Writer: Laura Johannes
Wall Street Journal

An unusual new extended-wear hearing aid can be worn continuously for up to four months and replaced when its battery dies. The device-which is buried deep in the ear canal and is invisible-is low-maintenance and allows patients to enjoy life without daily reminders of their hearing loss, according to the company that sells it. Some clinicians say patients love it; others say further research is needed on its long-term safety.

Many people with hearing loss shun mechanical aids for cosmetic reasons, or because of the hassle of frequently putting them in and out and changing batteries.

The Lyric, sold by InSound Medical Inc. of Newark, Calif., is a small cylindrical device roughly the size of two pencil-top erasers placed side by side. It's worn all the time-even when showering, sleeping and playing sports. The device can't be worn swimming, but a new model expected out later this year can be.

Only about 50% of patients with hearing loss are eligible to use the device, the company says. That's because many people have ear canals too small or not straight enough to fit it, or because they have medical limitations, such as Type I diabetes or a compromised immune system, that could put them at high risk for infection. It's powerful enough only for those with mild-to-moderate hearing loss.

Downsides include its high cost-about $3,000 to $4,000 for a year's subscription for both ears, which includes up to eight devices a year, as needed. Some patients experience pain or irritation in the ear, resulting in the need for the device to be removed for at least a few days, says New York ear specialist Michael Scherl. Unlike conventional hearing aids, the battery isn't removable, so you have to see a doctor or audiologist for a new device whenever it dies.

"Perfect? No," says Paul Pessis, a Chicago-area audiologist and past president of the American Academy of Audiology, a trade group. "We still don't have the perfect hearing aid." But Dr. Pessis, who has been selling the device since last summer, says "patients are loving its performance," including the natural quality of the sound. It's possible for patients to use a cellphone, and many are even finding they can use iPod ear buds, typically a major challenge with hearing aids, he says.

Unlike traditional hearing aids, which are typically placed behind the ear or in the outer portion of the ear canal, the Lyric is placed deep in the canal, about four millimeters from the eardrum. It is too deep in the ear to see. And the placement of the speaker so close to the ear drum allows for a clearer, more natural sound, says inventor Robert Schindler, co-founder of InSound.

The device is inserted, using lube and forceps, in a couple of minutes by a doctor or audiologist. It is Food and Drug Administration-approved for continuous use up to four months, though the average time it is left in place is 70 days, according to InSound. In addition to battery death, many devices are removed when they become clogged with ear wax.

Patients are given a small grappling hook to remove the device if needed; for example, it cannot be worn during MRI scans. A small key-chain magnet device is used to turn it on or off and adjust the volume; it can be left on all the time unless you want to, say, tune out a snoring spouse.

So far, no major safety problems have been reported, says InSound. Clinicians report some minor ear infections. One potential concern is a serious infection called malignant otitis externa, caused when an ear infection spreads to the base of the skull. So far, some 2,750 patients have received the Lyric with no serious infections, InSound says.

No peer-reviewed published data exist on the device's safety and efficacy. Dr. Scherl, in a 500-ear study he plans to present at a coming scientific meeting, says the device appears safe, but that about 3% to 4% of the study patients experienced irritation and inflammation, "analogous to wearing shoes too tight." It must be removed for several days for the irritation to heal, he says.


And, Lyric was also featured in the New York Times, as written by write Tara Parker-Pope!

The devices can squeal with feedback and overamplify background noises like the click of a turn signal or whir of a ceiling fan. They must be removed for showering or sleeping, and their batteries die frequently. Many users, out of exasperation, decide they'd rather live with hearing loss.

But now scientists have come up with a different kind of hearing aid. While the device, called the Lyric, is being used in only 500 patients, it appears to have overcome many of the problems associated with traditional hearing aids - without the expense and uncertainty of surgery and anesthesia.

The Lyric, made by InSound Medical of Newark, Calif., is hidden deep inside the ear canal, just four millimeters (about one-sixth of an inch) from the ear drum. While doctors for years have been implanting hearing devices in the middle ear, the Lyric is not an implant: it can be removed with a small magnet. It is worn 24 hours a day, and its batteries last one to four months.

Typically, anything that clogs the ear canal would trap moisture and pose an infection risk, but the Lyric is surrounded by a spongy material that allows moisture to escape. Because it sits so close to the ear drum, doctors say that it works more efficiently and that sounds are more natural because they don't have to be amplified as much.

