Local woman’s praise of device can be heard LOUD AND CLEAR

By Jonathan Kaminsky
Times-News
August 9, 2005

If a new ear implant currently being tested by the Food and Drug Administration lives up to its promise, the hearing aid as we know it may become an artifact of the past.

Only 35 people in the United States and Germany have had the new device surgically implanted as part of the testing.

Among them is 58-year-old Burlington resident Pat Andrews, whose device, called the Envoy, was recently implanted by Dr. Eric Kraus at the Ear Center of Greensboro.

Andrews, like the other patients, suffers from sensorineural hearing loss, a condition affecting the ear’s ability to transmit sound to the brain.

Because the device is in phase two of FDA trials, the company developing it, Minnesota-based Envoy Medical Corporation, shies away from making claims about its effectiveness.

The same doesn’t hold for Andrews, who has struggled with bad hearing for 30 years.

"People with my type of hearing loss will be thrilled with this," she said in a recent interview at her home.

After her device was activated last month, she said, the change was immediate.

When she walked out of the hospital, she heard an odd "whump" noise over and over. This, she soon realized, was the sound of car tires on the pavement.

That afternoon, she went out to eat with friends. When the waitress asked if she wanted coffee, her reply was an immediate "Yes, ma’am."

Three friends, who had reflexively turned to Andrews to repeat the waitress, were astonished.

"You can hear her!" they said.

Andrews said the Envoy has improved her hearing in the implanted ear from 40 percent to 80 percent. "This is the most exciting thing that’s ever happened to me," she said.

THE NEW DEVICE differs from today’s hearing aids in two important ways. First, it is implanted. That means it requires a fairly intensive surgery, which in Andrews’ case took about four and a half hours.

Being under the skin and out of sight is a selling point for the hard of hearing who don’t like the visibility of hearing aids.

For Andrews, this also means not having to worry about taking it out before getting in the shower or going out in the rain.

A downside: The device runs on an internal battery that must be surgically replaced after four to five years.

Over time, the company hopes to stretch the battery life to 10 years.

Second, and perhaps more significantly, the Envoy doesn’t rely on an artificial microphone. Instead, it senses sound coming in and stimulates small hairs in the inner ear to vibrate and transmit that sound to the brain, as happens in a normally functioning ear.

This is important because whereas an artificial microphone makes no distinction between different kinds of sound, the inner ear tunes out some sounds and sends others to the brain.

For Andrews, it’s the difference between understanding her grandchildren on the phone and getting sweaty palms trying to hear them through the static.

Among the novel features of the Envoy is its remote control. With it, Andrews sets her preferred volume level and also has three background noise settings to choose from.

The remote doesn’t work from a distance — Andrews holds it against her head to change the volume — but that hasn’t stopped some friends from grabbing it and trying to turn her off, she said.

Andrews’ biggest fear, she said, is losing the remote:

"Then what?"

OVER THE LAST 10 years, Envoy Medical Corporation has poured $60 million into developing and testing the Envoy, and plans to spend another $10 million before bringing it to market, the company said.

Although Andrews and the others participating in the trial don’t have to pay for anything, the Envoy, should it become available to the public, will be expensive.

The company predicts the device, surgery and follow-up visits will cost between $25,000 and $30,000. Hopefully, said Rochelle Amann, a company spokeswoman, insurance companies will start covering it within a couple years of its introduction.

The Envoy’s potential American market is the 22 million people who have sensorineural hearing loss but aren’t functionally deaf, said Amann.

For the deaf, there are cochlear implants, which have an exterior microphone and an internal component that bypasses the inner ear. They have been on the market for decades.

The Envoy is also not for outer-ear problems, which are treated both with and without surgery.

In 2002, FDA phase one testing of the Envoy yielded mixed results. While the device appeared to improve hearing, it also leaked fluid into the ears of the seven test patients.

The company’s engineers went back to the drawing board and last year rolled out a redesigned model, which, according to Kraus, seems to have corrected the earlier problem.

With phase two testing well under way, and an additional 25 devices to be implanted by the end of October, the company hopes to have FDA approval by the end of 2006 and the Europeans’ blessing by the end of this year.

KRAUS, WHO PERFORMED Andrews’ surgery, is one of 10 doctors in the United States and Germany participating in the trials.

To date, all 10 of the patients in whom he has implanted the Envoy are "doing very nicely," he said in a telephone interview.

All his patients have improved hearing and none have suffered major complications, he said.

The same is true of test patients treated by the other doctors, said Amann.

As with any surgery, there are risks involved, the most serious of which are facial paralysis and death.

In keeping with FDA requirements, each patient is being closely monitored and regularly tested for a year. In practice, Kraus said, he’ll be keeping tabs on his patients "for life."

If all goes according to plan, Envoy Medical Corporation will open two surgical training clinics within the year. The company plans to base one in Greensboro, with Kraus in charge.

"It’s very exciting," said Kraus of the Envoy. "Breakthroughs happen every ten years or so. This may be the beginning of one."

For Andrews, who runs a house-cleaning business, there are activities that she’s taking up again after a yearslong hiatus.

For one, going to the movies. The last one she saw in theaters was "Steel Magnolias." That was in 1989. And then there are the things she’s been doing all along, but which have taken on new layers of meaning. "I always used to sing in the shower," she said. "I never knew how bad I sounded. "But I’m not going to stop — now I really have something to sing about."

Jonathan Kaminsky can be reached at jonathan_kaminsky@link.freedom.com