Hi all,
Below is a brief report on my trial of the mutebutton device. The trial ended a few weeks back. It lasted 12 weeks. I said I would wait until it was entirely complete before I reported back.
The treatment involves the following. The pitch of your tinnitus (i.e. low or high pitched) is tested; you are simply asked to select a pitch that most closely corresponds to your tinnitus sound. You also select a volume where white noise masks the sound of your tinnitus. After this testing, you are given the device. It's the size of a large Ipod and comes with a pair of good earphones. There is a small plastic attachment, the end of which has some small raised bumps that vibrate. For a minimum of one hour a day, you simultaneously listen to a pre-programmed sound playing through the headhphones and hold the tongue attachment between your teeth so that small, regular vibrations can be felt on the tongue. The sound playing through the earphones is a mixture of some classical music and rainfall/pink noise. The stimulation on the tongue is a very mild vibration. There are controls to increase/decrease the vibration/and the sound.
The treatment is not at all unconfortable but is done in private, as it looks a little odd to be holding a plastic strip in your mouth while wearning headphones. Every two weeks, I returned to have the pitch and volume of my tinnitus tested and to fill out a very brief questionnaire and a tinnitus handipcap inventory. Circa 100 people with chronic tinnitus participated in the trial.
I am sorry to say that I had absolutely no benefit from the device at any point and my tinnitus remains as ever. I was told by the audiologist, however, that reports from other patients were encouraging. The audiologist, in short, seemed happy with the results of the trial, so anyone reading this may, should the treatment be offered in their country/area, want to try it.
I cannot say, however, that the data being collected was comprehenisve. The very brief questionnaire I filled in, when reporting back, asked very few questions and would not, in my opinion, stand up as a proper quantitative tool. For example, they did not ask how long I had used the device per day. As a result, they have no way of knowing whether using it for far longer than one hour, as some patients did I believe, correlates with greater success or not. Failure to measure such elementary variables struck me as quite odd. I do not at all doubt the bona fides of those working on the project, but I think that they are ultimately concerned to get their product to the marketplace and the trials were a hoop they had to jump through. It was an interesting insight into what a 'clinical' trial can mean in practice. I had expected professional statiticians, involved analysis, etc and was a bit disappointed at the crudity of the tests and analysis. One would hope that trials for another neuromodulatory effort, the Coordinated Reset device invented by Tass and ANM medical in Germany, are far more robust. They may not be. Having said all that, tinnitus is a very difficult condition to 'test' for.
I did not find any scientific papers that offered a detailed exposition of the treatment. The idea, as explained on the device's website, is that stimulating two senses in a particular fashion will allow the auditory cortex to 'learn' that the tinnitus sound is illusory. Neuromodulation is all the rage, in tinnitus treatments and elsewhere, but the science remains, in my view, embryonic.
I expect that this treatment till be lauched with some fanfare in the next few months. I was told that they do not intend to do any more trials, in Europe at least. Having completed one, they are free to go to the marketplace. The process of going to market with a medical 'device' is of course far more straightforward, under EU law, than if a drug is being proposed. The device will be available through audiology clinics only.
My own view after this trial, which I was very lucky to be included on, is that there simply is no 'cure' for tinnitus and that there is unlikely to be one for generations. I want one as much as everyone else and would still prefer money to be spent on hard science than on the unlettered psychobabble that many audiologists proffer. Nonetheless, I have decided to cease all investigations into a cure. If there ever is a real cure, one that works consistenly for most people, I will hear about it.
Best
Bill