Otolith Labs is pioneering the first medical wearable for the treatment of vertigo, a symptom experienced by more than 15 million Americans. Company CEO, Samuel Owen, and Chief Science Officer, Dr. Didier Depireux, join host Bob Traynor for a discussion of their promising new wearable technology under development for patients with vertigo.
The novel technology has been validated by several clinical studies, including multiple independent studies at universities and with leading automotive manufacturers. Otolith hopes to have FDA approval of their device by late 2023.
Bob Traynor 0:08
Welcome to This Week in Hearing. I’m your host, Bob Traynor. And I have a couple of very special guests with me today who have been involved in the development of a vestibular device, which could be an extreme benefit to our patients with vestibular disorders. Today, my guests are Sam Owen from Otolith Labs, and the Chief Science Officer at Otolith Labs, Dr. Didier Depireux and and I appreciate your your indulgence as I, as I introduce you very, very terribly. But let’s, let’s move on to to looking at the device itself. Now. Sam, did you need to have me set you up? So you can show some slides?
Sam Owen 0:59
Sure. So so let me know. And the first question is, and I’ll go to the proper slide
Bob Traynor 1:05
My first question Is Sam, give us a little idea of how you came about. Number one, I know your background is, is in physics, but how did you come about to work with the vestibular system, and, and so on and, and look at founding this company for this particular purpose?
Unknown Speaker 1:24
Yeah, so as I said, my background is actually physics. It’s not in medicine. And when I was working on a PhD in physics, I had taken a course in acceleration sensors. And then I happen to read this article that you have acceleration sensors in your inner ear called the vestibular system. And, you know, just as a curious scientist, I, like Well, I understand how acceleration sensors work, I wonder if I can interact with that. And, and the acceleration sensors in the inner ear really do work exactly like an acceleration sensor in a car or phone or something like that. Say, they’re inertial sensors. And what I mean by that is, they’re typically composed of two primary things. There’s some mass, and then there’s some force sensor. In the presence of some acceleration, the inertia of those mass will essentially hold things in place, which will then cause stimulation of that force sensor. And again, very much like what I learned right in, in school, except, you know, in this case, the mass instead of it being a weight is the otoliths. And instead of being a piezo or some other force sensor, it’s the cilia. And so very straightforward to understand. As a physicist, I was just like, Well, I wonder if I can interact with the human acceleration sensor somehow. And the idea of introducing mechanical stimulation, seemed pretty straightforward. You use, you know, a loudspeaker, you use a, you know, bass speaker, and eventually found out about bone conduction, and how there’s already this technology that’s designed to transmit through the skull to, to the hearing organ. And right next, that’s the distributor system. So I want to see, can I use some sort of off the shelf component to, to do that. It is possible to do it with off the shelf components, I was actually able to build a prototype with off the shelf components. And again, if you’re just trying to vibrate things, it’s it’s not that difficult. The issue is trying to do it safely. And so -great for lab experiments, I had something that that worked. Originally, we started trying to treat motion sickness, I get terrible car sickness, I was the very first person to be tested. That’s how I actually was able to bring Didier Depireux on to the team was he also gets carsick and he was pretty skeptical until he tried it. And then he’s like, wow, there’s there’s actually something here. And then it was only later on that we realized that we can put this into, use this to treat vertigo took us about two years. But eventually, we were able to develop a new technology that basically is small enough to be worn, yet incredibly efficient, incredibly silent, and is safe to be worn for extended amount of times, and it treats vertigo.
Bob Traynor 4:20
An interesting thing, and I and I understand that, that in some of the background information that was given, the device was pretty big to start with. But now it’s been it’s been digested into a smaller, smaller device. And Dr. Depireux you have some I know you are originally were originally at the University of Maryland, but on but now working with Otolith Labs in DC and and can you tell us a little bit about yourself and and how you’ve been involved in the development of this product?
