CLiKX DeviceCLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes

Inclusion Criteria:

1. Subject is scheduled to undergo tympanostomy tube insertion.
2. Subject is ≥ 6 months old at the time of informed consent.
3. Subject has an ear canal diameter of ≥ 4 mm.
4. 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).

Exclusion Criteria:

1. Subjects who are pregnant as confirmed by the institution's standard pre- surgery practice.
2. Subjects with known adverse reaction to anesthesia.
3. Subjects with atrophic, dimeric, severely thinned and scarred, severely thickened, severely retracted, atelectatic or perforated tympanic membrane.
4. Subjects with otitis externa.
5. Subjects with active acute otitis media.
6. Subjects with an ear canal diameter < 4 mm.
7. Ear drums that are overly vertical or horizontal
8. Subjects with an anatomy that precludes visualization and access to the tympanic membrane, in the opinion of the investigator.
9. Subjects with any condition that, in the opinion of the investigator, may place the subject at greater risk.
10. Subjects with suspected middle ear tumors or vascular lesions.
11. Subjects diagnosed with acute sensorial hearing loss
12. Subjects with a history of surgery involving the ear drum.
13. Subjects with hemotympanum.
14. Subject is not able or willing to comply with study procedures and follow-up requirements, in the opinion of the investigator.