TU Delft & Prof. Dirk De Ridder — Bimodal Stimulation Device for Treating Tinnitus

Interesting to discover an old post on the TinnitusFree Foundation Facebook page: the foundation teams up with Harman International Industries (company that makes audio electronics) for the financial support, development and testing of the TU Delft device. It seems that the project will continue under guidance of Prof. De Ridder of the Brai3n clinic.

 

I'm confused about all this. I thought it was similar to Susan Shore's device and now it seems to be an in-ear device. So what is this? What does noise 'in the current' mean in layman's terms?

 

Complete f**cking bollocks is what it is. They have no clue. Prof. De Ridder is an utter mess, he means well but he's all over the wall with his ideas...

But the key phrase here is "noise relief for people with severe tinnitus."

So it's just a fancy masker, mark my words. If it ever comes to market (I doubt it).

I would also like to remind that Prof. De Ridder is part of TinnitusFree Foundation's board, so he has a significant conflict of interest raising funds for his nonsense through the Foundation.

 

I think it's a poor translation from Dutch and it basically means bimodal stimulation. This is what Professor Serdijn said in an article about the TU Delft prototype and possible further development:

(Source)

I think the phrase 'noise relief for people with severe tinnitus.' is ambiguous, as it's not clear what the source is of this noise (brain or distraction via electronic device?), so I don't know why you assume the worst.
Professor Serdijn has stated in a recent podcast that he intends to work on a bimodal device that reduces the severity of tinnitus:

 

Nothing good will come out of TU Delft. Their research is of low quality, with longer and more critical questions left in the recommendations section than the whole body of the research.

 

I don't know where you get that idea, but here is a reference to their current position in the international Engineering & Technology rankings:

TU Delft claims 16th place in the international Engineering & Technology rankings

 

News just in: the TU Delft device will be tested in January 2024.

I've discovered an article that is published by TU Delft. It concerns a symposium about tinnitus and neurostimulation that will be held at the university's auditorium. Dr. De Ridder & Prof. Serdijn are listed as speakers.

Here's the article that is translated from Dutch:

Understanding and Alleviating Tinnitus

It whistles, buzzes, hums, and hisses. Tinnitus grips two million Dutch people and drives many of them to despair. Masking the sound, cognitive behavioral therapy, and even hearing implants – they all provide little relief. But now, scientists from various disciplines have joined forces. Can we silence tinnitus through crowd science and bioelectronics?

Nowhere in particular, yet everywhere, and overwhelming everything. Tinnitus. According to the latest clinical insights, tinnitus results from neurons in the brain not receiving the expected information and spontaneously firing signals. Moreover, a complex network of neurons is involved, spreading across multiple parts of the brain. Complicated matters that Dirk de Ridder, professor of neurosurgery and tinnitus authority, has mastered to the fullest. And he is eager to update you on it in this Health College.

A Spark of Hope
A better Understanding of tinnitus is only half the story. We also want a better treatment for it. That is possible with bioelectronics. Unlike traditional medicines, it allows for targeted and active intervention in the signaling of neurons. At the same time, it enables monitoring of how the brain responds. Professor of Bioelectronics Wouter Serdijn talks about the world's most sophisticated neurostimulation device, which will undergo clinical testing from January 2024. "This technology simultaneously provides sounds and small electrical stimuli to the brain, teaching it to make the ringing or buzzing disappear."

TinnitusHouse
Then there are the two million Dutch people with tinnitus. Maybe you are one of them. Joop van Gent talks about the TinnitusHouse project, where crowd science – comparing characteristics of thousands of patients – can make a difference; for yourself, for others, and as a guide for further research into an effective treatment for tinnitus.

One person out of the two million who will definitely speak up tonight is Robbert Henk Reijenga, guitarist and singer of The Raspers.

So, if you want to be fully informed about the latest developments in medical science, TinnitusHouse, sophisticated neurostimulation, and perhaps the first clinical results achieved with it, come to the Health College "Deafening Silence: Understanding and Alleviating Tinnitus."

(Source)

 

Anyone else feel like a new frontier is finally opening?

 

I might visit the symposium, I live 30 minutes away. Thanks for sharing.

 

Is there anybody here who will participate in the trial?

I live in Germany, otherwise I would have asked if I can participate.

On the other hand, I was part of a study many years ago that experimented with vagus nerve stimulation alone. It had no effect on my tinnitus. Not sure if combining it with sounds will have some positive outcome...

