otoset earwax removal audiology

Wax Removal with Push of a Button: Interview with Sahil Diwan and Jackie Phillips of Safkan Health

Cerumen, more commonly known as earwax, is one of the leading causes of hearing aid breakdown and a hinderance to the service delivery model as some providers refer patients to other professionals for cerumen removal.

In this week’s edition of our webcast, Sahil Diwan, Co-Founder and CEO of SafKan Health, and Jackie Phillips, Vice President of Sales for SafKan Health, offer viewers information on their novel and revolutionary product that removes many of the service barriers caused by cerumen.

Full Episode Transcript

Amyn Amlani
Welcome to This Week in Hearing. My name is Amyn Amlani and I have the privilege of serving as your host. Since we began this video webcast series A few months ago, This Week in Hearing has brought viewers information from a vast array of areas, such as technology updates, innovation, innovation, updates, service delivery considerations, changing market dynamics and legislative issues. We continue this trend of showcasing innovations that are entering the hearing care space. Today, I have the privilege of having discussions with Sahil Diwan and Jackie Phillips of Safkan Health. Safkan Health offers a novel and revolutionary hearing care product for removing ear wax. Welcome to you both.

Jackie Phillips
Thank you for having us.

Amyn Amlani
Absolutely. So Sahil why don’t we start with you? Why don’t you tell us a little bit about yourself?

Sahil Diwan
Yeah, absolutely. So it’s pretty much the beginning of my career. So not too much to tell here. But my name is Sahil Diwan. I’m the co founder and CEO of Safkan Health. I started the company with my brother a few years ago. He’s a biomedical engineer who’s actually had this problem for a long time of just developing too much wax. We’ll dive into that a little bit further down. But yeah, the history of the company so far is that we started the company around 2017. We’ve raised venture capital, we’ve had successful clinical trials, we’ve set up our manufacturing, we’ve already secured patents on the device also recently received our FDA 510 k clearance. We’re actually the only year cleaning product in the world to have that clearance. And Jackie actually recently joined the company just a few weeks ago. And since she joined us, we actually sold out a product in the first three weeks. So it’s been a pretty crazy initial launch. But everything’s looking really exciting.

Amyn Amlani
Yeah, yeah. No, it’s been a fantastic product from what I’ve been able to see. And you’ve hired one of the best and Jackie. So I know Jackie well, but maybe the audience doesn’t. So Jackie, would you introduce yourself if you wouldn’t mind?

Jackie Phillips
Yes, absolutely. Again, I want to say thank you for having us. Very excited to be here. But I am Jackie Philips, I am the VP of Sales at soft Khan health. I am as Sahil said, I am new to the team. But I’m not new to the industry. I have over 20 plus years in the hearing industry. Starting off working in the clinic, I am an audiologist, I worked in large ENT clinic for several, several years. And then transitioning into the hearing aid manufacturing side and then most recently, leaving a audiology diagnostic-clinical equipment company. And then now recently starting with Safkan Health, so I feel like I’ve had, I’ve been very fortunate to be able to see many sides of the industry. And I am very excited to start this new adventure with Safkan Health.

Amyn Amlani
Yeah, yeah, no, it’s fantastic. And you’re a fellow Texan, too, so that makes it even that much better. I know you’re from Washington, Sahil, but we won’t hold that against you.

Sahil Diwan
Yeah, yeah. I love Texas. Yeah, I think it’d be kind of the perfect pair. We’re based in Seattle, but now also in Houston with Jackie,

Amyn Amlani
that’s fantastic. And like I said, You hired one of the best. She’s She’s absolutely fantastic. Thank you. So let’s dive into this product. You’re just a little bit so you’ve developed this product that helps mitigate issues with with ear wax. So can you start out if you wouldn’t mind talking about what were some of the the drivers or the inspiration for developing this product that you call the otoset?

Sahil Diwan
Yeah, absolutely. It’s actually a pretty funny story. So my brother growing up, who is a biomedical engineer today would have to go to a physician every few months to get his ears syringed out. Honestly, growing up, we just started kind of was this weird kid with too much ear wax. But it turned out that this is a problem that affected millions of millions of people. So fast forward a few decades, and he studied Biomedical Engineering at the University of Arizona. And actually, while he was still an undergrad, he had come up with the idea for a device that essentially marries the irrigation type procedure you might see typically in a primary care setting with what an ENT surgeon does with microsuction. And marrying those two methods into a device that’s fully automated, wearable, standardizes the best practices, practices of the procedure, and really takes the guesswork and a lot of the risk out of the manual ear syringing or microsuction type procedures that you see today. So this is the device right here. As I said, we recently launched the product last month in Dallas had a an event that actually we met you at and ever since then it’s just been kind of crazy. So we’ve we’ve deployed all the devices that we have at this point, and very much focused on collecting product feedback from our early adopters.

