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

Please, I do not want to see any comment from Dr. Nagler. Many people told me LLLT helps. I do have positive result for now. Clinical trials cost millions and Dr. Wilden does not have that money to do so.

I will only believe what Dr. Nagler says "IF he goes through the therapy (both clinical and home device) himself for a least one year and has absolutely has Zero result. ", the he is qualified to speak here. Otherwise, it is blank criticism. No wonder @HelmutK does not come to forum anymore. It is a shame.
 
Please, I do not want to see any comment from Dr. Nagler.

Don't read 'em!

How did this turn from a discussion about LLLT into a discussion about me?

Clinical trials cost millions and Dr. Wilden does not have that money to do so.

A proper LLLT trial can be done for considerably less than $100K, and the funds are available for the asking. All Wilden has to do is submit a grant proposal and insure that the study will be run independently.

I will only believe what Dr. Nagler says "IF he goes through the therapy (both clinical and home device) himself for a least one year and has absolutely has Zero result. ", the he is qualified to speak here. Otherwise, it is blank criticism.

My ears ring 24/7 - it's like a cross between a jet turbine and a screaming teakettle. I am more than qualified to speak here. I wish I weren't. I wish I'd never heard of the word tinnitus.

Dr. Stephen Nagler
 
The fact you have tinnitus does not make you more qualified to make the judgement. Saying it as a scam without seeing the fact that a lot of people are benefitting from it is purely wrong. I just spoke to one friend who is physiatrist about this. He told me the statement is just wrong. Do not want to argue with you. Will ignore your comments from now on.
 
The fact you have tinnitus does not make you more qualified to make the judgement.

I didn't say I was more qualified to have an opinion. I said I was just as qualified as the next guy.

Saying it as a scam without seeing the fact that a lot of people are benefitting from it is purely wrong.

Lots of people benefit from placebo. See, for instance, the article I am attaching below.

I just spoke to one friend who is physiatrist about this. He told me the statement is just wrong.

The article was written by a psychiatrist. Perhaps your friend should read it!

Do not want to argue with you. Will ignore your comments from now on.

Good idea. I'll do the same!

All the best -

Dr. Stephen Nagler
 

Attachments

  • PlaceboBrown.pdf
    2.3 MB · Views: 54
A suggestion (@Markku or other staff). Is it perhaps worth creating two threads - one for a resumption of hostilities in the LLLT wars (perhaps call it something like 'LLLT efficacy debate') and another for support and information for those who are using the therapy? That way folks can choose which sort of discussion they want to view or take part in.

We all have the right to express our opinions, but as @CarrieLee indicates the strident statement of views in opposition to LLLT can create an atmosphere where those using it feel that they do not wish to post their experiences and their questions. There is just so much past antagonism around LLLT (on other forums as well as this one) that anyone who has done their research could easily feel intimidated about posting. On the Yuku board, for example, that antagonism includes a prominent member of this forum accusing a poster who defends LLLT of taking kickbacks. Against this background the repetitious argument about efficacy becomes repressive.
 
I don't share many thoughts with @Dr. Nagler but I have to agree with him with this one. There isn't much proof that LLLT works on T.

Although I believe that it might bring some subjective relief if hearing gets better around T frequency (T gets masked easier in normal sound environment etc. -> easier habituation). So if I had hearing loss around T frequency, I could give it a shot.

One of the main arguments here seems to be that why Dr. Wilden doesn't prove that LLLT works. Well, let's see, he keeps getting doubts from everywhere but still gets enough patients to live nicely and gets ppl cured/relieved? I think I would too take the money and treat the people who come to me and let the rest of the world rot. Can't really blame him for what he is doing. Not every man seek fame, glory and acceptance in form of nobel prizes or proving something to the rest of the world.
 
I think I would too take the money and treat the people who come to me and let the rest of the world rot.

I don't believe you, Zech. From your postings it seems to me that you are precisely the kind of guy who'd want to make a real difference for as many people as possible. Not for fame and fortune - but simply because it's the right thing to do, the moral thing to do, the ethical thing to do

Can't really blame him for what he is doing.

