Picture this:
Tympanostomy and a thumbs-up in the same visit.

Introducing the in-office alternative to traditional tympanostomy for pediatric patients.

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

Practical

87% overall in-office success rate2

Procedural success
About the study

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.

High Satisfaction

95% of parents were very satisfied with their Tula Procedure2

parent satisfaction
About the study

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.

Effective

94% tube patency at 3-week follow-up2

patency by tube
About the study

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.

Physician Perspective

Hear from our clinical investigators on their experiences with the Tula System.

Get in touch

To learn more, review case videos, or experience a hands-on demonstration, meet with your sales representative.

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