Amyn Amlani
Yeah, that’s really, really cool. And it just goes to show you you know, you’ve got an issue, and you see these solutions, but the solutions just aren’t maybe the best in terms of efficiencies and feasibilities. And you come up with a solution which is what makes this product so novel and innovative and I can talk about this A little bit later on, but I actually got to try the device, and just thought the world of it because I struggle with with with earwax as well, probably not as much as your brother does. But I do struggle with it and found this thing to be really, really cool. So Jackie as clinicians, you and I have been in the clinic, and you know, we have patients that come in with impacted wax, and we can’t then perform the services that we need, how does this product help alleviate or reduce the constraints on the service delivery? of the clinic?

Jackie Phillips
Yeah, absolutely. So that’s, that’s a great question. So, you know, currently, you know, first of all, I had no idea. You know, I’ve been out of clinic for a few years, and I had no idea how many millions of Americans are struggling with this, you know, wax impaction. And so, you know, I was spoiled, I was working in ENT clinic. So you know, really great with a currette. But if I got an impacted ear coming in, I would just walk them down to the to the ENT, so I was spoiled, I didn’t realize how much of it for most clinicians, this is such a hindrance to have impaction and have to refer out their patients to an ENT clinic and hope and pray that they come back to their clinic. So you know, this is the number one leading reason for conductive hearing loss. And so and also, I mean, I’m not I shouldn’t have been so surprised, because when the number one number one reason I would send hearing aids to the manufacturer for repair was due to clogged receivers with wax. So it is a cumbersome process in the clinic for the clinicians, because they come in and the patients are very upset because they throw their hearing aids down and complain about the hearing aids. But when we look into the receiver, it’s clogged with wax. And so they’ve got upset patients here and then you’re gonna have to take the hearing aid away from them for a week or two to send in for repair. And so you have this whole site bed cycle of just upset patients regarding the the hearing aid repair or the patient’s not being able to hear because they were impacted with wax. So it is a major problem. And a problem in the clinic currently, for many, for many clinicians.

Sahil Diwan
Yes, affects about one in 10 children, one in 20 healthy adults and one in three people over the age of 65. So that translates to roughly 35 million Americans and 700 million people around the world. So my brother is certainly not an outlier. Like we thought he may have been growing up a much bigger problem. And I think most people recognize

Jackie Phillips
Yeah, and another thing too is yesterday, I just learned from a audiologist, in an ENT practice that right now their clinic is a month out to get these patients for the ENT to actually clean their ears. So they want to Otoset because they’re going to start doing cleaning in the audiology clinic and not the ENT side. Because it’s a month wait for a patient to get their ears clean.

Amyn Amlani
You know, and that’s interesting, because if you look at the service delivery model that we have, you know, it’s it’s an inefficient model, because we have people that have to wait in order to get their hearing aids fit appropriately, they’ve got to come in three, four or five times. If they have earwax, we need to send them away and then bring them back. And so in this particular case, we’re in this at least this part of the of the service delivery model, you are now helping that process moving to become more efficient, that then lets the provider do the things that he or she needs to do to get that patient rolling and moving in the right direction as it relates to getting their hearing issues resolved.

Sahil Diwan
Absolutely. Our goal is to create greater access to care for this procedure with this device.

Amyn Amlani
Yeah, no, it’s it’s absolutely fantastic. So as we’re talking about this, let’s talk about how this Otoset works. So people are probably going well, you’ve got this product, we see these inefficiencies. We see how it might help. But what does it do? And how does it How does it function?

Sahil Diwan
Yeah, so as I mentioned earlier, it really is kind of this marriage of the irrigation type procedure that you typically do with a syringe or a spray bottle. Some providers actually use a Waterpik like the dental flossing device to perform the procedure today, certainly not what it was meant for. But that’s you know, just kind of shows the lack of tools that people have today providers and consumers to deal with this problem. And then also on the other side, we have that microsuction that pretty much only ENTs are doing you do see quite a few audiologists using it which is great, but for the most part that takes quite a bit of training and something that mostly ENT surgeons are only doing so what we did here is essentially what we did, again marrying those two things into this. So how this device actually works is you fill this top container up with body temperature water, you then attach these ear tips and waste containers to the device and the waste container is actually how we create negative pressure in the device and that’s how we get our microsuction and then here I’ll actually a little bit hard to see here but we do have the ear tip which has two channels, the top channels for irrigation so that’s where the water comes out and sprays into the ear towards the walls of the canal which is really important to break down that way. matter where it is, and then we have continuous microsuction from this bottom half of the ear tip, which then collects all of that waste into this bottom waste container for really quick and mess free procedure. So one cleaning cycle just takes 35 seconds, for severe, for severe impactions, you might have to run it two or three times. But that’s still an incredibly fast procedure. And for anybody interested, there’s a demo video on our website that that really clearly shows how the device works.

