Subject: Brain stem implants and children From: Monita Chatterjee <mchatterjee(at)HEI.ORG> Date: Fri, 16 Aug 2002 11:31:47 -0700I forwarded the email to Bob Shannon. Here is his response. ------------------------------- From: "Bob Shannon" <shannon(at)hei.org> Ward, The official FDA rule is 18 I think (maybe 15), but we've implanted a few kids as young as 12 who had NF2 if they needed tumor surgery (as exceptions - requiring a letter to the FDA from the implanting surgeon). We've not implanted anyone who didn't have NF2, partly because it radically changes the risk/benefit ratio if the patient doesn't need surgery to remove a tumor. In such a case the entire risk of the surgery is to put in the device. Although we've been approved to do that (in adults) we haven't yet. I'd be hesitant to do an ABI in a 4 year old - the benefits of the device aren't sufficient to justify the risks of surgery in my mind. It would be interesting to see if someone as young as 4 would be able to learn to use the ABI better than the average performance of adults, but to document that would take a serious committment on the part of the clinic and parents, and the acceptance of the risks. I'm not sure I'd recommend it - the performance of the ABI is still only at the single channel CI level and that doesn't seem worth the risk of surgery. If everyone's interested and willing to try it you should contact cochlear corp to find out how to write the letter of exception to the FDA. I'd try another CI first - it has a much better chance of success and less surgical risk. Bob --------