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Hearing Journal:
doi: 10.1097/01.HJ.0000293907.12435.ba
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As candidacy criteria loosen up, use of cochlear implants grows rapidly

Florian, John

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Freelance writer and President of John Florian Media, a communications firm based in Trumbull, CT.

ochlear implants aren't what they used to be. Nor are implant candidates.

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Those are two factors that have made the cochlear implant sector a bright spot in the hearing industry. The number of implants has grown by 20% a year in North America over the past 5 years and by 45% worldwide. What's more, advances in research and technology promise to expand dramatically the number of people eligible for implantation.

According to cochlear implant manufacturers, some 60,000 to 65,000 people have been implanted worldwide, about 24,000 of them in the U.S. It is estimated that this country has another 500,000 candidates for today's devices. However, technology now being developed could widen the pool to many millions of people.

As the use of cochlear implants increases, new opportunities will emerge outside formal cochlear implant centers for hearing healthcare professionals who learn how to program the devices and offer continuing patient care (see sidebar).

Introduced in the 1970s, cochlear implant devices and accessories are now in their third generation. Today's models pulsate at higher speeds with more electrodes, offer less conspicuous external components, and come with more effective hardware, software, and batteries. Moreover, they are enabling wearers to enjoy improved sound quality and log ever-improving speech-recognition scores.

Just over the horizon are:

* totally implantable cochlear implants

* hybrid devices that combine features of hearing aids and implants

* implants that work in combination with a hearing aid, in the same ear

* improved adaptability to telephones and assistive listening devices; and

* easier programming and adjustment.

Following, and in an accompanying article in this issue of The Hearing Journal, cochlear implant manufacturers, surgeons, and specialists tell about the ever-widening world of cochlear implant candidacy and technology.

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THREE MANUFACTURERS

Only three companies manufacture cochlear implants: Advanced Bionics Corporation (www.advancedbionics.com), Cochlear Ltd. (www.cochlear.com), and Med-El (www.medelus.com). All three now market worldwide, but Med-El did not begin sales in the U.S. until August 2001.

Advanced Bionics is based in Valencia, CA. Douglas Lynch, the corporate marketing director, says approximately 10,000 of its devices have been implanted, most of them in the U.S.

Headquartered in Australia, Cochlear has a U.S. division, Cochlear Americas, based in Englewood, CO. Sarah Harms, vice-president of marketing, says that about 45,000 people worldwide have received Cochlear's implants, and, she adds, its products represent a majority of those implanted in the U.S.

Med-El, an Austrian company, has supplied more than 10,000 implants worldwide. Approximately 1000 of those implants have been done in the U.S., says Chris Bertrand, president and CEO of Med-El Corporation/North America, in Durham, NC.

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HOW PATIENTS GET IMPLANTS

Some 300 cochlear implant centers in North America handle the job of qualifying candidates, implanting the device, programming it, and providing follow-up care.

Most patients are referred to centers by audiologists or hearing aid specialists, while others go on their own, often after finding a center listed on a manufacturer's web site.

Patients are encouraged to learn about implant brands so as to choose the product that fits their lifestyle and needs. “In most medical situations, the surgeon picks the brand, but with cochlear implants, it's different,” says Kiara Ebinger, PhD, who has conducted cochlear implant research and worked with patients. “The center will present the patient with all the options and recommend a brand if for some reason one is better suited than another for that patient.”

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CANDIDACY CRITERIA ARE CHANGING

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Many people with hearing loss do not know they're candidates for an implant. And often, neither do their hearing care providers.

“This field has changed so fast and so dramatically that not everyone is aware of where we are today,” says Donna Sorkin, vice-president for consumer affairs at Cochlear Americas and an implant wearer.

For example, consider the following patients who might come to your office, each with a question about cochlear implants.

You've known Patient A for many years as a hearing aid wearer with a severe loss. Yesterday he woke to silence. He's 81, completely deaf, and quite scared.

Patient B bounces on her mother's lap, a 1-year-old child who has worn hearing aids for the past 6 months without any benefit.

