Sept. 24, 2024
In the United States, about 1 million children each year have pressure equalizing (PE) tubes placed in their ears. Typically, this approach involves general anesthesia and postrecovery care and monitoring. A newer, Food and Drug Administration (FDA)-approved technology is available at Mayo Clinic Children's Center that reduces overall costs while maintaining safe and effective outcomes for children.
"Tympanostomy tubes, ventilation tubes, myringotomy tubes or PE tubes are used to help children who have repeated, long-lasting ear infections," says Shelagh A. Cofer, M.D., a pediatric otolaryngologist and surgeon at Mayo Clinic in Rochester, Minnesota. "They can also be used to help children who still have persistent middle ear fluid after an infection clears up."
Criteria for PE tubes include:
- Frequent ear infections — three within a six-month period, or four within a 12-month period with one infection occurring within the last six months.
- Must also occur with evidence of middle ear effusion or recent ear infection at time of consultation with otolaryngology.
- Middle ear effusions that persist in both ears for three months or a single-sided middle ear effusion that lasts for six months.
- Also occurs with s symptoms such as hearing loss, trouble with balance, pain or fullness in the ears, or difficulty focusing at school.
Children who have surgery for PE tube placement usually undergo general anesthesia in the operating room, which can be costly and restrictive for families. The risks of general anesthesia are generally low in healthy children. But as with any procedure, there are possible adverse reactions such as nausea, dyspnea and arrhythmia.
"Up to 50% of kids experience emergence delirium for up to 30 minutes after the procedure," says Dr. Cofer. "Because of this and other risks associated with general anesthesia, we began to explore alternatives."
"A few years ago, I was working with a company who wanted to conduct clinical studies on a new device, which works much like an ear-piercing tool," says Dr. Cofer. "We developed the method of very quickly and efficiently numbing the eardrum, using the tool to make an incision, depositing the tube and coming back out."
"With traditional PE tube procedures, it takes a number of passes to complete the insertion and accurate placement of the tubes," says Dr. Cofer. "We call the Hummingbird Tympanostomy Tube System a 'single-pass' tool because the steps involved in the procedure have been greatly reduced."
"In the clinic with the Hummingbird device, phenol applied with a microsponge is used to numb the eardrum," says Dr. Cofer. "And then tubes are placed with the device, similar to a piercing gun." The procedure to both ears with the Hummingbird device can be done in less than five minutes.
"It's a revolutionary step forward for our field," says Dr. Cofer. "This device really fits within our mission of developing effective — and safe — minimally invasive options for patients."
The Hummingbird device is FDA approved for children 6 months and older. "A patient can be considered a good candidate for the in-office placement procedure if they have the same indications for needing PE tubes, and do not have any contraindications," says Dr. Cofer.
"Pain was definitely at the forefront of my mind when we started doing the in-office procedure," says Dr. Cofer. "Through our clinical trials, we were able to evaluate the tolerability of the Hummingbird device, and we found that it was equivalent to cerumen removal."
Mayo Clinic Child Life Services also is involved throughout the process. "Every child requires their own unique preparation," says Diana Moll, a certified child life specialist at Mayo Clinic in Rochester, Minnesota. "I help set expectations and address fears and misconceptions. To normalize the clinic space, I engage in developmentally appropriate play with the patient prior to the procedure."
"Parents and caregivers play an important role in their child's care during the Hummingbird procedure," says Moll. "When talking with parents, I emphasize the role they play in being a calming presence for their child. We discuss how they can provide support, which can include bringing their child's favorite book or toy, using soothing words, or singing their child's favorite song."
"It was really reassuring to see that the device was rated as very tolerable, and the outcomes have been the same as traditional PE tubes," says Dr. Cofer. "In addition to the reduced time and cost, we've witnessed the invaluable benefit of parent involvement and providing immediate comfort for their child — a reduction in stress for both the child and the parent."
For more information
Refer a patient to Mayo Clinic.
Disclosure
Preceptis Medical funded Dr. Cofer's research on the Hummingbird Tympanostomy Tube System.