BackTable / ENT / Podcast / Transcript #131

Podcast Transcript: In-Office Ear Tubes in Children

with Dr. Jordan Schramm

In this episode of BackTable ENT, Dr. Jordan Schramm of Peak Pediatric ENT in Provo, Utah, chats with hosts Dr. Gopi Shah and Dr. Ashley Agan about in-office ear tubes for children. You can read the full transcript below and listen to this episode here on BackTable.com.

(1) How the Tula Ear Tube System Works

(2) Making In-Office Ear Tube Insertion Comfortable for Pediatric Patients

(3) Delivering Local Anesthetic Using Iontophoresis

(4) Comparing Tula Tubes with Traditional Tympanostomy Tubes

(5) Counseling Families on In-Office Ear Tube Insertion

(6) Anatomic Considerations for In-Office Ear Tubes

(7) Acute Otitis Media & In-Office Ear Tubes

(8) Strategies for Successful Tube Placement

(9) Identifying Good Candidates for In-office Ear Tube Placement

(10) Administrative Considerations for In-Office Ear Tubes

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[Dr. Gopi Shah]
This week on the BackTable podcast.

[Dr. Jordan Schramm]
The best day I had, which was epic. I got four cases done in 68 minutes I think it was from the first patient arriving to the last patient leaving. I just spent basically an hour of my time but I got four sets of tubes in without any OR time. I stopped to think about it and looked at reimbursement rates aren't-- like, you're not doing this for the money by any means, but compared to what they pay for the OR, it probably came out ahead on those days, saved the patient's money and did better for my office.

[Dr. Gopi Shah]
Hello, everyone, and welcome to the BackTable ENT podcast where we discuss all things ENT. We bring you the best and brightest in our field with a hope that you can take something from our show to your practice. Now, a quick word from our sponsor.

Smith and Nephew is committed to embracing the power of tomorrow with a broad range of innovative ENT solutions with products ranging from proprietary collation technology devices to the Tula system for in-office tympanostomy, procedures, and epistaxis solutions. Smith and Nephews' portfolio fits seamlessly into the OR or office settings. Smith and Nephew's areas of focus in ENT include laryngeal, adeno tonsillectomy, turbinate reduction, epistaxis, and in-office tympanostomy.

Learn more@smithnephew.com. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Now, back to the show. Hello everybody and welcome to the BackTable ENT podcast. My name is Gopi Shah. I'm a pediatric ENT, and I'm here today with my co-host and partner in crime Ashley Agan, how are you, Ash?

[Dr. Ashley Agan]
Hey, good morning, Gopi. Excited to be here. Good to see you. We have a really awesome episode and guest today. We have Dr. Jordan Schramm. He's a pediatric ENT practicing at Peak Pediatric ENT in Provo, Utah. Dr. Schram attended medical school at the University of Rochester, completed an ENT residency at the University of Nebraska, and then finished a fellowship in pediatric ENT at the Children's Hospital of Philadelphia. Jordan is here today to talk to us about in-office ear tubes in children. Welcome to the show, Jordan. How are you?

[Dr. Jordan Schramm]
I'm well, thank you. Thank you very much for having me.

[Dr. Ashley Agan]
Thanks for coming on. Can you tell us a little bit about yourself and your practice?

[Dr. Jordan Schramm]
Sure, I'd be happy to. As you mentioned, I'm currently practicing in Provo, Utah, which is just south of Salt Lake for those that are familiar. I've been in practice for seven years, total, spent about a year and a half in academia, and have been since that time in private practice. One of the focuses of my practice is pediatric hearing loss. It's one of my passions and we like to take care of the whole gamut of hearing loss, which we probably won't talk much of on this podcast, other than all the kids that have hearing loss related to middle ear fusions. That's a very brief background. I'm a Utah native and against all odds made it back to my hometown, as it were.

[Dr. Ashley Agan]
That's awesome. Yes. Today we're going to focus in on basically in-office myringotomy and tubes in kids. Maybe give us a little bit of background on that, how did you find yourself interested in that, doing that? Tell us more.

[Dr. Jordan Schramm]
Absolutely. Yes, I like to approach these discussions just with my experience. I did not get into this on purpose. For the background in-office ear tubes and children, as I'm sure you're aware, it has been done for years and decades, and more recently there's been a little more interest because there's been a couple of newer devices on the market to try and facilitate it since it doesn't really work all that well, like when you do it in adults.

There's the Hummingbird device, which I have not personally used. And then there's the Tula Tubes, which stands for Tubes Under Local Anesthesia, which is the device that I've been using. Specifically, the Tula system was FDA-approved, I believe, towards the end of 2019. The company that originally developed this device, so the system was soon after acquired by Smith and Nephew, and that was, I believe in January, 2020.

As they've told me multiple times, it was just impeccable timing for acquiring a new device. Early on after FDA approval because of the pandemic, not many people were able to use it. That is the time when I first really started to look into doing Tula tubes, and more or less it was my local rep saying, "Hey, we just bought this company. It's pretty cool. What do you think?"

I was frankly very doubtful it would be a successful procedure. I don't know if doubtful is the right word. I was skeptical, maybe that's a more fair word. I had heard peripherally about these devices, not in great detail, but eventually did my first case after spending a lot of time looking for that perfect pediatric patient that could actually, in my view, tolerate a procedure in-office and that was in December of 2020 when I did my first case.

It was a little bit of a prompting from the rep, a lot of resistance on my part. Eventually, I thought, "it does make sense. Let's give it a try and see what happens."

[Dr. Gopi Shah]
In terms of your exposure to the technique, do they have a course or something that you try on cadavers first or is this something that you practiced using in the OR on your regular tubes, or is it really just like, "Hey, it's not that hard," and you're just, "it's a little click." How'd you get comfortable with it?

[Dr. Jordan Schramm]
Yes. At the end of the day, you're putting tubes in ear drums and we're all very comfortable doing that in the operating room so it's not like it's the most technically difficult procedure concept for a practicing otolaryngologist. They do have a relatively brief training session that the company comes in our case, and I think in most cases they came over a lunch when I was in clinic, and a few of my partners were in clinic. They don't have a cadaver head they have a dummy head with this fake little eardrum that they can swap out.

