The FDA has given breakthrough device approval to a system to deliver tympanostomy tubes to young children with recurrent ear infections, in a physician’s office and under local anesthesia.

Tusker Medical’s Tubes Under Local Anesthesia (Tula) system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of the ear tubes and the anesthetic into the ear drum.

The iontophoresis system uses a small electrical current to deliver a local anesthetic into the ear drum before tube insertion. The electrical current accelerates tissue uptake of the ionic drug, according to Tusker’s website. Tula is approved for use in both adults and children as young as six months of age.

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