Antinitus Tinnitus Patch — Does It Work?

Discussion in 'Alternative Treatments and Research' started by Tinnitus Talk, Oct 10, 2015.

    1. Samir
      Obedient

      Samir Manager Staff Benefactor

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      But of course!...

      There is Rönngren, Blomqvist, Ménard, Randquist and Tranquilli. Three Swedish, one French and one Italian. What exactly gives these people authority? Unless it's Brahe, Oxenstierna or Vasa, I don't give them much credibility or authority.

      What kind of research and development is included here?

      Can you show us another source for this claim?
       
      • Agree Agree x 1
      • Funny Funny x 1
    2. Niko

      Niko Member

      Tinnitus Since:
      2000
      Cause of Tinnitus:
      Nightclub
      You live here, you should know, compare it with any other country you are familiar with.

      Find out if you are interested. I just stated that Sweden is leading when it comes to research.

      Usually people with common surnames that wish to sound more hip, purchase surnames as Brahe, Vasa... As these are really uncommon.

      Why, you can use google just as I? There is so much reading you can spend the whole next year reading.

      Claim? Asking for this is quite ignorant, don't you think?
       
      • Like Like x 1
    3. Samir
      Obedient

      Samir Manager Staff Benefactor

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      Oh I know! I got a letter yesterday from no other than the healthcare department of the county. They were asking me to participate in a questionnaire about the health care system here.

      anket.png

      There you go! There is your research in medicine.

      You do know the meaning of the word "leading" do you? What you are saying sounds like one of those sentences that are repeated over and over and over by the politicians here.

      Purchase a surname? What planet are you on? You cannot legally change your surname to a historical and noble surname like Vasa in Sweden. You let me know when you are Niko Vasa.

      I have spent many hours this year reading it. Thanks to articles being written in English, thanks to Google web search engine, developed by a US company, and thanks to PubMed, a biomedical search engine with centralized and open access, developed and maintained by US NLM and NIH. You let me know when Sweden has a single centralized access for its research papers, or one for clinical trials.

      Sweden number 11:
      r&d-papers.png

      Sweden number 10:
      r&d-citations.png

      Sweden number 9:
      r&d-impact.png

      You let me know when Sweden is number 1, or at least number 3. I know Sweden is ranked high, but saying that it's world leading is a bit of a stretch, don't you think? When it comes to medicine and medical research I think Sweden has lost its competitive edge. But it is thriving when it comes to high-tech, that's for sure.
       
      • Agree Agree x 1
    4. LukeYoung
      Frantic

      LukeYoung Member Benefactor

      Location:
      Toowoomba, Queensland, Australia
      Tinnitus Since:
      06/2016
      Cause of Tinnitus:
      A loud Concert - Noise Exposure
      Why is this thread turning into a who’s the better country.
      He was giving his feedback on the product.
      Thanks for letting us know that it worked for you!
       
    5. lapidus

      lapidus Member Benefactor

      Location:
      Sweden
      Tinnitus Since:
      1999
      Cause of Tinnitus:
      Noise induced
      It isn't since both posters are swedes.
       
    6. Samir
      Obedient

      Samir Manager Staff Benefactor

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      I'm sorry, I just don't like it when facts are being twisted and diluted with fiction. For profound claims you need profound evidence. If we don't question and seek the truth then we are no better than the quacks that market and sell Antinitus patches. It's a matter of principle. For all we know, this guy could be the CEO of the company. This guy believes in homeopathy.

      Check this video.
      James Randi: Homeopathy, quackery and fraud


      Skip to 3:57 in this video.
      Psychic Cringe Fails 2 - The Best of James Randi
       
      • Like Like x 2
    7. Samir
      Obedient

      Samir Manager Staff Benefactor

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      I took the time to translate one of the blog posts on Dagens Industri (Today's Industry).

      Published: 29 June 2017
      Sensori partners with World Veterans Federation

      Sensori AB (publ) has signed a contract to become "Companion of the World Veterans Federation" which includes educating and giving information about tinnitus and the sales of the Antinitus patch to the members in WVF (World Veterans Federation).

      WVF (http://www.wvf-fmac.org) is the biggest war veteran charity in the world, with 45 million members from more than 120 countries. The vision of the federation is to promote and protect peace and security, and to ensure the well-being of all the veterans and victims of war. The organization has an advisory status within the UN.

