear implant yet. You know, the other thing about cochlear implants is when you go to that, there’s really no turning back. Once you get a cochlear implant, you, you know, you’ve stuck an electrode in the cochlea. There is no sort of undoing that. And going back to a hearing aid. With the middle ear implants, at least our middle ear implant, you can, you can try it out. If you don’t like it, you can get it explanted and go back to a hearing aid, or you can progress onto a cochlear implant. But our device, you have a similar sound. The sound is mechanical in nature, right? So we take the sound in through the sensor and then we mechanically or directly stimulate the cochlea via the stapes. So you’re still getting the same sort of sound sensation that you would get with regular amplification or regular sort of anatomy. And how the device, you know, how your ear normally works, where with a cochlear implant, you’re electrically stimulating cochlea and you need that therapy to kind of overhear that electrical stimulation. So I think it’s a great option for people that are in between hearing aids and cochlear implants. And I would just say it’s sort of obvious. And I, I really think the industry has done itself a disservice over the years. It’s really obvious that we need more therapies to address all of these patients. You know, in the US you have 40 million people that have some. Some form of hearing loss. And to suggest that hearing aids are the only option for those people has done the industry a disservice. Cause it’s obviously not true. And then it just kind of looks like we don’t know what we’re talking about. So I think this is another option in between hearing aids and cochlear implants on the spectrum of hearing loss care. And I would say sort of the problem with the industry not accepting these over time has largely been about insurance. And insurance for middle ear implants has not been robust. It’s been sort of one off. If anything, we’re working very hard to overcome that. We have a couple of bills introduced in federal government with the Congress and the Senate, and then we also have went through the process of getting CPT codes for middle ear implants, for fully implanted active middle ear implants. And those will be going live in July. And our hope is that more patients and professionals will push for coverage and hopefully we can get some traction and make these a viable option to people. Yeah, that’s really good to know. I’m curious, off the top of your head, how many sites around the US implant these? The esteem. So for us, the esteem since 2010 to today, we probably had 30 sites at one point that had done some surgeries. I would say again, because the insurance issue, it’s not something that a lot of people are used to. So, you know, getting people to continue with it was a little bit of a challenge. We currently have a handful of sites that do a regular number of either new implants or battery changes. And as we progress, we anticipate that to grow. We also are looking at a next generation of that product. Not really talking too much about that yet, but we do have plans in the works that are sort of at the early stage of how can we move that product from where it was 20 years ago when we started this, which is really sort of, you know, the technology is almost 20 years old because we started the clinical trial in 2005. Where can we take that and bring it in to where we are now to really do a better job of allowing more programmability, longer battery life, allowing the audiologist and the patient more customization. So we have some great options there. And, and I also think it’ll make sort of the average annualized cost of the device much lower, which should hopefully make it more attractive for a larger portion of patients. That’s good to know. It sounds like something that’s really underutilized though across the board with, with clinicians. Yes. Unfortunately, the lack of insurance is, is a, is a real problem. And you know, it’s. I could go on, we could do hours on this topic because it is catch 22 or chicken or the egg. Right? I mean, if you don’t have utilization, then they say, well, we don’t need to give you reimbursement. Well, if you don’t have reimbursement, you can’t get utilization. And if you don’t get the societies and the professionals behind you, then you really can’t move it. So for a startup company like Envoy Medical who’s been trying to, you know, do the good fight for several years, the fact that the societies and the professionals haven’t lend their weight to it has been extremely frustrating. I see that start, that tide starting to turn and I think actually coming out with the acclaim and having a fully implanted cochlear implant now, people realize, okay, Envoy Medical gonna stay around. Envoy Medical actually brought two of the most innovative hearing products along in the last three decades to the hearing implant industry. So hopefully that adds some more credibility and as we push things forward, hopefully puts us in a better position. You know, and one of the things I’ve been reminding people of is Envoy is an American US owned and operated hearing implant company. We’re the only ones that are owned, operated, manufacturer, headquarter. You put it all, we’re the only ones that are here in the US So you’d think the American professional population would want to help us along. And I think we’re getting there and I think we’re starting to make some traction. Yeah, that’s good, that’s great. So as we wrap things up here, you’re the third person from. Actually we’ve had two cochlear implant surgeons on the last few weeks. And one of the questions that I always ask them, and I’ll ask it of you, is over the next five or 10 years, what are some of the innovations that you see in the pipeline? How do you think implantables are going to be? How’s that going to change? You’ve already kind of addressed some of these things already, but what’s your big picture thoughts on implantable devices. I think on the cochlear implant side of things, obviously I very bullish on fully implanted cochlear implants being, being the future. And I’m not going to name names, but I was just at a conference and I was with an analyst and the analyst asked a couple of my competitors. We were sort of all around talking and everybody agrees fully implanted devices are the future of the cochlear implant industry. Patients want it, it’s going to move in this direction and I think that’s going to be very exciting. Outside of, of that, I do hope the middle ear devices get a little bit more traction. I hope insurance coverage for audiologists and some of those things all come together to really incentivize people to get involved in other areas. You know, I, I do think people sort of pigeonhole themselves as either a hearing aid audiologist or a cochlear implant audiologist. Be nice to see more crossover. And then one of the other things that I hope continues. I know it was big in Covid and I think it’s sort of being pulled back a little bit is teleaudiology. I mean, I think, I think that. And remote programming and remote care. I think that’s a, I think that’s a big thing that would benefit a lot of rural communities and help sort of help with the disparity of care that we do. Sure, no doubt about it. Brent Lucas, CEO of Envoy Medical based White Bear Lake, Minnesota. Right, that’s correct. Yeah. It was great to have you on. One final question is where can people find more information on Acclaim and on esteem? You have a website that we can share? Yes, envoymedical.com so e-n-v-o- y medical.com follow us on LinkedIn and other social. And then we also are a public traded company. Ticker symbol is COCH. So sometimes if you want to, you know, use your Apple stock tracker app or whatever, we put out press releases and that’s a way of sort of keeping up to date with the stuff as we release big news. That’s good to know. All right, well, thanks again for your time. Really appreciate it, Brent. Yeah, thanks Brian. Thanks for checking in.