(RxWiki News) The US Food and Drug Administration (FDA) has approved a new system that allows ear tubes to be inserted without surgery.
This new system is referred to as the Tubes Under Local Anesthesia (Tula) System. The FDA approved it for use in children as young as 6 months old. The Tula System is also approved for use in adults.
This system allows the delivery of ear tubes in young children in a doctor's office under local anesthesia. This method is different from the way ear tubes (tympanostomy tubes) have been delivered in the past. Up until this point, the delivery of an ear tube required general anesthesia and had to be performed in a hospital or surgery center.
The Tula System allows the doctor to deliver the local anesthesia to the ear drum to perform the procedure.
Children often have ear infections, otherwise known as otitis media. The National Institute of Deafness and Other Communication Disorders (NIDCD) estimates that about 5 out of 6 children will have at least one ear infection before they turn 3.
Generally, antibiotics are prescribed to treat ear infections. If the antibiotics do not work or if the child continues to get ear infections, surgery to place a small tube in the eardrum may be recommended.
“Today’s approval offers patients an option for the treatment of recurrent ear infections that does not require general anesthesia ...” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a press release. “This approval has the potential to expand patient access to a treatment that can be administered in a physician’s office with local anesthesia and minimal discomfort.”
A common adverse event reported with the Tula System involved not having enough local anesthesia during the procedure.
The Tula System is not for everyone. It may not be an option for you if you have an allergy to certain local anesthetics or if you have a perforated eardrum, for example.
The Tula System's approval was granted to Tusker Medical.
Speak with your health care provider if you have any questions.
Written by Anyssa Garza, PharmD, BCMAS