They let you get your hands on the device itself with a microscope and just get the feel of what it feels like to click that button and get it into a synthetic eardrum. With that, as I recall, it was like an hour-long training or PowerPoint just to show you the details of the device and how it works. The first time I actually used it in a patient was in a real-life awake patient in the clinic.

(1) How the Tula Ear Tube System Works

[Dr. Ashley Agan]
Can we back up a little bit when we were preparing to first do this talk, I had to just Google and look up the Tula system and what it looks like and what it's about. Can you just talk a little bit about the technology that they have to anesthetize the eardrum and how the device itself works just to allow people to visualize what it looks like and what the device is?

[Dr. Jordan Schramm]
Sure, yes. I'd be happy to. It is a two-part system like you mentioned, and that I think sets it apart from the other device. The local anesthetic is part of the whole system, and so most of the time of the case is actually getting the topical anesthetic to work, and get through that process. For Tula, it uses a process called iontophoresis, which we describe it to the families as a gentle electric current. You place a plug into the ear, very similar in feel and shape to the plugs you would use for tympanometry or otoacoustic emissions, but it's connected to an ear set and you fill that ear canal with local anesthetic with epinephrine.

For the families, we tell them, this is basically the same medicine that they would use to numb your mouth at the dentist, but we're not injecting it with a needle. We're having it absorbed into the eardrum. The nuances of the setup are you got to get the ear set up so that it cannot leak out that local anesthetic from the canal. Then it's connected to a little control unit that's all self-contained. They're single-use, they're pretty straightforward, user-friendly, and you go ahead and start the iontophoresis.

The electric current slowly ramps up to the goal target and assuming there's no interruptions, it runs for 10 minutes. After 10 minutes, the entire surface of the tympanic membrane is anesthetized. I usually tell families that's like 90, 95% of the procedure time is just getting that to go. As you're running this iontophoresis, on occasion it may be a little bit uncomfortable, most patients tolerate it fine, but if it is a little uncomfortable, you can slow down the rate and it'll run for about 15 minutes instead of 10 minutes.

So far in the cases I've done, that has been just fine as far as tolerability of that process. Once all that complete, you remove all of that, and then I go under the microscope and you actually do the tube insertion, which is the cool piece. The second part, it's a tube delivery system that is all prepackaged and ready to go. It has essentially what looks like a little catheter attached to a handle and in that catheter is a tube already loaded.

This device you place it has a silicone tip so it's somewhat gentle. You place that up on the tympanic membrane and you click a button from the time you click the button, it's a half a second. There are actually four things that happen. There's a little blade that goes in and out through the tympanic membrane making the myringotomy followed right after by a little dilation device that dilates the myringotomy.

Then the third piece is a small little sheath that goes through that tympanic membrane and the tube gets inserted through that sheath. Everything pulls back and the tube is left in the drum. There's a cool little video on the teaching sessions we show where it shows that in really slow motion on a synthetic tympanic membrane from the underside as if you were looking from the middle ear space and it just shows all those things happen.

Then in real time with less than a half a second, you just see these tubes just pop into the drum. That's, I think the fun part of the technology, but most of the work, like I mentioned, is just getting through the iontophoresis.

(2) Making In-Office Ear Tube Insertion Comfortable for Pediatric Patients

[Dr. Gopi Shah]
Is the child just sitting in the parent's lap when you're numbing them up for those 10 to 15 minutes, or are they in the position? I just keep thinking of the chair flattened, the baby in papoose. I can't imagine them keeping in papoose for 15, 20 minutes. How's the positioning for the numbing and then is it the same as they are just ready to go for that 15, 20 minutes?

[Dr. Jordan Schramm]
In order to do this efficiently, again, the analogy would be trying to do otoacoustic emissions on a child, once you put those plugs in, you don't want to pull them out, so right at the beginning, if it's a very young child, I will briefly swaddle them so we can just get all those little connections set up properly, and get the iontophoresis running, and that's usually no more than three to five minutes.

They don't have to be laying down necessarily, I tend to do that because my goal is to do it as quickly as possible because I find that minimizes the distress to the child if we can get it done quickly. I get it all set up, then as soon as it's set up and running, we loosen up their hands, get them in mum or dad's lap, get them watching a movie, get him eating a sucker or whatever treat they have.

As it runs in the great majority of cases, they just sit there being distracted, but they're not held flat in that position that you're going to have them for the actual tube insertion. Once that's all done running, you can take all that out. In many cases, I actually have a separate clinic room where I'm doing the iontophoresis then I move them to the room that I have my microscope. Then that's where I really swaddle them up, get them nice and still, parents are well informed beforehand that we'll be doing this and that for the very young children, they're not going to be happy with us because we're going to be holding them still.

A lot of good help with MAs and nurses to just get them swaddled, positioned, and get the tube inserted as quickly as we can on one side, swap them to the other side and then release them and give them some type of a toy or sticker or something and get them out of the door.

[Dr. Gopi Shah]
You can do your iontophoresis bilaterally, you can get both yours getting anesthetized at the same time?

[Dr. Jordan Schramm]
Correct, yes. All the equipment of the control unit is designed for two ears. I typically set both ears all up and then start the running at the same time. Then typically, we just have a timer running as well, but there are some indicators on the control unit, but it doesn't give you the actual time. The control unit is actually measuring how much voltage or current has run total, and if there is interruption with leakage of anesthetic or something and you have to restart it, it doesn't tell you exactly how long.

I have a nurse or an MA in the room the whole time monitoring things, which allows me once the iontophoresis is running, I can step out and do other things, but there's just a timer running on the computer just so we have an idea of how long it's been going.

