In recent years, several innovative ENT physicians have been on the forefront of moving tympanostomy tube insertion for children out of the operating room and into the office setting. The chief benefits—avoiding the risks and inconveniences of general anesthesia, streamlining access to therapy, and easing the socioeconomic burdens on families—are well documented and acknowledged by most in the profession.
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April 2025But there’s less consensus on the best strategy for achieving that site-of-care switch.
On one side of the debate are surgeons such as Richard Rosenfeld, MD, MPH, MBA, distinguished professor and past chairman of otolaryngology at SUNY Downstate Health Sciences University in Brooklyn, N.Y. About 15 years ago, Dr. Rosenfeld started treating patients with recurrent otitis media and related middle ear conditions in his office using a manual surgical tube placement method. He couples traditional instruments and tubes from the OR setting with family/patient support methods he has been steadily refining over the years.
On the other side are a small but dedicated number of pediatric otolaryngologists who are championing a far more high-tech—and they say more feasible—approach: using automated systems such as Tula (Smith+Nephew) and the Hummingbird Tympanostomy Tube System (Preceptis Medical). These devices, approved in just the last few years, have been shown in some clinical trials to achieve near 100% success rates for in-office tube placement and 90th percentile scores in family caregiver satisfaction.
But here’s the catch: Neither approach has gained significant traction, with less than 10% of tympanostomies currently performed in ambulatory settings, according to a recent survey co-authored by Dr. Rosenfeld (Ann Otol Rhinol Laryngol. doi: 10.1177/00034894211008063). Respondents to the survey, sent to members of the American Society of Pediatric Otolaryngology, cited several factors for their reticence, including difficulty with anesthesia of the eardrum, inability to keep the child from moving, and patients’ pain and emotional trauma.
For these and other otolaryngologists, many of those safety concerns center on the risks posed by general anesthesia, triggered in part by a 2017 U.S. Food and Drug Administration (FDA) alert linking the procedure to neurodevelopmental dangers in children younger than three years of age (U.S. Food and Drug Administration. bit.ly/3PVQyNw).
“A strong case has been made that the risk is rare, but real,” Dr. Rosenfeld said. “I’m personally aware of a child who, [at] less than a year old, had tubes placed at a community hospital and ended up leaving a quadriplegic because of anesthetic complications. Now granted, that’s a one-off, but if you’re the family of that child, it’s not a one-off.”
Nathan Page, MD, a pediatric otolaryngologist and the medical director of the Phoenix Children’s Hospital’s Cochlear Implant Program, agreed that the 2017 FDA warning was the beginning of a sea change in how the medical community viewed the office-versus-OR tympanostomy debate.
“I remember being at a conference where Dr. Rosenfeld presented his technique of placing standard ear tubes with no sedation, and this was before the FDA alert was issued,” Dr. Page said. “Attendees started booing and shouting pretty negative terms like ‘unethical’ and even ‘torture.’ I mean, they were ready to grab pitchforks.” After the FDA alert, however, “the conversation really started to change,” he said. “Pediatricians did not want to refer their kids to me for tympanostomies because they said they were concerned about the risks posed by general anesthesia.”
And it wasn’t just clinicians, he noted. “I also had parents asking whether this could be done in an office setting.”
For otolaryngologists who were not comfortable replicating Dr. Rosenfeld’s technique, however, there was no viable office-based alternative—until, that is, the FDA began approving the automated systems and early adopters began using them.
Dr. Page is one of those early adopters. “My first thought when I started hearing about these automated systems was, well, we do all sorts of in-office procedures in young children without any sedation, whether it be foreign body removal, nasal cautery, etc. And we’ve always done tubes in the office for adults and teens who can hold still.” The big change with the automated devices, he noted, “was that I can now apply this to a one-year-old or a two-year-old. So, this seemed like a natural progression—and frankly a pretty big deal.”
Dr. Page and his team opted for the Hummingbird system, which gained an expanded FDA approval in 2022 for use in all children six months and older. Unlike conventional tympanostomy tube insertion, which requires several surgical instruments and multiple passes into the ear for tube placement, Hummingbird automatically makes a single incision and delivers a preloaded tube in a single pass, according to the manufacturer.
