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# Tusker Medical Ear Infection Tubes Approved
- URL: https://www.fdaweb.com/tusker-medical-ear-infection-tubes-approved/
- Published: 2019-11-26T12:00:00.000Z
- Updated: 2026-09-14T15:54:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145590

FDA has approved a Tusker Medical PMA for the Tubes Under Local Anesthesia System for delivery of tympanostomy tubes (ear tubes) that can be inserted into the eardrum to treat recurrent ear infections (i.e., otitis media). An [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-system-delivery-ear-tubes-under-local-anesthesia-treat-ear-infection?ref=fdaweb.com) says this is the first ear tube delivery system that can be performed in young children using local anesthesia in a physician’s office setting. The system comprises the anesthetic Tymbion, tympanostomy tubes, and several devices needed for inserting the ear tubes and the anesthetic into the ear drum.

Approval is based on data from 222 pediatric patients that showed a procedural success rate of 86% and 89% in children younger than age five and between ages 5-12 years old, respectively, the agency says. The most common adverse event observed was inadequate anesthesia during the procedure. FDA says the device should not be used in patients younger than six months of age or patients who have allergies to some local anesthetics.