Low-Level Laser Therapy (LLLT) for Tinnitus — Efficacy Debate

[FERNANDO GIL]

Sometimes I wish I was a rat,,,,,
http://www.researchgate.net/publica..._postnatal_organotypic_culture_of_rat_cochlea

 

[FERNANDO GIL]

I find your post to be highly offensive.

In my opinion LLLT is a scam. I have also been highly critical over the years of various medical clinics and medical doctors who rip off tinnitus sufferers with baseless promises. One particular very prominent ENT clinic in the US offering lidocaine middle ear infusions immediately comes to mind.

I have no "affiliation with the medical industry." I have no investments in medical products. I hold no stock in medical companies. I receive no royalties from any of my previous work in the field.

I am a past Chairman of the Board of Directors of the American Tinnitus Association and have devoted thousands of hours to tinnitus advocacy and tinnitus support. All of such efforts on behalf of the tinnitus community have been voluntary. I receive no financial benefit whatsoever. When I am invited to speak to audiology students in seminars at various universities and receive honorariums, I donate them right back to the scholarship programs at those universities.

I am retired. I do see a few tinnitus patients a month from across the globe because I am very very good at what I do, and there is a lot of suffering out there. Any profits are donated to tinnitus research.

The reason - the ONLY reason - I post on this board is to offer a unique perspective - that of a medical doctor who knows what it is to truly suffer from severe intrusive tinnitus.

The mere suggestion that I might have some sort of hidden agenda here disgusts me ... and makes me wonder why the hell I bother.

Stephen Nagler

"In the corporate sector, between 2002 and 2004, Dr. Nagler was Vice President for Clinical Affairs at Neuromonics (then known as Tinnitech Ltd), and between 2010 and 2013, he was Director of Tinnitus and Hyperacusis Services at General Hearing Instruments, Inc, where he helped develop wearable devices designed specifically for Tinnitus Retraining Therapy (TRT)."

I think "I have no "affiliation with the medical industry."" is not exactly right.....

 

[attheedgeofscience]

it is same as the trt!

In that case, could you please explain my before/after audiograms?

Thanks.

 

[SweetPeach]

In that case, could you please explain my before/after audiograms?

Thanks.

differense is minimal between before and after. inconclusive proof

look this http://www.tandfonline.com/doi/abs/10.1080/0002889748507047


Abstract
Results are given of an investigation into the reproducibility of audiograms, recorded by manual sweep-frequency audiometers. The standard deviation of a measured hearing level is 3 dB at 250 Hz up to 7 dB at 8000 Hz. To conclude from two audiograms that an actual increase in the hearing level has occurred at a given frequency, this increase must be at least 10 dB at frequencies below 4000 Hz, at least 15 dB at frequencies from 4000 to 6300 Hz, and at least 20 dB at 8000 Hz (5% confidence level), irrespective of whether the audiograms have been recorded by the same or by different audiometrists.

 

[Michael2013]

I was going to say the same thing. How do you know those aren't just natural changes? Was it a different audiologist? Could there have been ear wax buildup? There are lots of reasons to see changes up to 10dbs. Maybe if you took more tests over time you would find the average right in between those two? Or maybe you already have, I don't know.

 

[attheedgeofscience]

differense is minimal between before and after. inconclusive proof

look this http://www.tandfonline.com/doi/abs/10.1080/0002889748507047

Any particular reason you include a study of sweep frequency testing for a pure-tone audiogram?

I have a 25db hearing improvement at 8 kHz. Which is actually quite significant; the energy carried by a sound wave doubles for every 3db. Of course there is a limit to how much my hearing can improve given that all of my speech frequency hearing is within stage-I hearing loss - there is a physical limit to just how much a person's hearing threshold can be improved, after all.

Losing 25db of hearing threshold is a process that generally takes about 20 years for people who are not in NIHL environments. I reversed that hearing loss in two months.

Here is a person who initially had stage-I hearing loss: http://healingmenieres.wordpress.com/audiogram-results and who reversed 30db of hearing loss in approximately one year (at 250 Hz). So even if your referenced study was for pure tone audiometry, the results obtained would still be considered significant.

 

[attheedgeofscience]

I was going to say the same thing. How do you know those aren't just natural changes? Was it a different audiologist? Could there have been ear wax buildup? There are lots of reasons to see changes up to 10dbs. Maybe if you took more tests over time you would find the average right in between those two? Or maybe you already have, I don't know.

See this...

https://www.tinnitustalk.com/threads/my-introduction.1862/#post-39035

...and this

https://www.tinnitustalk.com/thread...aybe-we-can-know-more.3131/page-14#post-52050

 

[FERNANDO GIL]

differense is minimal between before and after. inconclusive proof

look this http://www.tandfonline.com/doi/abs/10.1080/0002889748507047


Abstract
Results are given of an investigation into the reproducibility of audiograms, recorded by manual sweep-frequency audiometers. The standard deviation of a measured hearing level is 3 dB at 250 Hz up to 7 dB at 8000 Hz. To conclude from two audiograms that an actual increase in the hearing level has occurred at a given frequency, this increase must be at least 10 dB at frequencies below 4000 Hz, at least 15 dB at frequencies from 4000 to 6300 Hz, and at least 20 dB at 8000 Hz (5% confidence level), irrespective of whether the audiograms have been recorded by the same or by different audiometrists.

How can you say is minimal?
audigrams are everything except a "correct science", but when you gain 20db ( at 8 Mhz) in hearing, trust me you notice. My tv volume used to be on level 25, I can now ear it at 8/10 easily. At night time with silencie in the room I can even ear it at volume 1/2 and notice everything they say clearly.

Please check my audigrams, they are all made at the same places and same audimetrist.