Patient C has what you've determined to be a severe, but not profound, hearing loss. He functions a bit on the telephone and has some residual hearing. But media reports about celebrities getting cochlear implants—Heather Whitestone McCallum, Rush Limbaugh—are intriguing. So he asks you, “Is my hearing bad enough yet?”

Who among these is a cochlear implant candidate? Actually, all of the above may be. Cochlear implants are no longer just for people who become deaf or profoundly impaired after developing language skills.

“There's still a mindset among some hearing health professionals that cochlear implants are a last resort and only for people who are completely deafened and derive no benefit from hearing aid technology,” says Lynch of Advanced Bionics. “But today that's not true. People who use very powerful hearing aids for a severe hearing loss are now candidates.”

Generally speaking, implant candidacy has expanded in two areas: degree of hearing loss and age of the patient—in both directions.

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Candidates may be younger, older, or less deaf

Originally, cochlear implants were developed for post-linguistically deafened adults.

By and large, those candidates had lived and worked in the hearing world rather than the deaf community, says Noel L. Cohen, MD, professor and chair of the Department of Otolaryngology and director of the Cochlear Implantation Program at New York University Medical Center. Their auditory memory was there, Cohen explains, so it was a matter of switching it back on after whatever trauma or disease had switched it off.

Next, implant researchers targeted post-linguistically deaf children, and then pre-linguistically and congenitally deaf children.

“There was no factual basis for the theory that the same device and same strategies would work on kids who were born deaf,” says Cohen. “But the results have been little short of astonishing. Even older kids—5 to 8 years old—who were born deaf get very, very substantial benefit from cochlear implants.

“If we implant them early enough, those kids are capable of learning how to hear and speak, and can attend mainstream schools,” he says.

Today's cochlear implant candidates include children as young as 12 months to adults of any age. Their hearing loss can be severe to profound, with word-discrimination scores as high as 50% with a hearing aid in the ear to be implanted, or 60% aided binaurally, says Cochlear America's Sorkin.

And what do they gain?

The average cochlear implant recipient understands about 85% to 90% of speech in context, without lipreading, according to Steve Staller, PhD, vice-president for quality, clinical and regulatory affairs at Cochlear Americas. Scores drop to 40%-50% for monosyllabic words without lipreading.

“We expect adults with cochlear implants to be able to carry on verbal communications without lipreading in many, many environments,” Staller says.

Clinical data suggest that people with more residual hearing perform better with a cochlear implant than those with a profound hearing loss, says Lynch. The likely reason, he explains, is that the auditory nerve is more viable in those with a less-than-profound hearing loss. “The central processing with the brain has been exercised with auditory information more recently.”

Implanting these candidates restores consistent high-frequency sound to help their understanding of speech, adds Patricia Chute, AuD, associate professor of audiology at Mercy College in Dobbs Ferry, NY. She explains, “Because of jaw movement or the way a hearing aid sits in the ear, it may not deliver consistent high-frequency sound. By contrast, the input from a cochlear implant is direct and efficient.”

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ADDING A HEARING AID

Whether to get an implant or a hearing aid is not necessarily an either/or proposition. Combining an implant for one ear with an aid on the second ear can produce a “dramatic advantage,” says Jon Shallop, PhD, of the Cochlear Implant Program at the Mayo Clinic in Rochester, MN.

He cites a patient with best aided sentence-recognition scores of 30% in one ear, and 40% in other. “This gives the patient 50% in both ears,” says Shallop, which makes him an implant candidate. “We would most likely select the poorer ear for the implant, which will bring that ear's score up to 80%. The person would also continue to use the 40% ear with a hearing aid and, together, you might get a score of 90%.”

Another benefit is “natural sound,” Shallop notes. While the implant does best with higher frequency sound, the hearing aid will deliver the low frequencies important for music and environmental sounds.

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A FAMOUS ADVOCATE

Even adults who lost their hearing prior to learning language skills may report success with cochlear implants. A well-known example is Heather Whitestone McCallum, the 1995 Miss America, who was implanted last August and is now a spokesperson for Cochlear Americas.