Amyn Amlani
Yeah, it will, we’ll try to include as much of that video as we can here so that folks have access, but we’ll also be sure to, to include your website so that they have access to that content as well, that we may not be able to get on this on this on this webcast. It’s incredible how you guys were able to think about this. So now you’ve created it. What’s the evidence to support this product? I mean, is it just something that you guys put together, but you know, working in a garage somewhere, and now you’re coming to market or, you know is is there some science behind this and in some validity behind it,

Sahil Diwan
it was kind of like that, honestly, in the in the early days when we started the company. So back in like 2017, I was basically sleeping like on a air mattress in my brother’s college apartment. And we’d build prototypes with our engineering team. And we were 3D printing everything, which is really cool. So the initial versions of the devices, we must have gone through 20 different versions, all 3D printed, we actually did clinical trials with 3D printed devices, too. So yeah, we use a lot of what we we had such a kind of tried to figure it out more like a software company where they move quickly on designs and iterate and just keep going. And 3D printing really allowed us to do that. So that’s how we actually did the r&d for the, for the product. But when it comes to our clinical results, so we’re very focused on clinical data and clinical support from clinicians. So we have investors that are healthcare systems, we have physicians who helped us actually develop, iterate, test the device, and we were the only 510k cleared your cleaning product in the world. So that means that the FDA actually looked at our clinical data, they looked at our cleaning validation, it’s 1,000 page document that you actually have to send to the FDA. And then you go through a round of questions. It’s usually a process a process that takes many years and millions of dollars to do so we went through that entire process. It definitely helped us build a better product, though it did take a lot of time. And actually one thing that we’re doing now that’s really cool is that we’re going to soon be coming out with a large publishable study with the healthcare system partner again just very focused on providing clinical data showing that this can and should be the new standard of care.

Amyn Amlani
Yeah, so two questions come to mind just for our re, our viewership. This is only for adults at this point in time.

Sahil Diwan
That’s correct.

Yes, we actually are developing both pediatric and consumer versions which we can talk about a little bit later, but this current device is meant for adult use.

Amyn Amlani
Okay, and then the second thing that comes to mind is what are the contraindications to use because I remember when when I went through the cerument management program and this was almost 30 years ago now you know, if you and we used to use an irrigator if you got the water too hot or too cold, you’d make people dizzy and you know all those kinds of things. So how, can you can you tell us a little bit about the contraindications and how you lesseneds to remove some of those in your product?

Sahil Diwan
Yeah, so in future versions, we’re actually in our next version, we’re going to be putting a temperature sensor in it. So that will really help with people who aren’t performing irrigation procedures today and aren’t used to the body temperature water. But yeah, it’s you know, very clearly you need to use body temperature water so the patient doesn’t get dizzy. But other than that, you know, you shouldn’t use this device on somebody who has perforated eardrums, ear tubes or an ear infection. But other than that, yeah, this this device is proven to be safe and effective.

Amyn Amlani
So just just basic common sense in the clinic as Jackie, you and I were trained to do. Yeah. And so now that you have this, this product, you’ve developed it, you know what the contraindications are. Looks like you’ve got some data that’s coming out to support it. The next question, at least in my mind, is what markets are a really good place for utilization?

Jackie Phillips
Well, that’s a good question. The first, first market when I first got recruited for this company, and come over, we talked about the channels we wanted to focus on. And the first one that comes to my mind is obviously audiology. Coming from that industry. I know what clinicians use I told the team that honestly we are very with currettes but we’re… with microsuction or irrigation is really not something you’ll find in many audiology clinics. And so I really felt like this was an area, a channel that’s been underserved, or this product or this service, they’ve been using currently, you know, they do use irrigation they’re using with a basin and a syringe in it’s very messy and it’s cumbersome and the patient has to interact with that. But this device when I saw it and how innovative it was and how easy it is to use. I instantly said the audiology market is the first one we should go and work with. And then eventually once we are you know step more established and really working more in the audiology industry, expanding out to general practice. Because again, they do not have the tools or proper tools or maybe training done actually impacted wax for their patients. And so they’re all all channels are referring into the ENTs. And as I’ve discussed earlier, an auntie is, is making patients wait over a month to come get for impaction. So it’s really getting too heavy for the ENT market. So the channels that we really should focus on is the first one is audiology. Obviously, that’s the best one start with, and then expanding to primary care and maybe urgent care, etc. And then some ENTs is obviously they need help having some that’s a lot faster, and not as messy in a safer procedure than what they’re currently using.

