The U.S. Food and Drug Administration approved a new method of inserting ear tubes into children, a potential game changer for the more than half million children who receive tubes in their ears annually. The new device, the Tubes Under Local Anesthesia system (Tula) allows doctors to place ear tubes using local anesthesia in their office, which could mean same-day relief for suffering children (and their parents).
"Ear infections are the most common reason why parents bring their child to the doctor," Dr. Laura Neff, a pediatric ENT surgeon at Children's Mercy Kansas City, told TODAY Parents. "And it's expensive, too."
A study looking at data from 2008 to 2014 found expenses related to acute ear infections cost $2.88 billion in the United States, she added.
"If you can only pay for one visit and have it done at the same time then you could potentially save a lot more money that way," Neff said. "Most families would prefer to have one longer visit than multiple visits."
Tula will allow doctors to deliver a local anesthetic into the ear drum using an electrical current to numb it for the insertion of tubes while keeping the child awake. The FDA said it examined data from 222 pediatric patients to determine its effectiveness and said Tula's success rate was 86% overall and 89% in children younger than 5.
"As millions of children suffer from ear infections every year, it is important to have safe and effective treatments,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health said in a press release. “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.”
Most parents have soothed children suffering from ear infections. They are extremely common: Nearly five of six children will develop one before turning 3 years old, according to the National Institute of Deafness and other Communication Disorders.
"Can you even think of a child who hasn't had an ear infection?" Dr. Chad Afman, a pediatric otolaryngologist at Spectrum Health Medical Group in Grand Rapids, Michigan, told TODAY Parents. "The procedure for placing ear tubes is probably the single most common surgical procedure in pediatrics."
Children who have four ear infections in a year or fluid behind their ears that muffles their hearing for three months are candidates for ear tubes, which eases their pain, prevents further infections and stops hearing loss. Currently, doctors perform them in the hospital under general anesthesia.
"The procedure takes about 5 to 10 minutes and usually the kids are going home about an hour after surgery," Afman explained.
There are risks with general anesthesia, including an allergic reaction or difficulty breathing. While the local anesthesia sounds attractive, Afman worries that it might be stressful or difficult to hold down a child.
"This device is a good way of getting the ear drum to be numb," Afman said. "But one of the drawbacks is with this — compared to a general anesthetic — is that you're still going to have a baby that needs to be restrained."
Some children could not receive tubes from Tula, Neff said, likely because they couldn't be restrained or were too nervous. Still, if local anesthesia could be used even in some cases, she believes it would save parents time, money and heartache.
"If you could cut the number of children that you had to put under general anesthesia even in half it would still be a big improvement," she said.