Brain stem implants and children

[Monita Chatterjee <mchatterjee@xxxxxxx>]

I forwarded the email to Bob Shannon. Here is his response.


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From: "Bob Shannon" <shannon@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



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