A Prospective Clinical Study of the Clikx Tympanostomy Tube Delivery System for Patients Requiring the Placement of Tympanostomy Tubes
This study looks at the safety and performance of the CLiKX device. The device is used to place ear tubes (also called ventilation tubes) in children and adults. These tubes help treat chronic ear fluid (otitis media with effusion) and other conditions where a doctor decides an ear tube is needed. In this study, surgeons will use the CLiKX device to place an ear tube in the patient's ear. The study will check if the surgeon can place the tube correctly in the right position. The procedure will first be attempted with no anesthesia or with local anesthesia. If needed, the surgeon may then use mild sedation or general anesthesia. The study will also look at how well patients tolerate the procedure by checking for side affects during the procedure. Finally, the study will look at how the device affects the procedure and patient safety. Researchers will review how the procedure is performed and will follow patients for up to 30 days after the procedure to continue to check for any side effects..
• Subject is scheduled to undergo tympanostomy tube insertion.
• Subject is ≥ 6 months old at the time of informed consent.
• Subject has an ear canal diameter of ≥ 4 mm.
• Subject is able and willing to provide informed consent or subject's parent/guardian is able and willing to provide informed consent and subject is able and willing to provide assent as age appropriate (age 7 years to 21 years old).