For delivering tympanostomy tubes a new system called “The Tube Under Local Anesthesia System (TULA)” has been recently approved by the FDA. This system is used to treat recurrent ear infections called “otitis media” by directly inserted into the eardrum. In the physician clinical setting, this is the first ear tube delivery system that is applied to the young children by using the local anesthesia. TULA system comprises of Tusker Medical tympanostomy tubes, anesthetic into the eardrum, anesthetic Tymbion and the devices essential for ear tubes delivery.
Click here to read the press release by FDA.
Children are highly prone to get an ear infection, probably more than the adult population. It is the estimation of the National Institute of Deafness and Other Communication Disorders (NIDCD) that before the age of three years 5 out of 6 children will have any type of ear infection.
At the beginning of infection, it is recommended by health care professionals to treat infections by using antibiotics. And if the infection is not treated with antibiotics and it proliferates then they suggest the surgical procedure that requires a small tube to penetrate the eardrum. The delivery system in the young children may perform in the hospital and surgery center that require general anesthesia
According to Jeff Shuren, (director) FDA’s Center for Devices and Radiological Health that every year millions of children suffering from ear infections i.e. otitis media, to save this great number of the population we must go for the effective treatment. The TULA approval gives an option to the patients to treat recurrent ear infections. With this approval, patients can access this treatment system in the local physician setting with great comfort.
By using the TULA system in the ear tube infections, we use the local anesthesia instead of general anesthesia in the clinical setting. For delivering the local anesthesia it uses a small electrical current into the eardrum. The system can be used in both adults and children younger than 6 months.
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The effectiveness of the Tula system was observed by administrating the drug in 222 pediatric patients to treat ear infections. The rate of success was 86% in the children aged younger than 5 and 89% in patients aged from 5-12 years old. Inadequate anesthesia is the common adverse effect seen during the delivery system. It is prohibited to use the system for those who already have some issues with their eardrum as the perforated eardrum.
The breakthrough Device designation was granted to the TULA system by the FDA. To develop an efficient device or product FDA provided the guidelines and interaction. A device must be capable to treat or diagnose the severe infections in disease or any condition to qualify the designation. It must meet the criteria such as no cleared and approved alternatives, devices represent a breakthrough technology or device availability must be patient’s interest.