New Products May Change the Way Tympanostomy Tubes Are Placed

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.