When the Lyric's battery dies, the entire device is replaced. Patients do not pay for a new device every time; instead, they pay an annual subscription fee of $2,900 to $3,600 for both ears (less if the hearing loss is in only one ear). Insurance plans typically do not cover the cost of the Lyric, or any other hearing device.

A magnet is used to control the volume, turn it on and off and remove it when the battery runs out. It takes only a few minutes for a doctor to insert a replacement device.

The Lyric does not work for everyone. In particular, some ear canals are too narrow to accommodate it, and the company estimates that it is not suitable for up to half of potential patients. A planned newer version should work for about 85 percent of patients, it says. The Lyric, made by InSound Medical of Newark, Calif., is hidden deep inside the ear canal, just four millimeters (about one-sixth of an inch) from the ear drum. While doctors for years have been implanting hearing devices in the middle ear, the Lyric is not an implant: it can be removed with a small magnet. It is worn 24 hours a day, and its batteries last one to four months.

Typically, anything that clogs the ear canal would trap moisture and pose an infection risk, but the Lyric is surrounded by a spongy material that allows moisture to escape. Because it sits so close to the ear drum, doctors say that it works more efficiently and that sounds are more natural because they don't have to be amplified as much.

When the Lyric's battery dies, the entire device is replaced. Patients do not pay for a new device every time; instead, they pay an annual subscription fee of $2,900 to $3,600 for both ears (less if the hearing loss is in only one ear). Insurance plans typically do not cover the cost of the Lyric, or any other hearing device.

A magnet is used to control the volume, turn it on and off and remove it when the battery runs out. It takes only a few minutes for a doctor to insert a replacement device.

The Lyric does not work for everyone. In particular, some ear canals are too narrow to accommodate it, and the company estimates that it is not suitable for up to half of potential patients. A planned newer version should work for about 85 percent of patients, it says.

Still, it is already getting an enthusiastic reception from patients and from hearing specialists not connected with the company. "There are a certain number of patients who just can't get over having something in their ear, just as there are a certain number of patients who can't wear contact lenses," said Dr. Chester F. Griffiths, chairman of the department of surgery at the Santa Monica U.C.L.A. Medical Center. "But that's the minority. The patients that have them love them."

Dr. Griffiths says he has no financial ties to the Lyric, nor does he receive a commission for referring patients.

One patient who swears by the device is Mike Waufle, the 53-year-old defensive line coach for the New York Giants. After a stint in the Marines and regular exposure to the sounds of gunfire, Mr. Waufle suffered hearing loss that grew worse and worse as he aged.

On the football field, he just turned up the volume on his headset. But the locker room was a different story. Some voices were impossible to hear (including that of his last boss, Jon Gruden, the former Oakland Raiders head coach). Players learned they needed to face him when they spoke to him. Using a traditional hearing aid, he found it difficult to control his own voice.

"I teach a lot in a classroom as a coach, but when I would wear a hearing aid my voice pattern wasn't very good," he said. "It was all over the place. I just took it out most of the time. I missed an awful lot."

As it happened, a team doctor was one of a handful of physicians test-marketing the Lyric, which has been available for about 16 months. Mr. Waufle tried it, and he says it has changed his life.

"My voice pattern is so natural, and I hear so much better," he said. "Obviously, it's easier to carry on normal conversations without having to always say, 'Huh? What did you say?' And it helps just enjoying life over all and being able to hear the simple things like birds and other sounds you take for granted."

Mr. Waufle says he has no financial ties to the company and receives no benefit for talking about his experience with the device. (The company says none of the people featured in testimonials on its Web site, www.lyrichearing.com, receive any form of compensation for their endorsements.)

Right now, the Lyric is offered only through a dozen clinics in California, Florida and New Jersey, but it should be available at about 100 sites by the end of the year. Some patients who don't live near a clinic simply fly or drive to a site four or five times a year. InSound is a privately held firm, although the pharmaceutical giant Johnson & Johnson is a major investor.

Dr. Robert A. Schindler, a co-founder of InSound and chairman emeritus of the department of otolaryngology at the University of California, San Francisco, says he has had hearing loss most of his life and has worn a Lyric since 2005. He says he remembers listening to an orchestra and hearing the light ping of the triangle.

"I realized I hadn't heard it before," he said. "That was a very exciting moment for me."