OtoBand by Otolith Labs — Head-Mounted Device for Motion Sickness Reduces Tinnitus

[Piney]

The Michigan trial I live too far away from. Otolith Labs from Washington said they would contact me for the Vertigo device trial but I haven't heard from them yet.

Some interesting info: I saw an audiogram today of a patient who had an acoustic neuroma. Medium level hearing loss and the hearing nerve wasn't transferring the right input, as per the audiologist. But he has no tinnitus. I just assumed the nerve played a role. Maybe not. I'm more perplexed than ever.

 

[FGG]

Some interesting info: I saw an audiogram today of a patient who had an acoustic neuroma. Medium level hearing loss and the hearing nerve wasn't transferring the right input, as per the audiologist. But he has no tinnitus. I just assumed the nerve played a role. Maybe not. I'm more perplexed than ever.

Just to add another data point, my tinnitus and hearing loss are bilateral and very symmetric.

On VNG I have a severely impaired right vestibular nerve (basically non functional) and a normal left one.

 

[MattS]

Sorry, forgot to follow up on this thread. Below is my continued conversation with Sam. It does seem like he is walking back his initial statement about being demoing the device, which is a little disappointing, (although maybe he would in person just not in writing?) But at least we have confirmation that it's the same device as the one from the linkedin article.

-----

The FDA has told us we are a Class II medical device. Legally this means we have serious and potentially criminal liabilities if we go around testing our device on patients without an ethics board approval or at the very least a clinician present. While we're considered a non-significant risk device we are in a very real way interacting with an internal organ and don't yet know what side-effects may occur (e.g. we had no idea we would reduce tinnitus, but imagine our liability if somehow we caused tinnitus).

We're about to start enrolling subjects in an IRB approved dosage trial for which tinnitus is not a disqualifying condition. Under IRB approval we're legally protected then to administer our technology to anyone enrolled. If someone has tinnitus and reports it helps or doesn't help their symptoms it'll be recorded. And if someone tries our device and for whatever reason decides they don't want to complete the whole protocol they're allowed to stop at any point and for any reason.

So until the FDA clears us for over-the-counter use, IN WRITING the only thing I can legally offer to patients asking to test our technology for certain conditions is the ability to be enrolled in a trial where their condition doesn't disqualify them.

Sam

As someone who knows the ins/outs of clinical trials, I can tell you that Sam is telling the truth. There is no possible way that he can let a patient just play around with the device under the auspices of a clinical "test". He's get closed down in a heartbeat, and then sued from every direction.

Sadly, the FDA process will take years. But enrolling in a clinical trial is always a possibility. And seems awfully low risk.

I'd head to DC for a bit, if I could get a crack at it!

 

[GlennS]

On VNG I have a severely impaired right vestibular nerve (basically non functional) and a normal left one.

How does that sort of thing happen? I have TMJ as well (worse on my left which is also where my T is worse) and pretty bad neck from sitting in front of a computer constantly. I don't know how much that contributes to my problems or what can be done about it.

 

[FGG]

How does that sort of thing happen? I have TMJ as well (worse on my left which is also where my T is worse) and pretty bad neck from sitting in front of a computer constantly. I don't know how much that contributes to my problems or what can be done about it.

I have seen so many specialists. At first it was vestibular neuritis, then vestibular migraines, then Meneire's, then Lyme, then viral, then back to migraines. This all started before my hearing loss and tinnitus which occurred after getting a toxic dose of Azithromycin (usually reversible, not in my case).

My audiograms and tinnitis are identical bilaterally. Ototoxicity was the cause of that but I did have unilateral vestibular weakness beforehand and i can say it didn't seem to protect one ear over the other from tinnitus.

 

[lcj]

Found two links to support the use of low dose ultrasound as a potential tinnitus treatment. It seems like this could be similar to the mechanism of action of the head mounted device. In which case, this could be tested without needing to enroll in the trial..

Low-powered ultrasound in the treatment of tinnitus: a pilot study

 

[Jeremy Weate]

I wonder if Otolith has submitted any patents for this...

 

[ChrisBoyMonkey]

I wonder if Otolith has submitted any patents for this...

Good idea... we can make our own specifically for tinnitus and patent it for that!

Who here knows how to do that kind of engineering?

 

[bmguitar]

I have come across with a Korean YouTube channel that sells a medical ultrasonic device (plus TENS and other functionalities, like one of those you find at physiotherapy clinics) and they claim to reverse many health conditions, including tinnitus, with hundreds of testimonials.

Obviously they are trying to sell the device and you cannot always fully trust these kinds of claims, but the testimonials seemed somewhat genuine and thought it might have actually worked at least for some people if not all, so I ordered a small ultrasonic device online like the one in the link you posted.

The device I saw on YouTube uses 1.2MHz ultrasound and maximum power of 9W (but they use the device on level 3 out of 10, so maybe 3W-ish?), but the one I bought is 1MHz (with possibly lower wattage) as I couldn't find any device that uses 1.2MHz. I doubt the Otolith's device actually goes up that high as it is a "vibration" device.