He's running a scam. He's using shadows and mirrors to play the misery and desperation of his fellow man (and woman). You'd never do that!

Dr. Stephen Nagler
 
A proper LLLT trial can be done for considerably less than $100K, and the funds are available for the asking. All Wilden has to do is submit a grant proposal and insure that the study will be run independently.

Thanks. Dr. Nagler is your word "good" so-to-speak? Can I take that piece of information to eg. Dr. Wilden if I wanted to? I was his patient during the Summer of 2013, as you know, but I have not seen him since. I briefly corresponded with him during Spring of 2014 regarding his current clinic location, but other than that, I have had no contact with him since. I therefore do not know where he "stands" in relation to a clinical trial, but I am not going to bother him with information regarding funding if it afterwards turns out to be just a false lead.

The reason I ask is because, I believe you are no longer part of the ATA, and secondly based on Markku's post in the ATA petition thread...
However, it may be required that we - the proposal owners - have to contribute financially towards the proposal. The financial burden we would have to carry needs to be clarified with the ATA.
...it did not exactly sound like the ATA cash register was overflowing with money. Therefore, I would be slightly surprised if I could simply write, say, Dr. Wilden an e-mail asking him to submit a proposal, and then it would all flow nicely from then on.


Regarding the LLLT study that I did a comparison of yesterday (but did not have the background details of), I have now managed to track down the group of "researchers" behind it:

http://www.hindawi.com/journals/isrn/2013/916370/

Below, a screenshot of the article (click on image to enlarge). You will notice that one of the study members is from GN Resound and given that they used laser therapy dosage rated at far less than 2,5% of Dr. Wilden's therapy, I have no choice but to restate what I did yesterday: there is ill intent behind their study. Yesterday, I was not so sure, as I didn't have the details. But now I am. It is a study designed-to-fail.

LLLT_Clinical Trial.png


Although, I would be disappointed on behalf of tinnitus sufferers seeking relief, I have no problem as such seeing LLLT or Trobalt failing in demonstrating efficacy. But if a therapy is going to end up being "failed", at least it should be failed for the right reasons. The above study is no better than the trash being sold by T-gone.

Since I have now have access to the study, I will calculate the dosage differences (between Dr. Wilden's therapy and "the study").

The study
Step 1. The laser was centered on the right temporomandibular joint, just anterior to the external auditory meatus of the ear, at a distance of approximately 2 inches from the surface of the skin. The hand-held probe was rotated from vertical to horizontal and back continuously for 15 seconds.
Step 2. The laser was positioned on midline of cervical spine with the beams running vertically from external occipital protuberance to the seventh cervical vertebrae. The hand-held probe was held at a distance of approximately 3 inches from the surface of the skin and continuously swept horizontally back and forth for 30 seconds.
Step 3. The left temporomandibular joint was stimulated, as described in Step 1.
Step 4. The laser was positioned on top of the head with the beams running across the head from ear to ear. The probe was held at a distance of approximately 2 inches from the surface of the head and continuously swept back and forth from the forehead to the occipital protuberance for 30 seconds.
Step 5. The laser was centered on the right external auditory meatus, with the probe held at a distance of approximately 2 inches from the surface of the pinna. The probe was rotated from vertical to horizontal and back continuously for 60 seconds.
Step 6. The laser was positioned over the cervical spine with the beams running horizontally. The probe was held at a distance of approximately 2 inches from the surface of the skin and continuously swept up and down from the occipital protuberance to the top of the shoulders for 15 seconds.
Step 7. The left external auditory meatus was stimulated, as described in Step 5.

Total dosage RIGHT + LEFT left ear = 15+30+15+30+60+15+60 seconds = 225 seconds (per treatment).
Power output = 2 x 7,5 mW

Energy (J) = Power (W) x Time (s)
E = (15 mW) x (225 s)
E = (0,015 W) x (225 s)
E = 3.375 joules

With a total of three treatments it means that the patients received 3 x 3.375 = 10.1 joules in total.

