In-Office Tympanostomy Tube Placement in Children (OTTER)

Inclusion Criteria

• Males or females at least 6 months old through 12 years old at time of consent
• Indication for tympanostomy tube insertion per Clinical Practice Guideline
• Behavioral capacity and cooperative temperament to undergo an awake procedure, based on physician judgment (not applicable to OR Lead-In subjects)
• Subject's parent/guardian and subject are able and willing to comply with the protocol and attend all study visits
• Subject's parent/guardian and subject are able and willing to provide informed consent or assent as age appropriate

Exclusion Criteria

• Significantly atrophic, retracted, bimeric, monomeric or atelectatic tympanic membrane
• Perforated tympanic membrane
• Otitis externa
• Active or recent conditions of the tympanic membrane (eg, prior myringotomy with incomplete wound healing or re-epithelization)
• 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
• 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
• History of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the anesthetic drug formulation (not applicable to OR Lead-In subjects)
• Familial history of insensitivity to lidocaine or other local anesthetics of the amide type (eg, history of inadequate anesthesia with dental numbing agents). (not applicable to OR Lead-In subjects)
• 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.
• Subject is 4 years or older and not able to complete all baseline assessments. Subject is younger than 4 years and not able to complete all baseline assessments, not including audiometry.