      Antintius is a Swedish innovation, the first patch in the world for treating tinnitus, and Sensori's first medical device product. A global laucnh of Antintus is underway.

      - We see very positively on the collaboration with Sensori and Antinitus because several million of our members are suffering from tinnitus, said Dan-Viggo Bergtun, President of WVF.

      Antintinitus will initially be distributed to the members by e-commerce and then by referral to private ENT and audiologist clinics, but also via durg stores in different countries.

      - This is a unique collobration with a very big international organization whose members, for understandable reasons, often suffer from hearing loss and tinnitus. WVF does a great job for the veterans all over the world, with focus on health, and we are convinced that Antinitus can be brought to light by their channels and help many members, said Tommy Rönngren, founder and chairman of the board.

      Sensori has under more than a decade worked with research, development and commercialization of the medical device called Antinitus. The company's own assessment is that Antinitus has potential to help more than 500 million people globally.

      About Sensori AB
      Sensori is a Swedish company that produces, markets and sells aids for alleviating tinnitus. The wholly-owned daughter company Antinitus AB is the legal producer of Antinitus, a half-moon shaped patch that is attached behind the ear and with help of a unique raster can regulate nerve function in the auditory system. Antinitus is a medical device product. Sensori AB (publ) is traded at NGM Nordic MTF, short name SORI MTF, with Gunther & Wikberg Fundcomission as Mentor.

      Source (in Swedish):
      https://www.di.se/pressreleaser/2017/6/29/sensori-blir-partner-med-world-veterans-federation/
       
    8. Samir
      Obedient

      Samir Manager Staff Benefactor

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      The text above reminds me of the following words uttered by James Randi.

      "It is absolutely ridiculous. I don't know what we're doing, believing in all this nonsense over all these years. Largely, it's the media who are to blame for this sort of thing. They shamelessly promote all kinds of nonsense of this sort because it pleases the sponsors. It's the bottom line, the dollar line. That's what they are looking at. We really need to do something about this."
       
    9. Ambassador
      Cool

      Ambassador Member

      Location:
      USA
      Tinnitus Since:
      June 2015
      Cause of Tinnitus:
      High frequency hearing loss and lifetime noise exposure
      • Like Like x 1
    10. Samir
      Obedient

      Samir Manager Staff Benefactor

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      Meanwhile, the product has been brought to attention of a long-running Swedish consumer rights and advisory TV show called Plus on the Swedish national television. And according to the latest news, it is now being investigated by the Swedish agency responsible for regulation and surveillance of the development, manufacturing and sale of medicinal drugs, medical devices and cosmetics (henceforth refered to as the agency).

      Published: 25 November 2017

      The agency is investigating the tinnitus patch

      The agency has started an investigation regarding the tinnitus patch Antinitus in spring. If the agency comes to the conclusion that the claims regarding the patch are false, it can stop the sale of it within all of EU.

      - The patch is considered to be a medical device and not a medical drug, but nevertheless, as a company you cannot claim whatever you want, you must have evidence that the product is working as advertised, says Helena Djzojic, chief of the unit for medical device technologies at the agency.

      At the same time, she says that the investigation will not be completed before the year's end.

      - I wish that I had come longer in this investigation than I have, but the investigation has been laying still, I have not had the time to prioritize this case. It is actually not a very difficult investigation, what remains is for a few external experts to get involved, who need to help me to have a look at some parts that are claimed about this product.

      The Plus editors: Is the product allowed to be sold in Sweden while the investigation is ongoing?

      - Yes, it is okay to sell it on the Swedish market while the investigation is ongoing. In fact, in all of Europe, because they have a CE approval. But we as an agency have a duty to act if it turns out that we find something in our investigation which is not okay. If the product needs to be forbidden, we can stop it within all of EU, says Helena Djzojic.


      Calls for independent studies
      Gerhard Andersson, professor in psychology at the Linköping university, who has worked with tinnitus since early 1990s. He reacts to the fact that Antinitus is described as a medical device product on the company's website.

      - It can be a low bar for product to be called a medical device. If it is a patch, it can be enough that the patch is not harmful. That is not the same thing as saying that a product could help with tinnitus.

