Sonova’s Advanced Bionic announced the WORLD WIDE recall of its HiRes 90K cochlear implants.
(from Advanced Bionic’s press release) “This action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explanation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.”
Sonova (the Swiss billion dollar hearing devices business that brought Advanced Bionics recently) sent out press releases to multiple business publications basically saying “we will have to see see what this means means to our profit line.” The Wall Street Journal reported promptly the same day that immediate impacts were already being seen “The news triggered a sharp drop in Sonova’s share price.”
The Wall Street article is really important so i hope folks will take the time to read it.
Bloomberg Businessweek also reports the drop in shares
The Australian Business with the Wall Street Journal reports predictions that Cochlear co. will take over the CI market in Advanced Bionics absence
NOTE: there is a pro-CI blogsite that has new info up (nov 27, 2010) re: the recent recall and the “failing hot” of some of the AB HiRes 90K CIs.
UPDATE: re Advanced Bionics Failing Hot CIs from the Hearing Blog Site
From Advanced Bionics letter to HiRes 90K CI recipients or parents:
In the unlikely event that this symptom occurs, continued device use may lead to damage to the inner ear and/or the auditory nerve. If you or your child experience pain related to implant use, remove the external equipment immediately and contact your cochlear implant clinician to schedule an appointment. If the evaluation of your device identifies this problem, device replacement is advised.
So a couple of questions:
1. how do you recall a device that is implanted in people’s heads?
2. how adversely affected were these two individuals to warrant a world wide recall?
3. how many other implants have caused trouble for their users? (the Advanced Bionics recall letter to recipients mentions 9 other cases) This is like Advanced Bionics THIRD recall??? How many folks have junked their Cochlear Implants? How many cochlear implants have failed without causing physical harm?
4. how come we cant get concrete figures and facts re: faulty CIs?
5. how come the A G Bell Association still has Advanced Bionics and Cochlear Americas as its Circle Alliance Founding Partners?
- Previously Advanced Bionics had been fined $1.1 Million Dollars for its faulty CI Now Advanced Bionics is doing a world wide recall of one of its CIs. Hmmmmmm.
- Cochlear Americas got slapped with a $880,000 fine from the US Dept of Justice for kickbacks and racking up the prices of their CIs and having the govt foot the bill).
We know they are big companies but is this really the company AG Bell wants to keep?
The more we learn the more we wonder.
Scroll Down to see AG Bell Circle Alliance Founding Partners
Note: What is our moral obligation when we learn of unethical dealings of Cochlear Implants Cos. (manufacturers and distributors) and agencies serving Deaf people? The ear business and corporate greed in general have shown that when folks don’t pay attention bad things happen. It is good that Sonova is recalling these devices but we do have to examine the costs and complication of the recall in-and-of-itself – its not as easy as driving ur Toyota to the dealer
There is also the fact that Sonova is not clear in who is to cover the cost of removing the CIs (very costly and risky procedure).
My heart is with the families who are facing a decision of what to do if their infant and/or child or they themselves have a Sonova Advanced Bionic HiRes 90K
Audism Free America (AFA) has a petition out calling for an independent and impartial investigations into the safety of cochlear implants. Feel free to review the petition and if you agree sign and circulate to friends and family. ASL Version
The families deserve answers.
NOTE: Weitz & Luxenberg is a law firm that already successfully sued Advanced Bionics in the past for faulty CIs (sealant leak etc). The famous Erin Brockovich is affiliated with this firm and there is a Deaf lawyer who has a CI that has handled the CI lawsuits – Teresa Curtin – see this link for past suits and a vlog with Teresa’s contact information at the end of the video.
Older blog entry from Mishka Zena “FDA: One C.I. Corporation Endangering Deaf People