This new system has been approved by the U.S. Food and Drug Administration (FDA) for the insertion of ear tubes, also known as tympanostomy tubes. The delivery of these tubes into the eardrum can help in treating ear infections like otitis media.
The Tula system is the first-ever system for young children in which tympanostomy tubes can be inserted in a physician’s office setting via the use of local anesthesia. Besides Tusker Medical tympanostomy tubes, the system also includes several other devices that are required to deliver anesthetics and ear tubes into the eardrum.
According to the director of the Center for Devices and Radiological Health, Jeff Shuren, this system provides patients with an alternative that can cure ear infections without using general anesthesia.
Every year, millions of children face the problem of ear infections, indicating the need for effective and safe therapies for the vulnerable population. The FDA’s approval allows the patients to have access to a treatment in which ear-tubes can be inserted in the physician’s office without causing much discomfort.
According to an estimation by the National Institute of Deafness and other Communication Disorders (NIDCD), every five in six children will suffer from an ear infection, at least once before their 3rd birthday. Most of the time, antibiotics are prescribed by physicians to treat ear infections.
But, if antibiotics aren’t able to cure this condition or it continues to occur, health care professionals suggest the insertion of a small tube (tympanostomy tube) in the eardrum using surgical procedure. Normally, this procedure requires general anesthesia to be given to patients and is performed in a surgery center or hospital setting.
On the contrary, the Tula system doesn’t require the use of general anesthesia for the delivery of the tympanostomy tube in the eardrum. Here, before tube insertion, a local anesthetic is delivered into the patient’s eardrum using a small electrical current.
The Tusker Medical has received the FDA’s approval of the Tula system. That can not only be useful for adults but also children above six months of age. For checking the efficacy of the Tula system for ear tubes delivery, the U.S. Food and Drug Administration has analyzed the data of nearly 222 pediatric patients.
Among the children aged less than 5 years, the success rate of this procedure was 86%. Whereas, the figure was found to be 89% in the children aged 5 – 12 years. Inadequate anesthesia during this procedure was the most commonly observed adverse outcome.
It is recommended to avoid the use of the Tula system in patients having an allergy to certain local anesthetics or in those having an age less than 6 months. Moreover, the use of this system should also be avoided in patients suffering from an eardrum-associated problem, like perforated eardrum.
Apart from approval, the FDA has also granted this system with the Breakthrough Device designation. To meet the criteria for such designation, a device must be aimed at diagnosing or treating an irreversibly devastating disease or life-threatening condition.
Moreover, the device should also meet one of the following conditions. It must be a revolutionary technology, shouldn’t have any approved alternative, and must provide more advantages than the existing approved alternatives. Also, the device’s availability should be in the patient’s best interest.