(3) Delivering Local Anesthetic Using Iontophoresis

[Dr. Ashley Agan]
Have you done it on yourself? Like have you felt how the iontophoresis feels just for-

[Dr. Jordan Schramm]
I have not. I probably should. I'd have to just purchase an extra unit or something I suppose. On the older patients or older kids, I should say, I haven't done any adults. I don't see adults, but we've done some teenagers, the 10 and older crowd. Typically, we have taken the opportunity to say, "Hey, what does this actually feel like?" Because they can actually give us feedback and also say, "Oh, feels like a little bit of an itch in there, or maybe a little tingle," but none of them have been distressed by the feeling of it.

[Dr. Ashley Agan]
Yes, I think that's the most interesting part about this is that whole part of it. Does the eardrum change visually at all? Because with phenol, we get a little bit of that blanching, so is there any cue visually to tell you, okay, the drum is numbed up? Or it looks normal.

[Dr. Jordan Schramm]
Not really. Granted, I'm not necessarily doing a very, super thorough binocular exam right before, just because I know I'm going to be-- I do a little bit. You want to clean out wax from the years before you put all the iontophoresis materials in the canal, but I'm not getting to those subtleties yet. I suspect you could see maybe some less prominent vasculature on the tympanic membrane because there is epinephrine in the solution, but from a practical standpoint, you're looking at a little kid's ear, it just looks like a drum.

One of the steps that we described is to do a tap test. Once you've run the iontophoresis, and you're then examining getting ready to actually insert the tube, there's all these pediatric friendly phrases that they recommend, and you say, "Okay, we're going to do this little tap tap." Basically, they describe taking a Rosen and touch the tympanic membrane. For the older kids, that's super useful. If you were to do this in adults, that'd be super useful because they can feel.

I have had most of them that have been a little bit older, haven't even-- you poke the drum which most people as you know would fly off the chair. They don't even move it's very obvious if it's numb. I've had a couple that have been probably partially numbed and maybe not fully numbed, but that's the only time you really get that feedback. The tricky thing is if you're two and under ballpark on your patient, almost certainly they're going to be upset from the swaddling and positioning, so I do a tap test, all the same time as using the actual tube delivery system, and click the button.

The analogy I would use for that would be, those of us that do a lot of scopes have kids in clinic, heavy pediatric practices. If they're old enough, sometimes they'll spray some topical on their nose, sometimes I won't, but usually, they're just upset anyway, so we just get it done.

(4) Comparing Tula Tubes with Traditional Tympanostomy Tubes

[Dr. Ashley Agan]
In terms of the tube, is this like a Paparella, or is it more rigid? What's the size dimension?

[Dr. Jordan Schramm]
It's a silicone tube, and in order to have it in that little delivery system, it has to be packaged pretty tightly. It's very comparable to a Paparella type tube or collar button tube as far as size and function, the precise diameters, the inner diameter of the lumen is 1.14 millimeters, so pretty standard. The flange, the lateral flange that you'll end up seeing after it's inserted, it's narrower than, I like to use collar button tubes as my standard tube in the OR, it is a little bit narrower than that just because it has to fit through the delivery system. That turns out to be 2.1 millimeters in diameter for that lateral flange.

Medially, it's more three separate flanges, so if you're familiar with triune tubes, that concept, except that they're just little flat flanges. If you look at the diameter, the outer diameter as it were of that lateral flange is 3.25 millimeters, so they're not super bulky, but they're bulky enough that it's more or less like having a medium flange of a collar button tube to keep it in place.

[Dr. Ashley Agan]
How long do they stay in for? Is a six months to two years, on average, 9 to 15 months, is it the standard. That's my feel for Paparellas, is that what this feel is for these or…?

[Dr. Jordan Schramm]
More or less yes. It's the same type of duration. There is some good data, I think the White Journal just this fall published the updated data and the literature that they've published, the mean duration before extrusion is 16.8 months with a median of 15.8 months. If you look at similar tube types, our standard Paparella, or collar button, whatever your preferences, the literature is very sparse, not very accurate on that, but you can find studies ranging anywhere from seven months to 18 and a half months on those types of tubes.

When I'm describing this tube, I basically tell families, this is going to be the same type of tube as I would put in the operating room as far as function and duration. It's a short, passing standard tube.

(5) Counseling Families on In-Office Ear Tube Insertion

[Dr. Ashley Agan]
As you're looking for the appropriate patients for an office tube, if we take all the kids that have an indication for tubes in the OR, we don't have to go into all that part. Is there a subset of those patients where you're like, "This is perfect for the office." Then also a subset where you're like, "Definitely don't do these in the office."

[Dr. Jordan Schramm]
Yes, for sure. At this point, I've been doing these for quite a while, in fact, we've done in our practice, we've done just over 100 cases now. I have evolved over the last couple of years to essentially offer to any patient that I feel is a good candidate anatomically, and that the family is a good candidate. I feel it's as much about parent selection as it is patient selection. This is where it's important to have some good shared decision-making.

When I first started doing these, within the first year to year and a half, I only did three cases. Early on, I was looking for older kids that I felt could be reasoned with and tolerate all the different things we were going to do, and it's hard to find that, frankly. Those are not most kids that needed tubes.

[Dr. Ashley Agan]
They're not always going to cooperate with you either. You think that they would but they don't always cooperate either.

[Dr. Jordan Schramm]
Sometimes it makes it more difficult when they can resist, right? I guess where things really changed for me is I came to a place where I was like, "This is cool, but if I'm going to just do this three times a year, is it really worth it all the headache in my practice to do this?" Internally I said, "I'm just going to offer this for all our standard candidates. It's FDA-approved down to six months of age, most of the kids that you're going to need the tubes are going to be between six months and two or three years, let's just do it.

It's not going to necessarily have the same feel as the videos that you'll probably see posted, where the kids are just happily watching their iPads and you just put tubes in, but that's okay. As long as we talk to families and help them understand all the pros and cons, I've been surprised at how many families are all gung ho, let's get this done in the clinic. A lot of the discussion is okay, what are the downsides of doing tubes in the operating room?

