The device, called the Tubes Under Local Anesthesia system, is the first ear tube delivery system that can be used in young children using local anesthesia in a physician’s office.
While physicians often use antibiotics to treat ear infections, if the antibiotics fail or if infections continue, physicians may recommend a surgical procedure to place a small tube in the eardrum, typically done in a hospital setting and requiring the patient to receive general anesthesia.
The TULA system uses a small electrical current to deliver a local anesthetic to the eardrum prior to the tube being inserted. It is approved in adults and children as young as 6 months.
In a clinical trial, the device had a success rate of 86 percent. The most common adverse event was inadequate anesthesia during the procedure.
The device should not be used in children under 6 months or who have allergies to some local anesthetics. It is also not intended for patients with pre-existing issues with their eardrum, such as a perforated eardrum.
Tusker Medical’s TULA system was granted breakthrough device designation.
Read the full news release here.
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