 

[Mosaik]

Btw it is KHz. 1000 Hz = 1 KHz, 1000 KHz = 1 MHz

 

[attheedgeofscience]

Btw it is KHz. 1000 Hz = 1 KHz, 1000 KHz = 1 MHz

Agreed. But to be perfectly correct it is actually kHz and not KHz...

 

[attheedgeofscience]

My tv volume used to be on level 25, I can now ear it at 8/10 easily. At night time with silencie in the room I can even ear it at volume 1/2 and notice everything they say clearly.

Agreed. This has also been the most surprising aspect of my experience ie. noticing how much better my hearing has become even though I had normal hearing to begin with and no problems following a conversation at normal speech levels.

However a 20-25db improvement in the upper speech frequency range has made a difference. That's for sure. The reason it is such a remarkable experience is because the reversal of hearing loss is a process which takes place relatively quickly (ie. 2 months or so...). So a person can really feel the difference - compared with the normal hearing loss process which would typically take about 20 years for 25db hearing loss. Hearing loss ususally takes place so very slowly that we don't notice it until the day when it becomes so bad that we actually cannot follow a conversation without having to ask people to repeat what they say...

 

[OptimusPrimed]

As someone who has suffered from distorted hearing and chronic tinnitus for over seven years, I am willing to accept new ideas and treatments which may mediate suffering. My acoustic trauma has caused be a great deal of suffering over the years. It has certainly reduced my quality of life and it is only positive thinking that helps me get by each day.

I first saw a pamphlet on LLLT in my ENT's waiting room. I would like to run out and drop thousands on treatment; but I cannot afford to do so. For me, it is important to know that these therapies actually work.

As such, I've conducted some searches using my subscription to PubMed. I was interested in finding out if there is any efficacy in treating chronic tinnitus. Tinnitus was my article of interest, not hearing loss.

17 papers on LLLT for tinnitus relief. The lower the number; the most recent the study. I did not name studies; they are available on PubMed with a simple "Laser therapy tinnitus" search. 11 studies state that there is essentially no real benefit from the therapy other than a possible placebo effect. 6 studies state possible positive effects and support further investigation. This is simply my quick 10 minute analysis. It is by no means scientific; but it does give the reader an idea of the ambiguous nature of this treatment. It is by no means a definitive treatment, and while it may help one person it is completely possible, or even likely, that the next patient will see no benefit. Furthermore I find it interesting that in a few studies the benefit dissipated a few weeks after stopping LLLT. This may further suggest some sort of placebo effect.

I'm not out to hate on those doing LLLT. I just know that it is expensive, and that acupuncture or TRT or some other therapy may be money better spent. Or maybe even a trip to a beach resort in Cuba or Bali.

All said however, if it is working for you than continue to do it. Anything that alleviates suffering is a good thing.

1. Conclusion. Combined central rTMS and peripheral LLLT is more beneficial as a new method for management of tinnitus rather than these two used separately. We found that combined stimulation was effective in tinnitus treatment. This effect remained for 4 weeks after the end of the treatment. However, each of rTMS and LLLT alone had no significant effect.

2. The results did show only very moderate temporary improvement of tinnitus. Moreover, no statistically relevant differences between laser and placebo group could be found. We conclude that medium-level laser therapy cannot be regarded as an effective treatment of chronic tinnitus in our therapy regime considering the limited number of patients included in our study.

3. This study found low-level laser therapy to be effective in alleviating tinnitus in patients with noise-induced hearing loss, although this effect has faded after 3 months of follow-up.

4. The treatment group was given LLLT, which consisted of shining low-level lasers onto the outer ear, head, and neck. Each laser treatment lasted approximately five minutes. Three treatments were applied within the course of one week. A battery of auditory tests was administered immediately before the first treatment and immediately after the third treatment. The battery consisted of pure-tone audiometry, the Connected Speech Test, and transient-evoked otoacoustic emissions. Data were analyzed by comparing pre- and posttest results. No statistically significant differences were found between groups for any of the auditory tests. Additionally, no clinically significant differences were found in any individual subjects.

5. In term of VAS scores, there seems to be no statistically significant improvement in patients' annoyance, sleep disruption, depression, concentration and tinnitusloudness and pitch heard between the two groups. Transmeatal low-power laser stimulation did not demonstrate significant efficacy as a therapeutic measure in treating tinnitus.

6. Over half of the patients (56.9%) had some form of improvement in their tinnitus symptoms. Mild improvement was reported in 33.8% of patients, moderate improvement was reported in 16.9%, and full improvement was reported in 6.15%. Of the patients who reported dizzy spells as a symptom of their tinnitus condition, 27.7% reported mild improvement and 16.9% reported full improvement. Common side effects of LLLT were noted among 20% of patients; however, all of them were mild and disappeared within a few days. Conclusion. Low-level laser therapy was found to be useful for treatment of chronic tinnitus.

7. Transmeatal low-levellaser irradiation is effective for the treatment of tinnitus and some variables like age and job can affect the treatment outcome.

8. The laser power was 5 mV and the wavelength 650 nm. The irradiation lasted 20 minutes daily for 3 months. The Tinnitus Handicap Inventory (THI) questionnaire was submitted at the beginning and at the end of treatment. The THI scores improved in the entire sample after treatment but more significantly in the group receiving low-levellaser stimulation. From the point of view of clinical classification, approximately 61% of irradiated patients had tinnitus severity decreased by one class, in comparison to 35% of the placebo group.

