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.”
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April 2025How 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
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