For young children who suffer from frequent ear infections, there is a new, anesthesia-free solution to traditional tympanostomy tube placement.
Ear infections are common in young children, and as many as one in 15 children will get tympanostomy tubes placed by age 3 years as a result.1 The procedure to place these tubes traditionally has required general anesthesia, but the new Tubes Under Local Anesthesia (Tula) System offers clinicians an in-office alternative that requires only local anesthesia.
The system isn’t meant to replace the traditional method for tympanostomy tubes altogether, but rather to give clinicians another option—particularly for patients who may not be a candidate for general anesthesia.
“The Tula System is the first ear tube delivery system that can be performed in young children using local anesthesia in a physician’s office setting, therefore avoiding the administration of general anesthesia,” says Kristen Pluchino, PhD, MPH, of the US Food and Drug Administration (FDA). “The Tula System is not intended to replace other methods for ear tube delivery, but rather the Tula System offers an additional option for patients.”
Pluchino stresses that it’s up to parents, patients, and clinicians to determine the best method for ear tube placement for each patient, and the FDA does not regulate the practice of medicine.
A breakthrough device
The FDA gave Breakthrough Device designation and final approval to the Tula System in November 2019.2 Tula is a system that allows tympanostomy tubes to be placed in a physician’s office using local anesthesia. Tympanostomy tubes, commonly referred to as ear tubes, are inserted into the eardrum to help prevent recurrent ear infections. A surgical procedure typically requiring general anesthesia, the Tula system uses the anesthetic Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine), Tusker Medical tympanostomy tubes, and several other devices to allow clinicians to place the tubes outside of the operating room.
How it works
The Tula device uses a small electrical current to deliver the local anesthetic into the eardrum before insertion. Fitted ear plugs are used to keep the local anesthetic in the ear canal and, once numb, the clinician can remove the ear plugs and create a small hole to insert the ear tubes using the Tula Tube Delivery System. The system consists of a sterile single-use device that includes a preloaded silicone tympanostomy tube measuring 1.14 millimeters that is deployed across the tympanic membrane within 500 milliseconds using a single-button control. Upon insertion, the cutting element of the delivery system is immediately retracted back into the device, according to device data provided by the FDA.3
“The Tula System gives families and physicians an option for in-office placement of tympanostomy tubes without use of general anesthesia. The Tula System begins with a novel child-friendly method to numb the tympanic membrane in about 10 minutes,” says Amir Abolfathi, chief executive officer of Tusker Medical. “The child may sit up, play with toys and watch videos throughout the procedure, which typically takes about 40 minutes. The Tula System is supported with an educational and training program designed with input from experts in otolaryngology, pediatric psychology, medical stress, and pain management.”
According to FDA,4 the efficacy of the Tula system was assessed in a clinical study involving more than 222 children aged 6 months to 12 years. Successful placement of tympanostomy tubes using the Tula system occurred in 86% of cases for children aged 6 months to 4 years, and in 89% of children aged 5 to 12 years. Pain scores during the procedure were assessed at a level of 3 to 4 on a scale of 10 during insertion, and at less than 2 after insertion.
Who can use it
The FDA approved the device for adults and children as young as six months old. It is contraindicated in individuals with thin ear drums that have a hole in them or have not completely healed from previous conditions; in individuals with injuries or cuts in the ear canal; in those with abnormal blood vessels behind the ear drum; in cases of infection in the ear canal; in those with implantable electronic medical support systems including pacemakers, defibrillators, or cochlear implants; in individuals who have had allergic reactions to local anesthetics; or in those with unusual ear anatomy that would prevent tube placement in the desired location.
Developers say the hope is that the new system will lead to a better experience for patients requiring ear tubes, as well as savings to healthcare costs.
“The Tula System was developed in close collaboration with physicians over many years, with a shared objective of providing patients and their families with an in-office treatment option for ear tubes,” says Matt Brokaw, vice president of marketing and sales at Tusker Medical. “This option not only addresses the risks and anxiety associated with the operating room and general anesthesia, but has the potential to deliver significant savings for our healthcare system as well.”
1. Nationwide Children’s Hospital. Ear Tubes. Available at https://www.nationwidechildrens.org/specialties/ear-nose-throat-ent-services-otolaryngology/find-a-service/ear-tubes. Accessed January 10, 2020.
2. US Food and Drug Administration. FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection. Nov. 25, 2019. Available at https://www.fda.gov/news-events/press-announcements/fda-approves-system-delivery-ear-tubes-under-local-anesthesia-treat-ear-infection. Accessed January 10, 2020.
3. US Food and Drug Administration. Summary of Safety and Effectiveness Data. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf19/P190016B.pdf. Accessed January 10, 2020.
4. US Food and Drug Administration. Tula System P190016. Dec. 20, 2019. Available at https://www.fda.gov/medical-devices/recently-approved-devices/tular-system-p190016. Accessed January 10, 2020.