Global

‡ In these countries please contact our distributor

Behavioral Management Program

Overview

Behavioral 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.

  • “We’re Going to the Ear Doctor” a child’s book that walks the patient through the procedure in a way which is easily understandable.
  • Tula Parents Guide explains the procedure to parents, letting them know what to expect.
  • Fun sticker sheet to reward the patient at the end of the procedure.
Safe and effective
  • 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.1
Practical
  • 87% overall in-office success rate2
High satisfaction
  • 95% of parents were very satisfied with their Tula Procedure
Effective
  • 94% tube patency at 3-week follow-up
References
1.PMA P190016 FDA Summary of Safety and Effectiveness Data.
2.Defined as tube placement in all indicated ears. 220 patients, 91% percent bilaterally indicated, evaluated for procedural success with 86% (103/120) success with patients under 5 years old and 89% (91/102) success with patients 5-12 years old.68 OR lead-in and 47 office lead-in not included, as per the study protocol.