New System for Ear Tube Insertion Approved by FDA: General Anesthesia Not Required

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Recurring ear infections in children are not only frustrating and painful–they can also cause serious complications. If antibiotics do not successfully treat an ear infection or if infections continue to occur, a physician may recommend the insertion of ear tubes. Until now that has required the use of general anesthesia in an operating room (OR). In November, the U.S. Food and Drug Administration (FDA) granted approval to Tusker Medical’s Tula System. The system will allow ENT physicians to insert ear tubes in an office setting using Tusker Medical’s TYMBION® local anesthesia system.

To support the regulatory approval process, RTI Health Solutions collaborated with Tusker Medical to design and implement a Preference Study to understand parents’ willingness to choose the Tula procedure. The study explained the in-office and OR-based procedure options and described the characteristics, or attributes, associated with each. Parents could choose the OR procedure with a fixed success rate of more than 99% or the in-office procedure with a lower success rate. The results indicated that parents would prefer the Tula in-office procedure as long as its success rate was at least 68%. The performance goal for the Tula pivotal clinical trial was set using the results from the Preference Study, an important advance in regulatory science.  

“For appropriate patients, the Tula System will give parents a choice between general or local anesthesia when having ear tubes placed in their children’s ears,” said Carol Mansfield, PhD, a senior economist in Health Preference Assessment at RTI Health Solutions. “It is always rewarding to work on studies like this that support the FDA regulatory process and advance patient care.”

View the FDA’s Tula System press announcement here.
View Tusker Medical’s press announcement here.

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