MicroTransponder: Latest News and Research

Yes received an email about 3 weeks ago saying:

Tinnitus Clinical Trial - Now Open for Enrollment in U.S.

MicroTransponder is pleased to announce that its U.S. Tinnitus Clinical Trial is now open for enrollment. The 30-patient study is being supported by the National Institute on Deafness and Other Communication Disorders (NIDCD).

3 sites are currently enrolling patients in this study and a 4th site will begin shortly.

The 3 sites currently enrolling patients are in:
1) Buffalo, New York
2) Dallas, Texas
3) Iowa City, Iowa

We are seeking patients that live within a 200 mile radius of those cities for participation in this trial.

Interested patients should visit the clinical trial website for additional information on the therapy as well as links to signing up at each individual site. The website is:

www.tinnitustrial.com


For those of you who live more than 200 miles away from the current trial sites or outside the U.S. - We are planning additional clinical trials in the EU, U.S., and other parts of the world as well. We also plan to seek approval in Europe to be able to offer our therapy to all patients that are currently seeking a treatment for tinnitus.

If you want information on additional clinical trials and future updates - please visit this NEW TINNITUS FORM Note - This is a different list from our general "Tinnitus Update List".

Thank you to each of you that has expressed your support for our research over the past few years. The process to develop an implantable device and begin clinical trials is time consuming, difficult, and requires a great deal of financial resources. We know how devastating it is to live with tinnitus and have been working for the past 6 years as quickly as we are able to bring the Serenity System therapy into the clinic. We expect that our U.S. clinical results will be favorable, as they were in our 10 patient study in Europe; and the next step would be to make the therapy commercially available in Europe and the U.S. for those who suffer from tinnitus. Please check our websitewww.microtransponder.com for news and updates. We will also continue to send out information via the current Tinnitus Update List when we have news to share.

-the MicroTransponder management team

 

Is the Microtransponder same as the VNS stuff? Why are there two threads about this? I'm confused.

 

One utilizes the vagus nerve, the other just sticks to your face.

 

Pasted the below from trial results... do these changes in MML seem really high, am i missing something here?

The average drop in MML for all patients was 12.33 dB immediately
after the treatment and 14.17 dB for the follow-up (see Fig. 3).
Patients in the no-drug group showed a mean decrease of 18.8 dB,
whereas patients in the drug group showed a decrease of 4.25 dB
immediately after the treatment. Four out of five patients (80% of
patients) in the no-drug group had a clinically meaningful decrease
in the MML (26.7 dB decrease). These patients continued to maintain
the benefit of the therapy in the long term (29 dB decrease)
suggesting that the beneficial effects of VNS are long lasting. For the
follow-up, patients in the no-drug group had a decrease of 12.75 dB,
whereas patients in the drug group had an increase of 2.25 dB. For
patient 004, no MML was obtained.

 

So basically if your on an anti
Depressant this wont work as good? I would be curious if someone did this while on no drugs, get a decrease then start a drug few monthes after.. Would it make the T flare back up? No one knows but id like to find that out.

 

The wording is unclear. That final statement for the follow up state the no-drug group had a decrease of 12.75 DB. Is that total from the base or in addition to the previous decreases?

 

I posted this in another thread I started here. I am leary because of the [ advertisement] claim on the right top of page'

http://www.hearingloss.org/content/nih-funded-studies-tinnitus

 

This news article was published recently, but I don't think there's any new information in it.
http://www.newscientist.com/article...your-brain-to-stop-tinnitus.html#.U-CpkPl_t8E

 

Does someone know if the invasive procedure is risky? Will it happend under general anesthetic or local?
It looks like something more complex.

 

It involves your brain. So yes, I am sure there will be some risk.

However, I did inquire about the trial, as I have family in Dallas. They told me I didn't qualify because I have a piece of metal in my brain, to clip off a ruptured aneurysm.

 

Cba to dig through the thread as im on mobile; this is only for tonal t right?

 

Where are the results for the VNS therapy trial? They said updates on how it went would be in late in 2015. Well it's almost 2016. Very interested to see how it went.

 

I don't think @J. Wing had good luck with it as I read on another forum. I heard nothing other than that. I was a little too far away from Iowa City to be involved in the trial.

 

Will VNS remove the noise? It better

 

http://medcitynews.com/2015/12/micr...hnology-to-treat-tinnitus-and-stroke-victims/

 

No: https://www.tinnitustalk.com/threads/microtransponder-latest-news-and-research.469/

Although it looks like the study has finished and results are expected in the spring: http://www.tinnitustrial.com/

 

for 6 it was a positive outcome, 4 of them no changes ... they did discover that the 4 people with no results were taking or had taken medicins before the trail ... so best to keep your hands of meds for a while before you would try this.

 

If I remember correctly they were on meds during the trial. Not just before.

 

Yes I have read that too. The medications were of the kind that could effect brain plasticity. I'm guessing anti-depressants of some kind.

 

There's a small update on the main page of http://www.microtransponder.com/

It says:

Note: We are in the process of updating this entire website. Check back in a few weeks to see the new site with additional information on our tinnitus therapy.

 

It seems that they have a good news to bring us

 

Hopefully. Also, if you check http://www.willrosellini.com/ the first post states that there is going to be another study soon. So, I would think that means they had good results.

 

who knows maybe they are planning to do another version more effective ?

 

A small update. I emailed Dr. Kilgard about the status of the results from the second clinical trial and when the third clinical trial would be announced. He said the paper for the results is currently being written, and that there is no set date for the third trial, but the FDA has already approved the design.

 

Another update. I received an email this morning which lead me to a new site with information that will be moved over to microtransponder.com.

The main page: http://dev-microt.pantheonsite.io/

If you choose United States/English it simply says the device is not yet available in the US and that there will be additional clinical trials, but other than that there is no new information.

If you choose Europe/English, there is some new information: http://dev-microt.pantheonsite.io/en-gb/tinnitus/patients/how-it-works

On this page you can watch a video from a man who, I assume, participated in the second clinical trial. He seems to describe his tinnitus as very loud (military/firefighter) and he goes on to say the therapy reduced his tinnitus by half: http://dev-microt.pantheonsite.io/en-gb/tinnitus/patients/videos

On this page, there is some information about the results from the second trial. It only gives results based off of the patients THI, but I'm sure there will be information about the reduction in the minimum masking levels in the official report, like there was in the first one: http://dev-microt.pantheonsite.io/en-gb/tinnitus/physicians/clinical-experiences

 

Any one know how much does it cost ?

 

I didn't find anything, but if you scroll down there is a "Contact Us" option where you can send them a message and ask.

 

Still one has to know there is no garantee this will help. Best is I think to to EEG loreta 32 or 64 but 32 is ok, to see where in brain t is localised....

then after doing tests continue toward advisable goal

 

The same can be said about any treatment for tinnitus.

I'm interested to see what they say about the people that didn't have clinically meaningful results. In the first trial, it was people who were on antidepressants or similar medications. Maybe they found out something new in this trial.

 

I listened to the video of the ex-infantryman who has had the procedure done... his t reduced by half after a couple of months of therapy using the device. He says his t is way less bothersome and "it literally has given me my life back" ....music to my ears. What any chronic t sufferer wants to hear.

If the procedure was available here in South Africa i'd get it done if I could afford it.