Well, we know about the fasting. Parents hate it when their kids are starving. They go to the operating room environment, they have to get all changed, it's uncomfortable. There's a lot more time off from work, time off from school, the side of general anesthesia. Almost universally, no matter the anesthesia protocol, when my ear tube patients wake up, they are delirious and screaming and you know how they are. If you do more than a few in a row, especially at the surgery center, you just have this course of kids that are just screaming. You just have to tell families, "In those cases, they will be delirious. I'm sorry, it truly is the anesthetic effects and it may be 20 or 30 minutes, it may be a few hours, and they get through all that.

There's increasing concerns out, I think in the public and in the medical profession about just the general anesthesia itself and kids, and those are all the negative things. When I started talking about the in-office option, we focused on the whole point of this, the end result is no different. You get a little silicone tube in the eardrum. Really you're changing the location. In the clinic, we go in detail, "Your child's not going to be very happy when I swaddle them.

It's no surprise that they're just not going to want me to do that to them." We try and minimize the time, we try and be efficient so that we minimize that distress. We try and incorporate some principles of child life. We don't have full child life, but we try and do this kind of one voice. We don't have too many voices going on. All these principles are the same thing with any in-office procedure scopes or otherwise in children.

When you're upfront with the families about, "Yes, your kids too, they're going to be upset briefly. When I'm done with the procedure with usually within minutes they're back to normal." You get them out un-swaddled, you get them out of the clinic, by the time they get down three floors from my clinic to the parking lot, they're their normal self. The bottom line is, I tell families for these younger kids, "Your child's going to be upset. They're probably going to cry and scream either way."

In one case they're delirious and inconsolable. In the other case, as soon as we're done, they're done. There are some families or parents that are just not comfortable with that often, not always. Often they're younger. Maybe they themselves have some anxiety issues. By and large, families are like, "Well if I can do it in the office, that sounds like a better option." I think the success rate of having successfully placed tubes in the clinic is a lot higher if you're careful about that selection process.

If you have a family that has been through the OR before for any reason for ear tubes or otherwise, it's not even anything I need to convince them on, they are almost always on board before I can even give them the whole spiel.

[Dr. Ashley Agan]
Do you ever have kids that they come in for their tube check after, now they won't let you examine them? Or have you noticed any percentage of kids that have an associated anxiety when they come back for follow-up visits because of the experience?

[Dr. Jordan Schramm]
That's a great question. I have been trying to follow my data pretty closely because this is a newer thing. That is one data point, at least retrospectively I have not really been able to gather. Anecdotally, it's a little bit variable that first post-procedure visit, depending on how soon you do it. If you're doing it a couple of weeks later, they may be a little upset with you. I wouldn't say I've had any so upset that I couldn't get the exam done.

Many of them are getting a postoperative audiogram as well, so our pediatric audiologist may say, "Oh, that kid didn't really like me." If it had been two or three months later, much less likely that they're going to remember that. By no means is that every child won't forgive you. By the time you get to the later follow-up, 6 to 12 months later, I haven't seen it be an issue.

I think I've only had one kid that really was holding a grudge, but that was an older kid that was seven or eight years old and on one of the sides, I think, he was just a little bit inflamed and local anesthesia doesn't work quite as well when you have infection going on as you know. I think he felt the one side a little more. I don't see it as a big problem. I think it's a temporary thing.

(6) Anatomic Considerations for In-Office Ear Tubes

[Dr. Ashley Agan]
In terms of anatomy, and favorable or not favorable anatomy, think of an anterior canal overhang or something difficult to really get around. What other anatomical things are you looking for when you make a patient selection? Also the child that does come in who, yes, we just took them to the pediatrician, they just started amoxicillin two days ago and you still see a raging kiddo. Do you ever have to cancel those not because it's not going to be as numbed up or making the procedure more complicated for any reason?

[Dr. Jordan Schramm]
Sure. Yes, you need to have favorable anatomy. It can be tricky to get around that anterior bony overhang. I think one of the failures that I had was a kid that had a history of cleft lip and palate and they tend to have more narrow canals anyway. It was a little bit older kid, but also just the angle of the tympanic membrane, you really need to find a portion of the drum that's perpendicular.

If you're not getting this device seated up fully onto the drum, you'll have a “short shot” as we call them. I had one of these that we tried a couple of times and just could not get that tube to go in. I think it was just too acute of an angle, not enough surface area of the drum that was perpendicular that I couldn't get it in. If you have really atelectatic tympanic membrane retraction pockets, I think it's fine if it's just your regular degree of retraction from a chronic middle ear effusion, but if you're worried about retraction pocket or atelectasis, it's probably not ideal candidate. Maybe a ton of myringosclerosis or operative ears with cartilage grafts and the like.

A lot of those cases or those types of kids are not the best candidates. It can be a little bit tricky to have a large enough canal in the 6 to 12-month range because the diameter of the device that you're actually putting in, I think it's just slightly over two millimeters, and so the smallest speculum I can really get it through is about a three and a half millimeter speculum. If you're under a year of age, you can only go so far in with a speculum of that size. You're seeing some of that cartilaginous canal in your view.

If you get the right view and you know that you're looking at that anterior inferior tympanic membrane where it is most perpendicular, I think many cases you can get that done, but not for a first case. You want to get a few cases under your belt before you start doing a lot of those. The second question, I think you asked about the acute infection, I can't think of a time I've canceled it. I could see that could potentially come up.

Anecdotally, for sure, I think the local anesthetic is less effective if there's a raging infection and I have placed them with active infections going on. In some ways, it can be gratifying because as soon as that tube goes in, all that puss is coming right out at you. In my clinic where I do these procedures, my microscope's connected to 4K screens on either side of the wall, so the families see it and they're like, "Whoa." Their kid's screaming, but it's like that satisfaction of, "I just saw, it's like a pimple-popper MD-type of a video. I haven't yet had the situation where I've canceled because of that, but that's something that you could consider.

(7) Acute Otitis Media & In-Office Ear Tubes

[Dr. Ashley Agan]
After you get the tube in, are you doing a lot of suctioning? If you have a kid that's got that thick mucoid effusion, glue ear, you're trying to work quickly because maybe they're upset. How much time do you spend trying to suck all that stuff out?

