FDA approves new cochlear implant
FDA: Implanted Hearing Device Approved
HealthDay News -- The FDA has approved the first implantable device for adults with severe bilateral sensorineural hearing loss at middle and high frequencies, but who have the ability to hear low-frequency sounds unaided.
The Nucleus Hybrid L24 Cochlear Implant System combines features from conventional cochlear implants with those of hearing aids, the agency said in a press release. The devices includes an external microphone and speech processor that is inserted into the ear canal and then transmits signals to an inner-ear implant.
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.
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 device is indicated for implant in only one ear, and is restricted to patients for whom standard hearing aids are ineffective.
"This device may provide improved speech recognition for people with this kind of hearing loss, who have limited treatment options," Christy Foreman, director of the agency's Office of Device Evaluation, said in a press release.
Approval was based on results from clinical studies involving 50 people with severe to profound high-frequency hearing loss in which participants' pre-implant baseline hearing ability served as the control. Most patients reported improvements in their ability to understand speech.
Common adverse reactions included low-frequency hearing loss, ringing in the ears (tinnitus), electrode malfunction, and dizziness. Among the 50 patients that participated in the study, 22 experienced profound or total loss of low-frequency hearing in the ear containing the implant, and six underwent revision surgery to replace the device with a conventional cochlear implant.
However, the FDA concluded that the potential benefits of the device outweigh the risks for patients who continue to have inadequate hearing with ordinary hearing aids.
"Prospective patients should carefully discuss all benefits and risks of this new device with their physician," the agency said.
The device is produced by Cochlear Ltd., based in Australia.