Cochlear Implant

Anniversary of Advanced Bionics FDA settlement

Jul 21st, 2009 | By Ed Wallis | Category: Cochlear Implant

Approximately one year ago, Advanced Bionics, the US manufacturer of cochlear implants, settled a civil suit brought by the U.S. Food and Drug Administration (FDA) based on the HiRes90k cochlear implant device. It is expected over 25% of the vendor B HiRes90k devices (implanted in most part through March 2006) will fail. While public relations [...]



Cochlear Implant Lawsuits

Jul 4th, 2009 | By Ed Wallis | Category: Cochlear Implant

Tim Edwards and Ed Wallis have filed two lawsuits on behalf of minors against cochlear implant (“CI”) manufacturer Advanced Bionics related to certain defective HiRes90k cochlear implants.  The two attorneys are currently investigating numerous other cases and are willing to provide any interested persons a free case evaluation. Additional lawsuits will be filing in the [...]



Officials: Device Maker Engaged in Illegal Marketing

Jun 18th, 2009 | By Ed Wallis | Category: Cochlear Implant, Medical Device

Federal prosecutors on Tuesday indicted a medical device maker and four of its executives on charges that they illegally tested and promoted a bone filler for unapproved uses. According to the indictment, Synthes Inc. pursued unapproved trials for its Norian XR product and promoted it aggressively among select doctors. It is unusual for federal prosecutors, [...]



FDA vs. Advanced Bionics, Settlement

Feb 1st, 2009 | By Ed Wallis | Category: Cochlear Implant

Advanced Bionics has announced it has agreed to settle claims made by the FDA filed in an administrative complaint in 2007. Per the actual letter contained on the website of Advanced Bionics, the company “decided to settle the matter, with the company paying 1.1 million dollars.” CEO Jeffrey H. Greiner agreed to pay $75,000.00. For [...]



FDA vs. Advanced Bionics, Settlement Agreement

Feb 1st, 2009 | By Ed Wallis | Category: Cochlear Implant

As you may be aware, the FDA and Advanced Bionic have settled their dispute over the wrongful conduct by Advanced Bionics over the HiRes 90k cochlear implant. Note that this settlement agreement announces Advanced Bionics has agreed to pay $1.1 million dollars as a result of allegations of wrongdoing and violating federal law as it [...]



HiRes90k Lirigation Information

Feb 1st, 2009 | By Ed Wallis | Category: Cochlear Implant

Did you or someone you know receive a cochlear implant from Advanced Bionics? If so, you should take note that the Food and Drug Administration (FDA) announced in March 2008 that it was “seeking a $2.2 million penalty against a California hearing device manufacturer for violations of federal law, including manufacturing standards violations and the [...]



Webinars on HiRes90k cochlear implant - Advanced Bioncs

Feb 1st, 2009 | By Ed Wallis | Category: Cochlear Implant

Advanced Bionics held a webinar to address the settlement between the company and the FDA. Allegedly, the company on this webinar attempted to persuade those who have received a now recalled cochlear implant to not sue their company.
Persons should be wary of such a corporate tactic. Those who have been injured as a result of [...]



Settlements may not be binding; you may be entitled to more.

Feb 1st, 2009 | By Ed Wallis | Category: Cochlear Implant

Advanced Bionics agreed to settle their dispute with the FDA by paying $1.1 Million Dollars. The CEO agreed to pay $75,000. The Company, conveniently, has denied wrongdoing.
If you have been injured as a result of the recall of Cochlear Implant Model HiRes90k, and have settled a claim with Advanced Bionics, your settlement may not be [...]



Bilateral Cochlear Implants

Feb 1st, 2009 | By Ed Wallis | Category: Cochlear Implant

A study at the Indiana School of Medicine reports that “cochlear implants in both ears significantly improves quality of life in patients with profound hearing loss and that the cost of the second implant is offset by its benefits.”  Read more HERE at Science Daily.
Important to this study, the School of Medicine’s findings may assist [...]



Advanced Bionics HiRes90k Timeline

Feb 1st, 2009 | By Ed Wallis | Category: Cochlear Implant

The following is the timeline for the Advanced Bionics HiRes90k cochlear implant recall:
September 24, 2004: The first recall of the device is made by Advanced Bionics because of a “potential presence of moisture” in the internal circuitry of its Vendor B model cochlear implants.  This recall included, supposedly, all cochlear implant devices on its shelf [...]