In late 2010, the FDA approved a new hearing device called the Envoy Esteem. The Esteem is a fully implantable hearing aid with an external remote control. The battery has a life of up to nine years. The device is indicated for patients with moderate to severe sensorineural hearing loss with a speech discrimination score of greater than 40 percent. Most patients who are candidates for the Esteem have already tried conventional hearing aids and are unsatisfied with them for any number of reasons from poor sound quality to frustration with using and wearing the hearing aid.
The Esteem works differently from conventional hearing aids, which pick up and amplify the volume of external sounds. The Esteem is implanted via an outpatient surgical procedure. A sensor is attached to the incus and a driver is attached to the stapes. The Esteem uses the patient’s own eardrum as the microphone. When sound vibrates the eardrum, the malleus moves and this moves the incus. The sensor picks up these vibrations and sends them electronically to the sound processor, which sends them to the driver, which is attached to the stapes. The sound processor is programmable and has a battery life of up to nine years. Changing the battery can be done via a simple outpatient procedure.
Patients are allowed to heal for approximately eight weeks after surgery and then the device is then activated. All programming can be done via the remote control. Usually a few postoperative appointments are done in the first six months to maximize the gains of the device. Most patients report significant gains in word recognition and hearing. Some patients have later gone on to have surgery in the contralateral ear.
The surgical procedure is technically demanding and the overall plan is to have 10 to 20 centers of excellence in the United States. In the Midwest, Dr. Sam Marzo, a Professor of Otology, Neurotology, and Skull Base Surgery, in the Department of Otolaryngology – Head and Neck Surgery at Loyola University Health System, has been trained in how to perform the surgery and has successfully implanted several patients since Dec 2010.
At present, the total cost for the device is approximately $30,000. This includes the device, surgical procedure fee, anesthesia fee, and surgery center fee. More information can be obtained at www.envoymedical.com