New University of Michigan Tinnitus Discovery — Signal Timing

Seems like a reasonable hypothesis.

 

We will have to wait and see if it indeed does help anyone at all. That's what they are trying to find out, hence the trial.

But from what I have read the Dorsal Cochlear Nucleus responds to input from the cochlea and the loss of input is what causes the system to go haywire. So logically there shouldn't be a difference between people getting damage from loud noise, viral infections, ototoxic medications etc. The result is the same, damage in the cochlea leading to loss of input to the Dorsal Cochlear Nucleus, which then leads to neuroplasticity in the DCN that results in perception of tinnitus.

But like I said, we are just going to have to wait it out and see what the results from trials are going to tell us.

 

I need some explanations.

Do I understand correctly that the investigated treatment is something like ACRN, which at one time was widely advertised, but it turned out to be almost ineffective.

It looks like headphones inserted into the ears, and generating certain sounds, plus some electrodes that are connected to the head.

Is real effectiveness of this device possible, which is maintained at least for a day?

 

Kind of, but the sound part is only one part of the process. That's why it's called "bi-modal stimulation": you need an electrical jolt in addition to the sound, and timed appropriately, for this to work.

Read their papers or watch their presentations: they explain why it's important to have both stimuli.

The initial results seem to indicate positive outcomes, which is why it's progressing in the research pipeline (with more studies).

 

It’s like hotwiring a car?

It’s like hotwiring / kickstarting the part of the brain that does not work / react properly anymore.

Hit it to get it un-stuck. Right?

 

Yes, of course, I very much hope that in the very near future the device from the University of Michigan will pass all the trials, it will prove effective and will enter the market.

This will be a lifeline for us, a temporary relief, until we learn how to regenerate the hair cells of the ear.

There are a number of questions:

- I hate the FDA very much, I'm afraid that corrupt FDA officials will simply ban it if they are not well off. They need to fight with the FDA.

- If the device goes to the market, who will mass produce it?

- The device will be used only in special clinics, with a specially trained worker who will set up this device? Or is it not that difficult to customize it at home?

 

https://www.fda.gov/medicaldevices/safety/medicaldevicebans/default.htm

What is a Medical Device Ban?
A medical device ban is a total prohibition on the current and future sales, distribution, and manufacturing of a medical device.

The FDA has the authority to ban a medical device intended for human use if it finds, on the basis of all available data and information, that the device presents a substantial deception to patients or users about the benefits of the device, or an unreasonable and substantial risk of illness or injury, which cannot be corrected by a change in the labeling. (see Section 516(a) of the Federal Food, Drug and Cosmetic Act; 21 CFR 895.20)

How Often Does the FDA use this Authority to Protect Public Health?
The FDA very rarely acts on this authority. Until 2016, the FDA banned only one other medical device, prosthetic hair fibers. The FDA found there was no public health benefit to this device. This device presented a substantial deception to patients or users about the benefits of the device. The prosthetic hair fibers did not stimulate hair growth nor conceal baldness, but could actually cause serious infections, illness, and injuries from their implantation. We believed that the labeling and advertising materials directly or implied misrepresented the device as safe, effective, and causing little or no discomfort, among other misleading claims....


What Process Does the FDA Follow to Ban a Medical Device?
The FDA makes the determination to ban a device by analyzing and weighing the risks and benefits the device poses to individuals. This analysis may include:

• Identifying and studying the device, including assessing adverse events,
• Analyzing the risks and benefits posed by alternative devices and treatments being used in current medical practice,
• Analyzing whether a change in labeling on the device mitigates the risk,
• Evaluating the medical literature,
• Conducting a panel meeting with outside experts,
• Discussing concerns with professional societies, and
• Reviewing information from health care professionals and patients.

The FDA can ban a device without actual proof of illness or injury, and only needs to find that a device has the potential to present the required degree of risk based on all available data and information.

The FDA may initiate proceedings to ban the device if:

• the device presents substantial deception in the labeling or an unreasonable and substantial risk of illness or injury, and
• such deception or risk cannot be, or has not been, corrected or eliminated by labeling or a change in labeling.

If the FDA decides to initiate proceedings to ban a device, a notice of proposed rulemaking is published in the Federal Register.

List of Medical Device Bans
The list below contains bans that have been proposed or issued.

Device Name Date
Electrical Stimulation Devices (ESDs) Used for Self-injurious or Aggressive Behavior Proposed April 22, 2016
Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove Effective January 18, 2017
Prosthetic Hair Fibers Effective June 3, 1983

https://www.fda.gov/medicaldevices/safety/medicaldevicebans/default.htm

 

Hi everyone, is there any updates from the trial ?? I thought it was expect to start in august, maybe i missed something ??

