November 28, 2010

Advanced Bionics is recalling about 28,000 of its HiRes 90k cochlear implants after 2 individuals reported loud noises and sharp pain 8-10 days after their implants were activated. Approximately 1,000 people have been recipients of these implants and may be at risk for similar problems. 

Advanced Bionics was acquired last year by Sonova, a Swiss company. Sonova is also behind the highly lauded Phonak hearing aids and FM systems. This acquisition seemed to show great promise: could Swiss precision and the backing of a strong company such as Sonova buoy Advanced Bionics formidable CI technology? Furthermore, could Sonova make Phonak’s FM systems work seamlessly with Advanced Bionics cochlear implants/sound processors?  It all seemed like an exciting idea.

Advanced Bionics was formerly with Boston Scientific, a merger that began unraveling publicly in 2007. It’s hard to know what really happened there. Some think that when Boston Scientific acquired Guidant Corp. for a hefty $28.4 billion, it subsequently tightened underling Advanced Bionics’ product development budget. Did this effect quality control or was quality control already an issue at hand? Class action lawsuits are currently underway for faulty CI’s implanted between July 2003 through March 2006.

The intellectual brawn behind Advanced Bionics has always been impressive. Alfred E. Mann, an inventor and founder of Advanced Bionics, also developed solar cells for spacecraft in addition to numerous medical devices for those suffering from debilitating medical impairments. Together with the University of California at San Francisco and The Research Triangle Institute, he developed the technology for the Clarion Cochlear Implant. This became the basis for one of Advanced Bionics’ first products to aid those with severe to profound hearing loss. 

The announcement of a recall may deter parents from choosing Advanced Bionics’ Harmony cochlear implant for their deaf child. One may wonder if these are manufacturing errors leftover from Advanced Bionics era at Boston Scientific, or if this error is reflective of Advanced Bionics new management under Sonova? Either way, it may take several years to rectify and rebuild product trust. Historically, Advanced Bionics has shown swift response to product error, culpability, and concern for its customers.  

Advanced Bionics is not the first cochlear implant manufacturer to face a lawsuit. Cochlear America, which garnishes the lion-share of the cochlear implant market (70% of sales), paid the U.S. Department of Justice $880,000 for violating the Anti-Kickback Act and False Claims Act. The charges were the result of paying kickbacks to physicians who recommended the Cochlear America CI product.

Former CFO and VP of Cochlear America, Brenda March, filed a whistleblower complaint with the U.S. Government revealing incentives for medical personnel to implant Cochlear America’s CIs. Surgeons, audiologists and other medical staff would get points each time their services resulted in a Cochlear America CI sale. The points led to freebies: the more earned, the bigger the freebies. Freebies included exotic holidays, first class airfare tickets for themselves and a spouse/guest, golf tournaments, all expenses flights/trip to Australia twice a year with significant free time & recreational activity; payment of salaries of employees, and general operating expenses of clinics (resulting in more profit for physicians or practices); free products (which they could then sell); and direct cash payments. In her legal complaint, Ms. March explained, “The express purpose of such payments are and were to encourage Physicians to direct hospitals…to purchase Cochlear Implant Systems.”

Sources:
Alfred Mann Foundation
Alfred E. Mann Foundation for Biomedical Engineering
Boston Scientific Is Undoing Merger With Advanced Bionics
Sonova Shares Tumble On Hearing Implant Recall

An interesting new study revealed that adults born deaf react more quickly to objects at the edge of their visual field than hearing people. The study found that deaf children might have a slower reaction to objects in their peripheral vision up until the early teen years, but that by the age 13-15 years, deaf youths react faster than their hearing peers. 

I find this research to be fascinating. There was a another study which showed that deaf children had greater visual acuity than their hearing counterparts. I’ll have to dig it up and post it. It was forwarded to me by a researcher who noticed our deaf son’s visual acuity while we were in a sound booth participating in a hearing-related research study. The researcher gave him a shape cube and one shape to busy himself while they played sounds. Our son found the matching hole for the shape even though it was upside down and facing the opposite side of the cube. We were all scratching our heads.

It’s possible that although a cochlear implant aids hearing, the brain does not recognize it as naturally doing such, and thus kicks other senses (such as sight) into higher gear. The brain finds a way to compensate for the hearing loss. This could also be why I have also seen it reported that those with vision impairments have heightened hearing. I will have to try and dig up some specific research studies on that phenomenon.

Reference: Dr. Charlotte Codina’s ‘Deaf and hearing children: a comparison of peripheral vision development’ report is published in the November issue of Development Science. Article: “Research Reveals Deaf Adults See Better Than Hearing People“, PhysOrg.com, November 11, 2010.

A fabulously talented artist named JK Keller from New York created this series of American Sign Language hands out of matchbooks he found on the street.

View the complete set.

ASL Matchbooks by artist JK Keller

by Sharon Begley
from a Newsweek article published Jul 9, 2009 & magazine issue dated Jul 20, 2009

When the Viaduct de Millau opened in the south of France in 2004, this tallest bridge in the world won worldwide accolades. German newspapers described how it “floated above the clouds” with “elegance and lightness” and “breathtaking” beauty. In France, papers praised the “immense” “concrete giant.” Was it mere coincidence that the Germans saw beauty where the French saw heft and power? Lera Boroditsky thinks not.

A psychologist at Stanford University, she has long been intrigued by an age-old question whose modern form dates to 1956, when linguist Benjamin Lee Whorf asked whether the language we speak shapes the way we think and see the world. If so, then language is not merely a means of expressing thought, but a constraint on it, too. Although philosophers, anthropologists, and others have weighed in, with most concluding that language does not shape thought in any significant way, the field has been notable for a distressing lack of empiricism—as in testable hypotheses and actual data.

That’s where Boroditsky comes in. Continue reading What’s in a Word? Language may shape our thoughts.

This site was created by a collective of polar bears working thoughtfully and carefully in the far northern regions of Antarctica. Toiling under the moonlight, and often tired from fishing all day, these polar bears have put together a resource for parents and family members of deaf children — and children with all forms of hearing loss (they just couldn’t figure out a domain name that included all that, sorry!).

Occasionally, friends would bring them chicken patties with barbecue sauce, and on those nights, they would get a lot done. Still, large paws are cumbersome, and it took quite some time for this site to become a reality.