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.

Sonova Reports 10 Percent Increase In Hearing Aid Sales And Resumes Cochlear Implant Shipments

Sonova Group, parent of the Phonak and Unitron hearing aid brands, issued a preliminary financial report announcing that its hearing-aid sales increased 10.1 percent in the 2010-2011 fiscal year, powered by strong market acceptance of its high-end hearing aids based on its new Spice sound processing hardware and software platform.

The Swiss holding company also announced that it is resuming sales of its cochlear implants outside the U.S. following approval by European regulators of manufacturing changes that it says solved its product quality problems with its Advanced Bionics cochlear implants following a worldwide recall after problems surfaced with several of its implants. The company also said it is filing notice of the manufacturing changes with the U.S. Food and Drug Administration (FDA) to gain approval for resuming sales in North America as well.

Sonova, which was rocked by an insider-trading scandal that resulted in the resignations of its chief executive officer and chief financial officer in April, said overall sales for the group, which includes its implant business as well as hearing protection products, grew 7.8 percent in the fiscal year. The company said it will report complete results for the fiscal year on May 24.

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

Sonova To Cut Staff In Wake Of Advanced Bionics Cochlear Implant Recall

The Wall Street Journal reported that Sonova Holding AG, parent of worldwide hearing aid market leader Phonak and other brands of hearing-aid and hearing-implant suppliers, will speed up an ongoing reorganization and cut staff by as many as 100 employees following the decision by its subsidiary Advanced Bionics (AB) to pull its cochlear implant products off the market until product quality issues are resolved. In November, the U.S Food and Drug Administration (FDA) announced that Advanced Bionics is voluntarily recalling its HiRes 90K cochlear implant device following two instances of a malfunction that required the surgical implant’s removal after “recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.” 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

Race To Acquire Siemens Hearing Aids Heats Up As Cochlear Ltd. And Synthes Join Fray

Reuters quotes sources saying Cochlear Ltd., one of three global suppliers of cochlear implant devices as well as a leader in bone-anchored hearing aids, intends to join two private equity firms in making a multi-billion dollar bid for Siemens Hearing Instruments, which is being spun off by its parent company. The report also says Synthes, a global medical equipment manufacturer, also will join the bidding.

This is a huge story for the hearing aid industry, which is going through a wave of consolidation as the leading global players try to simultaneously gain market share by broadening their distribution at the low end of the market while building war chests for a new generation of R&D-led innovation at the high end of the market. Putting the very high end digital technologies required for cochlear implants under the same roof as mainstream digital hearing aids will give a shot of much-needed energy into high-end hearing-aid innovation. Read more

Postmodern Man: Michael Chorost’s Cochlear-Implant Book, Rebuilt, Is About A Whole Lot More Than Cochlear Implants

You can learn everything you ever wanted to know about cochlear implants, and more, from Michael Chorost’s new book, Rebuilt: How Becoming Part Computer Made Me More Human. Read more