- The FDA has approved a new ear tube product that may allow children to avoid surgery for chronic infections.
- The TULA system can be done at a doctor’s office without anesthesia.
- One expert says, however, there are advantages to surgery for recurrent ear infections.
Children with chronic ear infections may be able to skip surgery because of the Tubes Under Local Anesthesia (TULA) system recently approved by the Food and Drug Administration (FDA).
The latest ear tube technology is inserted by trained physicians into the eardrums of children as young as 6 months. Local anesthesia is used in the in-office procedure.
“This approval has the potential to expand patient access to a treatment that can be administered in a physician’s office with local anesthesia and minimal discomfort,”
The tiny ventilation tubes improve airflow and help prevent fluid backup that puts pressure on the eardrum.
“Historically, ear tubes, or tympanostomy tubes, have been placed in the operating room,” Dr. Anna Messner, FACS, FAAP, chief of pediatric otolaryngology at Texas Children’s Hospital in Houston, told Healthline. “It is a short procedure that takes roughly 10 to 15 minutes.”
“People have been trying for years to figure out a good way to do it without anesthesia because, ‘Wouldn’t that be great?’ And I agree,” she said.
“It would save the children from going to the operating room and undergoing anesthesia,” she added. “It would be more cost-effective.”
Similar devices have been introduced in recent years, but they haven’t been used in a widespread manner.
“There have been a number of these developed by different companies over the years, and none of them have really caught on,” Messner said.
Ear infections are the single most common reason parents bring their children to their doctor.
According to the National Institute on Deafness and Other Communication Disorders (NIDCD), five out of six children will have at least one ear infection before their third birthday.
The majority of common ear infections in children are associated with viral infections. Secondhand smoke is also a contributing factor.
“And some kids are just prone to get ear infections,” Messner said. “There are kids who do everything perfect and they still get terrible ear infections.”
Signs of ear infections, says the NIDCD, include trouble sleeping, fever, problems with balance, and fluid draining from the ear.
“The most common age for children with ear infections is somewhere between 9 months and 3 years,” said Messner. “That age group is not known for lying quietly while examined, right? That just doesn’t happen.”
While ear infections are common in childhood and typically respond well to antibiotic therapies, recurrent issues are a cause for concern and require interventions beyond antibiotics.
“We only consider ear tubes for the kids who have infection after infection after infection where they get very sick and it’s disruptive to the whole family, or the kids who get an ear infection and they have fluid in their ears that won’t go away and it affects their hearing,” Messner said.
For these children, ear tubes make a major difference.
“There’s a reason it is so common and popular, and that’s because it is quite effective,” Messner said. “No matter how they are put in, in the operating room or the office, most kids who have ear tubes in place do not get ear infections.”
If they do get an infection, the excess fluid drains out instead of building up and becoming uncomfortable.
When children undergo ear tube surgery, “Anesthesia is given with a mask, most commonly there is no IV and no intubation,” Messner said. “So it is general anesthesia, but it is a fairly light general anesthesia.”
“The kids are breathing on their own the whole time,” she noted.
While the new TULA system provides families with the option for an in-office treatment, there are trade-offs to consider.
Putting children under general anesthesia has its advantages.
“There are two reasons to do the procedure under general anesthesia,” said Messner. “One, to provide pain control. Trying to numb the eardrum is actually quite difficult because it is deep inside the ear canal.”
The middle ear is also a small area to work with.
“You use a microscope when you do this,” Messner said.
Restraining the child is for everyone’s safety and to reduce the likelihood of injury.
“No matter what, if you’re doing it in-office, the child will need to be restrained. We obviously do not want kids to be in pain,” she said.
Due to these drawbacks, Messner doesn’t see this technology replacing the need for ear tube surgery under general anesthesia.
“Multiple people have tried this and multiple systems have already been developed and there’s often a little bit of a flurry when they first come out, but historically none of them have been that successful,” she said.
“The TULA system that was just approved by the FDA, to say it is a game-changer is grossly overstating what it is, quite frankly,” Messner said.
Similar technologies do exist.
“Iontophoresis, which is a topical anesthetic, has actually been around for decades,” said Messner.
It can be delivered to children in 10 minutes through needle-free electrical currents.
“The difficulty with it historically is that it takes a long time to do and sometimes it works well and sometimes it doesn’t,” she said.
The second aspect to consider, she says, is the little tubes being auto-inserted.
“You still have to hold the instrument and get to the eardrum. It’s successful somewhere between 85 and 90 percent of the time,” she said.
And it’s nearly impossible with a wiggling child.
“Parents need to be prepared that their child has to basically be wrapped up and restrained in order to do this,” said Messner.
“Some parents are OK with that and some parents are not.”
Older children may be more cooperative and the TULA option may work well in such situations.