Dr. Wilden's therapy
Daily Tinnitus Treatment

  • To spare the patient a sensation of dizziness, both inner ears receive a daily treatment (the distribution of low level laser light being adjusted to the individual extent of the impairment).
  • The low level laser light is applied by means of at least four high-quality laser light sources via the auditory canal and the mastoid and petrosal bone.
  • The low level laser light is applied by means of three lasers with a total dosage of at least 4000 joule. Every laser emits 830 nm and 630-700 nm at the same time. The low level laser light is distributed extensively to transfuse the whole surroundings of the organ with photon energy and thus ensure the best possible biostimulative effect.
    This is the prerequisite for an enduring positive long-term effect of the low level laser therapy.
  • The duration of the tinnitus treatment is 60 minutes.
  • The tinnitus treatment is carried out in a comfortable, lying position.
  • During the tinnitus treatment the correct positioning of the light sources is constantly observed.
  • The tinnitus treatment is continuously supervised.
  • At the beginning of the tinnitus treatment the patient`s condition is examined by means of an audiometry.
  • At the end of the tinnitus treatment the regeneration process is checked by means of another audiometry.
  • After the conclusion of the ten-day out-patient tinnitus treatment the doctor in charge stays in close contact with the patient until the best possible therapy result is achieved (free telephonic advice)..
  • The tinnitus treatment is absolutely painless and contains no risk at all (e.g. risk of infection)
Source: Dr. Wilden

Treatment dosage, E = 4,000 joules x 10 = 40,000 joules

Analysis

The study: dosage received by patient = 10 joules
Dr. Wilden: dosage received by patient = 40,000 joules

Ratio comparison = 10 / 40,000 = 0.03%

Yesterday (due to lack of background details), I estimated the dosage ratio to be of the order of 1 to 2.5%. Turns out it was far worse: 0.03%...! And that is not even factoring in the detail that the study used two probes one of which is a green diode laser. Now green laser light does not penetrate body tissue - so essentially that laser was worthless.

The study is so useless that if it involved tax-payer money, I would suggest the "researchers" hand that back to where they got it from.

attheedgeofscience
07/JAN/2015.
 
If LLLT was proven to work, I don't believe the market barrier you refer to would be an issue.

Let me explain to you what the phrase "barriers to market entry" means. Regardless of whether LLLT works or not, audiologists and hearing aid manufacturers have no interest in selling it - LLLT, that is. The reason is money. I thought my post from yesterday highlighted it very clearly given the two articles I mentioned, but apparently not:
Audiologists use their power to keep Hearing Aid Manufacturers from selling through the internet--which would lower prices to you the consumer. At the present time, there are about 9,000 audiologists and about 3,000 dispensers in the USA. The 10 major hearing hearing aid manufacturers court the audiologists aggressively to sell their products. It takes a lot of effort for a Hearing Aid manufacturer to dislodge the current line of hearing aids in the Audiologists office. If Starkey started selling hearing aids to an Internet retailer and the Internet Retailer sold them for half of what the audiologists did (because that is what the internet does to prices), it would destroy the Manufacturer/Audiologist relationship! Audiologists would not make any money off Starkey so Starkey would end up loosing all of their Audiologists. So the Audiologists and manufacturers have self preserving interest to keep their prices high. This is the opposite of a free market. Imagine if you could only buy oranges from one supermarket in your state---how much do you think they would cost? Probably about $20 an orange—well, you get the point.

Source: http://www.centuryhearingaids.com/report-and-discount

If you were running a business that ensured you got a certain markup each time you sold a pair of hearing aids, would you switch to some alternative (and receive less)?

Embrace_Hearing_vs_Audiologists_grande.png


The above is a comparison of the cost the consumer pays as a result of the market mechanism at play due to the scheme in place between audiologists and hearing aids producers (as highlighted in the quote).

@Dr. Nagler calls Dr. Wilden's therapy a scam. That may or may not be true. But, one thing is for sure, and that is that in the case of hearing aids - you - the consumer pays a hefty non-transparent price:
The choices audiologists present to consumers are almost invariably stark: Break the bank for the sake of your health or live with an untreated disability. Neither option is particular attractive.

