At present, almost all pediatric tympanostomy tubes are inserted in an operating room, under general anesthesia. More than 667,000 children younger than age 15 receive tubes each year, and insertion of tympanostomy tubes is the most common ambulatory surgery performed on children in the United States (Otolaryngol Head Neck Surg. 2013;149:8–16). Though the surgery is relatively simple, it requires a team of professionals, including a surgeon, an anesthetist or anesthesiologist, surgical techs and nurses, and post-anesthesia care providers. Most children tolerate the procedure and general anesthesia well; however, general anesthesia for tube insertion has a 9% incidence of minor complications and a 2% incidence of major adverse events, including laryngospasm (Arch Otolaryngol Head Neck Surg. 2002;128:1040-1043).
In recent years, there’s been interest in limiting children’s exposure to general anesthesia, as studies have suggested that repeated exposure to general anesthesia may negatively affect neurodevelopment (Otolaryngol Head Neck Surg. 2015;153:1067-1070). Yet for most children with persistent otitis media, the likely benefits of surgical tympanostomy tube placement outweigh the risks.
Two new products may change the way many tympanostomy tubes are placed.
The Tula System, which includes an iontophoresis system to deliver a local anesthetic to the eardrum and a tube delivery device, received FDA approval on Nov. 25, 2019, for in-office tube placement for patients age 6 months and older. The Hummingbird Tympanostomy Tube System received FDA 501(k) clearance on June 24, 2020, allowing otolaryngologists to use the device to place tympanostomy tubes in children ages 6 to 24 months in office, without general anesthesia.
Will the availability of these new systems alter risk/benefit calculations and potentially lead to a significant change in practice? It’s too soon to say. Jonathan R. Moss, MD, a Matthews, N.C.-based otolaryngologist who participated in clinical trials of the Tula System, said the new tube insertion systems represent “quite a paradigm shift.”
“I was surprised at how many children tolerated the procedure,” Dr. Moss said. “Overall, I think this is a great tool for otolaryngologists, but it isn’t going to be for every child.”
In-Office Tube Placement History
Although hundreds of different models of tympanostomy tubes have been introduced since the technology first became available in the 1950s, the basic tools and procedure have remained largely unchanged. Otolaryngologists routinely offer in-office tube placement to adult patients, but few attempt the procedure with children, who are physically and developmentally less likely to remain still throughout the procedure.
The indirect costs of surgical tympanostomy tube placement are significant for families. Parents have to take time off of work, and it’s usually at least a two- to three-hour event for a procedure that takes less than five minutes. —Kathleen C. Y. Sie, MD
According to a 2015 article that compared the outcomes and experiences of 46 children and families who opted for in-office placement and 48 children and family who had tubes placed in the operating room, there were no significant differences in median time to tube failure, and no significant differences in overall satisfaction and patient recovery. Four of 44 parents of children who had tubes placed in office reported that their child had nightmares or bad memories after the experience, compared to zero of the children who received tubes under general anesthesia, but that difference wasn’t statistically significant (Otolaryng Head Neck. 2015; 153(6); 1067-1070).
Kathleen C. Y. Sie, MD, has been placing pediatric tympanostomy tubes in office in Seattle for more than 25 years, initially using lidocaine iontophoresis, and more recently topical lidocaine cream, to numb the eardrum. Dr. Sie offers the in-office option to families of cooperative children, usually those older than age four. (She does not use the new Tula and Hummingbird systems.)
“The indirect costs of surgical tympanostomy tube placement are significant for families,” Dr. Sie said. “Parents have to take time off of work, and it’s usually at least a two- to three-hour event for a procedure that takes less than five minutes.” In contrast, in-office insertion can be completed in less than half an hour; it takes about 10 minutes to anesthetize the eardrums (both can be done at the same time) and just a few minutes to place the tubes.
Both the Tula and Hummingbird tube placement systems arose from a desire to innovate. Current tube placement procedures work well, but designers saw room for improvement. Both new systems are intended to make tube insertion convenient and pain-free, and both have the potential to decrease overall healthcare costs.
How the New Tube Delivery Systems Work
Tula is a two-part system: Local anesthesia is delivered by a unique iontophoresis system (which includes individually fitted disposable ear plugs, ear sets, and Tymbion, a lidocaine and epinephrine solution that’s specifically FDA approved for use with the Tula System) and the tube insertion device, which creates an incision in the tympanic membrane and places the tube.
The tube placement device is “very user friendly,” said John Gavin, MD, an otolaryngologist in private practice in Albany, N.Y., who participated in the clinical trials. The iontophoresis system, he said, can be a bit trickier.
“You have to make sure you get a good seal around the device to deliver the medication into the ear. You also have to be really careful to ensure that you don’t have air in the ear canal during iontophoresis, because then you may not achieve adequate anesthesia,” Dr. Gavin said.
Parents or guardians should be with the child throughout the procedure. They can play games with or otherwise distract the child during the numbing process and can hold and comfort the child during tube placement.
Placing the tympanostomy tubes using the device is a one-step procedure. “You just press a button, and an incision is made simultaneously with tube placement. It’s very fast,” Dr. Moss said. However, there is a learning curve.
