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Local doctors helping to pioneer fully implantable hearing aids
Ear doctors at Allegheny General Hospital are the first in the United States to test a fully implantable hearing aid that they hope will be a better and more fashionable alternative than popular aids worn outside the ear.
Doctors at the North Side hospital said Monday the device, which is surgically implanted beneath a patient’s skin, was used last week in four patients from Western Pennsylvania with the most common form of hearing loss.
The condition, called sensorineural hearing deficit, affects nearly 30 million Americans. Victims have partial hearing loss triggered by age or exposure to loud noise over a long period of time. In most of those people, tiny hair cells in the ears known as the auditory nerves are damaged.
“There’s never been anything like this before,” said Dr. Moisés Arriaga, an ear surgeon at AGH who, along with Dr. Douglas Chen, completed the procedures as part of a clinical trial. “Not only is the patient’s hearing being amplified, but they don’t have to wear anything in the ear canal, which is more than a cosmetic issue because it affects the clarity of sound.”
Hearing implant technology isn’t new. Until now, the implants have been tested by the U.S. Food and Drug Administration have parts that rest out side the body on the base of the neck. That’s the case of cochlear implants, which are used mostly for completely deaf people whose ear nerves are fully damaged.
In the new device being tested in the United States for the first time, medical experts said, even the gadget’s battery and speech processor are invisible.
Arriaga said this is a key advantage to traditional hearing aids, which are now only used by 10 to 20 percent of people who need them. He said people shun hearing aids because they dislike their look and the devices obstruct the ear canal.
The device implanted at AGH works with a sensor that picks up sound as it enters the ear canal. The sensor is implanted on the hearing bone behind the eardrum. It detects vibrations, which are sent to a tiny computer processor. The system then sends an electric signal to the hearing nerve in the inner ear, where it is translated into words or sound by the brain, Arriaga said.
Unlike conventional hearing aids, the device uses the body’s own eardrum as its microphone and basically amplifies the signals it receives. Makers of the new technology say this is an improvement because a microphone can muffle or distort background noise.
Advocates for the hearing impaired say the technology is a breakthrough, but caution that people with hearing problems should not hide their condition.
“I’m not convinced the answer is to make them invisible,” said Lori Hanin, director of Audiology for the League for the Hard of Hearing in New York City. “Hearing aids don’t work perfectly, so if you’re not hearing well and you’re missing things, no one will help you if you are hiding the problem.”
Hanin and others called the technology promising but too new to assess. They caution that other implantable hearing devices are costly and not covered by Medicare and most health insurers. Implantable devices can be anywhere from $10,000 to $20,000, compared to $700 for a conventional hearing aid.
Gail Linn, an Audiology expert at the American Speech-Language Hearing Association, said the device could be a welcome alternative for people who have abnormal ear canal and are unable to use conventional aids.
“I would just tell anyone to try a conventional hearing aid first,” Linn said. “It’s an invasive surgery that comes with complications of its own.”
Arriaga said that complications from the three to five hour surgery to implant the device can include hearing loss and infection, but the chance of that is very minimal.
Alleghney General and Virginia Mason Medical Center in Seattle are the only two sites testing the device, called the Envoy System manufactured by St. Croix Medical Inc. in Minneapolis. Arriaga said a total of 10 patients will receive the device, as part of an FDA trial to test its safety.
So far, the implants placed in the four local patients have not been activated. Arriaga said they were tested in the operating room and they appear to work fine. They will be activated in about eight weeks and be monitored monthly for about a year.
The first patient to receive the implant was a 66 year-old man from the North Side. He was followed by three others – a 73 year-old man from the West End, and a 58 year-old woman from Greensburg, Westmoreland County and a 63 year-old man from Johnstown, Cambria County.
Arriaga cautioned that it is too soon to know if the device will work.
“I sure don’t want to give the impression that this is tried and true. Although we’re excited, it’s still very early in the experimental process,” he said.
By Luis Fabregas – Tribune Review - March 19, 2002
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