MemberThis is why Tinnitus Quest was founded. Neurosoft, however, involves invasive surgery, which cannot be rushed. It is also a permanent implant and requires at least six months of follow-up care.
Neurosoft Bioelectronics: Implantable Electrodes to Treat Tinnitus
- Thread starter Christiaan
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AnonymousMouse
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I completely understand. I'm not just focusing on Neurosoft, but on the industry as a whole. Sometimes, things move incredibly quickly to hit the market, while other times, they seem to drag on endlessly with no updates or progress—for example, the Shore device.
IYIiKe
Member
- Jan 18, 2024
- 246
- Tinnitus Since
- 2023
- Cause of Tinnitus
- Possible Ototoxic Reaction to Sertraline and Hydroxyzine
Medical devices, particularly those involving surgery or treatments targeting the brain, take time to develop for good reason. Without proper safeguards, people with severe tinnitus might resort to dangerous measures, such as using car jumper cables to shock their DCN, or buying devices that could cause serious harm, including burns or even house fires.
These protections exist because, in the past, such regulations were not in place, which led to serious complications that were often worse than tinnitus itself.
While everyone wants a treatment as soon as possible, the reality is that progress takes time. I encourage patience, even if it means advocating for a treatment that you may never benefit from. If my actions today can help prevent someone else from suffering in the future, it will have been well worth the effort.
I can't tell the age of this page but it looks like there was an update and the study results are promising.
www.neurosoft-bio.com
Specifically the handicap score is very impressive.
SOFT TINNIT™ — Neurosoft Bioelectronics
www.neurosoft-bio.com
Specifically the handicap score is very impressive.
The results they mentioned come from a technique called Neurofeedback, not the implant. A small feasibility study is planned for this year.
The article also includes a patient sign-up option for the trial, as well as a tinnitus questionnaire that people may want to complete.
I didn't see the questionnaire, but I signed up for the treatment trial. I was curious—do you know if someone outside of the U.S. would even be eligible to participate? How do trials typically work when it comes to recruiting participants for testing?
It's a 10-hour drive to Geneva, but I signed up.
I'll fill out the questionnaire tomorrow.
Where are you driving from? I would take part in the trial, by the way.
I think the feasibility study is in Switzerland.
I'm in the Netherlands, so I could take either a plane or a train. The train wouldn't be much faster, but a direct flight is only about 90 minutes.
If I were accepted into the trial, I would definitely like to go. It depends on how long participants are expected to stay after the initial procedure, though; I only have 25 leave days!
Initial feasibility studies could cost as little as $200,000, depending on the equipment and overhead costs. Larger studies may require a few million. Once a large-scale study demonstrates efficacy, mass rollout could cost hundreds of millions.
There will never be a single "cure" that works for everyone.
Neurosoft seeks input on tinnitus patients' preferences.
They are looking for 500 participants. It can be completed now! This is NOT an intervention trial. It's all online.
Click here to participate! Do it now.
Nick
They are looking for 500 participants. It can be completed now! This is NOT an intervention trial. It's all online.
Click here to participate! Do it now.
Nick
- Jan 16, 2020
- 597
- Tinnitus Since
- 1992
- Cause of Tinnitus
- noise? infection? negative stress? other?
I might go even further than that. I recall one of the doctors saying years ago that once you develop tinnitus, it is some sort of "lesion" that is not well understood. Once you have it, you become more sensitive to further hearing damage.
That suggests living in a quiet part of the country might be beneficial.
So even if this new device reduces tinnitus, you could still be more vulnerable to further noise damage than someone who has never had tinnitus.
Of course, that's just my own speculation. I'm not an ENT or an audiologist.
Ear Drummer
Member
- Mar 27, 2015
- 33
- Tinnitus Since
- 03/2003
- Cause of Tinnitus
- Drummer/Lack of REM sleep/Bruxism|TMJ(?)
Completed. However, I must confess that I likely lowered the averages of this survey significantly because I am excessively fearful.
Scruffiey
Member
- Jan 18, 2025
- 94
- Tinnitus Since
- 10/2024
- Cause of Tinnitus
- Noise Exposure, Acoustic Shock & Possible ETD
I assume that since a surgical procedure is required, prophylactic antibiotics will be necessary. Having never undergone surgery—let alone brain surgery—before, I'm wondering what the standard protocol is. Is there anything specific we should be concerned about?
It's great if the procedure can cure tinnitus, but if there's a risk of worsening hearing, that wouldn't be ideal.
It's great if the procedure can cure tinnitus, but if there's a risk of worsening hearing, that wouldn't be ideal.
I had DBS surgery as part of a clinical study to address tinnitus and was not taking any antibiotics. Your assumption is incorrect.
@Jammer, you've probably shared your experience with DBS many times, but since it's highly relevant to the discussion about Neurosoft, would you mind sharing it again here? Did you receive an implant? Was there any electrical stimulation involved in your procedure? And was your experience positive or negative?
I was part of a clinical study at the San Francisco VA. Before surgery, I underwent several pre-surgical evaluations, including hearing tests, cognitive assessments, and an fMRI. I had DBS implantation surgery on June 26, 2016, which involved placing a stimulator in my chest and two brain electrodes.
About a month later, I met with the team and received my handheld controller, training, and data collection documents, and I began stimulation. My tinnitus had been mild to moderate for about 15 years and had slowly worsened over time due to accumulated acoustic trauma.
I recorded my response to each setting after three days, then changed the stimulation settings according to the test instructions. This continued for several months, with changes every three days. I never noticed any difference, positive or negative, in my tinnitus.
I met with the team again to review the data, and they decided to try higher voltage settings. After another five months, my tinnitus had gradually become more severe. I then took a break and turned off the stimulator, with the team's approval, to see if the increase in tinnitus would resolve.
Unfortunately, my tinnitus continued to worsen. I also noticed that the leads connecting the stimulator to the brain electrodes were tightening and causing discomfort, likely due to scar tissue forming around them.
At seven months, the system was explanted, and I discontinued my participation in the study. It took several years for the thick scar tissue in my neck to dissipate, and only then could I rotate my head without discomfort. My tinnitus kept worsening, and I eventually had to retire from my career as a medical device engineer, especially after being exposed to a pneumatic hammer drill at work (even while wearing earplugs). I could no longer focus or remain effective. I was 58 at the time.
This was an extremely disappointing outcome for me. Having been a medical device engineer for over 20 years, I understood how pivotal human clinical trials are in bringing new devices through FDA approval and into successful commercial use.
I am now at a catastrophic level and struggle to find enjoyment in life. Acceptance and the love of my family are what keep me going.
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