      Gerhard Andersson calls for more studies by independent researchers to get credible results for the tinnitus patch. He also calls for studies to show if the company's hypothesis really is true.

      - One should not simplify things too much. It is important to try new hypotheses, but it is also important to say that tinnitus likely does not have a single isolated cause in the inner ear. Tinnitus highly involves the brain too and its impulses.

      Source (in Swedish):
      https://www.svt.se/nyheter/konsument/lakemedelsverket-utreder-tinnitusplaster
       
    11. Frédéric

      Frédéric Member Podcast Patron Benefactor Advocate

      Location:
      Marseille, France
      Tinnitus Since:
      11/19/2012
      Cause of Tinnitus:
      acoustic trauma
    12. Mats Reimer MD

      Mats Reimer MD Member

      Tinnitus Since:
      03/2008
      Hi all, the Sensori company says the placebo-controlled trial I posted and will soon be published.
      I remain skeptical.

      The inventor claims that light filtered through the patch will alter the properties of the body water and this somehow works against tinnitus. He also claims this method can prolong the shelf life of milk by 300 %. And that the "synchronized" water gets a freezing point way below zero.
      Extraordinary claims require extraordinary good evidence to be taken seriously.

      About milk (in Swedish)
      https://www.metro.se/artikel/ljus-idé-för-färsk-mjölk-xr

      The patent
      https://encrypted.google.com/patents/WO2008100203A9?cl=en&hl=svA
       
    13. Tigo

      Tigo Member

      Tinnitus Since:
      2 years
      Cause of Tinnitus:
      genetic hearing loss
      • Informative Informative x 1
    14. Suzerman

      Suzerman Member

      Tinnitus Since:
      10 october 2017
      Cause of Tinnitus:
      Probably a mix of ETD and TMJ
      • Agree Agree x 1
    15. Karl28
      No Mood

      Karl28 Member

      Location:
      Melbourne
      Tinnitus Since:
      2001 bad since 2015
      Cause of Tinnitus:
      Loud music via headphones
      So it’s not a scam after all?
       
    16. AZeurotuner

      AZeurotuner Member Benefactor

      Location:
      Tucson, AZ
      Tinnitus Since:
      2010
      Cause of Tinnitus:
      Acoustic Trauma
      I still think it's a scam... The science behind it doesn't even make any sense, the text group was also relatively small (82 subjects), and the difference between the active and placebo group was only 20%. I'm just not buying it.
       
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    17. Sven
      Fine

      Sven Member Benefactor

      Location:
      Sweden
      Tinnitus Since:
      06/1999
      Cause of Tinnitus:
      Loud music
      Yes, it is.
       
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    18. Contrast
      No Mood

      Contrast Member Benefactor Hall of Fame

      Location:
      Clown World
      Tinnitus Since:
      late 2017
      Cause of Tinnitus:
      noise injury
      it is 99.9% safe to say that this is complete BS
       
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    19. Steve
      Creative

      Steve Member Benefactor Hall of Fame

      Location:
      Sheffield, UK
      Tinnitus Since:
      2003
      Cause of Tinnitus:
      Flu, Noise-induced, Jaw trauma
      This is a long post so the bottom line reads: This does not perform any better than placebo according to the paper.

      From the paper referenced above:

      The hypothesis is that the active (biomodulator) patch acts as a steady state coherent biomodulator. This is believed to stabilize and desensitize the auditory system, thus resulting in tinnitus relief. It is thought that this is achieved by soothing the chaotic audio-neuro- signal loops or what is also known as hyperactivity in a global network of long-range cortical connectivity, which creates the awareness and distress of the internal sound (i.e. tinnitus)​

      I'm not getting much from that myself :D. There are no references to any other work demonstrating the theory, no support anywhere I can find from the company to show how this works in the brain (or ear), no previously referenced work to inform the hypothesis. Just "it is thought".

      The primary objective of this research paper was:

      To assess the performance of the active (biomodulator) patch relative to placebo on the change of tinnitus symptoms after 21 days (Week 3). The key performance evaluations included tinnitus annoyance visual analogue scale (VAS), which was the primary variable.​

      There was no statistically significant difference on any of the measures after treatment. The patch did not perform better than placebo for the primary outcome.