Will update once I receive the device, but I'm not expecting it to work like magic.

For anyone out there who's willing to try this, you need to constantly move the device and not point at the same spot for too long as it can cause burn or damage. Also use gel.

 

[Piney]

Awesome, let us know.

 

[dd314]

 

[Vicious99]

Email from the inventor below.

View attachment 33709

They don't compensate for your time/expenses?

 

[Hammers]

They don't compensate for your time/expenses?

"You will be compensated for your participation" so for time, yes, travel expenses, no.

 

[Chriscom]

They don't compensate for your time/expenses?

"You will be compensated for your participation in the study."

Though I communicated with the company earlier this year, I didn't receive that email. I did click on the form link above and submitted (it's very short) and it said I was a good candidate and would receive an invite. Still not sure I want to participate, hoping to find out a little bit more about it. And yes I live in the DC area.

The questions, I gather for exclusion, were about things like head trauma, age (I'm close to the upper limit of 65+), and a rare condition whose name I can't recall.

 

[Lilah]

@Chriscom I got the same e-mail too.

 

[Piney]

This week I participated in the testing of this device. Unfortunately I didn't report any change while wearing the device, they did have a software issue when I put the headset on which I emailed them back on. I couldn't feel the device vibrating or anything so who knows. We'll see what they come back with. My tinnitus is from hearing loss, I'll keep trying to work on this.

 

[BuzzyBee]

This week I participated in the testing of this device. Unfortunately I didn't report any change while wearing the device, they did have a software issue when I put the headset on which I emailed them back on. I couldn't feel the device vibrating or anything so who knows. We'll see what they come back with. My tinnitus is from hearing loss, I'll keep trying to work on this.

Thanks for sharing your experience!

 

[Ozwel]

This week I participated in the testing of this device. Unfortunately I didn't report any change while wearing the device, they did have a software issue when I put the headset on which I emailed them back on. I couldn't feel the device vibrating or anything so who knows. We'll see what they come back with. My tinnitus is from hearing loss, I'll keep trying to work on this.

Will be interesting to know if your device was working fine. I'll stay tuned around here for some time

 

[Chriscom]

I participated in the current Otolith trial at a Washington, D.C. location today. Headline: It didn't help me, but the guy running the test said it had helped some.

• Notably, he said the company had attended some local (Northern Virginia) meeting this week, and they tested it on 10 people, two of which said it helped. In one case, the subject said it produced a mild reduction in tinnitus, and my Otolith tester didn't know how weak or strong the result was with the other one.
• They are still recruiting and very early in their planned run of 100 test subjects. Two people who'd signed up were no-shows today, so if you're interested and I suppose especially if you're local, sign up.
• We did a tinnitus test with different settings and a longer motion-sickness test. As stated, it didn't affect my tinnitus at all, although we experienced device issues as similarly related by Piney above. With the first tinnitus run, I didn't feel any vibration but heard a kind of high-pitched whine, at different levels. When we did the virtual reality motion sickness, it was a completely different experience--no whine, and I definitely felt vibration at different levels of intensity. When I mentioned this, we decided to do the tinnitus-only test again [the tester had made a calibration after the first tinnitus test when I used the restroom]. Same result though: Didn't make it better, or worse.
• I am still feeling a little bit nauseous an hour after the visit, though certainly better than immediately afterwards. No feeling of discomfort with tinnitus-only test, but the virtual reality headset definitely had its effect on me, eventually. You can stop it at any time and I was probably trying to tough it out a little bit more than necessary.
• To be clear, at no time did I feel like I was going to throw up or anything--they really do not want you to feel super uncomfortable, they say stop the virtual reality display as soon as you feel anything other than verrry mildly not perfect. It didn't help in my case that I usually have a snack around that time and constantly drink fluids, neither one of which I was doing at the time.
• The virtual reality view is sort of a white donut shape and scores of white and blue blocks grouped around it that slowly zoom in and out. The focus wasn't that great but he said this wasn't super important.
• The test was conducted in a shared workspace office, a brand name many would recognize. The glass-walled cubicle we tested in was tiny and just big enough for two people to sit across each other at a table.
• When I called to confirm I was arriving, I received a weird answer on the phone that made me unsure I had the right number-"Is this Otolith" - "Yeah." -- that sort of thing. This might have been the shared workspace receptionist; the fellow who ran the test was very kind and conversational. I enjoyed meeting him and he was pleasant to be with.
• Oh, and I got a $100 Visa debit gift card.
• Forgot to mention: He was aware of one other subject who wasn't helped who, like me, also had and acquired tinnitus after walking pneumonia, though I don't know if that is significant with a small sample size.

I apologize for the length, I do go on. Ask any questions and I'll answer as best I can. He said I could share all this with the forum.

