The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
tympanostomy tube delivery system
South Coast ENT
Port Saint Lucie, Florida, United States
Advanced ENT and Allergy
Louisville, Kentucky, United States
Ear Medical Group
San Antonio, Texas, United States
Evergreen Sinus Center
Kirkland, Washington, United States
Safety of Tympanostomy Tube (TT) Delivery System
Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.
Time frame: 7 days
Device Success
Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis.
Time frame: 0 days
Proportion of Subjects With Procedure Success
Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects.
Time frame: 0 days
Tube Retention
Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.
Time frame: 7 days
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