Long Term effectiveness of Solo+ TTD: A single step tympanostomy tube (TT) Delivery device.

Abstract

Background: Tympanostomy tube (TT) insertion is typically performed in children in the operating room under general anesthesia. Devices combining equipment and steps in TT insertion, facilitate TT placement and may enable a transition to in-office TT procedures avoiding general anesthesia. This study evaluates the safety and effectiveness of a new TT insertion device, Solo + TTD, with general anesthesia.

Methods: Children aged 6 months to 15 years meeting criteria for TT insertion were enrolled in an IRB-approved multicenter single-arm prospective study. TT insertion was performed in the operating room under general anesthesia using the study device. Intraoperative device success, rate of adverse events, function of ear tubes during follow-up (1, 3, 6, 12, 18 and 24 months), and use of additional instrumentation for placement of Solo + TT were evaluated. Interim data through 12 months of follow up are presented in this paper.

Results: A total of 59 ears in 30 patients were treated at two sites. The mean age of enrolled children was 2.4 years and 57 % were male. Solo + TT insertion was successful (± use of additional instrumentation) in 57/59 (96.6 %) ears with unsuccessful insertion in two patients due to irregular ear canal anatomy. Two ears required a second Solo + TTD cartridge for successful insertion. There were no serious adverse events related to the device or procedure. Non-serious adverse events at one-month (most common bleeding, otorrhea and blockage) occurred at rates (9/30 patients) similar to standard TT. At 1-month follow up, 96 % (51/53) ears had functioning TT. Through 12-months follow-up, 20 % of TT were extruded (9/44 ears) and 88.6 % of present TT (31/35 ears) were functioning.

Conclusion: The Solo + TTD tympanostomy tube device has a high rate of successful TT placement in children under general anesthesia. The device TTs function is similar to traditional TTs and other device TTs out to 1 year. Additional studies evaluating the device in children using topical anesthesia are needed.