FDA Panel OK's Implanted Hear Aid


Friday, July 21st 2000, 12:00 am
By: News On 6


WASHINGTON (AP) — Americans frustrated with their hearing aids may soon get to try a new surgical implant to help them hear better.

Advisers to the Food and Drug Administration unanimously recommended Thursday that Symphonix Inc. be allowed to sell its Vibrant Soundbridge as a treatment for the moderate to severe hearing loss that afflicts millions.

Regular hearing aids that are slipped inside the ear magnify sound.

The Symphonix implant, in contrast, takes sound and converts it to mechanical vibrations of the middle ear bones — the way normal sound moves those bones.

A receiver is implanted behind the ear, leading a wire down to a small electromagnet in the middle ear that drives vibrations when sound is converted to electrical energy, explained Nancy Brogdon, FDA's director of ear, nose and throat devices.

(The implant is very different than another surgical treatment, cochlear implants, for the profoundly deaf. Cochlear implants are electronic systems that send sound-generated impulses to the brain to bypass a flaw in the inner ear.)

The Symphonix implant was studied in about 130 Americans. They first were tested with hearing aids in both ears, and then with the implant in one ear and a hearing aid in the other. Patients could hear about as well with the implant as with two hearing aids, Brogdon said.

The study didn't prove the implant was superior to hearing aids, she said. But it has the advantage that it cannot be seen and can avoid certain other problems inherent to hearing aids, such as complications from ear wax and moisture.

The surgery did pose some risks, Brogdon warned, including facial nerve damage, altered taste and temporary pain.

The FDA didn't signal when it would decide the implant's fate. The FDA isn't bound by its advisers' recommendations, but it typically follows them.