Tympanostomy and a thumbs-up in the same visit.
Introducing the in-office alternative to traditional tympanostomy for pediatric patients.
The Tula® System is FDA-approved for patients as young as six months old.
Part 1Child-friendly Local Anesthesia
The needle-free Tula Iontophoresis System applies a low-level electrical charge to the TYMBIONTM ionic local anesthetic, accelerating drug uptake into the tympanic membrane. The child may play quietly, watch videos or snack during the process.
Part 2Rapid Tube Delivery
The Tula Tube Delivery System allows a physician to create a myringotomy and insert a 1.14 mm inner diameter grommet in less than half a second, minimizing the amount of time the child needs to remain still.1
Part 3Behaviorial Management Program
The Tula System is supported with an educational and training program designed with input from experts in pediatric psychology, medical stress and pain management.
Safety and Efficiency
In a recent clinical study of 337 subjects aged 6 months to 12 years, Tula System was demonstrated safe and effective. There were zero serious device, drug, or procedure-related adverse events.2
87% overall in-office success rate2
In the Tula pivotal study, 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.4
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 papoose boards. 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.
95% of parents were very satisfied with their Tula Procedure2
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.
94% tube patency at 3-week follow-up2
The Tula System allows physicians to create a myringotomy and insert a 1.14mm inner diameter grommet style tube in-office. Functional patency rates for office-placed Tula tubes are similar to rates reported in the literature for traditional tubes placed in the operating room.3
Only 7.6% of patients in the Tula pivotal study were suctioned in-office, yet high patency rates were maintained despite the low rate of suction. Notably, of ears with mucoid effusion at the time of intervention, 96.5% were clear of effusion at 3-week follow-up.
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