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Viel Spass
Trader
Thursday August 31, 6:47 pm Eastern Time
New type of hearing device wins approval in U.S.
(UPDATE: new throughout)
By Lisa Richwine
WASHINGTON, Aug 31 (Reuters) - A surgically implanted hearing device that uses a new technology to convert sound waves into energy won approval from U.S. health officials on Thursday.
The Food and Drug Administration said it cleared the Vibrant Soundbridge for treating adults with moderate to severe nerve hearing loss, the most common type of impaired hearing.
San Jose, Calif.-based Symphonix Devices Inc. (NasdaqNM:SMPX - news) makes the device, which surgeons implant in the skull behind the ear.
Other hearing aids placed in the ear simply magnify sound. The new device converts sound into mechanical energy, which vibrates structures in the middle ear in a manner similar to normal sound. The brain interprets the vibrations as sound.
The FDA said clinical studies showed the Vibrant Soundbridge was ``reasonably safe and effective.'' Hearing with the implant was about equivalent to standard hearing aids, the FDA said.
The implant is less visible than other hearing aids and was not associated with problems such as ear wax and moisture, the FDA said.
Also, ``the patient does feel the (Symphonix) hearing aid is more comfortable,'' Dr. Sidney Jaffee, an FDA medical officer, said in an interview.
But the implant also carries safety risks, including problems associated with surgery.
In the clinical trials, 2 percent of patients reported that their hearing become worse, and 5 percent had long-term ear pain. Also, 2 percent had permanently altered taste and 16 percent had a permanent feeling of fullness in the ear, the FDA said.
Surgery to implant the device, done on an outpatient basis, takes between 90 minutes and two hours, Symphonix said in a press release.
Patients using the Soundbridge in the clinical trial reported ``improved sound clarity and quality, better overall fit and comfort, and perceived benefit in many listening situations as compared to their own hearing aids,'' the company's statement said.
Symphonix is conducting an 18-month follow-up study to evaluate the long-term safety and effectiveness of the implant, the FDA said.
Nerve hearing loss occurs when the hair cells or nerves in the inner ear become damaged, usually from loud noises, genetic factors or ageing.
Viel Spass
Trader
Thursday August 31, 6:47 pm Eastern Time
New type of hearing device wins approval in U.S.
(UPDATE: new throughout)
By Lisa Richwine
WASHINGTON, Aug 31 (Reuters) - A surgically implanted hearing device that uses a new technology to convert sound waves into energy won approval from U.S. health officials on Thursday.
The Food and Drug Administration said it cleared the Vibrant Soundbridge for treating adults with moderate to severe nerve hearing loss, the most common type of impaired hearing.
San Jose, Calif.-based Symphonix Devices Inc. (NasdaqNM:SMPX - news) makes the device, which surgeons implant in the skull behind the ear.
Other hearing aids placed in the ear simply magnify sound. The new device converts sound into mechanical energy, which vibrates structures in the middle ear in a manner similar to normal sound. The brain interprets the vibrations as sound.
The FDA said clinical studies showed the Vibrant Soundbridge was ``reasonably safe and effective.'' Hearing with the implant was about equivalent to standard hearing aids, the FDA said.
The implant is less visible than other hearing aids and was not associated with problems such as ear wax and moisture, the FDA said.
Also, ``the patient does feel the (Symphonix) hearing aid is more comfortable,'' Dr. Sidney Jaffee, an FDA medical officer, said in an interview.
But the implant also carries safety risks, including problems associated with surgery.
In the clinical trials, 2 percent of patients reported that their hearing become worse, and 5 percent had long-term ear pain. Also, 2 percent had permanently altered taste and 16 percent had a permanent feeling of fullness in the ear, the FDA said.
Surgery to implant the device, done on an outpatient basis, takes between 90 minutes and two hours, Symphonix said in a press release.
Patients using the Soundbridge in the clinical trial reported ``improved sound clarity and quality, better overall fit and comfort, and perceived benefit in many listening situations as compared to their own hearing aids,'' the company's statement said.
Symphonix is conducting an 18-month follow-up study to evaluate the long-term safety and effectiveness of the implant, the FDA said.
Nerve hearing loss occurs when the hair cells or nerves in the inner ear become damaged, usually from loud noises, genetic factors or ageing.
