Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children

A Prospective, Multi Center, Non-randomized Clinical Trial to Evaluate the Ear Effusion Detection and Characterization System (EEDCS) to Detect and Characterize Middle Ear Fluid in Children

The study has three objectives:

1. To determine if the device can detect if middle ear fluid is present in children who are scheduled for tube placement (myringotomy)
2. If fluid is present to characterize the fluid as thick or thin
3. Evaluate the safety of the device

Inclusion Criteria:

• 6 months to 17 years
• scheduled to undergo myringotomy procedure

Exclusion Criteria:

• mastoiditis
• tympanostomy tubes
• chronic middle ear disease
• otitis externa
• perforations of the middle ear
• use of antibiotic ear drops within 2 days of surgery
• systemic antibiotic use