Elizabeth Cowen's face lights up with pure 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, who lives near Fort Lauderdale, Fla., 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 says. "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 says. 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.
"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."
The procedure is not for everyone, he says, 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 softspoken conversation.
"It's a miraculous invention," she says.
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 says.
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 says.
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.
The sound she heard was not normal, she said. Even her own voice sounded strange to her. And in some noisy settings, it was still difficult to hear the words being said to her.
"Not hearing is so socially isolating -- in a work environment, in a social environment -- people just don't understand how critical it is," she says.
Still, she was apprehensive about the surgery.
"I called some other people who had done it to talk about their experience. It's my head, it's my ear, and I was scared. But these other two people told me it was life-changing," she says.
One of the first in South Florida to undergo the procedure was Mary Corenblum, 82, of Pembroke Pines, Fla., who worked for Miami-Dade Schools for 32 years, the last 10 in the high school registrar's office.
"I was getting up in years, and the noise in a registrar's office, with computers and students, was more than I could deal with," says Corenblum, who worked until a couple of years ago, retiring at age 79. She, too, used hearing aids but was dissatisfied.
"I had been wearing a hearing aid in one ear for 10 years, and one in the other ear for five years. I was just not happy with them. I thought they were blocking some of the sound, and my ears hurt from wearing them," she says.
Corenblum learned about the clinical trial for the new device and after preliminary testing, she learned she was a good candidate. She had the surgery in November 1998.
"It's been a wonderful experience," she says. "I can go into a crowd and still hear my friends when they're talking. I hear other people, but there's no feedback like with a regular hearing aid."
Dr. Mark Widick, an otologist and neurologist with Ear, Nose and Throat Associates of South Florida in Boca Raton, performed his first Vibrant Soundbridge procedure in mid-April on an 80-year-old man.
"He did fine. He went home two hours later," Widick says.
There is no age limit for the procedure so long as the patient is in otherwise good health, he said. "Older people are fine, assuming they are in reasonable shape, but they may never see the cost savings that a young person would see."
Widick says someone like Cowen is the perfect candidate because she will have more years to enjoy the benefits, and would likely have had to replace her digital hearing aids again in a few years, so the cost might even out.
"We charge between $13,500 and $16,000. A pair of digital hearing aids is about $5,000 or $6,000," he says.
The cost of the new technology may come down as more people opt for it, Widick says. He estimates that 95 percent of older people with hearing loss would be good candidates.
"Anybody wearing a hearing aid could at least inquire about it because there would be a reasonable chance that they could benefit from it," Widick says.
"It's an astounding thing. There will be a certain amount of people who are going to think `Awww, it's just another hearing aid,' but the way this device works is so amazing. That little vibrating unit will probably still be in use 20 years from now."
For more information, Symphonix has a Web site, www.symphonix.com and a toll-free number, 800-833-7733.