[Dr. Jordan Schramm]
The short answer is zero. I don't do it at all anymore. Very early on, the first mucoid effusion or two that I did that sort of glue ear, I tried to suction it out with a three suction a little bit, which as you know, is completely futile. Even a five suction, if you're in the OR with those cases often is inadequate, you've got to irrigate, and or even you go to the seven or whatever. The other thing about these tubes, they're silicone and they're malleable.

If you grab onto them, you can actually pull them out of the drum pretty easily because they come out about as easy as a T-tube. If you suction with a five suction, you're going to be wider than the diameter of the tube. I've heard of cases where the tube has been suctioned out by the suction. I haven't done that myself, but you could pretty easily suction the tube out. This is where I really had to force my mindset to change because when you're in the operating room, of course, you're going to suction.

You have to, because when you make the myringotomy, often it obscures your visualization just to get the tubes in, you need to suction. Even if you didn't need to suction, there's fluid there, of course, you're going to suction. Even still when I'm in the OR, I still suction. Even if I don't, conceptually, I definitely know I don't have to suction out all that fluid, but it's hard not to and you just don't have that luxury in the clinic.

This is where it's been useful to follow some of my outcomes from the Tula tubes in the clinic where I'm not doing any suctioning and looking at rates of obstructed tubes that are bad enough that I need to go back to the OR for those mucoid effusions. I actually recently looked at this data to update one of these presentations. About 15% of them were obstructed if it was classified as a mucoid effusion, at least in our internal data.

This is of about, let's see, 53 ears that had a mucoid effusion at the time of placement. Only three of those tubes needed to have something done in the operating room. Two of them were on one patient that ended up having large adenoids and actually, that one had a lot of drainage, it just wouldn't stop. One was removed and replaced because the obstruction, we just couldn't get it cleared. I haven't looked at my data for the OR tubes placed under those circumstances, but it's not unheard of for those also to have the same problem.

You just got to rely on the fact that they're pressure-equalizing tubes and once you equalize that pressure, everything should get better. That was hard to do for me mentally, but I think I'm finally to a place where I just put the tube in and let the tube do what it needs to do.

[Dr. Ashley Agan]
Does everybody get drops? Do you follow the newest guidelines that are not recommending drops for every case? What are your thoughts?

[Dr. Jordan Schramm]
Excellent question. This actually has made it easier for me to adopt those new guidelines for my Tula tubes. If there's no fluid or infection, I'm not prescribing drops. I'm doing drops for the mucoid effusions or the infections. Early on for the serous effusions, I was doing drops and I've actually gone away from doing drops even for the serous effusions if they look pretty watery. I've tried to do that in my OR practice for tubes, it's been harder to implement there. There's a lot of other systems in place, but I would say more or less those new guidelines I've adopted with implementation of this in-office procedure.

[Dr. Gopi Shah]
When you're doing the procedure, does the numbing and the epi also cover the medial bony canal as well? I guess my question is, what do you do if you have any bleeding in the medial canal when you're trying to put the speculum in or when you're putting the device in?

[Dr. Jordan Schramm]
The iontophoresis really is only effective on the tympanic membrane. You don't really get any significant effect on the canal. It still is a lot like playing, it's real life operation. If you bump the canal, they're going to be upset. Families usually like that analogy and it's going to probably bleed like it would any other time. Now you're not going in with a knife, so you don't have quite as sharp of instruments going in. You're less likely to have a lot of bleeding from that.

Occasionally, you have some bleeding from the myringotomy site like you could have in the operating room. I haven't seen that as a big problem. If you really hypothetically, if you're going to have trainees start to do this that don't have a lot of just myringotomy or even ear cleaning experience, if you abrade that canal, then it's probably going to obstruct your view and then you're dealing with suctioning and there's a good chance you're not going to complete that case. It takes some finesse not to traumatize the canal during the procedure.

[Dr. Ashley Agan]
Do you have to be super thorough with suctioning that iontophoresis fluid out like they can now need to be perfectly dried? Do you have to worry about that going through the tube after you put the tube in or you can just suction most of it out and then it's fine?

[Dr. Jordan Schramm]
In most cases because between finishing the iontophoresis and setting them up to actually do the tubes, they're setting up right and moving around and usually we're drying off the outside because that fluid just drips out as soon as you take the plugs out. A lot of it is completely gone or mostly gone. The only suctioning I do of the iontophoresis fluid that local anesthetic with epinephrine is, if there's a droplet right on the tympanic membrane in that medial canal that's obstructing my visualization and then I'll just use a three suction.

Not too uncommonly, you will have cleaned the ear already prior to iontophoresis, but then you give them this whole "bubble bath" for 10 or 15 minutes the wax can loosen up. Right when you're getting that visualization, it's not uncommon you're revising a little bit of the cleaning and if I need to suction a little bit out, it's gone because again, you're under the microscope. Any significant amount of fluid you gotta get out of the way just to facilitate an accurate placement of the device. I don't find that it ever really makes it to the middle ear cleft or any significant portion goes through.
[Dr. Gopi Shah]
My two big when I think about ear tubes and kids in clinic, the two big things that come to my mind is if I dunk it, is it going to be hard for me to get out because in the OR I can just pull it out? Then my other concern is have you ever had times where you just can't do the other side? Like the child is just like, "No, we're not going to the other side. Get me out to here."

[Dr. Jordan Schramm]
Okay. For the dunking question, I've done a lot of these presentations and I had never dunked a tube. It's actually pretty difficult to dunk a tube if you have a normal tympanic membrane and you have to press pretty hard. One of the weird nuances I didn't realize I'd have to get used to is when you're putting this tube delivery system, this TDS right up on the drum, in order to make sure it's going to go in you have to feel a little bit of that feedback that you're fully on the drum, which is a weird sensation in a child that's awake.

They usually feel that pressure. If you have atelectatic tympanic membrane, you could push through it and medialize the tube for sure. Last week I had a case, maybe I'm getting more brave now that I'm doing this for a while, but I had this super awesome kid that I've seen for years that has Trisomy 21. A little bit older elementary school age kid. One of her tubes was out, one was in, I talked to mom about it. She's always been super chill in the clinic.

