Nov 25, 2019 :Tusker Medical recievied approval from The U.S. Food and Drug Administration for the delivery of tympanostomy tubes (ear tubes) that can be inserted into the eardrum to treat recurrent ear infections (i.e., otitis media).
These are the first Tubes Under Local Anesthesia (Tula) System that can be performed in young children using local anesthesi.
The Tula System consists of the anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices essential for the delivery of the ear tubes and the anesthetic into the ear drum for the treatment of recurrent ear infections that does not require general anesthesia.
In a physician’s office setting, this System enables the delivery of an ear tube to patients under local anesthesia.
Small electrical current used to deliver a local anesthetic into the ear drum preceding to tube insertion. It is approved for use in both adults and children (more than six months). https://fda.einnews.com/pr_news/503206800/fda-approves-system-for-the-delivery-of-ear-tubes-under-local-anesthesia-to-treat-ear-infection