In April, Advanced Bionics issued the following news report on its website concerning the settlement. Obviously, you should consider for yourself if you believe you have been injured emotionally or physically as a result of Advanced Bionics’ HiRes90k cochlear implant. Please EMAIL us today or call Ed Wallis at (901) 527-4673.
The News Report:
Information on the FDA’s recent announcement of intent to fine Advanced Bionics
Apr 7, 2008Many of you have heard about the FDA’s intent to fine Advanced Bionics. This announcement is about events that happened years ago. It’s old news. We’re trying to reach resolution with the FDA, but the process is complex and takes time. What you should take from these events is the following:
1. The fine is principally related to judgments the FDA is making about our quality system as it existed in 2003 — five years ago.
2. We are actively participating with the FDA to try and resolve these matters.
3. The process is complex and takes time.
4. The fine proposed by the FDA has no impact whatsoever on the ability of Advanced Bionics to operate its business.
5. The HiRes 90K is extremely reliable and, together with the Harmony, is the most durable implant system on the market.
If you would like more information, please VISIT THE COCHLEAR IMPLANT PAGE or email us today by clicking HERE. You can also call Tim Edwards or Ed Wallis at (901) 527-4673.
