The Tula System has been demonstrated as safe in clinical trials, and 95% of parents were very satisfied with the Tula procedure.1,2
“For Braeden, not going to the hospital was a big relief.”
-Braedan’s mom (Braedan is 7 Years old)
“It was definitely worth it.”
– Ellie’s mom and dad (Ellie is 4½ years old)
“She didn’t have to be separated from us… That was HUGE, to not have to hand her over to strangers.”
– Sloan’s mom (Sloan is 2½ years old)
“We went in the morning to have his tubes placed and went immediately after and got lunch and ice cream, and then we went to school.”
– Henry’s mom (Henry is 6 years old)
References
1 Lustig LR, Ingram A, Vidrine M, et. al. In‐Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery. Laryngoscope 130; S1-S9, 2020. Satisfaction results from parents of children who participated in the Tula pivotal clinical study, n=201.
2 PMA P190016 Summary of Safety and Effectiveness
The information presented about the Tula System is for educational, informational, and illustrative purposes only. It does not constitute and is not a substitute for medical advice and does not provide any indication, guide, or guarantee as to the response a child may have during a Tula System procedure.