New University of Michigan Tinnitus Discovery — Signal Timing

[Nick47]

it's reasonable to hypothesize that those with tinnitus and more extensive damage may not experience improvement or may have other factors that make them less likely to respond to treatment.

This is true. I have normal hearing in my left ear and severe-to-profound high-frequency hearing loss in my right ear. However, she says tinnitus is in the brain, so who knows. Mine is highly somatic, though.

 

[haha ear go eeee]

Are we there yet?

Jokes, I keep waiting a few months and checking this thread. I can't believe it's still not out yet. A snail's pace is an understatement, I think a snail could go faster.

 

[antonio77]

I feel like that's a necessary disclaimer. Many people experience strong anxiety related to their tinnitus, and a reduction in volume might not seem significant to everyone. Additionally, since we cannot measure the extent of damage in individuals, it's reasonable to hypothesize that those with tinnitus and more extensive damage may not experience improvement or may have other factors that make them less likely to respond to treatment.

I still don't understand why MRI isn't used to determine if a person has tinnitus. Years ago, it was reported that in people with tinnitus, a specific part of the brain lit up during an MRI. Why isn't this technique used to monitor whether someone's tinnitus improves or not? Am I missing something?

 

[IYIiKe]

I still don't understand why MRI isn't used to determine if a person has tinnitus. Years ago, it was reported that in people with tinnitus, a specific part of the brain lit up during an MRI. Why isn't this technique used to monitor whether someone's tinnitus improves or not? Am I missing something?

For a couple of reasons:

An MRI isn't used to diagnose tinnitus; it's done to rule out other pathologies that might be contributing to or causing it. I think you're referring to an fMRI, which may be able to identify certain brain areas that are activated and may or may not contribute to tinnitus.

However, that doesn't really tell you much. What's the point?

An insurance company isn't going to cover the cost of an expensive diagnostic tool when the treatment remains the same. There's no benefit in having an fMRI to identify tinnitus, which can be perfectly diagnosed based on symptoms presented clinically. There's no scientific basis for using it to monitor "improvement" in tinnitus, and any data gathered would be both costly and scientifically meaningless—a collection of uncontrolled, irrelevant data points. There's no scenario where insurance companies or doctors would want a patient to routinely get an fMRI just to monitor which regions of the brain are activated on a given day, especially when those activations may not even be related to tinnitus.

 

[Mr.VS]

For a couple of reasons:

An MRI isn't used to diagnose tinnitus; it's done to rule out other pathologies that might be contributing to or causing it. I think you're referring to an fMRI, which may be able to identify certain brain areas that are activated and may or may not contribute to tinnitus.

However, that doesn't really tell you much. What's the point?

After undergoing a 3T MRI scan, I discovered a small white spot on the right side of my brain, near the ear where my tinnitus is located. It's the only spot visible on the scan. The radiologist mentioned that this spot is likely a consequence of a past viral infection, without me even mentioning that I had COVID-19, which is when my tinnitus started. He also reassured me that the spot is harmless and that he doesn't see any correlation between it and the tinnitus. He added that the spot wouldn't have been visible with a scan of less than 3T.

 

[Karl Tallman]

Many of us are eagerly waiting to see when the FDA will approve the Susan Shore device—assuming Auricle has even submitted it for approval. Who knows? It might be sitting on a shelf somewhere, with no urgency to move it forward.

One thing we can do (for those of us in the U.S.) is contact our state senators or congressional representatives. Sending them a letter asking them to reach out to the FDA and urge prioritization of this approval might make a difference. While it may not guarantee results, if they receive 1,000 letters, it could potentially speed up the process.

I've drafted a letter that I'm sending to all the senators on the Veterans Affairs Committee, as I believe this could be a strong avenue to pursue. After all, no one can deny that our veterans suffering from severe tinnitus deserve access to this device as soon as possible.

Please feel free to use the attached PDF of the letter as a template and send it to your state senator if you can.