9. Soft laser therapy demonstrated no efficacy as a therapeutic measure for tinnitus.

10. Transmeatal, low power (5 mW) laser irradiation was found to be useful for the treatment of chronic tinnitus.

11. Changes of tinnitus loudness and tinnitus matching have been described. After a follow-up period of six months tinnitus loudness was attenuated in 13 of 35 irradiated patients, while two of 35 patients reported their tinnitus as totally absent. Hearing threshold levels and middle ear function remained unchanged. Further investigations by large double-blind placebo-controlled studies are mandatory for clinical evaluation of the presented TCL-system and its therapeutic effectiveness in acute and chronic cochlear dysfunction.

12. Transmeatal low-power laser irradiation with 60 mW is not effective for the treatment of tinnitus.

13. In this study we wanted to evaluate the outcome of using a combination of EGb 761 and soft laser therapy. We examined 120 patients with an average duration of tinnitus of 10 years. The patients underwent pure-tone audiometry, speech audiometry and objective audiometry tests. The intensity and frequency of tinnitus was also determined. EGb 761 was administered 3 weeks before starting soft laser therapy. Patients underwent 10 sessions of laser therapy, each lasting for 10 min. An improvement in tinnitus was audiometrically confirmed in 50.8% of patients: 10 dB in 18; 20 dB in 22; 30 dB in 10; 40 dB in 6; and 50 dB in 5.

14. Low-power laser treatment is not indicated in the treatment of tinnitus. Reports of significant benefits of this treatment in previous studies may be explained by the placebo effect.

15. No significant difference between laser and placebo was found in annoyance or loudness of the tinnitus and in changes of TEOAE amplitude. These results indicate that there is no relationship between the effect of low-power laser and changes in cochlear micro mechanics.

16. We conclude that low-power laser treatment is not indicated in the treatment of tinnitus. Reports of significant benefits of this treatment in previous, mostly uncontrolled or single-blinded studies may be explained by the placebo effect.

17. Although only 26% of the patients had improved duration, loudness and degree of annoyance were relieved in up to 58 and 55%, respectively, without major complication. Laser therapy seemed to be worth trying on patients with intractable tinnitus.

 

[dboy]

Thanks @OptimusPrimed. Yes, it is a controversial treatment and your post is a timely reminder to newcomers that there is no guarantee of improving T with this approach. Everyone should be aware that this thread is in the 'Alternative Treatments and Research' section so it is not a mainstream therapy for T. Some studies have shown benefit some have not. Some people have reported improvements in their T with it and some have not. Some have presented evidence of impressive improvements in their hearing profile, as well as reporting improvements in their hyperacusis. But if anyone wants a guarantee of effectiveness they should definitely look elsewhere.

It is worth noting that most of those who reported benefits have invested huge amounts of time and effort (and expense of course). It is hard for a study or trial to reproduce this accurately as it depends on having only highly motivated and persistent participants. It is not as simple as getting people to take a course of medication for a set time. All of the available studies seem flawed or open to criticism in some way, from what I have gathered.

That said, this treatment has attracted extreme negative reactions in the past and what in my judgement looks a lot like intellectual dishonesty from those who set out to rubbish it. The evidence of this is available earlier in this thread - and also on the thread on the Yuku board where the level of bullying of those who reported benefits (as well as those who simply expressed curiosity and an open mind) was quite shocking to me. Please let's not go there again folks, now that interest in LLLT is roused again by the positive reports we have had recently.

 

[tomytl]

Hi,
as a LLLT user I'm still sceptical about this therapy. If it would be a really successful therapy, why isn't there
a seriouse double blind study available? Instead of forcing a study, many of the sellers tell you about conspiracy of the pharma against LLLT. It has some parallels to homeopathy. You won't find any successful double blind study, instead of proof you will also find many conspiracy stories.
The concept of LLLT sounds very interesting, but there should be more interests to make some seriouse studies instead of selling overpriced devices to desperated people like us.
Why should we pay 3000 US Dollars for 2 diodes of 30mW? Do you really think 2 diodes,2 fibercables,1 timer, 1 display and a simple integraded circuit costs that much? It's more like, get the most out of it in a financial aspect.

Greets Tom

 

[attheedgeofscience]

And I would be very interested in knowing to what he attributes this improvement.

I believe the following posts should address your questions, Dr. Nagler:

https://www.tinnitustalk.com/thread...-end-up-being-the-cure.2225/page-8#post-81485

https://www.tinnitustalk.com/thread...-end-up-being-the-cure.2225/page-8#post-81464

 

[Dr. Nagler]

I believe the following posts should address your questions, Dr. Nagler:

https://www.tinnitustalk.com/thread...-end-up-being-the-cure.2225/page-8#post-81485

https://www.tinnitustalk.com/thread...-end-up-being-the-cure.2225/page-8#post-81464

Thank you.

Any thoughts as to the role of "tincture of time" or to the psychological benefit conferred purely by virtue of the fact that rather than waiting for nature to take its course, you are "doing something?"

These are very difficult issues, and I am not trying to box you into a corner. Just wondering how you personally see it.

stephen nagler

 

[attheedgeofscience]

Any thoughts as to the role of "tincture of time" or to the psychological benefit conferred purely by virtue of the fact that rather than waiting for nature to take its course, you are "doing something?"