A Typical Case
How Dr. Page employs the Hummingbird system depends on the child’s age. “If they’re under two or three years of age, then we’re going to rely on speed” to minimize their discomfort, he said. “We lay them prone and wrap them up with a blanket or sheet burrito-style, and we involve the parents as much as we can” to soothe the child. “And then we have a medical assistant hold the child’s head still so that I can make the fine movements needed to apply the system and get things done fast.”
How fast? “From that initial swaddling, through the actual procedure and then returning the child to the parent, it’s about three to five minutes,” Dr. Page said. “In many cases, we actually can do the procedure the same day as the consult.”
For older children, from about three to nine years of age, “we have to do a lot more preparatory work,” he said. This may involve bringing in Child Life Specialists, a team of certified professionals at Phoenix Children’s who use education and play to prepare patients and their families for surgeries and other challenging procedures. “As a team, we try to get these older kids engaged by talking to them about the part that’s going to hurt and the parts that are not going to hurt. Or we’ll ask them if they’d like to listen to music during the procedure,” Dr. Page said. This approach often precludes the need for any type of restraint, he noted.
To date, Dr. Page and his team have performed approximately 200 in-office tympanostomies using the Hummingbird system. “I’ve only had one aborted case: a significantly retracted ear drum where I could just not get the tube placed correctly,” he said. “Overall, the other cases really have been incredibly successful.”
Dr. Page’s clinical experience mirrors the published data on Hummingbird. In one study, 209 of 211 (99.1%) children aged six to 24 months had successful in-office tympanostomy tube placement, defined as completion in the office without the patient having to be rescheduled for an OR visit (Laryngoscope Investig Otolaryngol. doi.org/10.1002/lio2.533). The mean procedure time for bilateral cases was 4:53 minutes. No major adverse events occurred. Parent satisfaction with the procedure also was high, with 97.5% reporting in a survey that they would recommend it to other parents.
Where’s the Long-Term Data?
Such efficacy data suggest that in-office automated systems may be a viable option for selected patients, Dr. Rosenfeld said. But some questions still need to be answered, he noted. Whether it’s rates of successful tube insertion during the procedure or the incidence of otorrhea, early tube extrusion, or obstruction of the tube lumen, clinicians who are considering these devices “should remain alert to new publications” on those outcomes, he noted in a 2020 review of tympanostomy tube placement (Ear Nose Throat J. doi: 10.1177/0145561320919656).
“Dr. Rosenfeld is right to have those concerns,” Dr. Page said. “If we find out that these tubes extrude after eight months instead of 12-18 months, which occurs on average with conventional tubes” (Saudi Med J. doi.org/10.15537/smj.2022.43.7.20220323), then the risk-versus-benefit conversation about automated systems “is very different.” But even in that scenario, “I’d have to say I’m still a fan of the automated systems,” he said. “Yes, it would mean some children would need another procedure. But now it can be done in the office, versus rebooking them for another operation in the OR,” with all of the attendant stressors, hassles, and general anesthesia risks, he stressed.
Dr. Rosenfeld raised another concern: The cost of the devices, which can approach $700 or more per procedure when both ears are included, is not 100% covered by insurers. Again, Dr. Page agreed that “this is a legitimate issue.” Buying these devices “is certainly more expensive than the standard equipment we use in the OR, and frankly, we’re losing some money on every procedure,” he said. “Still, we feel that offering this is the right thing to do for our patients and their families, so it’s a cost we are currently willing to bear. Hopefully, some new codes [in development] will help.”
The Tula Experience
Erik K. Waldman, MD, chief of pediatric otolaryngology at Yale New Haven Children’s Hospital, also agreed that reimbursement issues are a barrier to more widespread adoption of automated in-office tympanostomies. Dr. Waldman co-authored a study that tracked two-year outcomes in 279 patients treated with the Tula device (Otolaryngol Head Neck Surg. doi.org/10.1002/ohn.336). This particular system employs an iontophoretic device that delivers a local anesthetic to the tympanic membrane, along with an automated tube delivery system that integrates myringotomy and tube placement. In the above trial, “the efficacy was amazing,” Dr. Waldman noted, with the primary outcome of tube retention at various time points throughout the study ranging between 93.9% and 100%. Despite those results, the system is still not widely used at Yale due to the lack of a clear path to reimbursement.
Remember, tympanostomy tube placement is an elective procedure.So of course it makes sense why families of younger patients may want to avoid the OR. But if we opt for placing tubes in the office, we must be ready to manage expectations and choose our patients wisely.—Erik K. Waldman, MD
“We are in active communications” with Smith+Nephew to assess progress on the payment front, he noted. “The emails have been circulating. We really want to be able to offer this to our families who have concerns about anesthesia in the OR.”