Didier Depireux 4:57
Yeah, so I was in academia for a long time. mostly involved in research on the inner ear pathways with a position at the School of Medicine and a position in the engineering department in College Park. And I was looking to do something a little more concrete than what you can do in academia. I was doing research mostly in tinnitus. And then it’s a long story. But as Sam said, he wanted contacting me and I thought, this, there’s no way this works, but he was pretty persuasive. So to shut him up. I just did it on myself. And for the first time in my life, I was able to read in the back of a car. So I thought, you know, I need to join this, plus at some level, it made sense, because you know, for in tinnitus, you can have tinnitus maskers that provide relief for about half of the tinnitus population or so by simply adding noise masking, the tinnitus can still hear the tinnitus, but you can cope with it, you can ignore it. And I saw a lot of analogies between what I found early on with sounds device, and tinnitus, it was like having a noise masker. But instead of being for tinnitus, or the hearing, it was for the vestibular system, we believe it works as a masker for the vestibular system. And so then after that, once I joined, it was a question of doing research in order to know focus on the parameters that are actually important. And having opinions from the ENTs and reorienting ourselves also towards,ya know motion sickness is important. But you can live even if you have motion sickness, whereas vertigo patients were a very interesting group that we felt good help. And we had a lot of indications early on, we could really help a lot of people with vestibular issues
Bob Traynor 6:40
and also those that see patients every day in the clinic. We do see a lot of patients who are unsteady or a little dizziness rather than not necessarily vertiginous, but but some dizziness that goes along with things. And I also see that that one of your your ENT, research people that’s that’s associated with your company is Dr. Michael Hoffer, who, who was with us on our American, the American Tinnitus Association board for a number of years as well. So I know that he’s probably involved in in in providing some of the key information which does offer substantial credibility as well to the project. I know that you guys just just got some some new funding to facilitate your research and development process. And Sam, would you like to talk about that just a little bit?
Sam Owen 7:41
Sure, it’s a little bit premature to speak too much of it, we did raise. So at this point, we’ve raised $3.8 million. And we’ve also received $1.8 million in non dilutive funding from groups like the Air Force and the defense health agency who care about vertigo and care about motion sickness. But we are currently looking to raise somewhere between around eight to around $20 million to get us through our pivotal trial get FDA approval. And if we raised more like the 20 million, raise the sales force, build a sales force and actually bring it to market. Yeah.
Bob Traynor 8:16
So So what do you think this technology is going to do to the standard of care? Now I’ll throw that out to to either of you guys to to facilitate that answer?
Sam Owen 8:31
Yeah, so this is the current patient clinical path that we’ve come to understand is that when vertigo first comes on, or you know, severe dizziness, it’s a very scary experience. You know, oftentimes people end up at the ER, very quickly people want to test is this a stroke is this something that’s time sensitive, over 90% of the time, it’s peripheral vestibular disorder, it may be completely debilitating, but it’s not going to kill you. So the ER Doc’s just want to get rid of that patient. They prescribe antivert, Valium, some sort of suppressant, it knocks you out. And hopefully in a couple of days, when you come get better, when you wake up, you’re better and the vertigo is resolved. But for the millions and millions of people where they aren’t better. Usually the first touch point is the ENT. And, you know, in ENT, there’s, there’s not a lot of, there’s no imaging that will tell you what’s causing your vertigo except for a few rare cases. It’s hearing the natural history, seeing if you’re responsive to the Epley maneuver, that sort of thing. So you’re given one diagnosis and it might be that you kind of fit what looks like migraines and ENTs and audiologists don’t like prescribing migraine medication because that is outside their field. So they send someone to a neurologist. Neurologist might prescribe migraine medication. Maybe it works, maybe there’s a adverse event to it. Maybe he doesn’t fully solve vertigo. And oftentimes, they end up right back at the ENT or the audiologist, and they’ll try something else. Okay, go see a physical therapist. All right? Well, they go to see a physical therapist, and, you know, the provocative maneuvers are really, you know, they get sick, they have trouble with it. And this revolving door of medicine is really what chronic vertigo patients run into. So there’s been a bunch of studies, but basically, chronic vertigo patients have seen somewhere between three and seven specialists. A study done by the Vestibular Disorders Association, showed that only 20% report an accurate and timely diagnosis. And, you know, eventually people just become these these self care experts where they join the Vestibular Disorders Association or other support groups, and just you know, what is helping anyone and doesn’t work for me, I’ll go see a chiropractor across the country if it just stops my vertigo. And what we are hoping to do is stop this cycle. So that going back to the original question, how are we changing the standard of care, there is no standard of care treatment for the symptom management of chronic vertigo and dizziness patients, the antiverts, the valiums, the the suppressants work counter to any long term recovery of, of chronic vestibular disorder. So the suppressing of the vestibular system prevents your brain from compensating for that that issue. So we are the very first symptom management treatment that doesn’t suppress the vestibular system, but just works hand in hand with the the physical therapy in the long term treatment in training the brain to naturally compensate for that asymmetry.
