Abstract
Objective: Investigate the safety and efficacy of a novel automated tympanostomy tube delivery system for the creation of a myringotomy and the placement of a tympanostomy tube for patients presenting with chronic otitis media with effusion and/or recurrent acute otitis media.
Method: A prospective, multicenter, single arm clinical study enrolled 53 subjects. Tube placement was performed in an operative setting using the Acclarent Tympanostomy Tube Delivery System (TTDS). Patients underwent physical examination and audiometry preoperatively and at one week postoperatively.
Results: A total of 53 subjects (47 subjects 5 years of age and younger) were enrolled in the study at 4 United States centers. From these subjects, 101 ears were enrolled and 5 were excluded because of study criteria related to condition of the tympanic membrane. There were no serious device-related adverse events. The primary efficacy endpoint, successful tube deployment across the tympanic membrane, was achieved: 95 of 101 (94%) attempted deployments in the cohort were successful. Tube retention was also evaluated as a secondary endpoint, and 94 of 95 (99%) tubes placed with the device were retained at follow-up.
Conclusion: The Acclarent TTDS is a safe and effective device for placement of tympanostomy tubes in patients with chronic otitis media with effusion and recurrent acute otitis media. Given the device’s safety, efficacy, and speed of tube delivery, further investigation of its in-office application under local anesthesia is warranted.
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