We took this child for a unilateral Tula. The family really didn't want T-tubes and so I did it on a unilateral on that child and she tolerated the whole procedure amazingly well. As soon as I did it, I saw that I had medialized it and I suspect what happened is that that drum was probably more atelectatic than I realized. The tube was just sitting right underneath the myringotomy and she was chill enough that I just, like you would do in the OR, grabbed it with an alligator, pulled it back, got it positioned with a Rosen and she was probably my best patient that day in spite of all of that.

I have now had one case where I dunked it. I think if you had a really wiggly child that was really older, that would be really difficult to do. What I have done on a handful of the short shots where occasionally you'll deploy a device, it makes the myringotomy, but the tube is not fully inserted. I have salvaged that with a Rosen and just pushed it the rest of the way in and adjusted it a little bit. Similar concept those kids, because I'm setting them up with, I have a nurse holding the heads really still.

I have family helping the child hold still with the swallow and everything. It's not like as soon as I deploy it, they're moving everywhere. They're trying to, but I'm keeping them still. Then we already have that position so we just turn the head and do the other side. So far, if I've been successful on the first side, I've been able to be successful on the second side. I've had, at least in our practice, we've had three that behaviorally just could not tolerate the procedure.

All three of them tolerated the iontophoresis really well, but they were all bigger and/or older kids that could not be fought. The first time this happened to me, it was about a two and a half, almost three year old kid. I did not have that kid swaddled. I had family trying to keep him still. We tried and we tried, and it didn't work. We ended up going to the OR after that. He did well after. Family wasn't disappointed or anything, we were transparent beforehand that this could happen.

What I took away from that experience is I tend to swaddle kids older than I normally would like up to age three. Anticipatory swaddling as it were, just so that we know that we can get it done.

(8) Strategies for Successful Tube Placement

[Dr. Ashley Agan]
Yes. That's what I was about to ask you that about, how if everyone's getting swaddled, even bigger kids, just because they look like they're going to be fine and then all of a sudden and there's the bigger they get, the stronger they get.

[Dr. Jordan Schramm]
I think the three to four year range is the most difficult age because they're big enough that you can't really swaddle them or restrain them in any way but they're still small enough that if they decide they're done, they're done. Then once they kind of get past that age, they're usually at least reasonable enough we can work with them and get it taken care of. Yes. I think the amount of time in the swaddle, again for these kids that are, I don't know, 18 months to three where I am swaddling them, I'm not doing any swaddling for the iontophoresis.

They all handle it just fine. For the really little kids. I'll swaddle them to start the iontophoresis and then loosen them up. Actually, a lot of the two to three-year-old kids that I've swallowed, you think they're going to be upset. Actually, they haven't been that upset with the swaddle if they're just playing with them like, hey, look. Look at this thing, it's going to give you a big hug and mom's right here and then before they know it, their head's being held still and then they realize something's about to happen, they get upset. The nice thing is you can really minimize the actual swaddle time and thereby minimize the psychological trauma to the child just to that portion of the procedure.

[Dr. Gopi Shah]
Can we just clarify swaddle? When you're swaddling, is it just a sheet or is it swaddle them in the sheet but they're on a papoose and now we've also papoosed because that's what I think of in terms of taking out ear foreign bodies, taking out a nasal foreign body. My patients are usually on a papoose, like we swaddle them in a sheet, but they're on a papoose board and the straps are on because they tend to squib and mom and dad, somebody might be still hugging their legs maybe and my nurse has the head and I'm on the other side.

[Dr. Jordan Schramm]
Now you're getting into the nitty gritty, aren't you?

[Dr. Gopi Shah]
I want to know, Jordan, that detail might be the thing!

[Dr. Jordan Schramm]
I think you could do any of those techniques. I guess the reason I use the word swaddle so much is when I'm talking to families, it's a lot less scary if you're saying we're swaddling than if we're going to strap your kid down. I don't actually have any papoose boards in my clinic. I haven't seen those since my training. They just feel a little barbaric. I just haven't done that in my practice. The actual material I'm using is stretchier. I don't know if either of you are parents, but I found out about these becoming a parent myself.

There's the really jumbo sized stretchy actual swaddles. We have dozens and dozens of those in our clinic. Any of our kids that need-- what we would've used the papoose board for during training, I use these really big swaddles. There's not actually a hard board underneath. The chairs are Saturday and T chairs slightly wider than usual. When they lay flat, it feels much more like a regular bed. They truly are swaddled tight and with that sort of stretchy give to it, you can get them pretty darn snug.

You do often have mom and dad holding hands and hips. I always tell mom or dad, whoever's doing the work hands and hips opposite from me. The child's looking opposite from me. They can have them face to face with their parent and comforting as best they can, but also holding them still obviously keep the hands from getting out to the swaddle, keep the hips from moving around. If it's a really big kid, there may be another, a third person holding the legs so that when they're kicking it's not jiggling things around.

I have my staff, my MA or my nurse really holding the head still and they do a lot of working out. They just keep that head still for me. Then I'm just focused on the microscope and as best as I can, I just try and use my normal calming voice. Even if the kid is screaming their guts out, of everything's okay, it's going to be fine. As much as anything you're keeping your own nerves calm, you're keeping parents' nerves calm. Again, if you don't have the right parent selection from the get go, it's not going to go well.

These are parents that are, they want this done and they're willing to do this and they do not want to go to the OR. Even with the most difficult kids that I've done, I have yet to have a parent come back and say, “boy, that was traumatic. I would never do that again.” Save for maybe one of the older kids that was just really upset. That has been the surprising thing. The paradigm shift for me is it's amazing how much I'm able do now in the clinic that I just never thought I could because in training you don't do that.

In some ways it's allowed me to do some things in clinic that I would not have beforehand. Like there are times where I like when I do tubes in the OR, I tend to use silicone material. If I have a silicone collar button tube, I've been able to pull those out of the tympanic membrane in clinic in some of these kids, whereas I never would have attempted that before. It's all these same principles of, okay, preparing the family, make sure they're okay with it, make sure they know there might be some discomfort.
Let's see what we can do, what we can't do, and we balance the pros and cons of doing it here with a little bit of discomfort versus going to the OR with everything that the OR is.

