Lenire — Bimodal Stimulation Treatment by Neuromod

[Bndsmheowqhe]

But what was said upstream is that Tinnitus Talk members are biased on the basis that only more severe sufferers come here looking for support. But then you can counter that by saying early adopters willing to try an under-tested device would also probably self-select for more severe cases (maybe not in the trials where the selection criteria was chosen by Neuromod, but with the product in release, yes). So for those who don't buy the data one way or another, it's an inkblot test.

The question I have is why isn't Neuromod offering updated testimonial videos or written statements from other users that have already completed the 12 week program? The argument could be made that some Tinnitus Talk members are not an ideal representation because of potentially more severe cases but surely out of 100s of people that have received treatment they would be able to pull together something that better reflects the mythical 80% improvement number that they love to throw around. Maybe they felt another round of "I think it's helping" videos wouldn't benefit their case.

 

[Harley]

The question I have is why isn't Neuromod offering updated testimonial videos or written statements from other users that have already completed the 12 week program? The argument could be made that some Tinnitus Talk members are not an ideal representation because of potentially more severe cases but surely out of 100s of people that have received treatment they would be able to pull together something that better reflects the mythical 80% improvement number that they love to throw around. Maybe they felt another round of "I think it's helping" videos wouldn't benefit their case.

There may not be another round of videos.
I think that they are possibly starting to realize that they might have cornered themselves with their decision to use Bluetooth headset in a device, where success or failure is measured in milliseconds.

The problem is that if they suddenly switch to a wired headset, it could be seen as an admission of guilt and could potentially open them up for legal action from those who have experienced the so-called "disimprovement".

This is just my own speculation of course, as the use of Bluetooth headphones is simply not making any sense to me in a device such as this and I just can't get past that one.

 

[threefirefour]

@Clearance,

Now that you've had Lenire for a few months, has your tinnitus improved?

 

[valeri]

If Lenire doesn't reduce tinnitus loudness than it's no better than TRT!

 

[Redknight]

The question I have is why isn't Neuromod offering updated testimonial videos or written statements from other users that have already completed the 12 week program?

They are recording them in November/December for release in the next few months.

 

[Bndsmheowqhe]

They are recording them in November/December for release in the next few months.

I'm very interested in seeing these if they actually materialize. What's your source?

 

[GlennS]

There may not be another round of videos.
I think that they are possibly starting to realize that they might have cornered themselves with their decision to use Bluetooth headset in a device, where success or failure is measured in milliseconds.

If that's the case, then they lied during the interview, because they said they understand the Bluetooth latency issue and have accounted for it 100%. I don't think Neuromod is the type of company to be foolish enough to outright lie. Spin, yes, Equivocate, yes. Lie, no.

 

[threefirefour]

If Lenire doesn't reduce tinnitus loudness than it's no better than TRT!

Exactly.

I'm very interested in seeing these if they actually materialize. What's your source?

He's part of the trials so he probably asked.

 

[ChrisBoyMonkey]

Exactly.

He's part of the trials so he probably asked.

He's actually undergoing the treatment, it's not exactly a trail anymore other than in a sense that they're still collecting data from the results.

He actually reported success too last I heard.

 

[threefirefour]

He's actually undergoing the treatment, it's not exactly a trail anymore other than in a sense that they're still collecting data from the results.

He actually reported success too last I heard.

That's what I meant, I just picked the wrong words, thanks. Yeah he had good improvement.

 

[Hazel]

Interview with Neuromod released!

Our podcast episode featuring our interview with Neuromod CEO Dr. Ross O'Neill is now public to all interested listeners!

Check it out and comment in the below thread:

Episode 7: Neuromod's Lenire — Treating Tinnitus the Bimodal Way

 

[threefirefour]

Interview with Neuromod released!

Our podcast episode featuring our interview with Neuromod CEO Dr. Ross O'Neill is now public to all interested listeners!

Check it out and comment in the below thread:

Episode 7: Neuromod's Lenire — Treating Tinnitus the Bimodal Way

Thank you Hazel.

Will do.

 

[Harley]

If that's the case, then they lied during the interview, because they said they understand the Bluetooth latency issue and have accounted for it 100%. I don't think Neuromod is the type of company to be foolish enough to outright lie. Spin, yes, Equivocate, yes. Lie, no.

I don't think they lied in trying to compensate for the latency and this is not my area of expertise, but from what I can recall, there are few posters on here with much deeper understanding of this issue.

According to them (or at least this is my interpretation of their posts), this latency is not consistent and therefore it cannot be 100% compensated for?

 

[GlennS]

According to them (or at least this is my interpretation of their posts), this latency is not consistent and therefore it cannot be 100% compensated for?

The interview is out. Listen for yourself. But they made a point that they selected a particular set of headphones where the latency doesn't vary.

