The FDA has cleared the way for Envoy Medical to market a first-of-its-kind prosthetic hearing restoration device. Unlike hearing aids, the Esteem device does not use a microphone or speaker. Instead, it uses the natural ear drum to detect sounds and sends a clear message to the brain, via the auditory nerve.
"Once implanted, Esteem is invisible, not just to others, but the patient is also unaware of its presence in their body. Recipients can resume a normal life," Shelly Amann, president of Envoy Medical, notes in a statement.
The approval follows a Dec. 18, 2009 unanimous vote by an independent advisory panel in favor of approving the Esteem for moderate to severe sensorineural hearing loss, which is usually caused by genetic factors or damage to the inner ear resulting from noise, viral infections, or aging.
As a condition of the approval, Envoy will be required to conduct two post-approval studies. In one study, Envoy must continue to follow-up on 61 subjects from the original study for five years to evaluate safety and effectiveness. Another study of 120 newly enrolled subjects will include an evaluation of the incidence of facial paralysis at one month after implantation and evaluate the effectiveness of Esteem five years after implantation.