Well, when I developed tinnitus in late April, 2013, it wasn' getting any better. Starting on June 10th that year, I did the cold laser therapy with Dr. Wilden (your "arch enemy" ) which did improve my hearing somewhat, but did little (if anything) for my tinnitus during that 8-week treatment period (June-July). I had hoped for more, but I also now - later on - recognize that predicting the exact amount of therapy needed can be difficult. So I have no grudge with Dr. Wilden, and in retrospect, I should have stayed with the treatment, I believe. Anyway... at the beginning of August, 2013, I decided to go for the stem cell treatment with the rejuvenation clinic in Bangkok. A month later, I had been visiting my Father in Switzerland. I was getting ready to drive back home to Leipzig and as I put my earplugs in for the 8-hour drive (I always protect my ears), I noticed that the tinnitus volume was somewhat lower. And I would say that that day pretty much marked the first day of my many months of improvements thereafter. However, due to 2nd thoughts on the treatment protocol the first stem clinic had used, I decided to go for another stem cell treatment in China (for a planned 500 million stem cells - a protocol I deemed important as the injections are done IV as opposed to being done directly into the cochlea which - if possible - would require much fewer stem cells). On my 2nd intercontinental flight from Europe to Asia around x'mas time 2013, I was again wearing earplugs for the 10-hour flight. And this time, I could still hear my tinnitus, but my ears were not "screaming" as they were when I did the same trip back in August. Was it the stem cells or the tincture of time? Hard to tell since comparative statistics cannot be performed on a one person sample. But here is what I do know: 3 weeks after I had returned home from China, I was still having some jetlag from the 3 weeks stay. I therefore woke up one night, and there was total silence inside my head. Total silence. Both in my left and right ear - the ear in which I have had tinnitus since birth. I now had confirmation that the noise I had always heard was not normal. The silence lasted 5-7 minutes. As the effect from the stem cells would "kick in" - a process that occurs over a period of 6 to 8 weeks - I would continue to have fleeting tinnitus and what can best be described as "auditory re-calibration" (as self-made up term, needless to say). I have estimated my improvement from the combined stem cell treatments to be about 50%. Was it the stem cells? I cannot prove it and - as a patient - it is not my job to do so either, but I am pleased that two other members of TinnitusTalk have confirmed similar experiences to myself:

Don't expect anything miraculous overnight, this is a process that will take time and might not even work. However its been a month and a half since my first injection and I am seeing some results in a sense there are fluctuations with my tinnitus however these days when I wake up my tinnitus is quieter than it was before going. I find by night time its back to normal, but really not as loud as it was pre-stem cells, but honestly, its a matter of waiting and seeing.
...
I would like to thank attheedgeofscience for all the information. Sometimes you have to go and find the cure yourself, it took four doctors to finally diagnose me with hearing loss. Can you believe none of the first three gave me a hearing test and simply dismissed me as ear infection? Even though they actually looked inside my ear. By the time the one who did diagnose me with hearing loss in my left ear, it was too late.

So for conditions such as tinnitus and hearing loss, stem cells are not necessarily a cure, and I have also "warned" against spending lots of money on something which is experimental:

Looking at a stem cell treatment from a cost-benefit point-of-view, I would not really recommend it. The chance of a good result for a condition like tinnitus is simply too unreliable (that's why it is experimental). So please don't start contacting this clinic with tons of questions about hearing loss and tinnitus: they cannot really promise you anything (so don't ask - you know what the answer will be).

However, as a Dane living in Germany, I was, am, and continue to be not entitled to participate in clinical trials such as AM-101. And that's why I decided to become my own physician, instead. Actually, to be honest, I did not "decide" as such... I had no choice! My own primary care physician was - like most GPs - simply not up to the challenge of helping people afflicted with tinnitus. And so, to the best of my knowledge, I became the first person ever to go through two stem cell treatments as a patient with tinnitus as a primary symptom.

Lastly I should mention that the stem cells have (also) had a number of other benefits: my life-long childhood eczema is gone, my sense of smell has improved, my knee joints - after many marathons - are not aching in the mornings, and my autoimmune eye-condition is gone. Just recently, I read the following pubmed article...

http://www.ncbi.nlm.nih.gov/pubmed/25125599

...and as I read it, I remember smiling to myself thinking "Tell me something I didn't know..."

attheedgeofscience
05/JAN/2015.

 

[Dr. Nagler]

Well, when I developed tinnitus in late April, 2013, it wasn' getting any better.

April 2013? So if it is fair to say that you attribute your improvement over the ensuing year to this, that, and the other thing, would it also be fair to say that had you pretty-much done nothing, you might have experienced the same degree of tinnitus improvement due purely to "tincture of time" - just like most other folks who do nothing over the first year?

Don't get me wrong. I am not about to argue with your success, and as you know I applaud you in your dogged determination. Indeed, I greatly admire you in that regard. I'm just trying to look at the other side of the coin. The coin does have two sides, yes?

Starting on June 10th that year, I did the cold laser therapy with Dr. Wilden (your "arch enemy") ...

Wilden isn't my arch enemy. I would just like to see a single reliable and verifiable controlled study published in a legitimate juried scientific journal to back up his claims, specifically his tinnitus claims.

Dr. Stephen Nagler

 

[Dr. Nagler]

All said however, if it is working for you than continue to do it. Anything that alleviates suffering is a good thing.

Stringplayer's First Law: Nobody who attained even minimal relief from tinnitus ever cared one iota whether or not that relief was attained through science.

Dr. Stephen Nagler

 

[bwspot]

Stringplayer's First Law: Nobody who attained even minimal relief from tinnitus ever cared one iota whether or not that relief was attained through science.

Dr. Stephen Nagler

What is the point you are trying to make dr.Nagler?

 

[attheedgeofscience]

April 2013? So if it is fair to say that you attribute your improvement over the ensuing year to this, that, and the other thing, would it also be fair to say that had you pretty-much done nothing, you might have experienced the same degree of tinnitus improvement due purely to "tincture of time" - just like most other folks who do nothing over the first year?

Absolutely. I cannot prove why I saw an improvement. And I have no intention of reliably trying to do so. That task belongs to the job profile of researchers and medical investigators (re: stem cells). However, I didn't have the time to wait 10 years before they come to a possible conclusion on such a topic. So I went ahead and did it myself.