 

[Nick47]

One thing we can do (for those of us in the U.S.) is contact our state senators or congressional representatives. Sending them a letter asking them to reach out to the FDA and urge prioritization of this approval might make a difference. While it may not guarantee results, if they receive 1,000 letters, it could potentially speed up the process.

In general, yes, I am a strong believer in patient advocacy. How many people reading this have contacted a representative about the state of funding or research for their condition?

How many will email or write to them today after reading this?

How many will not take action, citing reasons like "I'll do it later," "I'm too busy," or "It won't make a difference"?

As for this specific device, it probably won't make a difference unless Auricle lacks proper funding streams. Timelines are timelines.

 

[lymebite]

How many will email or write to them today after reading this?

I might, but my understanding is Auricle has not yet said if they have submitted to the FDA yet. If there is no submission, and the delay is with Auricle, not the FDA, there is no point in criticizing the FDA and writing to our Representatives and Senators.

 

[Nick47]

I might, but my understanding is Auricle has not yet said if they have submitted to the FDA yet. If there is no submission, and the delay is with Auricle, not the FDA, there is no point in criticizing the FDA and writing to our Representatives and Senators.

I mean addressing tinnitus as an issue in general. My advice regarding Auricle is to leave it alone.

 

[dj_newark]

Auricle is literally killing us by remaining so silent. This astounding level of apathy that they are showing is simply appalling.

 

[IYIiKe]

Auricle is literally killing us by remaining so silent. This astounding level of apathy that they are showing is simply appalling.

Sentiments like this discourage companies from sharing information with Tinnitus Talk or with individuals who try to "cleverly" stalk company members and then post their findings here. It is unrealistic to expect anyone here who is completely uninvolved in the development or accreditation of such a device to speak on it, let alone know Auricle's specific milestones.

No matter what is said, it will never feel like things are happening quickly enough or that enough is being done, so why bother at all?

 

[ploughna]

I've put it out of my mind and won't be holding my breath—if it happens, it happens. Any of the other approaches discussed in other threads on Tinnitus Talk are likely to come to market sooner. Everything that could be discussed has already been covered, so we might as well close this thread until there's an actual update from Auricle themselves.

 

[kingsfan]

Auricle is literally killing us by remaining so silent. This astounding level of apathy that they are showing is simply appalling.

Seriously. Lives are on the line here. I'm willing to take whatever risks the FDA are trying to mitigate. I'll sign a waiver. Just give us the help we desperately need.

 

[Rhawnhurst]

I can understand if their attorneys told them not to provide information, since it can't help, but could hurt the FDA process. I think members here are just looking for some comment that they are continuing to diligently work on getting it approved. I can't imagine how that could have any negative reprecussions.

 

[IYIiKe]

I can understand if their attorneys told them not to provide information, since it can't help, but could hurt the FDA process. I think members here are just looking for some comment that they are continuing to diligently work on getting it approved. I can't imagine how that could have any negative reprecussions.

You can't imagine? If you scroll back through previous pages, you'll find instances of people contacting employees on LinkedIn and Facebook. These are people desperate enough to overstep boundaries, with no hesitation.

Some, when informed that the process is more complicated than they realize, suddenly consider themselves experts, even going so far as to claim intellectual property ownership of the device due to a fundamental misunderstanding of how grant funding works in academia.

The updates you're asking for have been provided in many ways. However, some continue to demand day-to-day, week-to-week, or month-to-month updates, all while mocking the limited number of employees involved, as if there's endless capacity to hire a PR bot to repeat the same information in different words.

Even the forum owner attempted to set realistic expectations, but this effort was met with outrage.

Certain members have gone out of their way to discourage any form of collaboration by essentially stalking employees and then sharing well-intentioned discussions only to have others ridicule them.

It's a lose-lose situation.

 

[delta784]

Will the Susan Shore Device work for non-somatic cases?

