Medically-Treatable Hearing Loss System Approved

The U.S. Food and Drug Administration has approved the first totally implanted hearing system.

The FDA said the Esteem System is designed to treat moderate to severe sensorineural hearing loss, a type of permanent hearing loss usually caused by genetic factors or damage to the inner ear resulting from noise, viral infections or aging. Such a loss of hearing produces reductions in the perception of sounds and in the ability to understand speech.

Sensorineural hearing loss differs from conductive hearing loss, which occurs when sound waves cannot transmit well through the outer or middle ear or both, the FDA says, noting medical or surgical treatment can often restore hearing in people with a conductive hearing loss, which can be caused by earwax, fluid in the middle ear space or a punctured eardrum.

"The approval of Esteem provides patients with an option to alleviate their hearing loss by using a device with no readily visible external components," says Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

The system, manufactured by the Envoy Medical Corp. of St. Paul, MN, is designed to alleviate the effects of hearing loss in patients ages 18 years and older.