Should I have chosen not to share the story? I don't think it makes sense to reflect on that. What matters is that what I experienced has been described accurately and objectively. People who read "my stuff" can then choose to use the information. Or not. All that matters to me - really - is that they come away with roughly the same experience that I did (should they decide to attempt the treatment). By "experience", I mean experience in relation to:

• treatment protocol
• pricing
• competency of the medical staff
• treatment outcome

And that is why I am happy that there are now two other members of TT who can confirm what I have described.

Another reason why bringing information such as what I did to the Internet is because it is medical information which is difficult to come by. I will have to be brutally-self-centered-honest here for a minute: if an unproven stem cell treatment at a reputable clinic consists of 100 steps - including background research, medical documentation, correspondence, money transfer, logistics, time, and personal doubts - then most people would not make it past the first few steps. Fact. But now that I have done the hard work of showing how it can be done, it makes it so much easier for someone else to do the same. People no longer have to worry about whether clinic X, Y, or Z is legit or not - they already have that information; they also already know the "what, where, and who" of the clinic; they know the different treatment protocols used; they know the price range; they have an idea as to whether it is safe or not. All pretty important pieces of information if you ask me.

In terms of providing "evidence", I have shared what I could. For LLLT, I have provided a time series of audiograms:

https://www.tinnitustalk.com/threads/my-introduction.1862/#post-39035

And since there was a certain skepticism (from some people), I followed up with two other audiograms (that were stamped with a clinic signature at another (unbiased) regular ENT clinic; see page 3 in my introduction). Was it the LLLT that improved my hearing, or was it the position of the stars in the sky, or perhaps the pH-level of my blood? Who knows. What people choose to believe (or not) is not something I will lose any sleep over. I have provided the information reliably; people who read my posts can then choose to use it. Or not.

Wilden isn't my arch enemy. I would just like to see a single reliable and verifiable controlled study published in a legitimate juried scientific journal to back up his claims, specifically his tinnitus claims.

So would I. In fact, it would have been extremely helpful to me if it had been done already. Because that potentially could have saved me about 60,000 dollars. But because there are no long-duration LLLT studies done using treatment protocols in upper regions of the cold laser therapy range, 200-500 mW, the verdict on LLLT in relation to tinnitus is still unsettled. All I have/had to go by was the anecdotal evidence from random individuals around the world who said they saw improvements after eg. 6, 12, or 18 months of consistent use. It would indeed be nice to have known if such findings also hold true in a clinical trial setting. It is unclear to me why the various tinnitus organizations, for instance, never decided to look into that - and instead leaving the tinnitus sufferers in doubt (and potentially wasting their money).

attheedgeofscience
06/JAN/2015.

 

[skoupidis]

@attheedgeofscience
I really admire what you have done till now. I also appreciate your input here, it is most wanted and valuable.
Unfortunately, you haven't find silence till now, even though you really did search for every possible cure existent or nonexistent. I hope you do and sooner than you think.
I think that never stopping searching for a cure is a must, never giving up. The combination of knowledge of so many capable people here may lead to something one day. We do need a little help from the research and science area though. Experimenting with no results is what we get till now. And this may go on for ever! My negativity goes to them, believe me not to the people who try to find relief. Such people are courageous and admirable. But caution is always warranted, asking for a great deal of money while giving no results in the end is a phenomenon of our times (and all times) that will always be there. Taking advantage of people's pain and suffering is out there. This is why we need to be skeptical and we need to exchange experiences, to avoid such traps.

I can only hope that our attempts, trials, findings combined with honesty and sharing will bring about results. The scientists aim for the Nobel prize. We aim for our silence. We need it more... And SOONER!

 

[Dr. Nagler]

It is unclear to me why the various tinnitus organizations, for instance, never decided to look into that - and instead leaving the tinnitus sufferers in doubt (and potentially wasting their money).

Numerous independent controlled LLLT studies have already concluded that there is no efficacy. The response of the LLLT advocates is that those studies have been flawed in this, that, or the other way - yet they do not apply to "the various tinnitus organizations" for funding for what they consider to be unflawed independent studies. Having served for seven years on an ATA committee that reviews grants for such funding, I can tell you that ATA would love to fund a study that the LLLT advocates would consider to be definitive. Seems to me that the LLLT advocates would find it to be in their own best interests to settle this matter once and for all. Their problem is that ATA will not fund an LLLT study without assurances that the results would be published regardless of how it turned out - and that is a chance the LLLT advocates seem unwilling to take.

Dr. Stephen Nagler

 

[bwspot]

Numerous independent controlled LLLT studies have already concluded that there is no efficacy. The response of the LLLT advocates is that those studies have been flawed in this, that, or the other way - yet they do not apply to "the various tinnitus organizations" for funding for what they consider to be unflawed independent studies. Having served for seven years on an ATA committee that reviews grants for such funding, I can tell you that ATA would love to fund a study that the LLLT advocates would consider to be definitive. Seems to me that the LLLT advocates would find it to be in their own best interests to settle this matter once and for all. Their problem is that ATA will not fund an LLLT study without assurances that the results would be published regardless of how it turned out - and that is a chance the LLLT advocates seem unwilling to take.

Dr. Stephen Nagler

This feels like lllt might sort of a hidden scam and they better not let anyone know. So sad. If they write so much good stuff about it on their side why no test it. I just don't get it. The best would be really to get the hands on it and find out more. It either helps or not and we should move on. I am personally thinking about giving it a try myself but I am worried that his just gonna be waste of money.

 

[attheedgeofscience]

Numerous independent controlled LLLT studies have already concluded that there is no efficacy.