 

[HootOwl]

The interview is out. Listen for yourself. But they made a point that they selected a particular set of headphones where the latency doesn't vary.

I have no experience with sound engineering so I will defer to anyone on the forum who has expertise in this.

Can you truly guarantee no latency in Bluetooth headphones? Even with a very specific brand or model?

 

[ajc]

I have no experience with sound engineering so I will defer to anyone on the forum who has expertise in this.

I have to eat my own words from before. I asked a DSP (Digital Signalling Processing) expert and they said the AKG headphones Lenire uses have this aptX codec feature which provides predictable and constant latency.

 

[HootOwl]

I have to eat my own words from before. I asked a DSP (Digital Signalling Processing) expert and they said the AKG headphones Lenire uses have this aptX codec feature which provides predictable and constant latency.

Hm that makes the initial worsening for several members here even more perplexing. I know myself and others were thinking that this was because the latency in the headphones was causing the pulsation rate to be slightly off, resulting in the disinformation cells being excited and not repressed.

I wonder why Susan Shore's trial participants didn't report any worsening. Did she use a different firing rate entirely? Is there a way to check this?

 

[linearb]

I wonder why Susan Shore's trial participants didn't report any worsening. Did she use a different firing rate entirely? Is there a way to check this?

Sure, get Lenire to be as transparent with their full data and protocols as the UMich lab has been, and we can compare.

 

[Fabrikat]

Sadly, no joy for those with hearing loss outside their stated parameters.

With arguably more intrusive tinnitus and greater barriers to habituation when there is less ambient sounds coming into the brain, here is a cohort with a profound need, but who remain unserviced by Lenire.

Even those with hearing loss out by a few dB and even in only one frequency or even in one ear, regardless of the second ear qualifying, remain excluded and untreatable. I do not understand why. Even when compensated with hearing aids.

Ross O'Neill unfortunately has nothing to offer these people, other than to suggest alternative treatments. Treatments that don't exist. I imagine there are more than a few people that would be feeling quite empty about Lenire right now.

 

[GlennS]

I have to eat my own words from before. I asked a DSP (Digital Signalling Processing) expert and they said the AKG headphones Lenire uses have this aptX codec feature which provides predictable and constant latency.

Does it? I did some Googling and found this:

"Typical aptX latency ranges between 50 to 150 ms."
"Typical aptX(LL) latency ranges between 30 and 50 ms."

I haven't been able to find any technical info to explain under which circumstances the latency might vary moment to moment. I would imagine distance and interference would come into play.

When they're concerned about image latency, you can think of the image as the same as the electrical stimulation in the sense that there is little to no latency of seeing an image or feeling an electrical pulse compared to Bluetooth, so achieving synchronization requires that the core device knows how much latency there is and delaying the image (or the pulses) to match a (hopefully fixed) latency.

 

[GlennS]

I wonder why Susan Shore's trial participants didn't report any worsening. Did she use a different firing rate entirely? Is there a way to check this?

Three differences:

1) The makeup of Susan Shore's trial participants don't necessarily match up with Lenire's (the whole somatic thing).

(Yeah, I know a lot of tinnitus sufferers can modulate their tinnitus by clenching their jaw--I certainly can. It doesn't change the fact she is honing in on patients with that phenomenon and Neuromod isn't.)

2) The point of stimulation is different.

3) Stimulation suite is different (probably most significant, IMHO).

Listening to sound while something sends electrical impulses down nerves just defines a communication protocol. It's what you send down that protocol that determines how the brain gets hacked.

 

[valeri]

Why am I constantly thinking "another one bites the dust"?

 

[UKBloke]

The question I have is why isn't Neuromod offering updated testimonial videos or written statements from other users that have already completed the 12 week program?

This point is covered in the podcast. According to Ross O'Neill it relates to a GDPR issue. He also states that at some point in the future, Neuromod want to be able to publicly release commercial user results data.

What I found interesting is that he also stated that the current commercial user data results are available to the Regulator whose job it is to ensure Lenire is doing what it says on the tin. So it seems the data is out there, but whether or not we're going to be able to access it is another thing.

 

[Bartoli]

Can you truly guarantee no latency in Bluetooth headphones? Even with a very specific brand or model?

Not with zero latency. That's not even the case with wired headphones. But if it's a known and invariable amount of latency it can be compensated for. I'm not sure if it would be possible to do the same for variable latency... Maybe it would be if they were able to somehow adjust the tonguetip to the musical output. Still unnecessarily complicated IMO.

 

[GlennS]

According to Ross O'Neill it relates to a GDPR issue.

That's Neuromod reaching for an excuse. He could have everyone sign a waiver form to allow their data to be made public if he wanted. Most patients would probably do it.

And really, what matters here is aggregate data, not people's names and addresses. There is no intrusiveness having your data be crunched down into a chart. In fact, most of us provide that data online in ways we don't even know all the time. It's how online advertising works.