Bob Traynor 11:55
Somewhat similar to the tinnitus, masking issues in nature. So, Dr. Depireux, could you give us a little orientation of how does this relate with the Epley maneuver? There are a lot of colleagues that do that, you know, in clinics and so on. And would this be a replacement for that maneuver? Or would it be a in addition to that maneuver somehow,
Didier Depireux 12:21
maybe as a complement, so early on, in 2019, we had multiple clinical trials that were ongoing – calorics, on physical therapy and other things – nausea associated with chemotherapy. And of course, all these trials got cut short in academic centers, thanks to COVID. And so we had to turn around and start a telehealth trial whereby people we recruited online would give us their diagnosis and we send them device for some number of weeks, and then we can go into the details of this. But what we found is that we had the usual categories of people that get help so so we had BPPV, and vestibular migraine, Vestibular neuritis, Labyrinthitis and associated and Meniere’s disease. And among the people who had reported to us that they had BPPV, we found that most of them had gone through the Epley maneuvers, maybe five, maybe 20 times and it just did not help them. And of course that matches. You know the published literature that Epley maneuver, resolves issues of BPPV in about 70% of patients. There’s like five or 10% of patients for whom it doesn’t do anything. And then we have about 20% of patients who feel that Epley maneuver makes it worse. And so these are the typical BPPV patients that we get. And those it seems that we help them we have fairly uniform success rate we ask people try to devise to weeks and report on every episode and so on. And we find that 70% or so of patients across all diagnosis categories, but especially BPPV. Just say that they’re better that Epley maneuver has made them either didn’t work or made them worse and with our device that we’re finally able to deal with these episodes of vertigo begins.
Bob Traynor 14:18
Wow. Yeah, it’s, you know, this has always been an issue with the vestibular issue with the vestibular concerns is that they would go to the ENT the first thing he gets an ENG then you go back and say, Well, you got a little weakness on one side or the other and and here’s some here’s some stuff to try to fix that. You’re maybe give them some Cawthorne Cooksey exercises and, and so on. So we really haven’t haven’t had a way to kind of treat these things with something that’s efficient for quite a long time. And now we’re beginning to see more and more audiology people become kind of certified by the American Balance Institute and things of that nature but, but it’s interesting that there may be a product that could be used similar to a tinnitus device that may facilitate real benefit for patients. So, so my guess is this is not necessarily a, a brand new idea, but it certainly is a brand new technology that will be available at some point to patients. And, and I know that this may be available for my guess is is more for dizziness patients than it is for vertiginous patients. Is that Is that a true statement?
