As many readers are aware, last week Advanced Bionics has received TÜV approval to ship newly modified HiRes 90K implants with the CE marque, with submission to the US FDA pending. Over the last four days, we have repeatedly reached out to AB media relations, corporate, and other individuals with requests for more information contained in their TÜV and FDA applications, specifically as to the steps they have taken in Engineering, QA/QC, and Reliability, to assure audiologists, surgeons, and most importantly patients that the failures that occurred leading up to the November 23rd “voluntary” recall will not happen in the future.
We are interested in presenting facts surrounding the steps Advanced Bionics has taken to improve the reliability of the HiRes 90K; and we await their reply. If AB so chooses, a reply may be posted in the comment section of this article; and we will publish it unaltered.
If anyone from Advanced Bionics wishes to contact us, we can be reached anytime at Dan@Snip.Net ~
3 June 2011 Administrative Update: When I removed the Disqus comment plug-in, the comment nesting was lost, so all comments are now listed flat
12 April 2012 Update: Removed the recall ticker~