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No OR Time, No Problem: In-Office Pediatric Ear Tube Placement with the Tula System

Author Julia Casazza covers No OR Time, No Problem: In-Office Pediatric Ear Tube Placement with the Tula System on BackTable ENT

Julia Casazza • Oct 23, 2023 • 32 hits

Ear tube insertion is the most common indication for surgery in pediatric patients. According to the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS), persistent otitis media with effusion or recurrent acute otitis media with effusion should be treated with tubes. But what if ear tubes no longer required a trip to the OR? What if families could avoid the financial, anesthetic, and emotional stressors of surgery? Dr. Jordan Schramm, pediatric otolaryngologist at Peak Pediatric ENT in Provo, Utah, recently sat down with BackTable ENT to discuss his work using the Tula ear tube system for in-office ear tube placement in children.

This article features excerpts from the BackTable ENT Podcast. We’ve provided the highlight reel in this article, but you can listen to the full podcast below.

The BackTable ENT Brief

• The Tula ear tube system combines anesthesia, myringotomy, and tube insertion into one streamlined system suitable for clinic use.

• The Tula system uses Iontophoresis, the passage of a gentle electric current, which helps deliver local anesthetic to the tympanic membrane. At the time of myringotomy, the TM is completely anesthetized.

• Iontophoresis is painless which makes it suitable for the pediatric population. Patients describe it as a tingling or itching sensation on the eardrum.

• Tula tubes are similar in design and function to conventional ear tubes.

No OR Time, No Problem: In-Office Pediatric Ear Tube Placement with the Tula System

Table of Contents

(1) Streamlining Ear Tube Placement with The Tula System

(2) A Shock to the System: Local Anesthesia Using Iontophoresis

(3) Tula Tubes and Ear Drops

(4) Comparing Tula Tubes to Conventional Ear Tubes

Streamlining Ear Tube Placement with The Tula System

The Tula ear tube system combines the anesthetic and procedural aspects of ear tube placement in three easy steps. First, the tympanic membrane (TM) is anesthetized; lidocaine with epinephrine is placed inside the ear canal. The canal is sealed off with an earplug that uses a gentle electric current to stimulate medication uptake on the TM. At the end of ten minutes, the earplug is removed and the TM is anesthetized. Second, the otolaryngologist performs a myringotomy by placing a rubber-tipped stylet on the TM. With the press of a button, the incision is made and then dilated. Third, the stylet delivers a pre-loaded tube into the newly created opening.

[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.

Listen to the Full Podcast

In-Office Ear Tubes in Children with Dr. Jordan Schramm on the BackTable ENT Podcast)
Ep 131 In-Office Ear Tubes in Children with Dr. Jordan Schramm
00:00 / 01:04

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A Shock to the System: Local Anesthesia Using Iontophoresis

The Tula ear tube system makes use of iontophoresis – the application of a gentle electric current – to help local anesthetic reach the tympanic membrane. This application takes ten minutes. Dr. Schramm’s patients describe the sensation as a tingle or an itch. Unlike phenol, iontophoresis does not cause the TM to change color when anesthetized, so Dr. Schramm performs a “tap test” to test whether analgesia is adequate; he gently touches a Rosen knife to the TM and asks his patients whether they can feel it.

[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.

Tula Tubes and Ear Drops

Thanks to its streamlined design, tube insertion using the Tula system is more straightforward than that in the OR. In order to incise the TM and insert the tube, the operator of the insertion device needs to feel resistance from the patient’s TM. In Dr. Schramm’s experience, this helps ensure an appropriately inserted tube and makes “dunking” the tube (beneath the tympanic membrane) difficult to do. As an added plus, in-office insertion of tubes made it easier for Dr. Schramm to adhere to the AAO-HNS’s guidelines on ear drops following ear tube placement: only patients with active infection get drops.

[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.

Comparing Tula Tubes to Conventional Ear Tubes

The actual ear tube used in the Tula system closely resembles that used in operating room tube insertions. At 1.14 mm, the inner diameter of the tube is similar to that of a Paparella, or collar button, tube. The Tula ear tube has three flat flanges on its distal end that help it remain in place. After placement, Tula tubes stay in patients’ ears for a mean period of 16.8 months, which is similar to that of 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, is it?

[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.

Podcast Contributors

Dr. Jordan Schramm discusses In-Office Ear Tubes in Children on the BackTable 131 Podcast

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 discusses In-Office Ear Tubes in Children on the BackTable 131 Podcast

Dr. Ashley Agan

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

Dr. Gopi Shah discusses In-Office Ear Tubes in Children on the BackTable 131 Podcast

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.

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In-Office Ear Tubes in Children with Dr. Jordan Schramm on the BackTable ENT Podcast)
The Ins and Outs of Ear Tubes with Dr. Ashley Agan and Dr. Gopi Shah on the BackTable ENT Podcast)

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