“When you try to deploy the tube, if you don’t have the device lined up just right, the tube can bounce off the eardrum back into the ear canal; it doesn’t actually end up where you want it to be,” said Scott Schoem, MD, head of otolaryngology at Connecticut Children’s Medical Center in Hartford. “It takes a little bit of practice to get the right angle, to position it properly before you engage the device,” he said.
The entire procedure—from anesthetizing through tube deployment—takes approximately 40 minutes. A clinical trial found that physicians were successful in placing ear tubes in 86% of children (103/120) ages 6 months to 4 years and 89% (92/102) of children ages 5 to 12 years. Twelve patients were determined to have inadequate anesthesia in one or both ears after iontophoresis. Thirteen patients reported mild ear pain, with six of those reports coming within the first postoperative month (Laryngoscope. 2020;130:S1-S9).
No serious adverse events were noted in the clinical trial. One patient experienced tongue numbness that lasted for hours after iontophoresis; one experienced iontophoresis-related erythema, and another reported pain at the site of the return electrode. Approximately 2% (5/269) experienced otitis externa and 0.4% (1/269) experienced tympanosclerosis, transient mild ear bleeding, transient mild tympanic membrane inflammation, ear pressure, and dermatographia (Laryngoscope. 2020;130:S1-S9).
Unlike Tula, the Hummingbird system doesn’t include a specialized anesthesia process. Instead, the physician applies local anesthetic to the eardrum using a swab. After sufficient numbing, the physician uses the patented Hummingbird one-pass device to make a myringotomy and place and position the ventilation tubes.
According to Steve Anderson, CEO of Maple Grove, Minn.-based Preceptis Medical, maker of the Hummingbird, a clinical study involving more than 200 children ages 6 to 24 months showed a 99% success rate for tube placement. Results posted on www.clinicaltrials.gov show a 100% success rate for 199 patients and 393 ears, with zero adverse events. Preceptis plans a commercial launch of the Hummingbird device in select markets in the second half of 2020.
Successful use of either system requires careful patient selection. In-office tube placement isn’t the best choice for many children and families. A child with a retracted eardrum or prominent anterior overhang isn’t a candidate for in-office placement under local anesthesia, Dr. Gavin said.
Doctors must consider the child’s age and personality, as well as the family’s comfort level and motivation. “I’ve found that age plays a big role,” Dr. Gavin said. The new devices are approved for use on children as young as 6 months, but Dr. Gavin said he “found it more difficult to successfully place tubes in children under the age of 2, and even some kids between the ages of 2 and 3 were difficult.” Most children he treated tolerated iontophoresis well, but some of the younger ones were hesitant to lie down under the microscope after the ear was numb.
Dr. Moss would often “test” a child’s potential tolerance during a consultation visit. “I’d take them into the room where the procedure is done and clean wax from the ear canal to see how well they would tolerate it,” he said. A child who could handle wax removal was usually a good candidate for in-office tube placement with local anesthesia.
Assessing the parents’ comfort level is also extremely important. “Children tend to take their lead from the parent, so if they see the parent is comfortable, they tend to do well,” Dr. Gavin said. “On the other hand, if you see a parent is anxious when you’re describing the procedure to them, that anxiety may translate to the child.”
Families who are motivated to avoid general anesthesia and comfortable with the procedure are likely to do well; however, it’s impossible to predict a patient’s response to the procedure.
“I had one child, about 6 years old, who I thought would be a model patient. But once we started the iontophoresis, he became very nervous and apprehensive, and said he wanted to leave,” Dr. Moss said. “His parents reassured him, but he wouldn’t allow us to look into the ear canal.” The in-office procedure was canceled, and ear tubes were later placed in the operating room under general anesthesia.
Why Make Time for In-Office Tube Placement?
Inserting pediatric tympanostomy tubes in an office setting is significantly more time-consuming for the otolaryngologist than placing tubes in the operating room. In the OR, an otolaryngologist can place a set of ear tubes every 10 to 15 minutes. In the clinical setting, without a surgical team to prepare and anesthetize the patient, tympanostomy tube placement takes approximately 30 to 45 minutes per patient.
What physicians sometimes neglect to consider, though, is the time spent completing hospital or ambulatory surgery center paperwork. “People forget about all the effort that’s involved in filling out the history and physical, completing OR paperwork, and writing prescriptions afterward,” said Charles Syms, III, MD, an otolaryngologist in San Antonio, Texas, who was involved in the development of Tula but doesn’t have a relationship with or financial stake in Smith+Nephew, the medical technology company marketing Tula.
Doctors who are considering in-office placement should plan to spend time with the child and family before initiating the procedure, to answer any last-minute questions and help them feel comfortable. During the numbing process, it may be possible to see another patient, if other clinic personnel can supervise the child and family. Children can (and do) resume their usual activity almost as soon as tube placement is complete.
For some physicians, patients, and families, the new tube placement systems are a “game-changer,” said Dr. Syms, adding that in-office tube pediatric tube placement isn’t a good option for everyone.
“Like any new technology that comes along, there will be some who find these devices work well for their clinical practice and some who do not,” Dr. Moss agreed. “There are those who will embrace this new technology and those who may have reservations, and I understand both sides.”
Jennifer Fink is a freelance medical writer based in Wisconsin.
Stephanie Cajigal is a freelance writer based in Los Angeles.