Agreed. There was another TT-member who posted a series of reviews a few days ago here:

https://www.tinnitustalk.com/thread...l-discussion-dr-wilden.295/page-23#post-86759

There are a number of those reviews that conclude that LLLT is not effective. And there are a couple that suggest it is (in some way). I don't have access to the background details on those studies, but my guess is that some/many/all of them do not live up to the rigorous standards of a double-blind clinical trial and peer reviewed literature.
But as an example, let's take the 4th study that happens to be mentioned on the list:

4. The treatment group was given LLLT, which consisted of shining low-level lasers onto the outer ear, head, and neck. Each laser treatment lasted approximately five minutes. Three treatments were applied within the course of one week. A battery of auditory tests was administered immediately before the first treatment and immediately after the third treatment. The battery consisted of pure-tone audiometry, the Connected Speech Test, and transient-evoked otoacoustic emissions. Data were analyzed by comparing pre- and posttest results. No statistically significant differences were found between groups for any of the auditory tests. Additionally, no clinically significant differences were found in any individual subjects.

It is beyond human comprehension how anyone could expect to achieve results from a study using just 3 x 5 minutes of treatment (at any laser strength). Dr. Wilden uses a protocol equal to 10 x 1 hour sessions (30 mins. each ear) delivering a dosage in excess of 4000 joules per 1 hour treatment.

Now let's just talk facts here - facts!

• Study mentioned: 3 x 5 = 15 minutes.
• Dr. Wilden: 60 x 10 = 600 minutes.

The above facts therefore show that the study participants received 15 / 600 = 2,5% of the total therapy dosage that patients at Dr. Wilden's practice would have received. 2,5%...! And that's not even factoring in the difference in power output which I can almost with 100% certainty guarantee is not of the same magnitude as that used by Dr. Wilden (Dr. Wilden uses more). So in the end, the total therapy in terms of joules delivered to the inner ear is probably of the order of about 1% (vs. Dr. Wilden's protocol). Dr. Nagler, say you had back-pain, and you were to swallow 1% of an entry dose 5mg Morphine tablet, how much "benefit" would you say you would get from that? (1/100) x 5mg = 0,05mg. That's not a lot if you ask me. Actually, it is (probably) so little that you would not really notice any effect. For those reasons, I can only conclude that the researchers who were behind the LLLT study either:

• Did not know what they were doing (in which case they should not be researchers or physicians - and I truly mean that).
• Had an ill intent motive behind the study (eg. trying to discredit the therapy)
• Wanted to prove a null hypothesis for a specific therapy dosage volume (eg. "We want to confirm that "x" amount of therapy does not work for condition a, b, and c"). However, normally a study should come with an "open" rather than "closed" set of variables to explore ie. you would want to explore different treatment strengths in order to observe potential differences in outcome and not be restricted to something you assume would not work (needless to say).
• Some other reason that I am unaware of, but I don't see/know what that could be. Perhaps you do?

For sure, I was disappointed that I did not benefit more from Dr. Wilden's therapy. I admit it. And actually, I have no problem admitting it (because I am not affiliated with the LLLT business in any way). But given that Dr. Wilden was able to reverse hearing loss of up to 25db in my case (something which is considered impossible by the medical community), I am also someone who is willing to give him the benefit of the doubt (eg. perhaps I should have done more therapy or perhaps my sub-type of tinnitus does not respond to LLLT - medicine is not an exact science). It may be that you feel convinced that LLLT does not work. But I don't. And I haven't seen any studies that document LLLT's efficacy with protocols living up to my satisfaction (eg. as much as 30 hours of clinic grade therapy done over, say, a 6 month period). And I am pretty sure that if such a study was to be undertaken, then it would - as a minimum - come with a couple of interesting bi-products such being able to document improved hearing thresholds. And so even if the study failed in terms of its main objective (ie. eliminating tinnitus), I would still think that such a study would be highly useful. Who would want to wear hearing aids, if they didn't have to, right?

Having served for seven years on an ATA committee that reviews grants for such funding, I can tell you that ATA would love to fund a study that the LLLT advocates would consider to be definitive.

Well, the modus operandi of tinnitus organizations seems to be that they hand out grants rather than engage in research activities themselves. It is not for me to comment on how any organization should conduct itself, but as an example, we at Team Trobalt do not just sit around and wait for someone to engage us, we take the initiative, and develop relationships. So what I am saying is that it would have been helpful if some tinnitus organization out there had itself decided to conduct a study on LLLT (rather than wait for someone to come to them).

When I go to work as a finance specialist, I do not just sit on my flat ass and wait for my own manager to come and tell me what to do. I display initiative and self-management. If the ATA or any other organization would like lessons in basic leadership, they can contact me for help. They will appreciate the fact that, unlike the patient/doctor appointments of the doctors who serve the board, my appointments are always on time.

Seems to me that the LLLT advocates would find it to be in their own best interests to settle this matter once and for all. Their problem is that ATA will not fund an LLLT study without assurances that the results would be published regardless of how it turned out - and that is a chance the LLLT advocates seem unwilling to take.

I don't work for any of the tinnitus organizations and so I would not be able to confirm such findings. But if you have information as to any LLLT study being requested with "strings attached", I would be glad to know it (and in public). I do not want anyone being given special favours. Not LLLT providers, not stem cell providers, not anyone. So when you say "Their problem is...", I am wondering if you are referring to a specific case where that happened or whether you making a general assumption?

attheedgeofscience
06/JAN/2015.

 

[Dr. Nagler]

Well, the modus operandi of tinnitus organizations seems to be that they hand out grants rather than engage in research activities themselves. It is not for me to comment on how any organization should conduct itself, but as an example, we at Team Trobalt do not just sit around and wait for someone to engage us, we take the initiative, and develop relationships.