 

[UKBloke]

That's Neuromod reaching for an excuse. He could have everyone sign a waiver form to allow their data to be made public if he wanted. Most patients would probably do it.

And really, what matters here is aggregate data, not people's names and addresses. There is no intrusiveness having your data be crunched down into a chart. In fact, most of us provide that data online in ways we don't even know all the time. It's how online advertising works.

I agree. I must admit, this point for me was one of the key ones of the entire interview. Going forward, whether or not the Regulator will release some aggregated data is entirely up to them I suppose but if they won't then we're faced with a closed-shop situation, at least until Neuromod make good on their statement of trying to address the release of their commercial user base response figures. I guess the information we can glean from the User Experiences thread here at Tinnitus Talk is going to become more valuable by the day.

 

[Bartoli]

Some people might remember I sent Neuromod an email regarding the Bluetooth latency.
A couple of aeons later they replied. Apparently the e-mail got lost. I find their response convincing. Too bad it wasn't sent sooner. It explains things in the same way as Dr. O'Neill. If only they replied sooner this thread would've been 30 pages shorter at the very least.

I asked about 3 things

- importance of stimulation at the exact tinnitus frequency.
- Bluetooth latency.
- results so far.

Here's their response:

Thank you for your e-mail – apologies for the delayed response. My colleagues who check this e-mail forwarded your e-mail to my attention, however, I was out of the office at a number of international conferences.

The personalised parameters are customised to each individual's hearing profile as measured using a standard pure tone audiogram conducted by a qualified audiologist. The treatment is not customised based on tinnitus frequency or sound.

Throughout development Neuromod has taken steps to ensure that the relationship between the sound and tongue stimulus is well defined and reliable. These steps involved characterising the delay of the Bluetooth link to the provided headphones (AKG K845BT headphones) and compensating for this delay during treatment sessions. Neuromod has performed extensive validation to ensure that the required timing relationship is consistent and repeatable. This is currently one of the reasons why the Lenire® device restricts operation to just the AKG headphones – use with other Bluetooth devices is currently not possible.

With regard to experience with Lenire® outside of clinical trials, Neuromod is carefully monitoring performance to ensure it is line with results observed in clinical trials. Once sufficient data has been collected, we will be able to answer this question, however, it is too early to answer this question at this time.

With best wishes
Rosemarie​

 

[JohnK]

But if your THI is in the teens... Why are you here? Based on that, your tinnitus has very little effect on you, so why bother?

Because THI is about how much it distresses you, not how much you hear it. It's super high pitched and I hear it all the time. I'm not distressed much by it anymore but I'd still rather not hear it (or at least hear it a lot less).

Also it's immensely intrusive when I listen to music, and music means the world to me.

 

[Bndsmheowqhe]

That's Neuromod reaching for an excuse. He could have everyone sign a waiver form to allow their data to be made public if he wanted. Most patients would probably do it.

And really, what matters here is aggregate data, not people's names and addresses. There is no intrusiveness having your data be crunched down into a chart. In fact, most of us provide that data online in ways we don't even know all the time. It's how online advertising works.

Your assessment of him being too smart to outright lie appears to be accurate. I think he goes to great lengths to avoid saying things that are technically not true. That's one of the things that bothered me the most about the first interview especially when you consider that he refused to sign off on the video until after multiple revisions were made in editing. And while lying seems to be off the table for him he apparently has no moral objections when it comes to obfuscation, misdirection and sins of omission.

 

[GlennS]

Your assessment of him being too smart to outright lie appears to be accurate. I think he goes to great lengths to avoid saying things that are technically not true. That's one of the things that bothered me the most about the first interview especially when you consider that he refused to sign off on the video until after multiple revisions were made in editing. And while lying seems to be off the table for him he apparently has no moral objections when it comes to obfuscation, misdirection and sins of omission.

And that is exactly how politicians behave. Think of Bill Clinton's definition of "is".

Not aware that Neuromod asked for edits on the prior interview.

The other datapoint which is being lost in the shuffle is their drive to bury the Vimeo video of Hubert Lim's presentation. That chart data is now proving vital to us assessing this device in this thread. Why did they feel the need to bury it?

When asked about controversial topics, Ross attempts to sort of gaslight, to suggest that what seems fishy is all standard procedure hence we're seeing phantoms. And that may be true. I'm not an expert on medical device rollouts, but I think given MuteButton the burden is on Neuromod. Prior to that first interview, the general sentiment here was that MuteButton was a scam and Neuromod wasn't to be trusted. That interview really turned things around. That shows the power of controlled marketing. But really, for me, it's all about the testimonials. I certainly hope everyone understands by now that we have no choice but to lean on the Tinnitus Talk user reports.

Given that it's going to be a long wait before it starts to roll out beyond Ireland or Germany that's plenty of time for the datapoints here to accumulate.