We’ve reached a time when implantable devices have a real role as part of the spectrum.Explore This Issue
May 2011—Moises Arriaga, MD
“The fully implantable is a seductive direction to go,” said Franz, who noted that her company is developing such a system. She also pointed to the advantages of partial implantation. For example, when MED-EL introduced Amadé, a new digital external processor, in the U.S. last year, existing Vibrant Soundbridge patients could easily substitute it for their old processor without the need for surgery.
“MED-EL’s philosophy is to take an atraumatic approach,” Franz said. Soundbridge surgery does no damage to the middle ear and has no impact on residual hearing.” She contrasted that with implantation of the Esteem, which involves removal of a small part of the incus. (Envoy Medicals counters this statement by pointing out that the incus can be easily reconstructed should a patient quit wearing the device.)
Another limitation of currently approved totally implantable systems, she said, is that only people with purely sensorineural losses are candidates. However, she noted, MED-EL is conducting investigational trials on an implantation method for the Soundbridge designed to help patients with conductive or mixed losses. It involves coupling the device to the round window, which causes the bone of the outer wall of the cochlea to vibrate.
Despite the challenges facing middle ear implants, otologists and manufacturers alike generally anticipate a dramatic increase in the adoption of this still-new category of device.
“We’ve reached a time when implantable devices have a real role as part of the spectrum of treatments available to people with moderate to severe hearing loss,” said Dr. Arriaga. He estimated a potential U.S. market for MEIs in the high six figures.
“We just have to let people know it’s there,” he added. “Right now, a lot of people think there is nothing [that] can be done beyond hearing aids, and that’s not necessarily the case.”