 

this sounds like unhinged conspiracy theory thinking to me, can you show me some evidence of the kind of thing you're talking about? My own criticism of the FDA is very much in the other direction, as far as being too lenient about trusting industry's own research and allowing things that don't actually work that well to go to market.

 

Would really like to know this as well, as August is about to end in some days

 

Its running late. The trials are now commencing October / November.

 

>tfw the next season of Jojo is coming out before this trial

I-I don't know how to feel about this. I wish they would hurry up

 

Small delays in clinical trials is nothing to worry about.

 

What's the source for disqualifying if you have H? Can't find anything about it here:
https://umhealthresearch.org/#studies/HUM00143675

 

I think they can answer that question by contacting Jenny Bell.

For questions about this study, contact:
Jenny Bell E-mail:jennbell@med.umich.edu

 

http://www.alphr.com/health/1008092...e-din-of-tinnitus-with-electric-shocks-to-the

 

When are they starting?

 

Should happen this October.

 

How do you know?

 

She said in an interview it begins in early fall 2018, so Im approximating.

 

I have some misunderstanding.

As far as I know, somatic tinnitus is a type of tinnitus that is associated with physical movement and touch. It can be caused by muscle spasms in the ear or neck, or by any mechanical stimuli. This is a separate type of non-sensory genesis.

Most of us suffer from sensory tinnitus. Sensory tinnitus is, as a rule, a side effect in cases of disorders of the auditory sensory system.

So why can someone modulate their tinnitus while moving the jaw, and some do not. Although the cause for many is the same - a violation in the sensory auditory system?

I can not obviously modulate my tinnitus. Sometimes only.
I hope this device will be effective for me.

 

Explain to me please the meaning of the American Tinnitus Association, precisely in terms of "finding and financing treatment for tinnitus" from their side.

Yes, I agree that such an association should be about reminding about the problem, for public relations.

But here are their donations to research and "finding medicines" from tinnitus.

Does this make sense now? Their funds are very small, if not to say scanty - $6 million in donations in more than 30 years.

Moreover, there are already studies at some advanced stage, for example, the Susan Shore device, the University of Minnesota device, studies of potassium channels by Professor Tzounopoulos, Josef Rauschecker. Why come up and look for new research. It is better to help financially already existing. Especially Professor Tzounopoulos openly asks for this.

It is necessary to find a drug for tinnitus as soon as possible to alleviate suffering, as long as we cannot yet regenerate the hair cells.

 

That's true - They will be starting the next trials in October/November. I got the same message as @threefirefour did from Jenny.

 

Probably because T is complex and the genesis of the sound can be due to a variety of phenomenons.
The hypothesis of the bimodal treatments is that, in some cases, the genesis is located in an area that can be influenced by movement (you stretch or compress an area: that will have an effect on the tissue in that area, its cells, and possibly affect the sensory information that we perceive as sound, if those cells are involved in the phantom sound). That can be true even if that sound genesis process is the result of maladaptive plasticity triggered by hearing loss, and therefore, you can have "somatic T" (in the sense that you can modulate it when you move) even if your root cause is hearing loss (as is my case).

 

Who sponsors the research of Professor Susan Shore?

As far as I understand, the research is being sponsored insultingly little.

Besides, the evaluation of Susan Shore's research by ATA (American Tinnitus Association) is depressing - the site says very little about it. It can maybe somehow help someone. Something to that degree.

It drives me into misunderstanding. Also ATA further collects money and sponsors some research. It gives fixed grants of 50 thousand dollars.

This is ridiculous. This money is not enough for the researchers to even drink whiskey before the start of a study.

 

Should we have high hopes on this?

I touch my face I kinda feel the tinnitus or one of the 3 sounds increase a bit.

 

I believe that it is worth hoping deep down. But do not place too much hope on this device.

They have been studying tinnitus for more than 15 years. But in the world there still is no clear understanding of "from and to" what is tinnitus and where it comes from in the brain.

The device at first glance is rather primitive, and it was not worth those 15 years of research. Some engineer from Germany at this forum created a similar device for bimodal stimulation in a couple of days. This device, in principle, is equal to the amount of funding that is paid to tinnitus. It is negligible.

To study the obesity of pimps in Alabama receives way more money. This world has gone mad.

 

This is wrong. Go through the University of Minnesota link and you will see a diagram that explains sensory input. Long story short 80% of all tinnitus shares a common pathway this common pathway can be accessed through somatasensory inout.