Responses to some comments

As promised, I’m going to directly interact with patients on this blog.  I’m not an MD and so will quite frequently be out of my area of expertise.  However, I think it will be worthwhile to continue to think about the patient experience with our device and maybe I can get a “gut” feel for something and make a correct decision (when there is no scientific reason to decide one way or the other).   I felt I owed this to the patients who read articles with headlines that say “Cure for Tinnitus Discovered” and wonder when they can get their “cure”.   Hopefully, when you see how this development is happening it will cut out the guesswork on your part. 

So, in answer to some of the comments/questions:

1. Our first study in Tinnitus was designed to understand whether we needed a permanent implant or whether we could simply use a percutaneous lead (think wire with no battery).   Our prediction from the rat study was that the therapy would reduce the perception of tinnitus and the loudness to silence in less than 1 month.  What we have seen so far is that in some patients we see some dramatic effects in 10 days, but the tinnitus returns unless the treatment is “maintained”.  Since we can’t leave our percutaneous device in forever, we must develop an  implantable device. 
2. Understanding what under control mean is difficult in the tinnitus sufferer.  The gold standard is to use questionnaires which capture the amount your tinnitus is bothering you.  So, the questions don’t  focus on the actual loudness (objective), but rather how much the tinnitus is bothering you.  We are seeing drops of 40% to 60% in responders in the questionnaires (said another way, my tinnitus is bothering me 60% less than it usually does).   The problems with this measure is that some of the patients who haven’t gotten this kind of reduction still maintain the therapy worked and they would do the surgery again.  So, is the survey question set adequately capturing the therapeutic value?
3. The  results are a very good signal, but even amongst tinnitus experts there is disagreement about whether to focus instead on the actual loudness using something called the MML (minimum masking level).  It could be argued that this test is an ojective measure of how loud the tinnitus is.  We get this by essentially turning up noise until the tinnitus is masked and recording that noise level.  If the noise level needed to mask the tinnitus drops after giving our therapy, then the tinnitus sound is lower.  The problem here is that tinnitus patients have tinnitus that floats up and down, comes on or off at various times.  So, it is really hard to say what level the tinnitus is at in the first place  It is also hard to get patients to come in for all of this testing consistently.   
4. We expect that with the signals we are seeing in this clinical study that we will develop a permanent implant.  There was some doubt on our part as to whether we would continue on this research, but our Board has agreed to continue based on the promising results we have seen to date in the clinic.  This implant will enable us to deliver therapy over a longer time period and hopefully maintain the effects we see in the shorter term.  The timeline on the development of a product like this would be something like overseas clinical study (next study) starts in 2012 and finishes in 2014 with a CE Mark approval in 2015.  I would expect an FDA approval (if we saw safety and efficacy in our clinical studies) sometime after that.  I wish I had a better news about how quickly this therapy would be available.  In reading all of the emails from the patients, I can’t even imagine how difficult this disease is.