OKLAHOMA company gets FDA approval on implant for hearing impaired
Friday, September 7th 2001, 12:00 am
By: News On 6
OKLAHOMA CITY (AP) _ The Food and Drug Administration gave a company approval Friday to market a surgically implanted ear device judged effective for helping people with moderate to severe hearing loss.
The device made by Oklahoma City-based Soundtec Inc. would be cheaper than a similar device now on the market and the required surgery would be much less complicated.
``It's wonderful news,'' Soundtec president and CEO Ted Davis said Friday. ``We're excited to get started.''
The device is 44 percent more effective than traditional hearing aids in the range of sound where most hearing loss is reported, according to a 103-patient trial reported to the FDA, said Dr. William Luxford, an otologist with the House Ear Institute in Los Angeles, which does implant research.
Soundtec spokeswoman Cara Smith said the company has held workshops training about 300 doctors in the procedure to implant the device, and anticipates having about 1,000 doctors trained in the procedure by the end of the year.
San Jose, Calif.-based Symphonix won FDA approval of a middle ear implant device last summer. A similar device developed by Otologics of Boulder, Colo., is being tested.
The Symphonix device is implanted under general anesthetic during a two-hour surgery at a cost of $15,000 to $18,000 per ear, said Dr. William Slattery, director of clinical research at the institute.
The Soundtec device approved Friday by the FDA can be implanted in a 30-minute procedure under local anesthetic at a cost of $4,000 to $5,000 per ear.
Traditional hearing aids, which cost up to $3,500, magnify sound. The middle ear implants convert sound to mechanical vibrations of the middle ear bones _ the way normal sound moves through those bones.
Soundtec uses a magnet inside a canister, the size of a pen point, implanted on one of those bones, called the stirrup, so that it vibrates in a more accurate fashion and improves hearing.
In the surgical procedure, the tissue between the eardrum and the ear canal is incised so that the eardrum becomes a flap giving a surgeon access to the middle ear.
The magnet canister is placed on the stirrup and the flap is closed and heals in six to eight weeks. A sound processor is then fitted in the ear canal like a hearing aid and emits electromagnetic waves that activate the magnet and vibrate the stirrup.
Symphonix's device uses a microphone and battery that are surgically implanted in a patient's scalp. The microphone transmits sound through the skin to a receiver surgically implanted in the mastoid bone behind the ear. A wire leads down to a small electromagnet implanted in the middle ear that drives the vibrations.
No studies have been done comparing the performance of the Soundtec device to the performance of the Symphonix device. Studies submitted to the FDA show both are safe and effective for the treatment of moderate to severe hearing loss, said FDA spokeswoman Sharon Snider.
Some patients report that the devices eliminate distortions and feedback commonly associated with traditional hearing aids.
Soundtec is a privately held company.