Yeah, he made some great points there. And you know, from our, from our ENT advisors, they certainly didn’t become surgeons to be cleaning out, you know, so much wax, actually one of the highest volume procedures that ENTs performed today. And that really does come down to primary care physicians and audiologist not having the tools to safely and effectively perform the procedure. So the goal here again, is pushing this procedure into that first setting where the patient is going, not having to refer them out. And then doing it also in a lower acuity setting. So for healthcare systems, they really care about being able to perform procedures like this in more of an urgent care or retail clinic type setting, which is, again, even better for the patient.

And it currently we do have not we are mostly audiology clinics, but we do have two ENT sites that are currently using it. And then we also have a primary care physicians using it. So our main focus is audiology. But we are not forgetting about the other channels, because we do want to get feedback from all different areas, because each one has a different need, and a different type of client and different type of setting. Yeah,

Amyn Amlani
that’s that’s, you know, that’s that’s the way to do it in my opinion is is is to get it out to these different channels. See what, you know, if you had a Venn diagram, see what overlaps and what doesn’t, and then that will give you potentially some some ideas on, you know, segmentation, and some things that you might look at down the road. And one of the things that comes up in my mind as we look at segmentation, is it almost seems like there’s maybe a small group of individual patients who could self use this product. Am I right?

Sahil Diwan
yeah, so the, that’s actually the vision for the company. So we are first starting with the pair of headphones that you see, that is meant to be used by a healthcare professional in a healthcare setting, it’s meant to remove severe impactions. Right, so that’s something that you’re gonna go into, and get done by a healthcare professional. Our next step for the company are two different products. Number one, a pediatric version of it, we actually were recently accepted into this program that’s funded by the FDA, for pediatric device innovation, they focus on big problems that that children have, and again, one in 10 children are affected by this. And if it’s the leading cause of conductive hearing loss that obviously affects the way they learn and everything like that. So starting with the pediatric version next, and then after that, we’ll be doing a consumer version. So the consumer version is going to be quite different from the product we have today, you can think of the product we have today being used by healthcare professionals to be treating patients with severe impactions. Whereas a consumer version is meant to be a preventative version. So it would be the first FDA cleared consumer device, the first physician recommended device for home use to allow those 35 million Americans who have this issue like my brother, to prevent the issue from the first place at home, especially for hearing aid users, I think, yeah, there’s a huge opportunity there to actually work with audiologists to sell this consumer version to people with hearing aids, so they can take better care of those hearing aids, and don’t have to be, you know, having to ship those in for repair. And having weeks of amount of time not having their hearing aids.

Amyn Amlani
Yeah, it I could also see this, as you’re talking about the patient side of this, you know, I could also see this in in, in the market where people always have these earbuds and things in your ears as well, where the wax doesn’t have the opportunity to, to migrate its way out. And so if you can use it in a preventative kind of way, I think that’s really, really cool. As well, I, I’ve got three teenagers, I’ve got one young adult and two teenagers at home with things in these years. And I have one my daughter in particular, who would really benefit from something like this, because she’s got small, narrow ear canals. He’s got those ear pods in or AirPods in her ears all day long. And then we have to go out and get those things removed. And to Jackie’s point we’ve had to wait a couple of weeks in order to get in, not like it’s life or death, and then she needs a hearing aid. But it’s uncomfortable. She has a hard time hearing, especially if she’s sitting in the back of a classroom. So I can see how this particular product would help alleviate some of those, those day to day issues. So it’s like I said, it’s a really novel and revolutionary program that has a lot of unmet needs in this particular marketplace.

Sahil Diwan
Yeah, Our vision is to again, start with the clinical product, then go consumer and work with clinicians to go consumer By the way, and our goal is to do for years what Sonicare did for teeth.

Amyn Amlani
Yeah, yeah, that’s really cool. I’m going to change the dialogue here a little bit, because you know, we’ve concentrated on the product and what it does. But to me, the product also has a flip side to it. And to me, this is the most important piece, and that’s the service component, right. And so as we’re looking at the service component of this, you know, Jackie, let’s talk about how this product could be marketed as a service for these different channels that you’re talking about.

