Tusker Medical's Tula System

On Nov. 25, 2019, FDA approved Tusker Medical's Tula System, which is intended to insert ear tubes (tympanostomy tubes) into the eardrum to treat repeated ear infections or fluid in the ear in young children and adults using local anesthesia in a physician’s office. The Tula System consists of the Tula Iontophoresis System and the Tula Tube Delivery System. The Tula Iontophoresis System, which includes individually-fitted disposable ear plugs and ear sets, delivers a local anesthetic solution, Tymbion, to the eardrum resulting in numbness of the eardrum. The Tula Tube Delivery System is then used to place the ear tube in the eardrum.

How it works: The Tula Iontophoresis System uses a small electrical current to deliver the Tymbion to the eardrum prior to tube insertion. The fitted earplugs keep the local anesthetic solution in the ear canal. Once the eardrum is adequately numb, the physician removes the earplugs and uses the Tula Tube Delivery System to create a small hole in the eardrum and insert the ear tube.

The effectiveness of the Tula System for the delivery of ear tubes was assessed in a clinical study of 222 pediatric patients, ages 6 months to 12 years. Physicians were successful in placing ear tubes using the Tula System in 86% (103 of 120) of children ages 6 months to 4 years and in 89% (91 of 102) of children ages 5 to 12 years.

In the same study, pain and distress related to the procedure were evaluated. A video-based pain scoring method was used for younger children, ages 6 months to 4 years. Older children, ages 5 to 12 years, self-reported pain scores. For all patients, pain and distress were rated using a 0 to10 scale, where 10 represents severe pain or distress, and 0 represents no pain or distress. Children ages 6 months to 4 years had an average observed score of 4.0 for the ear tube insertion phase of the procedure, which decreased to 1.3 at the end of the procedure. Children ages 5 to12 years with successful ear tube insertion reported an average score of 3.3 for the tube insertion phase of the procedure, which decreased to 1.7 at the end of the procedure.

FDA noted that the system should not be used in patients with any of the following conditions:

An ear drum that is unusually thin, has a hole in it, or has not completely healed from a previous condition
Injuries or cuts in the ear canal
Abnormal blood vessels behind the ear drum
An infection in the ear canal, referred to as otitis externa or swimmer’s ear
Implantable electronic medical support systems, such as pacemakers, defibrillators, or cochlear implants
A history of developing an allergic reaction to local anesthetic, or numbing, medications, or to any of the added Tymbion ingredients
A family history of insensitivity to the numbing action of local anesthetic medications, including lidocaine
Unusual ear anatomy that would prevent ear tube placement in the desired location