(9) Identifying Good Candidates for In-office Ear Tube Placement

[Dr. Ashley Agan]
Yes, it's like an adult when you're thinking about doing an office procedure, your gut tells you-- just as you're talking to the patient, as you're doing the nasal endoscopy, if they're holding on to the chair, super stressed out, you're like, "No, this is not going to be a good office candidate." I'm sure if you're able to look in the kid's ear under the microscope, depending on can you look and clean out wax, what's the vibe? Very similar thing as far as deciding who's good for clinic and who's not.

[Dr. Jordan Schramm]
Absolutely. I think the word vibe is perfect. You walk in the room, the kid's screaming at you just by you walking in the room. I'm not thinking tula necessarily, although occasionally the families are like, "Yes, I want to do that and I'll hold my kid down." It's rare. Whereas other times when I was first doing it, I was doing a full microscopic ear exam with removal of wax to see how good they would do, how well they would tolerate that.

Now, if they can just tolerate a standard otoscopy in a reasonable manner without too much upset, and the family's good at just holding the kid on their lap and moving the ear to the side, to me that's good enough. Because I know that's going to be the same process once we're doing it, and I'm going to have to do the swaddle. I try not to use the word restraint because there's more paperwork with that. I know that's going to have to happen either way in those age groups, and so if I can get a reasonable view with the otoscope in the clinic and it's a kid that needs tubes, we'll have the discussion, talk about pros and cons of both options and let them decide.

[Dr. Gopi Shah]
In terms of rates of retained tubes or perfs, is it pretty similar to the standard Paparellas or collar button that people use in the OR with these tubes?

[Dr. Jordan Schramm]
Yes, the short answer is yes. Again, they have published some data already. Again, there's a laryngoscopy paper that's followed up by a white journal paper looking at those rates of perforations retained tubes. The short answer is it's pretty much identical. In my own practice, I didn't really ramp up. I did my first case in December 2020 I mentioned, but it wasn't until the fall of 2021 before I started doing them regularly. I haven't had the luxury of following my personal cases far enough to see that yet.

I know I've had one case of bilateral perforations after extrusion, about a year and a half later. I've had several that have extruded in a normal time frame. My very early data, they seem to be behaving just like any other short term tube as far as complication rates are concerned.

(10) Administrative Considerations for In-Office Ear Tubes

[Dr. Gopi Shah]
I can't help but think about. Just like overall cost. It's got to be significantly less expensive to be able to come in and do it. Like just taking the hospital and the anesthesia and all of that out of it seems like it would be a lot more cost efficient.

[Dr. Jordan Schramm]
Absolutely. It's for sure way less expensive overall. It is a new enough device that there's still not a standard CPT code for the procedure yet. That's one of the nuances. Once you get to the business side of implementing this in your practice, there's a category three code which you're probably familiar with. Category three codes are when you have a newer device or technology that's being implemented. The category three code for Tula tubes is very specific to Tula. It's not for any in office tube and it describes in great detail using iontophoresis for topicalization of the tympanic membrane and an automated tube insertion device.

If you read through the code, it doesn't say Tula, but it's like describing the entire Tula procedure. That's the code that we use for billing. At some point, usually these category three codes, eventually you can get a category one code just like your other codes for billing. With a category three code, there are no RVUs attached to that and there's no specific amount to bill attached to that. This was a big part of the learning experience implementing this into my practice is, "Oh, how do we actually make this a viable thing, and how do we make it so families can afford it?" Because there is a lot more cost to the device itself, but you're eliminating all of the facility fees.

Overall it is way less expensive to the system and to families to do this. I went into this when I started implementing this. I figured this is going to be a learning curve for me to some degree. For the first few cases, I don't know if I'll get any reimbursement or not. I'll maybe have kids with free ear tubes. Very early on I was okay with that because of my own learning curve. I've been pleasantly surprised, at least where I practice, that there are enough insurances that have covered this. It has become a viable option for my practice. There is one national insurance that has this CPT code, this category three code, as a covered benefit, and that's Cigna. Cigna patients, it's, wow, I can do it just like any other ear tube.

All the other national carriers, it's spotty or hit and miss, and there's a lot of conversations going on with those carriers to show that we should probably be covering this. The smaller insurances, the very, very small ones, they don't have the same power in the marketplace to negotiate with hospitals and surgery centers. They're paying out more than their big brothers and sisters. They have not questioned at all paying for this procedure because they themselves see the financial benefit right away.

There's a regional health carrier in the intermountain west that's part of the intermountain system, or a subsidiary that's called Select Health that is not as big compared to your big Blue Cross Blue Shield, but it's pretty big in our area. Even on that front, they've been reimbursing adequately to cover the device and a professional fee to make it a viable thing for. While they're not super small, they're not super big, they're seeing the benefit as well. That is probably the biggest area from a practical standpoint, that we still are working on more progress.

I am participating in a registry for some of my patients that's being sponsored just really to get more real world data. There's supposed to be, I think, about 10 sites across the country participating. I do have some patients that are able to get this procedure covered by the company by agreeing to download an app and give feedback on how tolerable was this how long do we have any complications? They'll be followed for the next few years, but it's not a study that's changing my practice.

It's just basically, let's get even more data, even more above and beyond the published data that got this device already approved by the FDA to show to payers that this is in fact safe and effective and probably will save the healthcare system money as well.

[Dr. Ashley Agan]
Was it difficult to train up your staff because you have a pediatric practice? Your staff's pretty familiar with getting the child set up for you.

[Dr. Jordan Schramm]
Yes, so I benefited greatly in that I only see kids, and in fact, in our practice, I have a separate office within our bigger practice that is our pediatric office. I have a subset of three or four nurses and MAs that see all my patients with me anyway, and they're very accustomed to helping me with procedures. There was some training that's Tula specific that the company was good about coming and training the staff on all the different parts of the device so they can assist me. It wasn't a very steep curve as far as the principles of swaddling and helping me keep the child still to do procedures all that was already built in.