 

Interesting, thanks. I live near-ish, so I might visit as well.

I wonder in which ways this device will differ from Auricle. At least it's going to be "vernuftig"

 

I'm seriously considering it.

About the pairing of VNS and sound stimulation for alleviating tinnitus: I've already responded to your question on page 1:

 

I just found out that TU Delft will hold two symposiums on the 6th of February: one in English (12:30 - 17:00 p.m.) and another one in Dutch (19:00 - 22:30 p.m.). The line-up of speakers is basically the same, except that Mark Janssen from Maastricht UMC (DBS study on tinnitus) will also attend the first event and share his insights. That makes it all the more interesting for me.

I'll probably go to the English version of the symposium. Hopefully I'll see some of you at the TU Delft auditorium.

 

Thanks for sharing this. I will attend as well, and maybe see you there.

 

I'll probably attend in the evening. The registration for the first event asks you to fill out your ENT or audiologist identification number.

Although not required, I'm not sure if they'd like for a mere mortal such as myself to rub shoulders with all these professionals (and score a free lunch + drinks in the process).

 

Haha, well, I'd like to think that our presence as 'ervaringsdeskundigen' (experts by experience) at least counts for something at the symposium, especially since most researchers in this field don't have that shared experience of living with severe/debilitating tinnitus.

Basically all the presenters listed for the 1st symposium will rehash their findings at the 2nd symposium in the evening and will probably stay afterwards for a chat. So one way or the other, you can still rub some shoulders with professionals, minus the free lunch of course

Anyway, for those who attend one of the two symposiums, here are the programmes on the 6th of February:

1st Symposium:



2nd Symposium:

 

New article on the TU Delft device is just out. The author explains how the cooperation between TU Delft and Brai3n for the treatment of tinnitus came into being, how the device works and when the first clinical trials will take place (somewhere in mid-January at the Brai3n clinic).

(Source)

Since the article can only be accessed via membership or paid subscription, I've used ChatGPT to summarize the important bits from the text.

 

Thanks, @Christiaan.

I read the article on AD today. I thought it was interesting to note that they might perform follow-up (clinical) trials in New Zealand – partly because of the current strict European regulations.

Nevertheless, if initial trials turn out to be promising, then eventually they'd still have to comply with said regulations when bringing the procedure back to Europe, no?

Or could they somehow skirt around these regulations in case their device has a proven track-record outside of the EU?

 

We really need something in Europe. My heart sank when Dr. Susan Shore said they are not anywhere near to submitting for approval in Europe or elsewhere.

 

Good question and I honestly don't know the answer, as I'm not an expert on international regulations. I can only assume that they might go after the CE Mark certification for medical devices after (hopefully) successful clinical trials. Meeting the general safety and performance requirements of the EU are necessary for the future commercialisation of a product like the TU Delft device.

Luckily, the EU has a so-called 'Agreements on Mutual Recognition of Conformity Assessment' (MRA) with New Zealand, which means that the two parties have a regulatory agreement that entails the recognition of one another's conformity assessments, decisions or (clinical) results. This could mean that products that are (partially) developed and approved outside our continent may be more easily approved (for commercial purposes) by the EU if it has an MRA with a particular country.

 

It looks like we will have a different approach in a couple of years when people visit an ENT/Audiologist. From 'you'll have to learn to live with it' (or something nicer but with the same substance) to 'ok, let's get you assessed and booked in for treatment.'

In the UK I expect this will be 2026-2028 though. There may be some diagnostics then too. It may also have to be accessed privately as the NHS require a high level of evidence to cost ratio.

I'm surprised that TU Delft have moved this quickly. This thread must be only 18-24 months old. Maybe nowhere near as meticulous as Dr. Shore but it's a results business and Dr. De Ridder tends to get his technology in clinic in quick time. The problems historically are that for most tinnitus patients his brain zapping treatments are useless and his cocktails worrying and rarely prescribed outside Belgium.

It will be interesting if the trial is successful, how it's been conducted, and what the primary outcomes are? He often does an open label, crossover design and uses the VAS.

 

I always look forward to your updates, mate. You've certainly got a better handle than I have on how all these trials and data fit together. Primary outcomes I think will be the usual suspects right now, TFI and all that business. Having said that, if we ever see a surge of real patients come to this site conveying positive outcomes in decent numbers (like what I guess we hoped we'd see with Lenire but didn't) then I reckon we'd instantly be able to discern effective treatment from the BS. Still, it's nice to see that researchers are engaging more with the public; it's got to be good for us in the end. What are you thinking is coming our way 2026-2028?