Since consumers can't choose to buy elsewhere, the industry gets away with making consumers pay through the nose while obfuscating the true price of hearing aids by "bundling" the devices in a "package" that includes unlimited follow-up care. From the industry's perspective, this is a very smart pricing strategy because it "captures" customers and makes them "sticky." Once the customer purchases a service package, he is effectively "locked in" and is unlikely to switch providers.

Professionals also benefit from asymmetric information in pricing the service package: They have a very good idea how much follow-up care the customer is likely to need, while a first-time hearing aid buyer probably doesn't.

From the perspective of the less-informed consumer, the medical purpose of the device may seem to justify a $5,000 price tag. What the customer may not realize is that he is really paying for a $2,000 device with a $3,000 service package attached. Trying to sell a service package at a cost of $300 per visit wouldn't be easy in a competitive marketplace, but as part of the "package" of care, that's often how the math works out.

Source: http://www.huffingtonpost.com/sam-tanzer/hearing_aids_overpriced_in_america_b_1572184.html
Now, if you are so pleased with your hearing aids, that's totally fine with me. But just know that you probably paid somewhat more than you had to, and that you could have gotten the same benefit from LLLT. I have generously provided information on my experience with LLLT along with my audiograms (as have several others on this board). I realize you are (still) skeptical even after seeing concrete evidence, but that is of course your very own decision. Personally, however, I will take my improved hearing over hearing aids any day.

attheedgeofscience
07/JAN/2015.
 
Thanks. Dr. Nagler is your word "good" so-to-speak? Can I take that piece of information to eg. Dr. Wilden if I wanted to.

If you want to tell Dr. Wilden what every tinnitus clinician and researcher already knows, go right ahead.

ATA, NIDCD, and similar research funding entities all have well-established mechanisms for identifying worthy projects. If you want to do a study and get funding for it, you submit a grant proposal. This is not rocket science, nor is it some sort of secretive clandestine process. It is how science is done and how progress is made. Several times a year committees comprised of internationally regarded clinicians and researchers meet to review the grant proposals with one of three outcomes: (1) a project is approved for funding, (2) a project is rejected for funding, or (3) concrete suggestions are offered for improving the quality of a promising proposal (e.g., methodology) so that it can hopefully be approved in the near future.

On the other hand, if you are asking whether or not I personally would be willing to go to bat for Wilden in this process, the answer is a resounding HELL NO.

Dr. Stephen Nagler
 
Dr. Nagler calls Dr. Wilden's therapy a scam. That may or may not be true. But, one thing is for sure, and that is that in the case of hearing aids - you - the consumer pays a hefty non-transparent price:

Just to be clear here. I have called Dr. Wilden's tinnitus therapy a scam. And I have outlined the reasons I feel that way. I have not offered an opinion one way or the other about the purported effect of LLLT on hearing thresholds.

Please let's not cloud the issue. This has nothing to do with how audiologists make money selling hearing aids.

Dr. Stephen Nagler
 
Hi @Dr. Nagler
I would like you to have a comment on the the just above study from a hearing aid company, concerning LLLT.

Do you consider it a SCAM? Or a valid study.
I would appreciate a simple answer.

More or less like: yes or no.

Apreciated
 
A suggestion (@Markku or other staff). Is it perhaps worth creating two threads - one for a resumption of hostilities in the LLLT wars (perhaps call it something like 'LLLT efficacy debate') and another for support and information for those who are using the therapy? That way folks can choose which sort of discussion they want to view or take part in.

We all have the right to express our opinions, but as @CarrieLee indicates the strident statement of views in opposition to LLLT can create an atmosphere where those using it feel that they do not wish to post their experiences and their questions. There is just so much past antagonism around LLLT (on other forums as well as this one) that anyone who has done their research could easily feel intimidated about posting. On the Yuku board, for example, that antagonism includes a prominent member of this forum accusing a poster who defends LLLT of taking kickbacks. Against this background the repetitious argument about efficacy becomes repressive.
@dboy
I echo your opinion. I don't need to see another person crashing the forum like this when people try to seek support here. The staff of this forum may want to think of that. Thank you!