Jackie Phillips
Absolutely. Especially in audiology, it’s, you know, we’re visiting with a lot of audiologists the past few weeks, and there’s a lot of people who don’t, really, they send everybody to out for referral. So this actually can be an extra revenue source for many clinicians who are having to refer out because it’s not intimidating, that’s another thing is a lot of conditions say, Well, I do cleaning, but the rest of my staff does not do cleaning, because they’re so nervous, or, you know, it’s very intimidating with the equipment that we do have. So they see this as a very inviting product for clinicians to use, because it’s just a click of one button. It’s not nothing else to do this one person isn’t, you know, a lot of the things are they’re using now they’re saying it’s a two person procedure, and they’re having to pull another person out from their job. So you’ve got two people trying to do a procedure. With this procedure, it could be a healthcare professional, or it could be an audiology assistant help tech in the clinic. So you can, you can train someone else in the clinic to perform this procedure, because it’s a classification one. So if that person is able, in another scope to look in a patient’s ear that otoscope, they can, they can actually clean a patient’s ear with the otoset as well. So they can look in the patient’s ear, oh, I have wax, but the otoset on, press the button in 35 seconds, they’re done. You know. So our philosophy is that our saying is, is for – five minutes or less from start to finish with a cleaning of a patient’s ear. So in currently, they’re used, they’re saying it’s 20 to 30 minutes, they’re getting prep time, getting the patient ready, and then perform the procedure. So look how much time we’re cutting down. So if we can have less chair time for the patient for the clinician, and they can, that means they can see more patients, instead of having to fill up your schedule with your cleanings. And it takes up to 30 minutes. Sometimes, imagine having only five minutes in your schedule and imagining it’s not the healthcare professional is the technician or the assistant doing this job. So think of how many more people that we can actually bring into the clinic, perform this procedure and open up the schedule for the hearing care professional to see other patients that they really need to see more, more frequently.

Amyn Amlani
Yeah, in as you’re talking, the other thing that’s going through my mind, Jackie is, you know, now it becomes a one stop shop, you’re not sending the person out. So what does that do to patient centered care, you know, you’ve now elevated all of that. So I’ll leave that with you. I mean, it’s I think it’s a fantastic way to to enhance that that patient journey.

Jackie Phillips
Well, it’s actually personalizing the patient’s care. So we want to actually enhance that patient’s experience not saying that they’re not having a great experience. Now, we just want to enhance their patient’s experience and satisfy the patient more than they already getting from the condition. But also, we want to personalize each experience that the patient has when they come to see this clinician, and Boston consultant is a great article. I mentioned this at all my talks about personalizing patient care. So anytime you personalize a patient’s experience, you can see up to 10% increase in revenue because you’re personalizing their experience in your practice. So I can’t imagine anyone who would not want to be able to see more patients and also be able to see an increase in revenue up to 10%. Because you’re personalizing your patients like you said it’s a patient centered focus clinic now and that’s that’s huge for patients they will keep – you will have loyal patients and you’ll have word of mouth of patients saying you need to go here because I’ve never experienced anything else like this. So absolutely.

Amyn Amlani
What you just said is really interesting, because now you’ve got you know, this patient centered care, you’re using the the overhead, you know that the other staff members, it helps them become part of that that medical process. But then the other part of this is you’re also reducing the costs in your clinic because you’re not having to buy all this other equipment, you’ve got this product that you know is I’m assuming a lot cheaper than then all the currettes and the forceps and all those other things that would be needed and then you’ve got to clean them and you know all this stuff that has to happen afterwards.

Sahil Diwan
And the return on investment for our devices is really quick. You know, for the most part you shouldn’t be breaking even and profiting from it in the first month. And we priced it that way because again, we want to create greater access to care which actually grows the market. And if you can provide this device to your lowest your lowest cost provider in your lowest acuity setting, that’s just going to mean that patients have better access to care. And then on top of that, nobody really likes doing this procedure today, you know, it’s messy, it’s not fun for the provider or for the for the patient. So this certainly enhances that that experience for both it also

Jackie Phillips
it also attracts patients to your clinic. So we also have been seeing that, and you I don’t know if you remember, but back in when the video otoscopes first started coming out, and you know, clinicians would advertise “is it wax? Or is it your hearing?” is sort of the same thing, you know, come in to see if it’s wax or hearing and if it is wax, we have a very cool, innovative device that takes less than five minutes to clean out your wax problem, or impaction that you may have. So it’s very much of attraction for patients to come in. And then also you’re retaining your patients, because you’re not referring them out to any more ENTs. And then lastly, the satisfaction of the patient, you know, again, we’re going back to the experience of the patient, which is why we’re here we want to make sure we always are enhancing their patient, the patient’s experience, because the happy patients are going to tell their friends and their family to come in to see this clinician, because they’ve had such a great experience. And then on the flip side, for the clinician, less chair time of having to see this patient more and more. One of the things that I’m seeing, which I think is a very clever idea is having a subscription model for this. So clinicians are offering their patients who come in frequently, why don’t we do with notice that we have a subscription model every three months, every six months, wherever depending on the impaction frequency, they would come in and pay a fee a yearly fee to come in to have this procedure done on them. So I think that’s a very clever way to keep in touch with your patients and a service that you’re not you haven’t been offering but now you can offer to your patient. So a value add service to your patients who will stay loyal to you because you’re offering something like

Amyn Amlani
this. Yeah, yeah,

Sahil Diwan
yeah. It’s also a big differentiator for early adopters. I think, you know, early adopters are certainly types of audiologists, and in primary care physicians that want to differentiate their practices from their competition. And that’s important to them. And we’ve spent time you know, making product that looks cool, the branding around, it makes it appealing. So that when they do do run when they do run marketing campaigns within their community, and with their current patient base, that they are attracting more patients to come in for this procedure.