 

Auricle looks likely.

Others if they are successful:

• The Bionics Institute's objective measurement of tinnitus
  
• Neurosoft
• Possibly some personalised tDCS stuff
• Potassium channel modulators - could be fool's gold
• TU Delft

 

A friend has sent an email asking if this can be watched online. Are there any members definitely attending? I'm assuming we will see some pilot trial data on the device.

I'm also interested in Mark Janssen's presentation on DBS.

 

I will attend the symposium (the 1st one) and will also take notes for you guys.

 

Hi everyone,

I want to share some insights from a recent interview with Prof. Dirk de Ridder and Prof. Wouter Serdijn on the Dutch radio about the TU Delft device.

Here's a brief summary:

The device: the prototype is a bi-modal system and it's about the size of a bread bin. It operates by emitting sound from headphones that aligns with an individual's tinnitus frequency and providing electrical stimulation through the vagus nerve, with clips designed for a specific part of the ears. The aim is to notably reduce the loudness and awareness of tinnitus.

Clinical trials: they are planning a 3-week trial in New Zealand, which is expected to start within the next month or two. This upcoming trial is set to include a control group and an additional trial group that will receive extra brain stimulation, to assess if this approach intensifies the reduction of tinnitus symptoms. From my perspective, there seems to be a bit of ambiguity surrounding a possible trial at Brai3n in Ghent. It's not entirely clear if it will go ahead as planned.

Prototype adaptability: It's also worth noting that the researchers are open to modifying the prototype based on trial outcomes, which shows their commitment to continuously improving the device in response to findings and their faith in this project.

I’ve attached an image of the prototype for those interested:



(Source)

Update from Brai3n about the clinical trials:

Translation: "The first test phase will take place in New Zealand, a more extensive clinical study at the Brai3n clinic."

 

I definitely like the idea of an additional trial group using extra stimulation. Curious as to what that means.

 

Thanks @Christiaan.

So it's the vagus nerve...

I'm not sold. Where is the pre-clinical work on this? Dr. De Ridder frustrates me now. He always seems to skip the dirty work of animal research and pre-clinical testing.

 

There is already literature on animal AND human testing...

Yeah I'm a bit suss too. Prof. De Ridder's War on Tinnitus presentation mentioned using Dahlia4 to reduce hypothalamic inflammation. He then linked a Dahlia4 supplement created by another researcher at his university. That seems a bit suspicious. However granted - this supplement seems to have helped a bit and reduced my tinnitus. It's worth a go if anyone thinks their tinnitus is inflammation linked.

Secondly, Prof. De Ridder was caught cheating in a sailing competition.

 

This is from the article that I've summarised and posted on the 9th of January in this thread.

Electrical engineer and neurosurgeon believe to have found a solution for tinnitus

Why did you first start looking for the cause of tinnitus?

"If you know the cause, you can find the solution. But that cause is difficult to determine. Our brain is a mystery," explains Serdijn. "Via 'hairs' in our ears, vibrations are sent to the auditory nerve of our brains and converted in the brain into everything we hear. From music and talking to the babbling of water. These hairs in our ears wear out as we get older, or they can be damaged as a result of an explosion or prolonged exposure to too loud music."

It's as if our brain cells run off with the sound and start making noise or chatter with each other, as Serdijn calls it. "In other words, we had to try to silence those noisy brain cells. That means you have to give the right signal at the right time. Think, for example, of tapping on a glass in a busy restaurant. When someone does that, it almost always becomes dead silent. In other words, we have been looking for a signal like tapping on a glass. It seems that we have found that signal and the right moment."

How did the research into something so elusive in our brain begin?

About five years ago, it seemed an impossible task. First, Serdijn and his team investigated a way how they could 'speak' with our brains, supplemented with insights from neurosurgeon De Ridder. The test results have become increasingly successful over the last few years. "In mid-January, we will test with subjects in the BRAI3N clinic in Ghent."

"If those tests are successful, we will then do them on clients at the University of Otago in New Zealand, where De Ridder holds a chair. Why New Zealand? In Europe, we are bound by stricter regulations. If you want to research something here, it can take you half a year or a year. If the so-called clinical tests are indeed positive, we can help people faster."

Note: it seems they have already performed pre-clinical tests, but the question remains how they have conducted them. This is one of those questions that I hope to ask at the symposium next month.