A current procedural terminology code is likely needed to cover the cost of the device and the 30 to 40 minutes spent in counseling and surgery in these cases, Dr. Waldman noted. He also noted that “without better reimbursement, Tula can’t be used in Medicaid patients, which are a large percentage of our patient base.”
Dr. Waldman said he looks forward to the cost challenge being solved because “overwhelmingly, patients and families love Tula.” In fact, when the Tula trial ended and a few patients who needed the tubes redone due to extrusion called for another procedure, “I had to tell them Tula was no longer available.” Having to switch those patients to the OR, with all its attendant hassles and potential risks, he noted, “was really upsetting to them, after having had such a great experience with the in-office awake option.”
Dr. Waldman noted that not all children are good candidates for the device. He cited, as an example, patients with narrow ear canals and other anatomy that precludes sufficient inspection of the tympanic membrane. “Tula has a fixed diameter; we have to be able to see well enough to use the device in an awake patient,” he explained.
There’s also the issue of the patient’s disposition. Hyperactive children or those having “insufficient behavioral compliance,” as described in the Tula trial, led to those patients being excluded from the study. “We were pretty selective in choosing our patients,” Dr. Waldman said. “Awake procedures are not for every child.”
The disposition of the parents also plays a big role. “Some parents feel that anesthesia is awful, while some feel that any amount of their child’s crying or discomfort is awful.” Both of those divergent dispositions “could tilt the balance for or against an in-office procedure.”
More Hummingbird Experience
Shelagh A. Cofer, MD, a pediatric otolaryngologist and surgeon at the Mayo Clinic Children’s Center in Rochester, Minn., agreed with Dr. Waldman that patient selection should not be taken lightly when choosing the best site of care for children needing tympanostomy tubes. “I always say that it’s got to be the right patient, the right parent, and the right place,” said Dr. Cofer, who has participated in several Hummingbird trials, including the aforementioned study showing a 99.1% success rate.
I always say that it’s got to be the right patient, the right parent, and the right place.” —Shelagh A. Cofer, MD
For those who do qualify, “think about all the steps they can skip” when compared with a child who is scheduled for OR tympanostomy tube placement, Dr. Cofer noted. “First, the patient sees their pediatrician and gets a referral to an ENT practice,” she said. “Then they often have to wait weeks or even months for an appointment, followed by an evaluation. If they’re deemed a candidate for tubes, and the OR is the chosen site of care, they must schedule that procedure for a later date, requiring yet another day off work for the parent. Meanwhile, the child continues to suffer from chronic ear infections, hearing loss, or other potential complications. Eventually, they undergo surgery in the OR and return for yet another follow-up.”
With the Hummingbird in-office system, in contrast, “everything is streamlined,” Dr. Cofer said. “After a referral, the patient has a single ENT visit. I conduct the consultation, and within 15 minutes, we place the tubes. After about 30 minutes, you’re basically done and on your way.”
As for the issue of cost, Dr. Cofer agreed that reimbursement can be a complicated issue to navigate. Although “somewhat shielded” from the intricacies of insurer contracting, she said a lot of work was done at Mayo to negotiate coverage for both the device and the longer time spent with younger patients treated with Hummingbird. Part of those discussions led to more favorable reimbursement, she said—so much so that her team has a dedicated Hummingbird clinic, where for a half day each week, they perform the in-office procedure on patients deemed to be good candidates.
Therein lies another benefit Dr. Cofer cited for Hummingbird. “I am a tertiary pediatric ENT specialist, which means I have a lot of complex cases to get through each week,” she said. “Hummingbird is so fast that it frees up my time to treat those more difficult patients, who often do need to be managed in the OR.”
Next Steps
Assuming other institutions have success meeting the reimbursement challenges for the automated devices, what else needs to happen for them to gain more traction? “Well, I have to say that I’m not sure this is ever going to be the standard of care,” Dr. Page said. “There’s far too much inertia with the current very safe methodology for doing tubes in the OR, even given the general anesthesia risks.”
Dr. Cofer agreed. “Any qualified ENT surgeon can walk into an OR, put in ear tubes for an anesthetized patient, and walk out in five minutes,” she said. “But is that really the best strategy for the patient, or does this just work out better for the surgeon? I’m just not sure practitioner convenience is the right criteria for these patients.”