Didier Depireux 15:55
It seems to work across the board. I mean, it’s not a magic bullet across all trials, we find a bad fairly uniform success rate of about 70% to 80% of patients record improvements. For instance, in the Meniere’s patients in the Meniere’s population, they are really happy about the fact that they have this constant kind of dizziness, you know, background of dizziness, but they have these violent episodes of vertigo. And they put this is that this is really where the device really helps them. It’s when they have these very severe attacks. And the device does not cure anything, just like tinnitus masker, but it helps you cope with it. And it helps you deal with vertigo. Although sometimes it’s probably all that’s needed. For instance, in one of the trials that got aborted, we had on device in a vestibular physical therapy clinic, and patients who normally would only be able to go for maybe five minutes with the exercises that make them even more vertiginous than they normally are. We’re now able to do a full 30 minutes right from the get go. Because they were able to cope with their their vertigo.
Bob Traynor 17:04
So the deal is that in the past the vertiginous patients particularly let some of the Meniere’s episodes, people just have to go sit next to a wall someplace and hope that they don’t fall down somewhere. So, so this really does offer some hope for patients now. I know you guys are in an expedited FDA program. So how does that correlate with possible availability for patients with these issues?
Sam Owen 17:41
Yeah, so as you mentioned it last summer, we received FDA ‘breakthrough designation’, the breakthrough device designation, which is to say that the FDA recognizes that we are treating a degenerative condition in a way that there exists no treatment options. And so the FDA has prioritized getting approval for this technology now we still have to pass all the same clinical rigor of anything. But the moment we have that done, we’ll be fast track to approval. So up to this point, we’ve had roughly 120 people with chronic vertigo in pilot studies understanding who should be included in the who we’re helping, how do we help, etc. And that’s informed what is going to be our pivotal trial, which is the trial that the FDA is asking for. So we’ve had five conversations with the FDA at this point. And we’re proposing them a finalized pivotal trial here soon with funding will be will execute on that. Our goals to have that done in roughly a year. And then with this breakthrough designation, this fast track to the FDA, we hope to have FDA approval by late 2023.
Bob Traynor 18:56
Wow. So this would be that available to our to our patients that that have this issue. So um, so are there some upcoming trials that that patients can sign up for somehow to facilitate the development of the product and get it to that place where it will become available?
Sam Owen 19:21
Yeah, so like I said, we recently completed 120 person trial we recruited from people who came to our website and you know, sign up saying let me know when this is available, the upcoming pivotal trial will actually be an at home trial. So the device will be sent to patients. It may be a little bit more region specific as the FDA is asked for the patients at the beginning of the trial to have a physician checkup but if someone is interested in participating in this trial, they sign up. When we have IRB approval and this is a kicked off trial. We will let everyone in our database know about and let them know which physicians are and what clinics are recruiting helping us recruit these patients. So that’s that’s the big upcoming trial, we anticipate doing additional trials as well, the time frames a little bit less clear, just because we were focused on getting this pivotal underway, but we’ll be looking at long term improvement, you know, what happens with the dizziness handicap inventory, when this is given to someone for six months or 12 months? You know, what happens to the cost of care? What happens to you know, are they missing as many days of work, you know, kind of understanding that that true quality of life improvement, not just the immediate? Are we helping the the individual episode, but you know, how does this improve people in long term? Eventually, we want to look again, at using this with physical therapy. But yeah, so we have a bunch of other trials that we’d like to do. But right now, the best way, if anyone who’s interested wants to find out more, it’s to go to our website, www.otolithslabs.com. And sign up to be on our on our list. And that’s that’s how we reach out to people to let them know that trials are underway.
Bob Traynor 21:11
Super, so this would also be appropriate. That’s the also appropriate avenue for not only patients but for, say, audiologists or ENT people that would be interested in being involved with your program in the development of the product as well.
Sam Owen 21:32
Yes, absolutely. Um, so we would love to have a multi site, we’re planning on a multi site trial for pivotal. And if someone says, You know what, I see a lot of dizziness patients, and I would love to be one of these sites that, you know, can offer this to patients, we would love to get in touch with you, you know, walk you through the protocol, we’ll, you know, have you involved in have an additional site to help recruit and move this, this forward?