      Secondary objectives:

      To assess the performance of the active (biomodulator) patch relative to placebo on the change of tinnitus symptoms 4 weeks after end of treatment (Week 7) compared to baseline. The key performance evaluations included tinnitus annoyance VAS, same as the primary variable.

      To assess if the active (biomodulator) patch could improve the tinnitus patient’s quality of life after the treatment period (Week 3) and 4 weeks after end of treatment (Week 7) compared to placebo. The key performance evaluations included: tinnitus handicap inventory (THI), questionnaire on well-being, and tinnitus annoyance and tinnitus related symptoms VAS including hyperacusis.​
      And the results?

      Tinnitus Annoyance VAS: There was no statistically signifiant difference (p = 0.52) between the 2 groups at Week 7.

      THI: There was no statistically significant difference (p = 0.39) between the 2 groups at Week 7

      Wellbeing: There was no statistically significant difference (p= 0.78) between the 2 groups at Week 7

      Hyperacusis VAS: There was no statistically significant difference (p = 0.23) between the 2 groups at Week 7

      The patch did not perform better than placebo for these outcome measures.

      The final outcome measure:

      To assess the performance of the active (biomodulator) patch compared to placebo on the proportion responders at Week 7. Responders were defined as patients at Week 7 having a decrease from baseline of at least 2 points in the tinnitus annoyance VAS.​

      The single measurement that improved was the "responders" category they chose. I can't see any reasoning that some people are deemed as responders but I do know that the figures here are unbalanced and I believe cannot be relied on. There is not enough data to make a proper comparison. 82 people in total took part, 16 were analysed as responders. 12 from the "active" group and 4 from the "placebo" group. I can't see how any proper comparison can be made from these figures.

      From the abstract:

      Conclusion: In a cost-risk-benefit rationale according to this study it can be reasonable to recommend the biomodulator patch for treatment of tinnitus. Improvements were shown at Week 7 (4 weeks after the end of treatment period).​

      The patch is safe to use. Maybe there isn't enough text to say that there was no statistical difference to placebo? They do have that at the end however:

      CONCLUSION

      The patch acts as a steady state coherent biomodulator and could have a resetting effect on the auditory system for downregulating tinnitus awareness.

      In summary, the patch was safe and well-tolerated and showed efficacy with significant difference between the active and placebo groups at Week 7 (4 weeks after end of the treatment period). The active patch group had 30% responders (i.e. decrease from baseline in at least 2 points on the tinnitus annoyance VAS) compared to 10% of responders in the placebo group. There was no significant difference in performance between the active (biomodulator) and placebo groups directly at the end of treatment (Week 3).

      So the conclusion I read is that it could work but isn't proven and there is no significant difference between the Antinitus patch and placebo. I am happy to be corrected if I have got this wrong.
       
      • Like Like x 2
    20. Sven
      Fine

      Sven Member Benefactor

      Location:
      Sweden
      Tinnitus Since:
      06/1999
      Cause of Tinnitus:
      Loud music
      • Like Like x 1
    21. Tom Gatwick

      Tom Gatwick Member

      Tinnitus Since:
      09/2008
      https://www.antinitus.com/sensori-presented-abstract-clinical-studies-tritinnet-regensburg-germany/
      Sensori has presented an abstract and clinical studies at TRI/TINNET in Regensburg, Germany

      Update on the latest effort in scamming people.

      Because of Sensori’s participation in TRI/TINNET, the Antinitus studies have received international attention by
      medical experts and, as a result of this, Peter Åhnblad has been invited to the ‘International Conference in Ear
      Nose and Throat Disorder’ in Japan (14–15 May 2018) as key note speaker. The international presence at
      international congresses within ENT and audiology is an important part of the company's commercialisation of
      the Antinitus product.


      :) How were these scammers allowed to attend this conference?
       

      Attached Files:

      • Good Question Good Question x 2
    22. Steve
      Creative

      Steve Member Benefactor Hall of Fame

      Location:
      Sheffield, UK
      Tinnitus Since:
      2003
      Cause of Tinnitus:
      Flu, Noise-induced, Jaw trauma
      Erm, presented?

