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Implanted Hearing System Approved
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WEDNESDAY, March 17 (HealthDay News) -- The Esteem implanted hearing system is the first completely implanted system approved by the U.S. Food and Drug Administration for adults with moderate-to-severe sensorineural hearing loss, a permanent lack of hearing, the agency said Wednesday.
Sensorineural hearing loss can be caused by genetic factors or by inner-ear damage resulting from causes such as loud noise, a viral infection or general aging, the FDA said in a news release.
Three implanted components comprise the system: a sound processor, a sensor and a driver that converts electrical signals transmitted by the sound processor to the inner ear, which perceives them as sounds.
The most severe adverse reactions resulted from the implant surgery, and included facial paralysis (7 percent) and taste disturbance (42 percent). Most of these reactions resolved during the one-year clinical testing of the device, the agency said.
The device is produced by Minnesota-based Envoy Medical Corp. As a condition of approval, Envoy must conduct longer-term studies of the device's safety and effectiveness, the FDA said.
-- Scott Roberts
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