Earset Healthy Volunteer Study

Performance of the Acclarent Iontophoresis System With Earset (IPSES) in Healthy Volunteers

The study will recruit healthy volunteers to undergo the Iontophoresis procedure using the Acclarent Iontophoresis System with Earset (IPSES).

Inclusion Criteria:

• At least 12 months old

Exclusion Criteria:

• Pregnant or lactating females
• Subjects with history of sensitivity or reaction to lidocaine, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution
• Significantly atrophic or perforated tympanic membrane
• Otitis externa
• Damaged or denuded skin in the auditory canal
• Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
• Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
• Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure.