Head-Mounted Device for Motion Sickness Reduces Tinnitus

So I had a very nice email chat with Sam Owen at Otolith. Within a few months, they plan to launch a usability study/dosage trial involving virtual reality, and someone like me with tinnitus but without vertigo could take part. At my request Sam placed me on a list and I'll be notified when they're ready to go. I didn't try Sam's patience too much with multiple questions but I imagine that type of person would be part of a control group, since the device is aimed at treating vertigo, after having been shown to prevent motion sickness.

I'm not sure I'll participate because, reading into the mention of virtual reality, it sounds like part of this will be an effort to create temporary vertigo/dizziness as before. Maybe I'm being superstitious, but I may not want to risk inducing that permanently (or even temporarily!). I have several markers of Meniere's but not vertigo and based on what I've read, I should be thankful for that. But I'll decide after I learn more about the trial.

So I haven't succeeded in arranging a visit just to test for tinnitus effects, which was the first request I made. However it's great to get direct communication from the company that they're aware of its effect on tinnitus patients, at least the handful they encountered (all/many, I don't know), even if they have no idea why. I'm sure they'll investigate this avenue further.

 

@Chriscom good info! Thanks for the follow up.

I would keep pushing to get a demo. What did Sam say when u asked if u could come into the office?

 

Well, that's what I opened with--I "just" have tinnitus, think I could stop by for a test drive? Sam kindly responded with the info about the upcoming vertigo trial. Basically my question was clear and his answer was clear.

I don't blame them, especially if it works at all for our condition--can you imagine what this office would be handling once everyone with T in the DMV (DC/Maryland/Virginia) got wind of this? And while it seems super-safe, if I were running a trial I wouldn't necessarily want to place this on non-vetted heads. Because IIRC the initial tinnitus discovery correctly, it turned up on subjects that had already been screened for that round of tests. Who knows if that device could have damaging effect on a hidden incipient aneurysm, or something covered in their subject screens.

I salute anyone who wants to pursue it further, but considering as Sam put it "We have no clinical data on tinnitus, have any idea which forms of tinnitus we may help, and above all make no claims regarding the efficacy of our device with tinnitus," I don't blame them for focusing at this moment on the issue that their investors have actually invested in.

 

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.

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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

Sent from my iPhone



On Aug 26, 2019, at 7:32 PM, lcj wrote:

Hi Sam, if these testers want, are they able to come to your office to try the device? Or do they need to sign up for a clinical trial first?


Sent from my iPhone

On Aug 24, 2019, at 11:22 AM, Samuel Owen <sam.owen@otolithlabs.com> wrote:

It’s been slightly updated but not ready for commercial sale. We’ll be able to try multiple power levels in our office.

Sent from my iPhone

On Aug 24, 2019, at 2:04 AM, lcj wrote:

No prob! I hope you get a lot of testers

Btw is this the same device as the one that Spencer Salter found accidentally works on tinnitus patients (through his testing on motion sickness)? Or has it been updated?

Sent from my iPhone

 

I sent a brief email to Sam too and he responded that he will contact once they are ready to do the study. I have not decided if I will go through with it; I will need to ask him more questions when the time comes. After reading the response to @Chriscom 's email, I may not go with it.

 

Thanks for the updates. Their approach sounds prudent, not to mention staying within the guidelines of the law and safety. Glad their research is on track to continue.

 

If they’re truthful and it reduced T and you could stop the trial anytime I’m not sure why you wouldn’t give it a shot. If it was a drug or surgery I would understand hesitation. If it’s a vibrating headband and some VR goggles I’d be inclined to go for it.

 

I do have some dizziness/mild balance issues sometimes and I would not want to turn that into vertigo, similar to ChrisCom's reason. At the moment I do not know much about the device. I will definitely ask them a lot of questions once they contact me.

 

The thing about this technology is that the results are supposed to be instantaneous (unlike most treatments which can take months or even longer). It would be very easy to test the effectiveness, and the participant could provide feedback on the results immediately.

"I have since offered the device to other tinnitus sufferers (image below). They all have a similar smile. Some took the device home to use in the quiet where tinnitus is perceived at its worst. Afterwards, they don’t want to give the device back."

(my italics)

 

https://www.defenseone.com/technolo...-drugs-and-could-mean-lot-us-military/152960/

Click on word Oto tech. Maybe, we’ll see.

 

I’m not letting this device go, people need to know if it works or not? While looking at this device I was reading something about Ménière’s and it mentioned the Vestibular nerve attached to the cochlea when operating wrong can cause T. I never thought about that, could it be the link between visual snow and T? Could it be that people who lose hearing and don’t get T have a healthy Vestibular nerve? Is everyone looking at the wrong nerve for Tinnitus? Is that why they claim this device for motion sickness might do something? Is that why these bimodal devices zap all the circuits because both nerves are attached to the Cochlea? Or am I way off base?

 

I think you're on to something. Maybe you should email an expert like Dr. Shore on the matter.

 

I lived too far away for the trial.