Amyn Amlani
Yeah, and then the other thing that you can also promote, as we talked about a little bit earlier, you know, cleaner ears means the hearing aid stays functional longer. Because it stays functional longer. It’s more like, you know, you don’t have to buy one in three years, you might have to buy one in five years instead. And so that’s also I think, a critical point because it extends the life of that product. And hearing aids are cheap. I mean, they’re they’re pretty expensive. So you know, it’s it’s, it’s a well rounded model that allows for the economics for the patient and for the provider. And then it also allows for the inefficiencies enhances both of those issues that we’ve been facing for a number of years. So it’s it’s a tremendous thing that you guys have created.

Sahil Diwan
Yeah, I think, yeah, I don’t wear hearing aids, but I can certainly understand how frustrating it must be to spend thousands of dollars on your hearing aids, and then not have them for weeks at a time simply because they got too much wax into them. So we see both products or clinical product and our consumer product helping to solve that problem.

Amyn Amlani
Yeah, yeah. Alright, so let’s dive into something else here. So we’ve talked about the product, we’ve talked about the service. Now the education behind this, I mean is do we got to take a class? Or what do we got to do in order to understand how this product works? And then I’m also going to, I’m also going to tag that on, what are some of the deficiencies Jackie, that you’re seeing as a clinician that providers don’t have it this product will help overcome

Jackie Phillips
Yeah, absolutely. So unfortunately, and I can speak from experience not all audiology programs have you know, have the robust program classes in regards to streaming management or wax removal. So it’s kind of hit and miss I, I’ve really been talking to a lot of educators and a lot of clinicians about their experience in school. And a lot of them tell me they got their experience on on site at the, at the neck, the first clinic when they graduated, so they didn’t really I didn’t really get much of any education in the in the university, but got learned ons on site as well. So what itself can help what we are really focused on is it’s something I’m very passionate about is education within the universities of this device, and in cerument management. And so I have been in college I have been contacting universities to discuss having like a maybe a lunch and learn with the hearing aid class or the cerument management class if they have one, and going in and speaking at these universities, To discuss the ease and the safety and the quality of this device for their students when they do get out into the real world practicing. So we are very active in that department, and really hope that the universities embrace this and want to have us to come and speak to their students, because we strongly believe it’s, it’s an answer to something that’s been not approached or discussed in the universities very much.

Sahil Diwan
Yeah, I can certainly understand that. And it’s not, that follow suits for our other markets, too. There’s not too much training around cerument management in general, with our device, though, it really is a very quick 15 minute training session, the device is incredibly simple to use, it really just has one button, the only part you need to learn is how to actually fit it on a patient side, which is quite similar to fitting a pair of headphones, it takes, you know, probably one, two, three patients to just understand using button how to fit it properly. And other than that, you know, you’re good to go. So we’ve seen with our early adopters, pretty much all of them having great experiences right off the bat without any additional training. And, you know, we’ll create more robust training materials as we go forward. But it is something that really just takes 15 minutes or so to learn.

Amyn Amlani
Yeah, yeah, that’s, and that’s a, that’s a, I think that’s an important piece is, it’s pretty simple to use. And because it’s simple to use, you do have to have a little bit of training, but it’s not, you know, something that takes days or weeks or months in order to learn.

Sahil Diwan
Yeah, the training is more about you know, how to prep a patient how to fit it to a patient, and then you know how to how to operate the button. That’s really it, or how to clean it. But other than that, yeah, this is an automated device. So we’re taking that manual side of the procedure out of it, which is helping to reduce risk, and just creates a more consistent, more efficacious procedure.

Jackie Phillips
It’s really nice, because it’s all contained in the headset, as well. So there’s nothing outside the headset, and I think that’s really the one the press of the button. And everything being right here on the ears is really a differentiator from everything else in the in the market right now. Nothing else is ever seen quite like this. So it is it’s quite amazing to use an easy one one touch basically.

Amyn Amlani
Yeah, yeah, that’s, that’s great. So, Sahil you said earlier that you guys have developed this product, and you are going to have some future developments as this product continue to evolve, can you share potentially what some of those developments might be?

