New device restores single-sided deafness
San Mateo, Calif.—The Food and Drug Administration in January approved the SoundBite hearing system, a device that restores single-sided deafness.
Although the product was designed for use by ear, nose and throat specialists and audiologists, there is a dental aspect to it because it works by being fitted around two posterior maxillary teeth. The device is then aided by a small microphone in the ear canal that conducts sound through bones and teeth.
SoundBite was invented by Amir Abolfathi of Sonitus Medical. Michael Murray, M.D., an ear, nose and throat doctor from San Jose, Calif., Gerald R. Popelka, Ph.D, a professor of head and neck surgery at the Stanford University School of Medicine, and Dr. Ross Miller, an orthodontist from Sunnyvale, Calif., conducted the clinical trial on the device and the May/June Otology & Neurotology journal contains a controlled, randomized study on 28 patients with single-sided deafness who wore the device daily for 30 days.
Dr. Miller stressed that in order to be considered for SoundBite, patients must have good dental health. He said the device is designed to work on mouths with permanent restorations—including implants, root canals, bridges and crowns—since it relies on the teeth to hold it in place.
SoundBite is currently doing a small commercial pilot program with select ENTs around the country, with broader commercial availability for early next year, he said.
For more information, visit www.sonitusmedical.com/product/technology.cfm.