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Ear Infections In Children Could Be Treated Now With Local Anesthesia

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The U.S. Food and Drug Administration or FDA approved a new system for the delivery of ear tubes into the eardrum under local anesthesia and minimal discomfort to the patient to treat recurrent ear infections.

The regulator granted approval for Tusker Medical's Tubes Under Local Anesthesia (Tula) System as the first ear tube delivery system that can be performed in young children using local anesthesia in a physician's office setting.

The Tula System consists of the anesthetic Tymbion, Tusker Medical tympanostomy tubes or ear tubes, and several devices needed for the delivery of the ear tubes and the anesthetic into the ear drum. This system also does not require general anesthesia.

The System uses a small electrical current to deliver a local anesthetic into the ear drum prior to tube insertion. It is approved for use in both adults and children as young as six months of age.

"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," said Jeff Shuren, director of the FDA's Center for Devices and Radiological Health.

The National Institute of Deafness and other Communication Disorders (NIDCD) estimates that five out of six children will have at least one ear infection (otitis media) before their third birthday.

These infections are generally treated with the prescription of antibiotics. If this fails, a doctor may recommend a surgical procedure to place a small tube in the eardrum, a procedure that is performed in a hospital setting or surgery center under general anesthesia.

The Tula System was granted Breakthrough Device designation by the FDA. This designation is generally granted to a device that must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease with no approved or cleared alternatives.

The system was approved by the FDA after evaluating procedural success rate data from 222 pediatric patients to assess the effectiveness of the Tula System for the delivery of ear tubes. The success rate was 86 percent in children younger than age 5 and 89 percent in children between ages 5 to 12 years.

The FDA said the most common adverse event observed was inadequate anesthesia during the procedure. The Tula System should not be used in patients younger than six months and is not intended for patients who may have pre-existing issues with their eardrum.

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