In‐office insertion tympanostomy tubes in children using single‐pass device

OBJECTIVES: Insertion of tympanostomy tubes (TT) is generally accomplished in children in the operating room under general anesthesia. We report on 229 children treated in‐office with a novel device. METHODS: Investigators participated in an IRB‐approved, prospective, single arm, multisite investigation of in‐office TT placement in awake children. Topical anesthetic was applied, and protective restraint was used. TT placement was performed with a single‐pass TT insertion device. Safety was assessed by monitoring procedural events. RESULTS: Four hundred and forty‐four ears were treated in 229 children at 10 sites. Children were in age groups 6‐24 months (n = 211, mean = 13 months) and 5‐12 years (n = 18, mean = 8.3 years). Two hundred and fifteen children received bilateral TT placement, and 14 received unilateral placement. Overall, 226/229 (98.7%) children had successful TT placement in the office (209/211 in 6‐24 months and 17/18 in 5‐12 years). Three children were rescheduled for the operating room due to anatomical challenges or patient movement. Median procedure time for bilateral cases in both age groups was 4:53. Two minor adverse events (AEs) were reported in one patient. Per independent assessment of 30 procedure videos by clinicians, TT placement was tolerated acceptably by all children. CONCLUSION: In‐office TT placement in awake young children using topical anesthetic, enabled by a single pass delivery device, was safe, successful and well tolerated. The American Academy of Otolaryngology (AAO) recently released a Position Statement supporting in‐office TT placement in appropriate children. These results affirm an in‐office alternative for clinicians and parents who have concerns with the risk, inconvenience and cost of surgery in an operating room under general anesthesia. Level of Evidence: 2c. Clinical Trials Registration Number: NCT03544138.