Right. ATA has a volunteer team of sixteen internationally regarded researchers and clinicians that awards grants based on merit rather than on relationships. In fact, the committee is blinded regarding who it is that is actually applying for the grants. All they care about is the quality of the methodology and the role the proposed study can potentially play in the search for a cure for tinnitus. Members of the committee serve one-time-renewable staggered four-year terms.

I am wondering if you are referring to a specific case where that happened or whether you making a general assumption?

I am making an assumption that since the money for such a study has been readily available for years and since a reliable and verifiable study confirming the efficacy of LLLT in the treatment of tinnitus would spell untold riches for LLLT manufacturers (think US military alone!!!) not to mention the incalculable benefit to society, the only possible reason I can think of for us to be still having this sort of discussion on tinnitus boards in 2015 instead of celebrating wildly in the streets of Stockholm and across the globe is that the LLLT folks strongly suspect that their red light will not stand up to independent scrutiny regardless of the parameters (power, time, protocol, etc.) that they themselves dictate.

It's incredible, when you think of it. The LLLT folks criticize the independent studies that show no efficacy on the grounds that the investigators use the wrong parameters, but they refuse to dictate the parameters that they consider to be the right parameters so that a reliable and verifiable independent analysis meeting their own criteria can be undertaken. What's with that?

Dr. Stephen Nagler

 

[attheedgeofscience]

I am making an assumption that since the money for such a study has been readily available for years and since a reliable and verifiable study confirming the efficacy of LLLT in the treatment of tinnitus would spell untold riches for LLLT manufacturers (think US military alone!!!) not to mention the incalculable benefit to society, the only possible reason I can think of for us still having this sort of discussion on tinnitus boards in 2015 instead of celebrating wildly in Stockholm and across the globe is that the LLLT folks strongly suspect that their red light will not stand up to independent scrutiny regardless of the parameters (power, time, protocol, etc.) that they themselves dictate.

Thanks, Dr. Nagler.

Well, I did mention earlier on that a bi-product of LLLT is improved hearing thresholds. Right now, there is really only one "therapy" available against hearing loss: hearing aids. And given the size of the hearing loss market, I trust you would agree that the hearing aid industry is big business:

• Market Size - $4,369.3 million in 2013, source: http://globenewswire.com/news-relea...y-Technology-Analog-Digital-Is-Expected-.html
• Approximately 12% of the U.S. population or 38 million Americans have a significant hearing loss, source: http://chchearing.org/facts-about-hearing-loss/

Of course with such a big market, the hearing aid companies would not be too happy to give away their market share to a therapy that quite clearly has certain advantages over hearing aids:

• the patient is not handicapped by a device
• LLLT cures the root cause and does not just treat the symptom
• LLLT does not lead to any potential further hearing loss
• The therapy - LLLT - costs less than a top of the range hearing aid

However, in econonmics there is this term called "barriers to entry" (of a market). Since the hearing aid companies like to keep their market share, they would not like to see it being erroded by some other therapy. Indeed the hearing aid companies do quite a bit to "promote" their products (I have highlighted important parts in blue):

If you go to have your hearing tested at an audiology clinic, there's a good chance the clinician will receive a bonus from a manufacturer if they sell you a hearing aid. Despite the existence of an audiologists' code of conduct, such links are so common they're considered industry standard. Hagar Cohen investigates.

A few years ago, the family of film producer Tony Buckley started nagging him about his hearing.
He went to get a test at a Sydney-based clinic, where an audiologist very quickly urged him to buy a set of hearing aids priced at nearly $12,000.

'We hadn't had any finalisation of the results of the tests when he was already selling me hearing aids,' says Buckley.

'I looked at the audiologist and I said, "You don't happen to be owned by the hearing aid manufacturer?" He was quite shocked and looked at me taken aback.'

What Buckley didn't know at the time was that around a third of the audiology clinics in Australia are owned by hearing aid companies.

A Background Briefing investigation has found that even audiologists who don't directly work for manufacturers often receive commissions and other incentives to sell hearing aids to their patients.

One company offered a trip to Las Vegas for the audiologist that sold the largest number of high-end devices.
None of this is disclosed to patients.

'When it's not disclosed, it just doesn't stack up against what the community expects,' says audiologist Chris Whitfeld, who worked for a clinic owned by a hearing aid company until he left two years ago.

'Those kinds of pressures should either be removed, preferably, or at least disclosed.'

The pressure on clinicians to sell is sometimes very direct.

In 2009, audiologist Dahlia Sartika worked for a another clinic with a hearing aid manufacturer as its parent company.

That year, she was required to participate in a sales training session.

'Something happened at the very beginning of the training,' says Sartika. 'The trainer started the training by saying that he never had extensive training but like all of us but he was very successful in hearing aids. He has his own practice ... then he suddenly took out a copy of my certificates.'

Sartika was shocked find out that her professional certificates, normally framed on the wall of her clinic, were now in the hands of the marketing trainer.

The trainer presented her certificates to the group before tearing them up.

'He ripped my certificate in front of everybody, saying, "This is all meaningless if you do not sell." I couldn't really hear what he was saying because I was so shocked.'

Now there's a push by a group of independent audiologists to change the way the industry works, but they're in the minority.

In the meantime, hard of hearing people—mostly older adults—remain frustrated by the system.
Better Hearing Victoria receives many complaints from people who feel they've been tricked into spending thousands of dollars on devices they'll never wear.

'It's true that when you have a hearing loss, it is possible to misunderstand or mishear something,' says the NGO's CEO, Carol Wilkinson.

