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.

Waterproof Advanced Bionics Neptune Cochlear Implant Processor Is "Swimmable"

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.

Advanced Bionics Neptune Cochlear Implant Processor Can Be Clipped Onto Clothes Or Strapped Onto Your Arm

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.

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).

To Appreciate Music, You Need To Discern A Much Wider Range Of Frequencies And Amplification Than To Understand Speech

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 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 Valentin Chapero Rueda Says Cochlear Implant Recall Might End 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.”

The severity of the problem that prompted Sonova’s voluntary recall-–the company disclosed that in two instances, “recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device”—has left the hearing industry wondering about the fate of Advanced Bionics, which Sonova Holding acquired a little more than a year ago.

As one of only three global cochlear implant makers, besides market leader Cochlear Ltd. of Australia and Med-El of Austria, a too-long absence from the market by California-based AB would threaten to reduce competition and slow the pace of innovation and expansion in the cochlear implant market — not to mention putting a dent in the finances of Sonova, parent of worldwide hearing aid market leader Phonak and other brands of hearing-aid and hearing-implant suppliers.

“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.

Voluntary Recall: Applied Bionics Pulls Its HiRes 90K Cochlear Implant Off The Market

The fact is that in the more than 40 years since they were invented, cochlear implants have proven to be about as safe as any other surgical implants, with the main risks being those associated with going under general anesthesia. Patient satisfaction has improved dramatically as new generations of sound processors have made their way to the market, which recently has been growing at a rate of 20 percent per year.

In the meantime, Cochlear Ltd. of Australia, the world’s biggest cochlear implant maker, was quick to issue its own statement that “this problem pertains solely to the devices manufactured by Advanced Bionics and does not affect the Cochlear Nucleus(R) line of implants.” Cochlear Ltd., with about 70 percent of the $1 billion (USD) market for cochlear implants, reported 13 percent growth in units sold in a global recessionary environment its 2009-2010 fiscal year, and 20 percent unit sales growth in the second half of the fiscal year.

Considering that there are only three major global providers of cochlear implants (Med El of Austria is the third), a recall by any one manufacturer can seriously disrupt supply and impact growth of the industry. But the fact that market leader Cochlear continues to prosper while AB has a financially sound parent indicates that the recall–assuming the problem can be solved quickly and decisively–might instead be a temporary setback for AB as well as a temporary opportunity for Cochlear to increase its market share.

Cochlear Ltd.'s Water-Resistant Nucleus 5 Cochlear Implant Sound Processor

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.

Researchers found that bilateral implants helped people hear regular conversational speech as well as speech in noisy environments better than those with just one implant.”We didn’t know that cognitive skills and emotional issues would so significantly improve with the implantation of a second cochlear device,” said senior study author Richard Miyamoto, M.D., Arilla Spence DeVault Professor and chairman of the Department of Otolaryngology-Head and Neck Surgery. “In addition to the physiological improvements we saw in patients who had bilateral implants, we found that patients were able to function better in noisy environments and definitely felt better about themselves.” The authors of the study, which appeared in the May issue of the Otolaryngology-Head and Neck Surgery journal said they hope their findings will encourage insurance companies to justify coverage of a second implant. Currently regular insurance most often covers the cost of only one implant. Michael Chorost, author of Rebuit: How Becoming Part Computer Made Me More Human, recently documented his experience getting a second hearing aid in The Journal of Life Sciences. He had successfully lobbied his insurance company, Aetna, to change its policy to offer coverage for bi-lateral implants. And his quality of life instantly improved:

And then I tried music. I started with Debussy’s Clair de lune, a slow, reflective piece played by an oboe and a harp. I could feel the new ear feeding me its version of the soundstream. It didn’t sound as limpid and clear as the left, but it was giving me music, mirroring the left. Mirroring? Actually, no, I realized. The headphones were shifting the sound intensities back adn forth between them, playingoff of each other.

Stereo.

And I was caught up in it: following the countours of the piece, its wholeness, its proving of the emotional resonances of sound; a moonlit glade with the stars wheeling overhead.

“It sounds lovely,” I breathed.

Wow.

It held my attention the way a good story does. I listened to it three more times, once with only the right, once only with the left, then once with both again. Disassembling and reassembling the piece.

I realized that listening to music with one ear is essentially pointless. Music reaches into you and works on your brain. To do that, it needs to work on all of the brain. Hearing music with only one ear engages on half of the brain. Hearing Clair de lune with two ears was like the difference between a live and a dead body: the form was the same, but the experience was oh so different….

It’s like cupping water with two hands instead of one. You can do it with one. But you get much, much more with two. My brain, like everyone else’s, was designed to work with two ears. Being bilateral gives me a fresh chance, after 30 years, to hear the world whole and full.

Michael Chorost has seen a difference that I’ve experienced with and without my hearing aids. My hearing in my right ear is not bad enough to require a cochlear implant, but my left ear is pretty bad. Even with the most powerful hearing aid, I can’t understand regular conversation or use the phone with my left ear alone. But I have found that even its diminished capacity provides an extremely important boost to my hearing and well being. My right ear, with good amplification, gets speech and the telephone pretty well on its own. You would think I wouldn’t need that second, less-effective aid on the left side. But when I take out my left hearing aid, I start to experience many of the limitations Michael Chorost experienced: I can’t hear where sounds are coming from, and I can’t hear speech as exactly as when I’m using the left hearing aid with my right. Using only one ear is very disorienting. It makes me anxious. I’ve realized the left hearing aid provides the locational cues as well as the little extra hearing assistance that can make all the difference in comprehension as well as my ability to feel relaxed in my environment, rather than anxious and disoriented. Hearing in stereo really does make a huge difference in my ability to “hear the world whole and full.”

Former Boston Celtics great and current Minnesota Timberwolves General Manager Kevin McHale has recently made news for his 5-for-1 NBA mega-trade, but it’s his 4-for-1 deal that’s been turning heads outside the basketball world: four cochlear implants for the cost of one. In partnership with four other board members, McHale has co-founded the Help Me Hear Foundation, an organization dedicated to granting free cochlear implants to impoverished deaf children. He will also act as the foundation’s national spokesperson.

Basketball Great Kevin McHale Raises Money for Cochlear Implants

Hearing impairment and deafness in children can cause major developmental setbacks. For families who cannot afford appropriate care for a deaf or hard-of-hearing child, these setbacks can become permanent. According to the HMH website, “At a minimum, a deaf child will not be able to communicate via spoken language, will develop reading skills more slowly, will have more difficulty understanding mathematical concepts, and will be limited in schooling and vocational choices.” Emotional isolation and stymied social development can result.

However, a cochlear implant can have a dramatic effect on normalizing the development of a hearing-impaired child. The ability to hear sounds translates into an ability to communicate orally, a crucial skill that alone can prevent developmental stumbling blocks. According to a press release distributed by the foundation, the impact of a cochlear implant can be so profound that a ten-year-old child who received a cochlear implant at age one or one and a half would be indistinguishable from hearing children to most people.

Kevin McHale summed up the importance of the Help Me Hear Foundation’s work when he explained why he decided to get involved: “Every child deserves a chance to hear. I love the fact that the goal of this organization is to create independent, productive people. It’s a small, one time, investment that will have a lifetime of benefits. The impact will be felt not only by the children, but, by the families of these kids. I’m just happy to be a part of it.”