JUST REPORTED:

First Fully-Implantable Hearing Aid Under Consideration

A panel of ear, nose and throat experts is considering whether to recommend approval of the first fully-implantable hearing aid. Patients with mild to severe hearing loss would be able to use the device.

A company-sponsored trial showed that all patients had improved their hearing after implantation with the Esteem hearing system, made by Envoy Medical Corp. of St. Paul, Minnesota. Fifty-four out of 57 patients reported improved scores on a speech reception threshold test. But there could be lingering side effects that include a disturbance in sense of taste. Facial palsy was also a concern.

The device is implanted in the middle of the ear. Doctors would need to separate the three bones that make up the ossicular chain of the middle ear, along with removing a small bone called the incus.

About 5.3%, or three out of 57 patients, required revision surgery after receiving only a “limited benefit” from the device. In these instances, investigators found fibrous adhesions that stopped the hearing aid from working.