FDA APPROVES IMPLANTABLE DEVICE FOR MANY WITH HEARING LOSS
Author Unknown, contributed by a Beineinu parent
People with certain vision problems had spectacles for centuries, and then came Lasik surgery. For several decades, people with hearing loss due to noise, viral infections, or aging have had hearing aids to help maintain an aural tie to the world. Now many of those patients will have a surgically implantable hearing system called Esteem.
The new device is considered to be the first hearing aid that has no externally visible component. It consists of a sound processor, a sensor, and a driver, all of which are implanted under the skin. A clinical study considered by the FDA showed that 93 percent of the patients who received the implantable hearing device had hearing as good as or better than they had with an external hearing aid. Seven percent experienced poorer hearing.
AS with Lasik, however, undergoing surgery to restore lost hearing hs its risks; 7 percent of study participants who received the Esteem system experienced facial paralysis, and 42 percent experienced taste disturbances—both results of the surgical procedure necessary to implant the device.
While most of those problems went away within a year, the FDA has directed the St. Paul Minnesota based manufacturer of Esteem, Envoy Medical Corporation, to follow a group of subjects from their first study and to enroll 120 new subjects in a trial designed to gauge the facial paralysis risk and benefits of the system five years after surgery.