Implanted Hearing Device Approved
THURSDAY March 20, 2014, 2014 -- The first implantable device for adults with a severe or profound form of a condition called "sensorineural hearing loss" has been approved by the U.S. Food and Drug Administration.
Sensorineural hearing loss, the most common type, occurs when the inner ear's cochlea is damaged. Aging, heredity, loud noise, certain drugs and some types of illness are common causes, the FDA said.
Symptoms of sensorineural hearing loss may include difficulty hearing faint sounds, problems understanding people with higher-pitched voices, and inability to hear high-pitched sirens, such as those emitted by a smoke detector or ambulance.
The Nucleus Hybrid L24 Cochlear Implant System may offer hope to people with inner ear damage who don't benefit from conventional hearing aids, the FDA said Thursday in a news release.
The device was evaluated in clinical studies involving 50 people with severe to profound high-frequency hearing loss. Common adverse reactions included low-frequency hearing loss, ringing in the ears (tinnitus), electrode malfunction and dizziness.
The device is produced by Cochlear Ltd., based in Australia.
The FDA has more about hearing loss.
Posted: March 2014