Cochlear Implant Failure Rates Appear To Be Low In Spite Of Recalls

Results of a study published in the December issue of Archives of Otolaryngology – Head & Neck Surgery, found that rates of cochlear implant failures in a sample of Canadian children implanted between 1990 and 2010 were less than three percent. It’s one of the few studies I’ve seen that attempts to show how reliable cochlear implants are, and according to the authors of the study, the findings indicate a very low failure rate in spite of publicity over the past two years about cochlear implant product recalls.

Advanced Bionics had a major recall starting in 2010 that kept its leading cochlear implant product line off the market well into 2011, and in October 2011 Cochlear Ltd. announced a voluntary recall of its main implant line after reports of a small percentage of failures in past implanted units. When it announced the recall, Cochlear Ltd.’s share price fell 20 percent, but when it announced in late December it discovered the cause of the product failures, the share price bounced back.

Even though the first cochlear implants were developed decades ago, and even with the enormous progress we’ve seen in their ability to restore hearing, we are still early in the game when it comes to performance of the systems and improvements in implantation techniques. It’s good to see both Cochlear Ltd. and Advanced Bionics voluntarily recalled their products when they discovered problems in a small fraction of devices that had been implanted, rather than waiting for regulators to blow the whistle.

If the three major global players can stay on top of the inevitable problems that arise and continue improving the products and performance at the rate they have over the past decade, we can expect to see a lot more deafened children and adults getting their hearing back.

Advanced Bionics Takes The Plunge With Waterproof Neptune Cochlear Implant Sound Processor

Advanced Bionics (AB), the cochlear implant maker owned by Sonova Group, may have been out of the market for a while due to a product recall last year, but it apparently used the time to catch back up with a hot new product that will pose some competitive headaches for the other cochlear implant makers.

AB’s new waterproof Neptune cochlear implant processor, the first  “swimmable” cochlear implant system, was just approved for distribution throughout Europe, following approval in December by U.S. and Canadian regulators of distribution in North America.

At first look, you might wonder why a waterproof cochlear implant system is such a big deal. I don’t wear my hearing aids when I go swimming, and other than a slight fear that I won’t hear the lifeguard’s warning that there are sharks in the water, I get along well enough without them. So why do you need a waterproof cochlear implant system?

One big reason: consider the fact that babies born deaf are now often fitted with cochlear implants right away to help them acquire language at the same rate as hearing children. Then think back to your childhood days splashing around in the pool or in the water at the beach. Not being able to hear a parent yelling at you is a lot more dangerous than my fears about missing shark warnings.

And whereas most adults take a quick dip, most kids will spend as many hours in the water as they are allowed. And for those adults who like to swim a lot for real exercise, I imagine being able to wear the CI while doing laps might be a benefit as well.

The Neptune product is also a new design. Whereas most CI processors are hung behind the ear, the Neptune is a small, seemingly indestructible unit that can be clipped do your lapel or breast pocket, or attached to an armband, with a wire extending to the magnet connector that’s affixed to your skull behind the ear.

For highly active adults and kids, I can see the armband option as a great way to stop worrying about whether the processor will stay put when you’re running, biking or swimming.

Between the cool design and impressive waterproofing technology, I’m glad to see the Number Two cochlear implant maker, now that it’s back on the market following its recall, competing aggressively with new high-tech product designs.

Check Out This Awesome Video On Why Cochlear Implant Users Can’t Hear Music Well

Kudos to Hearing Review for catching this awesome video of a TED conference talk on why cochlear implant users can’t hear music well. This one hits home for me, because when I lost most of my hearing nine years ago, music suddenly became a discordant jumble of noise that was impossible to enjoy any more. Now I find it’s exactly what cochlear implantees experience.

Dr. Charles Limb describes how devastating the loss of  music can be to his cochlear implant patients while explaining in layman’s terms why it happens. As both a musician and a cochlear implant surgeon, he combines his two passions to study the way the brain creates and perceives music. He is an Associate Professor, Otolaryngology, Head & Neck Surgery, at Johns Hopkins who performs cochlear implantations on patients who have lost their hearing. He is also an accomplished musician on the faculty of the Peabody Conservatory of Music who plays sax, piano and bass.