Heather was only 18 months of age when a virus and/or the drugs used to treat it left her profoundly deaf in both ears. Using signing and visual cues, she was able to attend public schools and college. But sound eluded her until the cochlear implant.

“Hearing my audiologist's clapping hands when the implant was turned on brought unimaginable joy to my heart,” she says.

Understanding speech is another matter. “It will take someone in Heather's situation quite a bit longer, and she will probably not get to the same level as someone who was deaf for, say, 5 years prior to the implant,” says Staller at Cochlear Americas.

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YOUNGER IS BETTER

The evidence shows that the earlier a child receives an implant, the quicker that child is likely to gain speech/language skills. Therefore, says Sorkin, “Audiologists need to know that we are now successfully implanting at 1 year of age.”

“Many implanted children are developing age-appropriate language by the time they enter first grade,” Sorkin says. “That was unheard of 10 years ago.”

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DEGREE OF LOSS NOT THE ONLY FACTOR

Determining a child's candidacy is based on more than audiologic tests, points out Sorkin, who was formerly executive director of the Alexander Graham Bell Association for the Deaf and Hard of Hearing and of Self Help for Hard of Hearing People (SHHH). She explains, “I would never say that every child who has an appropriate audiologic profile should get a cochlear implant. It is also a question of the child's family and what they can provide in the way of support.”

Sorkin continues, “What happens after the device is implanted is just as important, if not more important than the device itself. The audiologist who sees the child has a key role in educating parents about what needs to follow.”

Yet Sorkin finds that parents are still getting too little information. For instance, a recent Cochlear Americas survey found that only 41% of parents of children with cochlear implants received comprehensive, unbiased information from early-intervention providers about the range of options. The majority received information that was “biased and focused on just one option,” says Sorkin.

Nevertheless, approximately 9000 children under age 18 have been implanted in the U.S. out of about 45,000 who are candidates, says Sorkin. “That's a pretty high penetration rate, much higher than for adults.” Why? Sorkin says that it's because parents generally act early to enable their child to learn language.

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ADULTS MAY BE RELUCTANT

Even adults who know about cochlear implants may shy away for some of the same reasons that people refuse to wear hearing aids. The surgery is another factor that may discourage prospective users. Plus, many people believe they're simply too old for a cochlear implant. But that's not necessarily so.

More and more people in their 70s and 80s are getting implants and regaining the pleasures of sound and speech. They're hearing their grandchildren, communicating with their spouses, understanding their physicians, and ending the isolation of silence.

Audiologists have a major role in identifying people who would benefit from implants, says Sorkin, who wore hearing aids for many years before her implant surgery. She's grateful for the day her audiologist told her, “Donna, I think you can do better,” and steered her to a cochlear implant center.

Sorkin adds that a key benefit for her has been less fatigue in trying to understand speech. “A lot of people can ‘get along’ with reduced hearing,” she notes. “But they're working really hard to hear, focusing on watching lips. It's not fair that they should have to work so hard when a cochlear implant can help.”

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REIMBURSEMENT IS A KEY ISSUE

The average cost of a cochlear implant in the U.S. is $45,000 to $50,000 for the first year. That covers pre-operative evaluation, surgery, programming, and other services. Future upgrades and tuning, particularly for the changing needs of children, keep the expenses flowing in later years.

Fortunately, health insurance covers much of the cost. But this effectively lets insurance companies determine the range of future cochlear implant candidates.

For example, as the accompanying article on technology explains, hybrid cochlear implant/hearing aid devices could expand candidacy to people with only a moderate hearing loss. And implanting both ears could significantly improve a patient's speech recognition. But will insurers consider these procedures medically necessary?

“The key question is reimbursement, whether or not it will be supported by the insurance companies,” says Chute at Mercy College.

So, even as technology dramatically expands the potential universe of candidates, when it comes to turning candidates into wearers, often the insurer gets the final word.

© 2003 Lippincott Williams & Wilkins, Inc.

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