Sahil Diwan
Yeah, and that’s actually what we’re doing with our early adopters. So you know, the early adopters, it really was kind of first come first serve, we sold out a product so quickly, which is a great problem to have. And right now we’re we’re very much working with our early adopters, on their product feedback, you know, kind of the main thing that we’ve been hearing is a temperature temperature sensor for the water is is a good thing to add, certainly something we’re going to be adding into the next version of the device. Other than that, you know, we’re looking at, for example, like a pretty cool induction charger. So you just put this on the stand and it charges like that, rather than having to plug it in different ear tip sizes, you know, as we collect more data and treat more patients, and potentially even putting a camera inside of the device. So those are some cool features that we’re planning on on doing in the future. And then as I mentioned, we are starting to develop a pediatric version already, along with the consumer version. So all these devices solve different, I mean, they live in different settings. And they are similar to each other in many ways. They’re also quite different. And otherwise,

Jackie Phillips
I think that this is really different. This stands out from the company from our company is that we listen to our clinicians, they give us feedback. And we truly are taking this this information they’re giving us it’s very crucial information. And we’re turning around and we’re implementing it into the next generation. And since we are a smaller company, we’re very agile, we’re able to really listen and turn around react with r&d and engineers, right very quickly. So that’s something I think is very impressive, because you don’t see that with a lot of companies, a lot of companies a lot bigger, it’s a big ship. And to get something change, a feature change could take a really long time. But for us, we’re very quick. And we’re very agile. And we’re really responsive. And we can’t say enough about our early adopters and the great feedback that they’re giving us. And so a lot of them are helping us as they’re part of our team, almost, they’re helping us create this next generation, it’s going to be better than this generation, it’s already good. So I’m impressed to be able to to be able to offer that to everybody we’re working with that you’re going to be helped design and next generations coming forth. So it’s pretty cool. It’s very exciting to be where we are right now.

Sahil Diwan
And it’s awesome how you know, our customers are just incredibly busy people. And it’s great how they’re taking time out of their week to talk to us pretty much every week on anything, any tiny little thing they can think of that they want to see improved, because they know that we will incorporate it and then in turn, they will actually see and have an even better product going forward. So we’re very focused again, on clinical data and support from clinicians. I think that again, as a differentiator from us from any other product in the market, that we are very much involved with our customers, incorporating their feedback actively, so things only get better and better.

Amyn Amlani
That’s incredible that you guys are able to do But Jackie, one of the things that’s going to come up is clinicians might be thinking about the economics behind this. Any thoughts?

Jackie Phillips
Absolutely. Well, we’re I’m watching and we’re watching very closely, the Medicare Audiologists Access Service Act that Senator Warren pose, I think a couple years ago now. And so we’re current, we’re really watching that closely to see if that act will pass MAASA is what the nickname is and if it does pass, it will alter the definition of Audiology services for Medicare patients. And what that really equates to is that there will be a CPT code for earwax cleaning with Medicare patients going forward. So if that passes, that’s a big change a game changer for many clinicians to be able to open that door and have their own CPT code that they don’t have to refer to a doctor to get a CPT code. Because currently, as I said earlier, patients are having to do self pay. So patients want to have a one shot place. So when they get to the point where the clinician says, You really got impaction in your ear, you know, I can send you to an ENT or be covered under, you know, there’ll be CPT or there’ll be a code to pay for that with your insurance or with Medicare, or I can do it but there’ll be self poay, and the patients are typically saying I’ll just stay here and pay for it, because I don’t want to have to leave. So what a great service that will be if that does pass for for clinicians to have their own CPT code for this procedure. And as I mentioned earlier, the subscription model is I think, gonna really be a pop, I’m seeing it for more and more clinicians that we’re working with, they’re talking about having that subscription for their repeat patients with wax impaction. So I think those are gonna be some of the game changers for wax removal going forward.

Sahil Diwan
I think msost patients, especially within audiology are used to self pay. And as I mentioned earlier, this device pays for itself quite quickly. And we’ve priced it that way, because we want people to adopt this device, and we want them to use it. And that only grows the market and you’re able to treat more patients. So we’re very much focused on that. Yeah. And don’t really have anything else to add there. But self pay is how the procedure is done today. And how people are seeing that return on investment. Yeah, yeah.

Amyn Amlani
Well, you shared a lot with our viewers today, you know, in terms of what this product is the service, the economics, the education that’s behind it. And so as we come to the end of this, are there any final thoughts?

Sahil Diwan
Yeah, I you actually were able to try our device. I wanted to see if you were willing to share your experience with the viewers?

