Charles on… anything that comes along

I haven’t written much about child3 and his cochlear implant because, well, things are going so well in general. His speech improves all the time (”I don’t want it!” is his favourite new phrase), his listening skills get better (he can hear us saying things, or the sound of the front door, in a room where we have the Today programme with its babble of voices on in the background), all is rosy.

Then you come across this:

The FDA announced that the implants “pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.” “Advanced Bionics shipped [cochlear implants] in violation of the law between January 2005 and July 2006.”

The reason: a supplier, Astro Seal, provided components that once incorporated didn’t keep the implants waterproof. Now, if moisture gets into the implant (inside your head, above your ear) then when you attach the external processor - which powers it via FM waves which also carry the signal - then the wearer, besides not getting any hearing, gets unpleasant electric shocks.

The backstory: the FDA had told Advanced Bionics to stop shipping implants with these parts in 2003. Yet somehow they hung around in the system. And child3 was implanted in May 2006. Did that mean he might have one of the potentially faulty implants, which AB itself said had a fail rate of 20% within 3 years?

Note that the FDA/AB recall isn’t for implants already, um, implanted -

In March 2006 Advanced Bionics recalled all unimplanted HiResolution 90K cochlear implants containing the Astro Seal component because some of the devices were not water proof and were failing at an unacceptable rate. Mrs. Rappaport’s device [she’s the one suing for damages in the link], unfortunately, had already been implanted by the time of the recall. [Hers failed.]

The FDA estimates that 3,477 of the devices with the Astro Seal component had already been implanted at the time of the 2006 recall. Of those an estimated 1,502 devices were implanted in children under 18 years old.

It wasn’t good finding this on a Sunday evening. Everything’s going swimmingly. But this brought on visions: it stops working, and then we have to go with the nuclear option - explantation. (Implant = put in, explant = take out.) That is, taking the old one out, and putting a new one in. Probably in the same ear. (Would you, though? Or would you implant in the other ear?) That would mean some period during which you’d realise it wasn’t working. And then you’d have the explantation operation, and then at least six weeks for it to heal, and then you’d have to start all over again on the process of “tuning” - getting the brain to start realising what it’s hearing via the implant. OK, young brains have amazing plasticity (their ability to adapt to new inputs) but this feels like a step too far. And that delay, in the time when he should be learning more speech, words, perhaps even written language. Even implanting the other ear some time ahead, if you knew you were going to explant

It’s at this point that you wonder quite what you’ve done to your child. Is that his salvation in his head? Or a ticking time bomb? We’d never had any doubts about the benefits of cochlear implants, but for me this was the most uncomfortable moment of all. The Damoclean sword hanging there: is that seal waterproof? Will it hold?

So being able to check on the next day and confirm that child3’s is not one of the affected implants was the best possible news. Weights lifted, all that sort of thing. But it’s also a reminder that technology isn’t perfect. Hell, nothing is. And the choices we make are all fallible; all we can hope is that they’re the best for the longest possible periods of time.

Update: Advanced Bionics has got in touch to point out that it manufactures in the US - which means the FDA is right on its doorstep, and on its case, with visits every couple of months to the manufacturing. That’s different from other CI makers, based outside the US; while they still have to get FDA approval for work in the US, there’s not the same in-depth inspection. Plus, they don’t get fined for errors.

There’s probably something to be written about how one would hold CI makers to consistent standards: what do you count as an “event” that needs to be reported to the national devices agency? But that’s outside my purview. I’m just relieved, is all.

These posts might be related (the database thinks..):
• My own call for papers - on cochlear implants (8 May 2006; score: 93.57%)
• I might watch through my fingers: cochlear implants live on the Net! (6 July 2007; score: 88.68%)
• Better cochlear implants; the power law of homelessness and pollution (13 February 2006; score: 74.8%)