The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under moderate sedation and local anesthetic.

The study was a multi-site, prospective and retrospective, treatment-only post-market study of the H-TTS. The study was performed in a commercial environment. Patients were already have a scheduled tympanostomy procedure with the H-TTS under moderate sedation and local anesthetic.

Inclusion Criteria:

• Age 6 months through 5 years of age
• Candidates for ventilation tube placement
• H-TTS used under moderate sedation and local anesthetic

Children 6 months through 5 years of age, who are candidates for placement of VT.

One site enrolled patients prospectively. Data from the other three sites was retrospectively procured from a previous multi-site moderate sedation study using data that was not previously submitted to FDA.

Intra-operative and pre-discharge

All adverse events (AE) that occured from when the H-TTS entered the ear through discharge were reported. The event type, treatment, severity and relationship of the event to the procedure or to the study device will be assessed by the surgeon.

Prospective definitions for anticipated adverse events and serious adverse events were included in the protocol attachments. Common occurrences (e.g., minor bleeding, purulent discharge) during a tympanostomy procedure were not considered AEs.