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.
Alternative hearing aid bridges the silence
The Vibrant Soundbridge is returning natural sounds to people with hearing loss.
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