Advanced Bionic settles with the FDA

I wanted to share with you all a copy of the press release from Advanced Bionic CEO Jeff Greiner that was posted on HearingJourney.com

Dear Patients and Professionals:

Today, Advanced Bionics agreed to settle a matter with the U.S. Food & Drug Administration (FDA), resulting from a decision we made in 2003. That decision concerned a determination that no formal FDA submission was needed when we added a new vendor (Vendor B, later terminated in March 2006) to our manufacturing operation. Four years later, in 2007, the FDA filed an administrative complaint against us stating the FDA's belief that a formal submission should have been filed. We responded to the Agency, pointing out that it had already approved both vendors when it approved the system.

While we do not agree with the FDA, we do believe that accepting its terms is in the best interest of our patients, our company and our need for a long standing relationship with the Agency. So, we have decided to settle the matter, with the company paying 1.1 million dollars and me, as CEO, paying 75 thousand dollars.

Over the years, we have increased our focus on the reliability of our entire implant system. At present, our internal device (Vendor A) has a 2 ½ year CSR of 99.1%, and our external product durability leads the industry. That being said, we expect that the quality of our products will only get better in the years to come.

As we move forward, we are stronger than at any point in our history: singularly focused on cochlear implants, well funded, possessing better leadership in key positions, and having a strategic plan built around patient care.

We very much look forward to continuing our partnership in this community. Please call me if you have any questions about these or other matters.

Very sincerely,

Jeff Greiner,
President and Co-CEO