 

[Lilah]

I participated in the trial today. No impact on my tinnitus. The device was working fine I believe (I felt the vibrations). Pretty much everything I experienced with the testing is described by @Chriscom above. With the vertigo portion, I stopped when I felt slightly uncomfortable at each run, so I didn't get to the point where I was dizzy.

 

[Chriscom]

I participated in the trial today. No impact on my tinnitus. The device was working fine I believe (I felt the vibrations). Pretty much everything I experienced with the testing is described by @Chriscom above. With the vertigo portion, I stopped when I felt slightly uncomfortable at each run, so I didn't get to the point where I was dizzy.

Thanks for going & updating us. This may be a good time for me to say I completely recovered from any feeling of slight nausea or dizziness (dizziness is too strong a word for me but I can't think of anything else) later on that evening, and I've faced no further issues since then.

 

[Jacob Meyerkopf]

Hey Y'all,

I've been looking into this device, and have a Phone Interview on Friday with the team developing it at Otolith Labs. I wanted to open it up to the community to see if anyone had questions they wanted answered. This could help guide the team's efforts to create the device with tinnitus sufferers in mind.

Please, post your questions here, and I will integrate them into my interview. Thanks!

 

[Mathieulh]

This appears to be yet another palliative, money wasted, BS.

We all know the only true treatment is to target the cause of tinnitus (some form of hearing loss for most cases), this goes through either:

- Regeneration of the cochlea and its nerves/synapses (some drugs do exist that do just that, we just can't access any of them, go figure... The fact that we know, though actual studies, that these drugs are safe and yet not made available, despite the lack of existing treatment (and no, I don't count CBT/TRT/Habituation as "treatment"), is borderline criminal in my opinion, we need to wait until 2025+ for something that could be available now because of stupid bureaucracy).

- Improved cochlear implants (the current ones rely on a late 50s technology that has, to this date, not been improved because the patents have not yet expired so there is no incentive to further research and development, just add some external bluetooth control module, do not change the underlying technology at all, and get an extension on the patent, yeah!).

- Hearing aids that target high frequencies (that's not even currently a thing for some reason, if I had to guess it'd be profit related, heck high end headphones cost less than hearing aids do and cover the entire human hearing spectrum, is there a technical reason hearing aids should be any different?).

Everything else is a waste of time and money that could be invested elsewhere (into actual, useful research).

 

[Tybs]

This appears to be yet another palliative, money wasted, BS

I tend to disagree. While I fully support the statement that the focus of research and treatment for tinnitus should be on the possible causes, a (working) device that eliminates tinnitus while wearing it would bring great relief for sufferers in the meantime. Sure, the device is not an actual "cure" in itself, but if it grants someone the choice of having silence for some periods of the day, then it makes the condition less difficult to life with while science is catching up.

 

[Tybs]

Hey Y'all,

I've been looking into this device, and have a Phone Interview on Friday with the team developing it at Otolith Labs. I wanted to open it up to the community to see if anyone had questions they wanted answered. This could help guide the team's efforts to create the device with tinnitus sufferers in mind.

Please, post your questions here, and I will integrate them into my interview. Thanks!

My question: does it affect all cases of T, or only a subset?

 

[Mathieulh]

I tend to disagree. While I fully support the statement that the focus of research and treatment for tinnitus should be on the possible causes, a (working) device that eliminates tinnitus while wearing it would bring great relief for sufferers in the meantime. Sure, the device is not an actual "cure" in itself, but if it grants someone the choice of having silence for some periods of the day, then it makes the condition less difficult to life with while science is catching up.

Does it though? Most people seem to report no improvement/change whatsoever.

 

[Tybs]

Does it though? Most people seem to report no improvement/change whatsoever.

That's with Lenire. To my knowledge, the head device in this topic has not been reviewed by members of Tinnitus Talk.

 

[Chriscom]

That's with Lenire. To my knowledge, the head device in this topic has not been reviewed by members of Tinnitus Talk.

If you look just a few posts up, you'll find my detailed post about trying the device; it did not ease my tinnitus, and fellow community member Lilah said it didn't help her either.

The Otolith employee who conducted the test on me said it had helped some; details in my Jan. 23 post. It's only like seven posts up from yours.

 

[Tybs]

If you look just a few posts up, you'll find my detailed post about trying the device; it did not ease my tinnitus, and fellow community member Lilah said it didn't help her either.

The Otolith employee who conducted the test on me said it had helped some; details in my Jan. 23 post. It's only like seven posts up from yours.

Ah, I missed that one. My bad: thx for the heads up

You mention an infection as the primary suspect for your tinnitus. How likely would you consider hearing loss to play a role as well?

 

[Chriscom]

Ah, I missed that one. My bad: thx for the heads up

You mention an infection as the primary suspect for your tinnitus. How likely would you consider hearing loss to play a role as well?

Major likelihood. I had hearing loss and tinnitus basically diagnosed at the same time. This followed my recovery from very severe walking pneumonia. My two ENTs said we'll never know for sure, but it was likely associated with that.