In my right ear, I have two tones: one is the typical tinnitus tone, and the other sounds like Morse code beeps. This somatic tinnitus doesn't bother me much in daily life. However, my left ear has non-somatic, drug-induced tinnitus. Since it's said that all tinnitus originates from the Dorsal Cochlear Nucleus, I assume there's a good chance this device could work for non-somatic cases as well. Is that correct?

 

[ColinUK]

I suppose there's no point in worrying about this, as it seems years away from becoming a consumer product. If it ever does come out, we'll quickly be able to determine who it works for and how. Until then...

 

[dd314]

Will the Susan Shore Device work for non-somatic cases?

In my right ear, I have two tones: one is the typical tinnitus tone, and the other sounds like Morse code beeps. This somatic tinnitus doesn't bother me much in daily life. However, my left ear has non-somatic, drug-induced tinnitus. Since it's said that all tinnitus originates from the Dorsal Cochlear Nucleus, I assume there's a good chance this device could work for non-somatic cases as well. Is that correct?

She speculated that it might work for both in the Q&A. Technically you can't ask a guinea pig if it has somatic tinnitus, then again you can't ask if your tinnitus machine worked either.

 

[delta784]

She speculated that it might work for both in the Q&A. Technically you can't ask a guinea pig if it has somatic tinnitus, then again you can't ask if your tinnitus machine worked either.

Yes, but haven't they tried this on humans as well? I assume all the cases were somatic?

 

[kingsfan]

Yes, but haven't they tried this on humans as well? I assume all the cases were somatic?

Somatic tinnitus was one of the prerequisites of the trials.

 

[dj_newark]

@linearb felt good effects from the Susan Shore Device, while he was using it. Those good effects didn't last after the trial.

The 1st trial lasted 4 weeks and the second one lasted 6 weeks. Given that in the second trial, the second half of the study was invalidated because the participants didn't return to baseline, one would surmise that 4 weeks of usage was not enough to achieve LTD.

Sentiments like this discourage companies from sharing information with Tinnitus Talk or with individuals who try to "cleverly" stalk company members and then post their findings here. It is unrealistic to expect anyone here who is completely uninvolved in the development or accreditation of such a device to speak on it, let alone know Auricle's specific milestones.

No matter what is said, it will never feel like things are happening quickly enough or that enough is being done, so why bother at all?

They're not sharing any information anyway. So what's your point? Never have I been involved in stalking anyone at Auricle. So I'm not sure why you bring that up in response to my post. True, I had been corresponding with Dr. Shore for about 10 years, but it was always respectful and mutual, and that did stop about the time that the second trial ended.

You're always obnoxious in responding to my posts, and I'm curious as to why!

 

[IYIiKe]

They're not sharing any information anyway. So what's your point? Never have I been involved in stalking anyone at Auricle. So I'm not sure why you bring that up in response to my post. True, I had been corresponding with Dr. Shore for about 10 years, but it was always respectful and mutual, and that did stop about the time that the second trial ended.

You're always obnoxious in responding to my posts, and I'm curious as to why!

Like it or not, this forum has gained a reputation due to certain members' actions and their interactions with Auricle, which have led to Auricle having little incentive to engage with members or administrators.

Many people are unaware of why Auricle is reluctant to share information with individuals seeking positive updates here. Posts like yours assume that these decisions are made without merit or business considerations, which can be needlessly provocative. I believe that the persistent harassment of their employees is counterproductive; if not for such actions, we might have more information and updates available.

 

[Markku]

Like it or not, this forum has gained a reputation due to certain members' actions and their interactions with Auricle, which have led to Auricle having little incentive to engage with members or administrators.

Many people are unaware of why Auricle is reluctant to share information with individuals seeking positive updates here. Posts like yours assume that these decisions are made without merit or business considerations, which can be needlessly provocative. I believe that the persistent harassment of their employees is counterproductive; if not for such actions, we might have more information and updates available.

