Office-based tympanostomy tube placement: A safe and efficient alternative
Tympanostomy tubes are commonly placed to treat chronic otitis media with effusion and recurrent acute otitis media.
In fact, tympanostomy tube placement is the most common ambulatory surgery performed in children, with nearly 700,000 procedures performed each year. Approximately 20% of these children will require more than one set of tympanostomy tubes. Tympanostomy tube placement is a procedure that has been traditionally performed in the operating room under a brief general anesthetic.
Procedures under general anesthesia are associated with increased health care costs and prolonged recovery times, and exposure to general anesthesia itself has intrinsic risks. The rate of major anesthetic-related complications for tympanostomy tube placement in children is estimated to be 1.9%. There is also contemporary debate about the potential long-term adverse neurocognitive effects of general anesthesia in children, particularly in young children who have repeated anesthesia exposures.
In-office tympanostomy tube placement without general anesthesia is not a new concept. The senior author has placed tympanostomy tubes in the office for more than 30 years in carefully selected young children and teenagers using an iontophoresis device or phenol application for local anesthesia. One recent report of in-office tympanostomy tube placement without local anesthesia in a selected cohort of children found parental satisfaction comparable to a group who had tubes placed under general anesthesia.
There has been recent innovation in office-based tympanostomy tube placement solutions. In the United States, there are now two available commercial systems. Tula (Tusker Medical) uses an iontophoresis system to apply a submilliamp electrical current to facilitate mobilization of a lidocaine/epinephrine mixture placed in the ear canal to anesthetize the tympanic membrane. This process requires approximately 10 minutes, and both ears can be anesthetized simultaneously. Subsequently, a proprietary tube delivery system is used to quickly create the myringotomy and place the tube. The OTTER study used this device in 337 patients aged 6 months to 12 years, and successful tympanostomy tube placement occurred in 85.8% of children aged younger than 5 years and 89.2% of children aged between 5 and 12 years. There were no serious adverse events related to the procedure. Tube retention at 6 months was 91.8%, and 94% of parents were satisfied with the in-office procedure. Tula is FDA approved for in-office tympanostomy tube placement patients older than 6 months of age.
Hummingbird (Preceptis Medical) is another system that allows for myringotomy and tympanostomy tube placement using a single-pass device. A recently published multicenter clinical trial reported the use of this device for in-office placement in awake children. The study included 229 children aged between 6 and 24 months or 5 and 12 years. Topically applied phenol was the anesthetic used in most study ears. In-office tympanostomy tube placement was successful in 99.1% in children aged 6 to 24 months and in 94.4% of children aged 5 to 12 years. The Hummingbird has received FDA 510K clearance for in-office use in children aged 6 to 24 months.
Avoidance of general anesthesia and a decrease in procedure-associated time/cost are strong drivers for office-based tympanostomy tube options. This may become more popular with more clinician and family experience. Considerable debate continues about the merits of in-office tympanostomy tube placement, centered around the need for a cooperative or restrained child as well as the issues with appropriate pain control during and after the procedure. Office-based tympanostomy tube placement will not be the option of choice for everyone, and thorough preoperative counseling is required to allow optimal patient selection and shared decision-making with parents. Contraindications for an in-office procedure include significantly atrophic, atelectatic or retracted tympanic membranes and anatomic features that limit access or visualization. Certain physicians, parents and children may be uncomfortable with awake in-office procedures and prefer the operating room setting with general anesthesia.
The American Academy of Otolaryngology-Head and Neck Surgery issued a position statement on office-based tympanostomy tube placement for children in July 2019 that affirmed this option and emphasized the need for appropriate patient selection and shared decision-making between clinicians and families.
Office-based tympanostomy placement can be a safe and efficient alternative for selected children and well-informed families.
For more information:
Melissa M. Liu, MD, PhD, is a resident in otolaryngology-head and neck surgery at the Johns Hopkins University School of Medicine.
David E. Tunkel, MD, is the director of pediatric otolaryngology at Johns Hopkins.