Dr. Waldman offered this final consideration when doing this site-of-care calculus. “Remember, tympanostomy tube placement is an elective procedure,” he stressed. “So, of course it makes sense why families of younger patients may want to avoid the OR. But if we opt for placing tubes in the office, we must be ready to manage expectations and choose our patients wisely.”
David Bronstein is a freelance medical writer based in New Jersey.
Disclosures: Dr. Cofer reported that she has participated in research trials funded by Preceptis Medical. Dr. Waldman has participated in research trials funded by Tusker Medical, a subsidiary of Smith+Nephew. Dr. Rosenfeld reported that he’s a consultant to Karl Storz for in-office tympanostomy tube procedures.
A Pioneer’s Approach To In-Office Pediatric TT Insertion
Richard Rosenfeld, MD, MPH, MBA, distinguished professor and past chairman of otolaryngology at SUNY Downstate Health Sciences University in Brooklyn, N.Y., has long known that there is resistance to his approach of performing in-office tympanostomies in children using a manual surgical tube placement method and family/patient support.
Whether it’s the open criticism and incredulity he often gets from attendees at medical conferences where he presents his technique or a practitioner survey he published that documented significant doubts and concerns about performing in-office tympanostomies (Ann Otol Rhinol Laryngol. doi: 10.1177/00034894211008063), “I know this is not for everyone,” he said.
“I am an outlier, probably about eight standard deviations away from the mean on this,” he said. “When I present at meetings, lots of attendees tell me they think I’m a bit crazy to do this.” But for Dr. Rosenfeld, there’s nothing crazy about offering patients and their families a rapid, effective, proven, and repeatable means of alleviating their child’s middle ear symptoms.
The fact that he does it with tubes that have been in use for more than three or four decades and thus have a long-term, documented record of success—as opposed to some of the proprietary tubes used in the automated systems recently approved by the FDA—is a major plus.
A case typically begins with Dr. Rosenfeld explaining the procedure to the family members present and letting them know he’ll be using a technique known as a papoose board to keep the child from moving during the procedure. “I’ve heard this called a restraint, but it’s actually called protective stabilization if you read the practice guidelines from the pediatric dentists who often use it,” he explained. “It’s an extremely safe and ethical technique for pediatric medical procedures. But the goal is to be fast—and I am very fast” (American Academy of Pediatric Dentistry. https://tinyurl.com/ffxphxs9).
Dr. Rosenfeld begins by numbing the eardrum with phenol as a topical anesthetic for children who are two years of age and older. “The problem with phenol is that it stings, and so the second you put it on the eardrum, the younger kids get extremely agitated. So, we give them a double dose of acetaminophen as premedication, which in a randomized trial provided comparable post-procedural pain relief to topical lidocaine solution” (Can J Anaesth. doi: 10.1007/BF03022879).
The actual tube placement is then done with Armstrong beveled fluoroplastic tubes “that have been around for about 50 years,” he said. “I’ll even do these in patients I used to shy away from, at least in the office setting—those with narrow ear canals,” he said. “But now I’ve learned to do those nearly just as fast using softer T tubes, which can fit in those narrow spaces.”
As for how fast a typical procedure is, “my average time is three or four minutes for both ears if it’s an uncomplicated child.”
Dr. Rosenfeld stressed, however, that speed is not the only attribute a surgeon needs when doing in-office tympanostomies. “I’ve learned over the years that you really have to manage the expectations of the family members who are present,” he said. “I tell them, the odds are great that as soon as I lay your child down and we wrap them up, they will start crying. And if I gave you a pain scale to describe your child’s pain level, you’d tell me it was 10 out of 10—but at that point, I am not even touching them!”
His message to them is that their child is not in pain—”They’re just mad, frustrated, and they want to leave,” he explained. “But if you just hang in there with me, nine times out of 10, within 30 to 60 seconds of my letting your child out of the papoose, they’re going to stop crying, and if you give them a pacifier or something to eat, they’re fine; it’s rare to see any persistent post-procedural pain.”
Dr. Rosenfeld stressed that as a surgeon, “you just have to be very efficient; this isn’t a time to be learning how to do tubes. I tell the residents, do a thousand in the operating room, then you can maybe try it in an awake child in front of parents in your office.”
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