      There was a guy there at one poster session looking at his feet, seemed quite embarrassed to be there. Not a single person spoke to him during the session that I could see, it was like there was an invisible force field around him. I looked at the poster for a short time until I realised what it was, he made no effort to engage as every other person presenting a poster does.
       
      • Like Like x 3
    23. Frédéric

      Frédéric Member Podcast Patron Benefactor Advocate

      Location:
      Marseille, France
      Tinnitus Since:
      11/19/2012
      Cause of Tinnitus:
      acoustic trauma
      • Informative Informative x 1
    24. Contrast
      No Mood

      Contrast Member Benefactor Hall of Fame

      Location:
      Clown World
      Tinnitus Since:
      late 2017
      Cause of Tinnitus:
      noise injury
      The best away to avoid legal action in situations involving non threatening and non harmful information on the internet is to completely ignore the threats to your email. Acting unprofessional and edgy about it is also a good strategy.

      They send you a long paper about legal action
      my response
      TLDR didn't read. lol
       
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    25. Contrast
      No Mood

      Contrast Member Benefactor Hall of Fame

      Location:
      Clown World
      Tinnitus Since:
      late 2017
      Cause of Tinnitus:
      noise injury
      • Like Like x 2
      • Agree Agree x 1
    26. Sven
      Fine

      Sven Member Benefactor

      Location:
      Sweden
      Tinnitus Since:
      06/1999
      Cause of Tinnitus:
      Loud music
      Scam. I'm certain.
       
    27. Contrast
      No Mood

      Contrast Member Benefactor Hall of Fame

      Location:
      Clown World
      Tinnitus Since:
      late 2017
      Cause of Tinnitus:
      noise injury
      upload_2018-10-4_22-23-28.png

      It doesn't allow shipping in the US.

      upload_2018-10-4_22-24-11.png
       
    28. Phendran
      Benevolent

      Phendran Member

      Location:
      Sweden
      Tinnitus Since:
      2009
      Cause of Tinnitus:
      Unknown
      At least when they tried to establish these in Sweden they were quickly put under the magnifying lens of the Swedish drug administration and I'm not sure how things have gone after that.
      Supposedly even the makers of the band-aid don't know exactly why it works if at all, and they have been open with that. Which I guess is a step-up from actually selling something they know doesn't work.

      https://www.svt.se/nyheter/konsument/lakemedelsverket-utreder-tinnitusplaster

      Gerhard Andersson is a researcher I've talked to personally and he wants more studies to be done.

      If anyone truly does get relief with the Antinitus-stuff I hope we hear from them soon. It's sold for a lot less than stem cells.
       
      • Agree Agree x 1
    29. Mats Reimer MD

      Mats Reimer MD Member

      Tinnitus Since:
      03/2008
      Finally!
      The Swedish Medical Products Agency stops the sale of the phony Antinitus patches.

      https://www.svt.se/nyheter/konsument/kritiserat-tinnitusplaster-stoppas-fran-forsaljning

      Translation of the news above:

      Sales of tinnitus patches are stopped

      The patch Antinitus, alleged to relieve tinnitus, is now forbidden to be sold to Swedish consumers. This according to a decision by the Swedish Medical Product Agency.
      Swedish Public Service Television consumer's program Plus has previously reviewed the tinnitus patch. Several researchers then criticized the lack of science behind the product, which despite this was available for purchase on the Swedish market.

      After a long investigation, the Medical Products Agency decided to stop the product from being sold in Sweden.

      "The company has presented clinical studies and submitted different data, but has not been able to prove that the product has the effect they claim," says Helena Dzojic.

      She is the Head of Unit for Medical Technology at the Medical Products Agency, and has led the investigation of Antinitus. According to her, the product will be stopped from sales within three weeks, unless the company appeals the decision. If the company fails to comply with the decision, they may be fined SEK 170,000 each time the ban is violated.

      The reason why the product is not immediately banned is because no person who have used the product has been harmed.

      We have tried to get a comment from Sensori, the company behind the product. At our previous review, the company meant that the product was working, but at the same time they could not explain why.
       
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    30. Samir
      Obedient

      Samir Manager Staff Benefactor

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      :beeranimation:
      :LOL:

      They should immediately ban it. Not because no person has been harmed, but because no person has been helped by it.
       
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