On the one hand, you're right; people sending Susan & Auricle accusatory or threatening emails has undoubtedly had a negative impact. We're not talking about innocent emails here congratulating them on their efforts, but rather self-entitled and vitriolic ones (or obsessive, like hundreds of emails over the years from a single person). However, I should note that not all of these emails have come from Tinnitus Talk members, but rather from the overall tinnitus community.

On the other hand, if Hazel and I hadn't encouraged Auricle to communicate more transparently, we wouldn't have had last year's Q&A or much else.

That said, I can say without a shadow of a doubt that all the emails people have sent them have made our efforts to facilitate updates more challenging.

 

[dj_newark]

Like it or not, this forum has gained a reputation due to certain members' actions and their interactions with Auricle, which have led to Auricle having little incentive to engage with members or administrators.

Many people are unaware of why Auricle is reluctant to share information with individuals seeking positive updates here. Posts like yours assume that these decisions are made without merit or business considerations, which can be needlessly provocative. I believe that the persistent harassment of their employees is counterproductive; if not for such actions, we might have more information and updates available.

Who is harassing Auricle and its members? All of my interactions with Dr. Shore have been positive and infrequent. I haven't had email contact with her for years at this point. I don't even post to Tinnitus Talk much anymore, mostly due to vitriolic reactions like yours. Your accusations of me harassing anyone are patently false. I have a right to air my frustrations in a public forum at the slow pace of approval. We are very late in the game; if they haven't yet submitted, that is on them.

 

[Jonno02]

A lot of companies have social media policies, too. At the company I work for, anyone who shares information that hasn't been officially released is instantly dismissed.

 

[Rhawnhurst]

We all share the same goal, and some of us may post strong responses due to our frustration with our condition.

However, in a free enterprise system where there's money to be made, we can assume that Auricle is working as quickly as possible. If another company develops an effective alternative solution before them, they risk wasting vast amounts of time, money, and dreams.

No amount of "stalking" (if that has occurred) or direct communication with employees will speed up Auricle's approval and commercialization process. So, within the Tinnitus Talk community, we should agree to refrain from probing further and allow things to unfold as they will.

From what I can see, the administrators are sensible and reasonable, and they have had success in getting a response from Auricle. I believe they could, at their discretion, attempt further communication if needed. For any questions, we should continue to direct them to the administrators as our primary points of contact.

 

[Nick47]

There is no doubt Auricle are moving as quickly as possible. As others and I have said, every day it's unavailable is a day of lost profit. Other treatments are moving through the pipeline, too.

 

[IYIiKe]

Who is harassing Auricle and its members? All of my interactions with Dr. Shore have been positive and infrequent. I haven't had email contact with her for years at this point. I don't even post to Tinnitus Talk much anymore, mostly due to vitriolic reactions like yours. Your accusations of me harassing anyone are patently false. I have a right to air my frustrations in a public forum at the slow pace of approval. We are very late in the game; if they haven't yet submitted, that is on them.

No one accused you of harassing Auricle.

However, posts like yours, which criticize the lack of daily, weekly, or monthly updates and frame it as if they are killing people or being intentionally apathetic, disincentivize Auricle from engaging with the community.

Several people who have posted in this thread have even gone to the extent of messaging Auricle employees on their private Facebook, LinkedIn, and other platforms.

You're welcome to express your frustration, just as I am to express mine. But sentiments like yours, which suggest they are killing people, and the lengths others are going to out of desperation to criticize or disparage Auricle, are entirely counterproductive.

 

[delta784]

There is no doubt Auricle are moving as quickly as possible. As others and I have said, every day it's unavailable is a day of lost profit. Other treatments are moving through the pipeline, too.

What are the other treatments moving through the pipeline (in addition to potassium channel modulators)?

 

[Nick47]

What are the other treatments moving through the pipeline (in addition to potassium channel modulators)?

Feel free to browse through the Research News category. I'm not counting KV7 drugs because, at best, I'm only 50/50 on them.