If you do not have a very heavy pediatric practice, you may have a much steeper learning curve to do this regularly in your clinic.

[Dr. Ashley Agan]
Do you have, like a workflow or a procedure day or a morning where it's just—

[Dr. Jordan Schramm]
Yes. When I first started doing it, I just worked it into the day because I was only doing one randomly here and there, and it was okay, but it was a little bit tricky. Once I started doing them regularly and I had, I think, at least 10 or 15 cases done, I started doing maybe two on a day. I worked myself up to four in a day, or I should say in an afternoon. I may have to expand that because I have a little better access temporarily for this procedure, but typically what I do now is every other week on a Thursday afternoon. Normally I see clinic patients at least starting times between 8:00 AM, and 4:30 PM. The last hour and a half or so of my clinic is blocked out for tula cases on every other Thursday.

That gives me enough time to get four cases done and have all my staff focused on just the Tula workflow. It turns it into a mini in office procedure suite. I mentioned I have four total clinic rooms that are set up for ENT, but only one of them has a microscope as the procedure room. The others are more standard ENT rooms without a microscope, and our microscope is mounted up on the ceiling, so it's nice. It's out of the way.

For my workflow now, I will bring the first patient back, start them with the iontophoresis, get it all set up myself personally, and make sure it's running. Once it's running, I know I've got about ten minutes or so, I go and bring the next patient back for the next case and start the iontophoresis. By the time that's set up and running, usually that first iontophoresis patient is done. I've had a nurse or an MA monitoring it the whole time. They can do simple things like if there's a small little leak, they can top off a little bit of that numbing medication.

Really it's you as the physician doing all this work. There's not a lot of room for a midlevel to do all this. That's another place where it's really important to have a nurse that actually understands the system. If it gives you an error on the device to restart the iontophoresis, occasionally I have to go in and tweak it or maybe replace an earplug so that it can run. Being able to alternate cases makes it really efficient and then once that first case is done running, move them over to the procedure room and do the actual insertion and then continue on. I usually get four cases done total. Usually that's total from the first Tula patient arriving to the last patient leaving my clinic because there is some overlap in procedure. It's probably an average of an hour and a half, on a difficult day, maybe two hours. The best day I had, which was epic, I got four cases done in 68 minutes, I think it was, from the first patient arriving to the last patient leaving. If I can use the word epic, I don't know if that's updated.

[Dr. Gopi Shah]
You can use that.

[Dr. Jordan Schramm]
It was like, wow, I just spent an basically an hour of my time and I got four sets of tubes in without any OR time.

[Dr. Ashley Agan]
That's amazing.

[Dr. Jordan Schramm]
I stopped to think about it and looked at reimbursement rates aren't-- like, you're not doing this for the money by any means, but compared to what they pay for the OR, it's probably came out of ahead on those days, saved the patient's money and did better for my office. It can be done, but it's not day one.

[Dr. Ashley Agan]
Just thinking about your time when I moved to start doing things in the office, it's just so like, I'm the rate limiting step as opposed to when you're in the operating room, there's a lot of, you're waiting on things to happen that are just out of your control. There's something really nice about being able to run your procedure days because you're saving your time too, which is also very valuable.

[Dr. Jordan Schramm]
100%. I couldn't agree more. I'm fortunate the last couple years at a couple of the surgery centers where I operate, where they've given me two rooms at a time and those are the days in the OR where I actually become the rate limiting step, but most ORs you're not the rate limiting step. You have a lot of built-in time for turnover, talking to families, anesthesia time. In the office, I truly am the rate limiting step, just like when you're seeing regular clinic patients. For sure you can boost your efficiency that way.

[Dr. Gopi Shah]
Well, as we round it out, any final tricks or pearls or anything you want to leave our listeners with?

[Dr. Jordan Schramm]
I think the biggest thing for me is I just had to open my mind to the possibility. I've been pleasantly surprised with how much I can get done. I do think there's going to be a different learning curve for you if you have a very heavy pediatric practice versus if you're doing very minimal. Part of that is you as a physician, probably a lot of it is your office staff in your office setup. Just have a conversation with families.

I'm not in the habit of looking at what the payer is on a patient that I'm seeing whether it's a government payer, or otherwise I just see the patients. I've sort of just explained to the families both options, whether or not they're going to have an insurance that'll actually pay for it or not, and let them know that it's not fully covered by all insurances yet. I think eventually we'll get there.

It's just nice to have the conversation and see patient's reactions and you may be surprised at how many families are just primed dying to just have this done instead of going to the operating room. Just keep an open mind and see what you can do. Kids are resilient, they're very forgiving. That's quite amazing. I think these little things, or at least it seems like a little thing to change your practice, but it does have a big impact in your patients' lives, for sure.

[Dr. Gopi Shah]
Yes, that's awesome. If people want to find you, do you have a website with pediatric ENT or are you on any social medias that you want to share?

[Dr. Jordan Schramm]
Yes, so our practice in Utah is Peak ENT. We're not heavily in the social media space yet, but I'm happy to interact with other physicians. I've done it quite a bit actually, different round tables and things. I have an email that you guys have. If they were to contact the show, I'd be more than happy to have you put them in contact with me by phone or by email.

[Dr. Gopi Shah]
Awesome. Well, thank you so much, Jordan. I think it's a wrap.

[Dr. Jordan Schramm]
My pleasure.

Podcast Contributors

Dr. Jordan Schramm

Dr. Jordan Schramm is a pediatric otolaryngologist and head and neck surgeon with Peak ENT Associates in Salt Lake City, Utah.

Dr. Ashley Agan

Dr. Ashley Agan is a practicing ENT and assistant professor at UT Southwestern Medical Center in Dallas, TX.

Dr. Gopi Shah

Dr. Gopi Shah is a practicing ENT at UT Southwestern Medical Center in Dallas, TX.

Cite This Podcast

BackTable, LLC (Producer). (2023, September 21). Ep. 131 – In-Office Ear Tubes in Children [Audio podcast]. Retrieved from https://www.backtable.com

Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.