In-Office Tympanostomy Tube Placement Using Iontophoresis and Automated Tube Delivery Systems.

ABSTRACT:

Objectives

(1) To evaluate safety, tolerability, and technical success of lidocaine iontophoresis and a tympanostomy tube placement system for adults in an office setting and (2) to meet regulatory evidence requirements for new drugs and devices.

Study design

Prospective, multicenter, single arm.

Setting

Patients were recruited in 8 community-based practices in the United States between June and September 2017.

Subjects and methods

This study evaluated tympanic membrane anesthesia and tube placement in 30 adults. Anesthesia was achieved via iontophoresis of a lidocaine/epinephrine solution. Tube placement was conducted using an integrated myringotomy and tube delivery system. Tolerability of tube placement was measured using a patient-reported visual analog sca

SUBMITTER: Yen DM 

PROVIDER: S-EPMC7040928 | biostudies-literature | 2020 Jan-Mar

REPOSITORIES: biostudies-literature