Implantable hearing system OK’d
FDA approves device which has no visible components
WASHINGTON – 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. With a Food and Drug Administration decision announced Wednesday, these patients will now have available a surgically implantable hearing system called Esteem.
The new device is considered to be the first hearing aid that has no externally visible components. 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 or better than they had had with an external hearing aid.
As with Lasik, however, undergoing surgery to restore lost hearing has its risks: Seven percent of study participants getting the Esteem system experienced facial paralysis and 42 percent experienced taste disturbance – both the result of the surgical procedure to implant the device.
While most of those problems went away within a year, the FDA has directed the St. Paul, Minn.-based manufacturer of Esteem, Envoy Medical Corp., 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.