At the top of the LLLT threads you can now see this:

Screen Shot 2015-01-24 at 23.12.09.png


Maybe this helps. Thanks for the suggestion.
 
Hi @Dr. Nagler
I would like you to have a comment on the the just above study from a hearing aid company, concerning LLLT.

Do you consider it a SCAM? Or a valid study.
I would appreciate a simple answer.

More or less like: yes or no.

I cannot give a "yes or no" response because it's a loaded question.

"SCAM" is not the opposite of "valid study."

A scam is a purposeful misrepresentation of the facts for the purpose of taking advantage of the public.

Dr. Stephen Nagler
 
Just to be clear here. I have called Dr. Wilden's tinnitus therapy a scam. And I have outlined the reasons I feel that way. I have not offered an opinion one way or the other about the purported effect of LLLT on hearing thresholds.
But surely in arguing (as I think you have) that the light cannot reach the cochlea you have implicitly argued that it cannot affect hearing thresholds?
 
I'd like to share an email that I sent and response that I received from Dr. Wilden back in August of 2014. I didn't know about the grant proposal option that Dr. Nagler mentioned...otherwise I would have included it in my email. I truly hope that (attheedgeofscience) does contact Dr. Wilden with the proposal option and posts his response.
-Brian

Dear Dr. Wilden,
Your name came up on a forum that is discussing LLLLT, and I was wondering if you have ever considered running a double-blind, placebo-controlled, peer-reviewed trial? It would be really easy to run such a trial, and definitely not cost prohibitive. Additionally, something like that would definitively prove that your laser therapy works. I look forward to hearing back from you.
-Brian


Brian,
Thank you for your email. For this I recommend that you read on www.dasgesundeohr.de my new texts. The responsible institutions are not willing to work with LLLT. I am only a normal member of the medical community, telling what experiences I have. I was asking all German speaking ENT universities to make such a study like you mentioned. I did not receive any answers.
You are very welcome to make your own studies by using our home therapy by Dr. Wilden. Go for this at www.lux-spa-ibiza.com
Dr. Lutz Wilden
 
But surely in arguing (as I think you have) that the light cannot reach the cochlea you have implicitly argued that it cannot affect hearing thresholds?

I believe that @attheedgeofscience has offered some rather compelling photographic evidence to the effect that LLLT light can, indeed, reach the cochlea. So it seems that my initial impression based upon some studies in the literature may have been wrong.

Dr. Stephen Nagler
 
RE: ATA's finances in general:

Not sure how many in this discussion are from the USA (seems like not many) but we have a service here for 501(c)(3) (nonprofit public charities) organizations where the Form 990, the financial disclosure form filed with the Internal Revenue Service on an annual basis for nonprofit organizations, is open for public inspection. I have uploaded ATA's most recent Form 990 here. Considering the total net assets at the end of the year is only $415,414, including a loss of $175,790 in the most recent fiscal year, it is totally fair to say that ATA's financial reach is somewhat limited.

I'm not posting this at all to contribute to the "are they good or bad" type of debate--just factually, it is unrealistic that they would be overly helpful given the limited amount of cash they have on-hand. They donated $150,000 in grants in the year--hardly enough to be funding multiple types of studies, good or bad. This is not to say that if some funder or some big movement to improve the standing of this organization could not change things--but realistically, the $$$ in pharmaceuticals, etc., dwarfs the amount an org like ATA could donate.

Again, this is not intended to stoke any debate--ATA is in the same position as thousands of other advocacy / support type nonprofits in the USA -- limited in funds and dwarfed financially by gigantic corporations. Like @attheedgeofscience I work in the finance industry, in particular with nonprofit orgs in the USA. So it's a passion of mine!
 

