Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)

You may not qualify if:

• Significantly atrophic, retracted or retraction pocket at location of tube placement, bimeric, monomeric or atelectatic tympanic membrane.
• Perforated tympanic membrane.
• Otitis externa.
• Hemotympanum.
• Damaged/denuded skin in the auditory canal.
• Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane potentially causing abrasion or irritation to the external ear canal.
• Notable ear discomfort experienced during audiologic or otoscopic examination.
• Anatomy that precludes sufficient visualization of and access to the tympanic membrane.
• Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane.
• Pregnant or lactating females
• History of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine, or any hypersensitivity to local anesthetics.
• Familial history of insensitivity to lidocaine or other local anesthetics of the amide type.
• Electrically sensitive medical support systems (eg, pacemakers, defibrillators, cochlear implants)
• Other conditions that would preclude performing the study procedure including iontophoresis system ear plug incompatibility.
• Health conditions that, in the opinion of the investigator, would present undue risk to the subject, based on device/anesthetic drug product label warnings and precautions