The FDA Nov. 26 approved a Tusker Medical device that can be inserted in the eardrum to treat recurrent ear infections.
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.