In-office insertion tympanostomy tubes in children using single-pass device.

Area of Science:

• Otolaryngology
• Pediatric Medicine
• Medical Devices

Background:

• Tympanostomy tube (TT) insertion is typically performed in children under general anesthesia in an operating room.
• This approach carries risks, inconvenience, and costs associated with surgical procedures.

Purpose of the Study:

• To evaluate the safety and efficacy of in-office TT placement in awake children using a novel single-pass insertion device.
• To provide an alternative to traditional operating room procedures.

Main Methods:

• A prospective, single-arm, multisite investigation involving 229 children.
• In-office TT placement was performed in awake children using topical anesthetic and a novel single-pass device.
• Safety was assessed by monitoring procedural events and adverse events (AEs).

Main Results:

• Successful TT placement was achieved in 98.7% of children (226/229).
• The procedure was well-tolerated by all children, with only two minor AEs reported in one patient.
• Median procedure time for bilateral TT placement was under 5 minutes.

Conclusions:

• In-office TT placement using topical anesthetic and a single-pass device is a safe, successful, and well-tolerated procedure for children.
• This method offers a viable alternative to operating room surgery, aligning with recent guidelines supporting in-office procedures.
• The findings support an in-office option for clinicians and parents concerned about surgical risks, costs, and inconvenience.