Implants a generation beyond hearing aids

May 27, 2001|By Nancy McVicar, South Florida Sun-Sentinel.

Elizabeth Cowen's face lights up with delight as the audiologist taps keys on a tiny computer.

"How does my voice sound?" asks Susan Lopez, who works at the University of Miami School of Medicine Ear Institute.

"You sound great," Cowen answers. For the first time in more than 15 years, she is hearing well without wearing a hearing aid, and she doesn't need to read Lopez's lips.

Cowen, 51, of Cooper City, opted for an innovative alternative to hearing aids called the Vibrant Soundbridge.

The device was approved by the U.S. Food and Drug Administration eight months ago after clinical trials at the Ear Institute and elsewhere proved it safe and effective.

Cowen had surgery in mid-February to insert a tiny sophisticated gadget, a transducer, into her middle ear.

The device, about the size of a grain of rice, was attached to a small bone called the incus in her middle ear.

Dr. Thomas Balkany, director of the Ear Institute, performed the two-hour procedure, cutting through the mastoid bone behind the left ear while Cowen was under general anesthetic. He placed a second component, an internal receiver, slightly above and behind the ear.

"This is for people with nerve-type hearing loss, the most common type of hearing loss that exists," Balkany said. "The most common cause of it is the normal aging process, but it also occurs in younger people because of a genetic predisposition, noise exposure and certain medications."

Balkany and other ear specialists at the institute have performed 15 of the procedures so far with good results, he said. The technology works for people with moderate to severe hearing loss. Just 41 physicians or clinics across the country have been trained to offer the new procedure, including Dr. Richard J. Wiet, chief of the Division of Otolaryngology for Evanston Northwestern Healthcare and a participant in the implant clinical trials.

"We did the first one in the Chicago area, at Evanston Hospital. We've done a second ear, and we have two other prospective patients lined up," Wiet said. "I'm very impressed."

He added a caveat, however, that it is better for a patient to try hearing aids first rather than resort to surgery without considering the options.

Nevertheless, Balkany said, "most people who receive Vibrant Soundbridge are very happy about the quality of the sound. I think that's because it's a direct-drive system. The energy of sound is applied directly to the bones of hearing in the middle ear, so it's more natural."

It is isn't cheap

The procedure is not for everyone, he said, and the cost (about $15,000 total) is not covered by health insurance.

Elizabeth MacDonald, a field clinical specialist with Symphonix Devices, which makes the Soundbridge, said the company recommends that patients try a good-quality hearing aid first. (Symphonix, based in San Jose, Calif., does not make hearing aids.)

"We recommend a less invasive approach first," she said. "Some people do fine with hearing aids."

Cowen was one of the people who did not like her hearing aids.

Eight weeks of healing were required before the final step that would restore Cowen's hearing. Lopez attached an audio processor about the size of a quarter, held in place by a magnet attracted to the internal receiver behind the ear.

The audio processor "turns on" Cowen's hearing by picking up sound and transmitting it across the skin into the internal receiver, which in turn, transmits it to the transducer in the middle ear, causing it to vibrate.

That sends an enhanced signal along to the fluid-filled inner ear, the cochlea, which stimulates her auditory nerve connecting to the brain, which interprets it as sound.

Cowen could hear the hum of the air conditioner in the room, a plane headed in for a landing at Miami International Airport and soft-spoken conversation.

"It's a miraculous invention," she said.

Cowen began losing her hearing at age 30.

"It's not just something that happens to old people. Part of it is probably genetic, but I also think all those loud concerts I went to in college contributed to it. I would come out of there with my ears just ringing," she said.

She hid hearing aids

For years she hid her hearing loss from family and friends, covering the hearing aid she hated with hairstyles that fell over her ears. It was uncomfortable to wear and did not do a very good job, she explained.

She learned to read lips but was missing a lot of what was going on around her.

"Sometimes her daughters would be calling her from across the room, and I would have to put my hand on her shoulder to get her attention," said her mother, Gladys Cowen of Miami.

Out of frustration and necessity--she needed to be able to hear to perform her duties as general manager of Harrison Uniform in Miami--she spent $6,000 on state-of-the-art digital hearing aids for both ears, which helped, but she hated them, too.