Amyn Amlani
Yeah, absolutely. I’d be happy to. So as you pointed out earlier, you guys had come down to Dallas, there was a manufacturer event that they had put on all day and had various companies come in, and you guys were one of them, and were able to present, I actually had to come in late because I had to work all day. But during the happy hour period, you guys were kind enough to continue to demo this particular product. And so I sat down in the chair, not knowing what to expect, I did have wax in my ears. And I thought man, this is fantastic. I don’t have to go into the to the primary care physician or in the ENT. And hopefully this will remove what’s in my ear, particularly I think it was my left ear at the time. And your brother put the device on, you know, kind of explained to me what was going to happen and he was dead on. There were no surprises. It wasn’t anything that was startling or anything that was overly loud or overbearing or anything and the water was set just right. So you know, it was it was fantastic. It didn’t get dizzy or anything. And like you said, you know, less than a minute later. I’ve got this water in my ear it’s being dried out and it dried out my ears, I would say probably about 90%. And you know, and then you can look in the in the waste container there and actually see that the wax had been removed. And for me that was like, Oh, great. This is fantastic. You know, I couldn’t hear any differently because I don’t think it was impacted. But it made me feel better. And I’m like, you know what this thing is out of my ear. Now, I’m less likely to have an impaction you know if we go a few months down the road, because I’ve always got earplugs from having conference calls all day. And I just thought this is a really really cool and fantastic tool. Where has it been for the last 20 years?

Sahil Diwan
Yeah, we started the company when I was 25 and 23 so we were too young so that’s why it hadn’t happened for a long time. But a funny story actually about about the container color when we had our 3D printed prototypes we always made them a solid color so you couldn’t see the wax afterwards and when we were doing clinical trials, people really wanted to see the wax that came out so we ended up going from kind of a cloudy or not clear plastic to a completely clear plastic which is right here so people can see what’s coming out of the ears. So just a funny thing that that kind of influenced the design of the product just straight from the the patient’s feedback.

Amyn Amlani
Yeah, in going back to what Jackie said, you know, it’s a differentiator because now I can see that the product is actually done something. And then if personally my satisfaction was higher using the product knowing that the wax was now out if it had been hidden or concealed, I might have just said, Okay, well, why don’t you just put some water in my ear? But where’s the proof in the pudding? And, you know, so so I think that was a smart thing to do is having those things clear, at least from my perspective, and some people might think it’s, it’s gross, but I think there’s, there’s a fair amount of people that would say, Hey, you know, I see that you’ve done something. And I appreciate the fact that we can now move that patient journey along, and we don’t have to deal with, with earwax being an issue,

Sahil Diwan
people are obsessed with your wax, all you got to do is go on YouTube and type in wax removal and you’ll see how obsessed people are with it. But now Yeah, that’s that’s certainly right. And we very much care about the patient experience. And like I said, we’re on the first version of the device. It’s a great product already, people are really liking it, but very much focused on incorporating our early adopters, feedback and customers going forward, every customers being back into the device to make it a better and better experience.

Amyn Amlani
Well, so you know Jackie, it’s been an absolute pleasure to have you guys on I know, our viewership will will absolutely have questions and comments and things. And, again, we’ll put the website down at the bottom so that they can take a look at your website, if they’re interested in this product. I think it’s a real game changer. It’s really, really cool. As we start to see the profession of Audiology evolve, and this is one piece of that evolution. And so congratulations to you guys for building a product, getting people on board. And you know, it’s just going to elevate us as we move through the healthcare space in in time.

Sahil Diwan
Thank you. It’s very nice to be we appreciate that. Absolutely.

Jackie Phillips
Thank you so much.

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About the Panel

Sahil Diwan is the Co-Founder and CEO of SafKan Health, a medtech startup with a mission to bring ear care into the 21st century. In just a few years, the SafKan Health team has raised venture capital, run successful clinical trials, secured multiple patents, received FDA 510(k) clearance, and brought a new medical innovation to market.

Jackie Phillips, AuD, serves as the Vice President of Sales for SafKan Health, and is responsible for market development and sales as well as developing growth strategies for the U.S. and markets around the world. Dr. Phillips is integral to leading the company’s sales organization to achieve critical, strategic growth goals. Dr. Phillips has given her time and talent to the hearing industry in many capacities for over 22 years. Prior to joining SafKan Health, Dr. Phillips worked for Natus Medical and Siemens Hearing. Prior to working on the manufacturing side of the audiology industry, Dr. Phillips worked in a clinical capacity for Houston Ear, Nose, and Throat Clinic.

Amyn M. Amlani, PhD, is President of Otolithic, LLC, a consulting firm that provides competitive market analysis and support strategy, economic and financial assessments, segment targeting strategies and tactics, professional development, and consumer insights. Dr. Amlani has been in hearing care for 25+ years, with extensive professional experience in the independent and medical audiology practice channels, as an academic and scholar, and in industry. Dr. Amlani also serves as section editor of Hearing Economics for Hearing Health Technology Matters (HHTM).


About HHTM

HHTM's mission is to bridge the knowledge gaps in treating hearing loss by providing timely information and lively insights to anyone who cares about hearing loss. Our contributors and readers are drawn from many sectors of the hearing field, including practitioners, researchers, manufacturers, educators, and, importantly, consumers with hearing loss and those who love them.

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