Attachments

  • ATA 990.pdf
    1.3 MB · Views: 27
Let me explain to you what the phrase "barriers to market entry" means. Regardless of whether LLLT works or not, audiologists and hearing aid manufacturers have no interest in selling it - LLLT, that is.
I don't need the patronization, I understand what it means just fine. I just happen to disagree with you. Again, there are 25+million people, or approximately 75% of people with hearing loss that do not wear hearing aids! The audiologists and hearing aid manufacturers do NOT have this stronghold on the market of people with hearing loss. If LLLT worked, the amount of sales and people it reached would jump exponentially compared to that measly $4.3MM global market size of hearing aid sales (is that number even right? It honestly seems too low and hardly "big business" on a global scale). There is so much more money to be made in this market where there is currently little to no competition. If an audiologist or ENT could offer a cure and allow them to tap into a small part of the 75% of people without hearing aids, no amount of kickbacks or the like by aid manufacturers would stop them.

Any startup company that can guarantee restored cochlea hair cells or improved hearing would have no problem overcoming any barriers created by hearing aid manufacturers. They would have no problem getting all the investment money they needed once they shared the results. It appears universally agreed that LLLT is useless for tinnitus, yet Dr. Wilden still treats people for it? If he is willing to scam those people out of their money, how can you trust anything by him?

Bottom line, the overarching problem is NOT hearing aid manufacturers creating market barriers, it is that when LLLT comes up, it is associated with the word "scam" by many people who have tried it.

Now, if you are so pleased with your hearing aids, that's totally fine with me. But just know that you probably paid somewhat more than you had to, and that you could have gotten the same benefit from LLLT. I have generously provided information on my experience with LLLT along with my audiograms (as have several others on this board). I realize you are (still) skeptical even after seeing concrete evidence, but that is of course your very own decision. Personally, however, I will take my improved hearing over hearing aids any day.
I don't recall you having much hearing loss to being with, and I thought your improvement was only around 15dbs in some frequencies. Taking into consideration natural fluctuations, that wasn't much change. Did your LLLT treatment come before or after your stem cell treatments? How about someone who lost their hearing completely? Are there any people out there who used LLLT and saw a meaningful improvement in their speech recognition scores? If this actually did what you claim, it would go viral!

I know I paid an inflated price because so few people buy hearing aids. Demand is low, so device costs are high. Thankfully (I guess?) my hearing in one ear is so bad that hearing aids are useless for it so I only had to buy one.

-Mike
 
Is a valid study in your opinion?

For a study to be valid, in my opinion, it needs to be both reliable and verifiable. I cannot just glance at a summary or abstract and make that sort of determination.

Can you compare it with the a treatment done from dr Wilden?

No, I can't.

If Dr Wilden would make a TRT double-blinded study, Would you consider it a valid study? Even if made according to the TRT standars studies ?

I once read an article Wilden wrote about TRT - and he is obviously so totally clueless about the entire process that I wouldn't trust a TRT study of his as far as I could spit.

More importantly, this is an LLLT for tinnitus thread. It's not a hearing aid thread or a TRT thread. Perhaps we could stick to the subject at hand?

Dr. Stephen Nagler
 
And GN Resound are expertise in LLLT of corse.

I suspect not.

But what does any of that have to do with LLLT and tinnitus, which yet again I would like to remind you is the subject of this thread.

Dr. Stephen Nagler
 
Just to be clear here. I have called Dr. Wilden's tinnitus therapy a scam. And I have outlined the reasons I feel that way. I have not offered an opinion one way or the other about the purported effect of LLLT on hearing thresholds.
Just to clarify possible implications of this, would it be fair to infer that you believe that improving the hearing of people with tinnitus will (or would) have no effect on their tinnitus?

This is a point which has huge implications for the future of tinnitus so would it be possible for you to give a little detail about why you believe this - if in fact it is fair to infer it logically from your separation of treating tinnitus and treating hearing thresholds?
 
Just to clarify possible implications of this, ...

The only "implication" I care about is whether or not LLLT does what its advocates claim it does for tinnitus. How it gets there is of no concern to me.

Dr. Stephen Nagler
 

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