'The problem is that, in my job, I just hear the same thing being "misunderstood" over and over again.'

Source: [URL='http://www.abc.net.au/radionational/programs/backgroundbriefing/2014-11-30/5920176[/QUOTE']http://www.abc.net.au/radionational/programs/backgroundbriefing/2014-11-30/5920176[/URL]

And another:

You may not have factored in these undisclosed payments - marketing co-ops/dollars, other INDUCEMENTS and hidden payments, which are likely not reflected on the invoices and representations to the government. Undisclosed financial inducements, payments, quid pro quos of any sort e.g. marketing co-ops, freebies, gifts, trips, "free" hearing aids, pdf (practice development funds), rebates, or other private arrangements, to sell the hearing aids of a specific manufacturer. These practices are rampant in the hearing aid industry and potentially compromise the delivery of hearing health care.

...

Examples of undisclosed inducements could be gifts of various sorts, computers, i-pads, software, trips, prizes in substantial amounts. Were the prizes, recently offered by GN Resound ($10,000.00) inducements or kickback for the sale of their hearing aids? Financial payments, practice development funds, marketing funds, "meals and entertainment", and other secret agreements, including retirement plans, discounted or free equipment against hearing aid purchases, including rebates, financing agreements could be deemed questionable payments in the delivery of health care.

Manufacturers engage in these practices openly.
Band together and just say NO! JOIN UNITY. MAKE IT MATTER!

Some manufacturers not only make the payments (kickbacks and undisclosed payments) but also generate the invoices you rely on. They shift the onus on to you to disclose these inducements. You blindly submit these invoices to the government for reimbursement. By your complacency, you potentially promote illegalities.
What do some manufacturer have to say about the high cost of hearing aids to private practices? Some remark that "marketing funds, … coop, or practice development … meals and entertainment."…etc. drive up the cost of hearing aids. They have to get paid from some where.

Source: http://www.unityhearingcare.com/#!fraud-and-abuse-in-hearing-health-care/c1kpb

To answer your original question directly, I cannot tell you why LLLT is not in widespread use, but the above is one potential reason ie. protection of market share and an obvious affiliation with audiologists who receive bonuses from the hearing aid manufacturers. With such a scheme in place, it is difficult to break into a market.

When I met Dr. Wilden in the Summer of 2013, he explained to me the amount of "dirt" that the hearing aid producers throw at LLLT with studies designed-to-fail in order to keep LLLT from becoming legitimate.

So perhaps that is one reason. What do you think?

 

[RaZaH]

I would be super happy to get improved hearing although it had no effect on T .
Sucks that there is no relieable study on the efficiancy of LLLT .
I dont trust a simple hearing test , they are so unreliable and in my opinion way to coarse to be considered anything scientific. Hearing tests should be done with much higher resolution ,multiple times and then averaged.
Maybe then we would have something tangible.

 

[Michael2013]

Approximately 12% of the U.S. population or 38 million Americans have a significant hearing loss

And of that 38 million, there are more than 25 million that don't have hearing aids for one reason or another. In many cases (mine for quite some time) it is due to the stigma attached to them. It seems to be a largely untapped market for someone who can cure hearing loss without having to wear devices on their ears.

If LLLT was proven to work, I don't believe the market barrier you refer to would be an issue.

-Mike

 

[Dr. Nagler]

Thanks, Dr. Nagler.
Well, I did mention earlier on that a bi-product of LLLT is improved hearing thresholds.

PT Barnum would love that line of reasoning. The issue here isn't what LLLT might or might not do in terms of hearing thresholds.

Sort of reminds me several years ago when going to see Dr. Shemesh in Israel for his miraculous tinnitus cure was all the rage. Folks came back with glowing reports. Moreover, they were thrilled with the bonus: they got to spend six weeks in the Holy Land and felt tremendously uplifted about the entire experience. Fast forward a couple of years, and the fellow who had arranged for all those international visitors to Shemesh's clinic confessed that he was not aware of a single individual who had experienced any lasting benefit whatsoever in terms of his or her tinnitus. A few months back in reality ... and they realized that they were no better off than the day they left. Still and all they were all glad they went. Every one of them!

The issue here is LLLT and tinnitus, not LLLT and hearing thresholds. I will repeat my position: Since the money for a legitimate LLLT tinnitus study has been readily available for years and since a reliable and verifiable study confirming the efficacy of LLLT in the treatment of tinnitus would spell untold riches for LLLT manufacturers (think US military alone!!!) not to mention the incalculable benefit to society, the only possible reason I can think of for us to be still having this sort of discussion on tinnitus boards in 2015 instead of celebrating wildly in the streets of Stockholm and across the globe is that the LLLT folks strongly suspect that their red light will not stand up to independent scrutiny regardless of the parameters (power, time, protocol, etc.) that they themselves dictate.

When I met Dr. Wilden in the Summer of 2013, he explained to me the amount of "dirt" that the hearing aid producers throw at LLLT with studies designed-to-fail in order to keep LLLT from becoming legitimate.

So perhaps that is one reason. What do you think?

What do I think? Honestly? I think it's a bunch of horse manure. All shadows and mirrors. The funds exist (and have existed for years now) for Wilden to dictate all the parameters on an independently-conducted LLLT tinnitus study. If anything, we are talking here not about a study designed-to-fail, but rather about a study designed-to-succeed!!!!!

Jakob, you are one of the brightest, most meticulous, and most committed individuals I have encountered in my twenty years on the tinnitus boards and newsgroups. I hold you in extremely high regard, and I simply cannot believe that you have allowed yourself to be sucked into what basically amounts to an elaborate parlor game. You asked me what I think. Well, that's what I think!

Dr. Stephen Nagler