The Tula pivotal study is a prospective, multicenter study evaluating the safety and effectiveness of in-office ear tube placement with the Tula System in children aged 6 months to 12 years. The procedural and post-procedural results through 6-months follow up were published in 2020.1 A new publication extends the findings to show successful tube placement was accompanied by positive long‐term outcomes.2
There were zero serious device, drug, or procedure-related adverse events in the study. Patients were treated in-office without use of sedation, anxiolytics or mechanical restraints. Behavior management techniques of distraction (toys, videos), engagement with patient, and framing (age-appropriate communication about the procedure) were among the methods used to minimize patient anxiety and distress.1
Procedural success was defined as tubes placed successfully in both ears for a bilateral case. 91% of patients in the Tula pivotal study were bilaterally indicated. Unsuccessful procedures were most commonly due to behavior (5%) or inadequate anesthesia (3.2%). In more than half (53.6%) of the cases that failed bilateral tube placements, doctors were able to successfully insert an ear tube in one ear.3
Parent satisfaction was recorded at the 3-week follow-up with 95% percent of parents noting “Strongly Agree” (82%) or “Agree” (13%) to the following statement: “Overall, I am very satisfied with the in-office ear tube procedure.” A total of 201 parents completed the survey.
“There’s hesitancy at any time you transition from an operative procedure to an office-based procedure, but what we’ve found is with proper instruction, proper patient identification, and proper technique, this procedure can be done safely and very efficiently in the office.”D. Macy Vidrine, MD, FAAOA
“I really like the Tula System because it gives parents the option of getting their child’s ear tubes placed without a general anesthetic. From a parent’s perspective, this is an enormous advantage – less time off work and performed in an office setting. This technology represents a broader movement in our field towards patient-centered therapies.”Lawrence R. Lustig, MD
“This personally hits home because my daughter had tubes when she was one year old, and we went to the operating room. I’m really excited that now we have the option to do that same procedure but in the office setting where a child wouldn’t have to be NPO, they could drink even during the procedure, and I think that’s a tremendous improvement in what we can do today.“Ritvik Mehta, MD
We provide a broad array of materials and tools along with a dedicated field team to support you throughout the reimbursement lifecycle. Payer engagement to expand coverage, policies, and patient access to the Tula procedure is a priority for our reimbursement team. Explore information on coding and billing for Tula, frequently asked questions, and published health policies in favor of Tula.