Fair Hearing

The FDA’s recent alert about a possible link between cochlear implants and bacterial meningitis (see article, page 1) may not be the most devastating blow ever to have confronted the neurotechnology industry, but it is certainly a serious matter. In many ways, this crisis presents a test for our young industry; how we respond and bounce back from this situation may well be indicative of our level of maturity.

One side benefit of the relative lack of media exposure that the neural prosthesis industry receives is that this crisis has not gained the intense public scrutiny that has greeted other industries when confronted with unflattering data or allegations. The silicone breast implant industry is one example that comes to mind. But even if the meningitis scare is not plastered across every newspaper and cable news show in the country, it would still behoove the industry to be prepared for a time when the media will be much more attuned to our products’ shortcomings—be they real or perceived.

Based on what we have seen thus far, the cochlear implant industry deserves high marks for its response to this crisis. We are particularly impressed with Advanced Bionics’ willingness to withdraw its product from the U.S. market voluntarily while it investigates the role, if any, of the positioner piece in increased incidences of bacterial meningitis. This cautious and customer-friendly approach is all the more impressive when it is understood that sales of cochlear implants represents the only current source of revenue for the young company.

It may well turn out that the positioner has no effect whatsoever on a cochlear implant user’s susceptibility to meningitis. But if so, the public and the government will hopefully be all the more impressed with Advanced Bionics’ attention to safety and afford the company more credibility down the road as new products and new technologies come to market. Of course, if it turns out that the positioner is indeed the culprit, the company’s prompt response—prior to any government or regulatory intervention—should produce the same enhanced level of credibility.

One lesson that stands out in this situation, however, is the importance of flexibility and diversity in a product line, whenever approval cycles are a potential factor. It’s hard to imagine why it should take the FDA a lengthy amount of time to approve the use of the Clarion’s HiFocus electrode without the positioner, but the company would have been better off with this option in the bag already.

It might be tempting for other manufacturers of cochlear implants to take advantage of Advanced Bionics’ plight to acquire market share, but we hope a more cautious competitive posture will prevail, just as it does when the yellow flag is waved at Indianapolis Speedway. A safety issue that confronts one vendor—again, real or just imagined—is bound to impact other vendors in the long run.

There’s nothing wrong with presenting data that shows that a perceived risk associated with a particular product is no greater than what is faced by the general population, and indeed, that may well be the case here. But the public perception of that presented data will go much more smoothly if the industry has taken pains to be aware of its public relations, as well as its scientific, responsibilities.

James Cavuoto
Editor and Publisher