If you listen to the comparison on the video between “normal” symphonic music and an estimation of what people with cochlear implants hear, you will understand the problem better. Cochlear implantees can’t hear the difference–both sound equally bad (I can’t hear the difference either).

Part of the problem is that neither cochlear implants nor hearing aids are optimized as much for music as for speech. The chart that Dr. Limb displays shows the frequencies and sound levels you need to replicate or amplify for speech, versus the much wider range of frequencies required to convey the richness of music.

But the problem also extends to the brain’s ability to process sound as both music and speech, including the emotional impact music can have. Dr. Limb is fascinated with the idea “that acoustic vibrations in the air can make you feel deep emotion, something that can affect your life.” Music requires a comprehension of pitch, tone and timbre, but cochlear implantees, and people like me with certain kinds of hearing damage, can’t discern warmth in a tone or the timbre of a violin versus a trumpet–qualities that enable music to stir powerful emotions.

The interaction between the mechanical hearing functions and how the brain processes sound and music still is not very well understood. Sound waves are shaped within the ear canal and transmitted through the ear drum and middle-ear bones to the hearing-hair-cell nerves in the cochlea, where they are transformed into electrical impulses carried by the auditory nerve. But then the brain takes over and interprets those sound waves, understanding them as speech, music, a baby’s chatter or cry, random noise or other sounds.

Readers of Musicophilia by Oliver Sacks will be familiar with the mysteries of how the brain processes sound. I found some comfort in the research the book reviewed on the brain’s amazing ability to rewire itself to improve its comprehension of audio inputs after the hearing organs have been damaged. In one of his case histories (and to a lesser degree in my own experience), the brain is able to improve its comprehension of speech over time, and to a lesser extent music as well–to fill in the gaps when the hearing organs are malfunctioning.

But as Dr. Limb makes clear, a lot more is unknown than known at this point. How the brain processes and discerns the quality of music — pitch, tone and timbre — is relatively new territory for researchers. While cochlear implants (and hearing aids) have been wildly successful in restoring the ability of the deaf to hear and understand speech, there’s still a long way to go before they can restore a complete ability to appreciate music.

“If you had a sense to lose, we are furthest along medically and surgically with hearing,” says Dr. Limb, but he adds, “Most implant users really struggle and dislike music because it sounds so bad. So when it comes to this idea of restoring beauty to somebody’s life, we have a long way to go.”

Cochlear Ltd. Sales Increase Points To Growing Global Demand For Cochlear Implants, Including Bilateral Sets

Cochlear Ltd. reported a 16 percent increase in profits for the first half of its fiscal year on a 20 percent increase in unit sales of its cochlear implants, pointing to a strong recovery from the recession as well as a growing number of patients opting for a second implant to get bilateral hearing from both ears.

Cochlear CEO Chris Roberts told The Wall Street Journal that strong growth in sales in developing markets where cochlear implants have only recently been introduced indicated acceptance of the implant technology to restore hearing has gone global, providing a positive outlook for long-term growth of Cochlear and the implant industry. He added that in North America and Europe where cochlear implants are well established, there is growing demand for bilateral implants providing stereo sound from restored hearing in both ears. Currently, fewer than 10 percent of patients have a second implant, providing another opportunity for strong growth in the industry.

Roberts also downplayed the market impact of the recent recall by Sonova Group of its Advanced Bionics (AB) subsidiary’s Hi-Res 90K cochlear implants due to a product malfunction. He told BusinessWeek that cochlear implant patients are slow to switch brands and that financial analysts overestimated the positive impact the recall may have had on Cochlear Ltd.’s sales. Sonova CEO Valentin Chapero Rueda last week indicated AB’s cochlear implants could be back on the market by April. There are only three global suppliers of cochlear implants: Cochlear Ltd. is the global leader, Advanced Bionics is the second largest player in the market, and Med-El of Austria is third.

Sonova CEO Says Recall Of Advanced Bionics Hi-Res 90K Cochlear Implant Might Be Over By April

Bloomberg News confirmed that Sonova Holding AG is working feverishly to fix the problems that spurred a global recall of the Advanced Bionics (AB)Hi-Res 90K cochlear implant and hopes to end the recall as early as April or at the latest by the autumn of this year.

