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.

Applied Bionics Cochlear Implant
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.


  1. anonymous says

    will the high rate of automobile accidents keep me from getting behind the wheel again? not bloody likely.

    I too sympathize with the people who’ve had problems with their implants.

  2. WisDeaf says

    You asked “Will Safety Concerns Slow The Growth Of The Cochlear Implant Industry In The Year Ahead?”

    That is a fair question. My response to the question is no. It will continue to thrive regardless of the AB CI recalls. It is an unfortunate situation that occurs within the company. It does appears that they have issues with their quality of work within their company. However, there a lot of people, who have AB CI, are doing very well. It is just the unfortunate few had problems with it. Hopefully, they will be able to resolve the issues with the electrodes with the positioners along with their implant.

    With their CI being recalled, is it possible for other companies to obtain more business as a result of the AB recalled? The answer is yes because it might shield some people away from AB products instead of going to them. What I am impressed is they would take care of the situation immediately instead of waiting for more people with different problems with the AB CI. That is a very responsible approach to ensure the quality and its consumer services to those people are good.

    So, the Cochlear Americas and Med-El are taking an advantage of it. However, Med-El had some of their product be checked out. I hope it is not too serious at this point. Cochlear Americas is definitely one of the top sellers for the CI and are doing very well. According to FDA and its company, their reliability had been outstanding and the quality of their CI had last a long time with very few failure rate overall. The benefits outweigh the cons in terms of bioethical points of view.

    My heart does goes for people, who are unfortunate with the CI despite it only occurs with very small percentage. When they have side effects or have their equipment malfunctions, it is not a very happy situation at all. We have to expect that there will be some failures and side effects in any implant regardless of CI, Retinal, Heart, Knee, Hip, and other kinds of medical implants. Some might require more than one surgery to correct the implants. Again, it is very unfortunate for those people, who have to go through those situations.


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