Bob Traynor 22:03
Super. So, so I guess we’ll be we’ll be looking forward to seeing more from Otolith Labs and this particular product, and how now how does that do you have a slide or something we could you could show us how it actually fits on a patient, and what the size is these days versus what it was before. I know, I saw that in one of the one of the back, some of the background information that was of interest to me, because a lot of patients wouldn’t want to have a great big deal back on their head, you know, and my understanding is that it’s really pretty minimal in size anymore.
Sam Owen 22:51
So this is the device that we’ve used in our current clinical trials. The you know, the size is basically what you’re going to see in the future devices, both in the clinical trial, and when we’re prescription and ready to go. Very simple headband design right now. So it’s your universally ergonomic, you just have to make it comfortably snug, don’t make it too tight. So it’s causing headaches or anything, it doesn’t have to be that whole hard. And basically a device just has to make contact with a bony area of the head, either the mastoid or the occipital we’ve been using the the right mastoid in our trials for consistency. But we’ve done trials with cadavers to know that you can actually have a various number of placements and and find it effective. What we’re planning on doing for the upcoming trial, and then eventually the released is a much more sleek looking device. And there will be a refillable component, essentially, the transducer, this is crucial, because in order for our device to be effective, it actually is a very precise level of vibration that’s required. And so if this gets dropped or somehow loses calibration, it’s important that you know, this is replaced regularly, we can’t guarantee this will be calibrated for three years, which is a requirement of a DME. So the what it would be is again, a sleek little headband that has a device that’s replaced every three months. And when we do come to market, we want to price this to encourage trial for those that this works for. It’s instantaneous, and it’s profound. A number of people in our trials were saying, you know, I’ve been able to do things for the first time in 10 years, this is life changing. And so, you know, this isn’t, doesn’t have the super expensive components of like a miniaturized hearing aid where you have very, very unique, you know, circuit boards or batteries and stuff this is gives us some flexibility where we can encourage trial. We probably would look at a price point of what patients are currently spending out of pocket right now anyway. And again, for those it works, it works instantly. And it’s it’s pretty profound in
Didier Depireux 25:02
Yeah. Sorry, something. Feeling sorry, this is something that’s fairly remarkable for me as a scientist is nice still have no understanding of is that either it works or it doesn’t, we haven’t had a single patient say, the after half an hour, I felt a difference. It’s always, like, if they if it works for them, they always say like, it was like less than a minute, and I knew this was it. I just find that just so amazing. But it is an advantage to either it works or it doesn’t. And there’s no in between.
Bob Traynor 25:33
It’s interesting, because as a clinician, we can have one or two of these in the clinic and and see how they work as demos, because it sounds like it either as Dr. Depireux said it either works or it does not. And, and so the so you could just have it as a demo device. And if it’s working, then then maybe give it a try for a few days and see how it goes. And then and then actually do an order or whatever is necessary as we do often with hearing aids to some degree.
Didier Depireux 26:08
Bob Traynor 26:10
Well, I thank you guys so much for being with us here on This Week in Hearing and providing some information about a fabulous li interesting product that’s possibly on the way to really help our patients, though. So audiologists and ENT physicians, as well as any of the patients that see this, you can go to otolithlabs.com and register and be registered for either being a a professional involved in the project or a patient that really needs some assistance with this type of assistance. Thanks so much, Dr. Didier, and Sam, for being with us today and telling us about your fabulous product at This Week in Hearing
About the Panel
Robert M. Traynor, Ed.D., is a hearing industry consultant, trainer, professor, conference speaker, practice manager and author. He has decades of experience teaching courses and training clinicians within the field of audiology with specific emphasis in hearing and tinnitus rehabilitation. He serves as Adjunct Faculty in Audiology at the University of Florida, University of Northern Colorado, University of Colorado and The University of Arkansas for Medical Sciences.