Sonova CEO Valentin Chapero Rueda earlier this week indicated in an interview with the Swiss newspaper Handelszeitung that the AB cochlear implants could be back on the market by April, but a Sonova spokesperson clarified the projection in the subsequent Bloomberg story, saying “There’s also a likelihood it could be autumn. Nothing’s final.” Read more

Will Safety Concerns Slow The Growth Of The Cochlear Implant Industry In The Year Ahead?

Just when the cochlear implant industry seemed to be on a roll, the recent announcement by the U.S. Food and Drug Administration (FDA) that Advanced Bionics (AB) is voluntarily recalling its HiRes 90K cochlear implant device raises safety concerns many thought had been put to rest long ago. AB has shared little additional information about the status of the recall since its November news release, in which it described the problem in concise but graphic detail:

“This action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device….This voluntary action is being taken to ensure continued patient safety and product quality. The risk of any significant adverse medical events appears to be remote at present.”

There was immediate speculation that the recall might slow the growth of the cochlear implant market and/or pose a serious financial challenge to AB parent Sonova Holding AG, which acquired the California company in 2009. But while Sonova shares tumbled right after the Nov. 23 announcement, they are still trading well above their low for the year set earlier that month. Read more

Cochlear Ltd. Gets FDA Approval For Water-Resistant Rechargeable Batteries for Cochlear Implants

Cochlear implant recipients will be able to enjoy visits to the beach and swimming pool following the recent approval by the U.S. Food and Drug Administration (FDA) of the new water-resistant rechargeable batteries in Cochlear Limited’s new Nucleus 5 cochlear implant systems.

Cochlear’s next-generation Nucleus 5 system, introduced in 2009, features the industry’s smallest behind-the-ear sound processor, the thinnest implant, a wireless remote assistant that makes it easy to change program settings, and an “Autophone” sensor that knows when you are on the telephone and automatically switches from the external microphone to telecoil reception. Cochlear also claims it has documentation of superior speech comprehension with the new system.

All those advanced features and slick packaging won a prestigious Red Dot design award for Cochlear Ltd. in June. But when you consider how important it is not to worry about getting caught in the rain or how much fun it can be to hear the waves splashing when you’re taking a dip in the ocean, it’s no wonder the water-resistant feature is getting so much attention. Cochlear says the Nucleus 5 device can be submerged in water for up to 30 minutes.

“No other cochlear implant system has ever come close to providing patients with this level of confidence around water,” said Chris Smith, president of Cochlear Americas. “With other cochlear implant systems, patients are forced to weigh the risk of accidentally dropping their sound processor in water and destroying it versus the benefit of hearing in and around water. With Nucleus 5, when using our new rechargeable battery option, there are no risks to weigh.”

When you think of the number of deaf children who use cochlear implants from infancy, it’s gratifying to know there’s one more activity of a normal childhood they’ll be able to enjoy. It’s also gratifying news for harried parents who must make sure the precious equipment that gives their kids the gift of hearing survives the rough-and-tumble of a normal active childhood.

It’s Official: Bilateral Cochlear Implants Improve Quality Of Life

What people like Michael Chorost have long-suspected appears to be true: hearing in stereo is good for your health. A study by the Indiana University School of Medicine found “cochlear implants in both ears significantly improve quality of life in patients with profound hearing loss and that the cost of the second implant is offset by its benefits.” Read more

Oticon Introduces Kid-Friendly Amigo FM Assistive Listening Devices

Hearing the teacher’s voice without the stress and strain of speech-reading can mean the difference between long-term success and failure in school, especially for younger children. When hearing-aid manufacturers target school-aged customers, they do well by doing good. Read more

“Musical Ear” Auditory Hallucinations Finally Get A Medical Diagnosis In The New York Times

I’ve written several times about the weird phenomenon of hearing noises and music in my head ever since my sudden hearing loss, and when I cited Dr. Neil Bauman’s fascinating, in-depth book on auditory hallucinations, Phantom Voices, I made a rather strong statement about the lack of research that’s been done on the subject by the traditional medical and scientific community. Read more

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