NUEYNE-T100 Tinnitus Device Combines Vagus Nerve Stimulation and Sound Therapy

Discussion in 'Research News' started by Vadimus, Oct 22, 2023.

    1. Vadimus

      Vadimus Member

      Tinnitus Since:
      04, 2023
      Cause of Tinnitus:
      Otosclerosis, benzo withdrawal, SSRI
      NUEYNE-T100 is yet another device using both electrical and auditory stimulation, from a Korean company. NU EYNE researches and develops the treatment protocol for tinnitus by combining the approaches of auricular vagus nerve stimulation and sound therapy in synchrony.

      9049cddf893cd30b386ad3609369922f.jpg

      NUEYNE-T100 Tinnitus Device Pipeline

      pipeline.jpg

      Phase I trial results:

      Effects of Transcutaneous Trigeminal Electrical Stimulation and Sound Therapy in Patients with Tinnitus

      The THI used in this study is one of the most commonly used questionnaires to evaluate the severity of tinnitus symptoms. Previous studies have demonstrated the reliability, validity, and consistency of the THI. The THI consists of 25 items with three subscales (functional, emotional, and catastrophic). In the present study, emotional and catastrophic domains were statistically significantly improved. Among these, catastrophic subscales that have a high correlation with depression, anxiety, somatic symptoms, subjective loudness, and annoyance decrease significantly after TTES.
       
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    2. Tomas80

      Tomas80 Member Benefactor

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Unknow. Maybe stress?
      What does the timeline in the picture mean? Is the device in the commercialization stage for migraine? If it becomes available for migraine, can I buy it and use it for tinnitus? Is it that simple?
       
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    3. SarahMLFlemmer

      SarahMLFlemmer Member Hall of Fame

      Location:
      Central California
      Tinnitus Since:
      11/20/2022
      Cause of Tinnitus:
      Accutane (withdrawl)
      I have overactive bladder, migraines, and tinnitus :meh:

      ...is the study saying the device was only used on people who had tinnitus less than 3 months?
       
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    4. ErikaS

      ErikaS Member Benefactor Hall of Fame

      Location:
      Pennsylvania, USA
      Tinnitus Since:
      09/2022
      Cause of Tinnitus:
      Ear infection/Ultra High Frequency SSHL in Right Ear
      If you go to their website, you will see the product for migraine and the product for tinnitus are two completely different products. Each focused area has its own unique product to target the condition.
       
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    5. Nick47

      Nick47 Member Benefactor Hall of Fame

      Location:
      UK
      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      At least 3 months, which to me is too short. That said, many had tinnitus for years as you can see in the table.
      You are assuming the same device will treat all conditions?
       
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    6. Jonno02
      Frustrated

      Jonno02 Member Benefactor

      Tinnitus Since:
      2012. Worsened 2022.
      Cause of Tinnitus:
      Primarily loud music. Secondary - ETD + TMJ
      The tinnitus device comes with a phone app. Would be nice to be able to change our tonal frequency with this as it appears the Michigan Device can only be changed by practitioners.
       
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    7. AUTHOR
      AUTHOR
      Vadimus

      Vadimus Member

      Tinnitus Since:
      04, 2023
      Cause of Tinnitus:
      Otosclerosis, benzo withdrawal, SSRI
      It's not a great graph, but from what I understand it shows that Phase 1 and 2 clinical trials for their tinnitus device are complete.

      I think they have a different device for migraines.

      ELEXIR is the treatment device for migraine:
      https://nueyne.com/en/product/product05.html

      BEETHOVEN is the treatment device for tinnitus:
      https://nueyne.com/en/product/product03.html
       
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    8. El BUZZ
      Buzzed

      El BUZZ Member Hall of Fame

      Location:
      South Spain
      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Acoustic trauma
      Participant number 10 of the trial has had tinnitus for 240 months = 20 years.
       
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    9. UHPTS
      Uninvolved

      UHPTS Member

      Tinnitus Since:
      10/2019
      Cause of Tinnitus:
      Taking drugs on penile fracture
      Their device looks like it is market ready. Also because it is driven by a phone, new/updated features will be downloadable as soon as they become ready. I assume parameters like tinnitus pitch will be adjustable by a user and there won't be a need to visit the ear doctor to get the device.

      This device compared to Dr. Shore's device is like Tesla to most other automakers.

      <fingers crossed>
       
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    10. DimLeb

      DimLeb Member

      Tinnitus Since:
      03/2021
      Cause of Tinnitus:
      Idiopathic Cochleopathy or Maybe Loud Music
      Judging by its name and its use of the word "neuroplasticity", it looks like it's just another Lenire.
       
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    11. Nick47

      Nick47 Member Benefactor Hall of Fame

      Location:
      UK
      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      Yes, but where is the evidence of effectiveness? Loads dropped out of the trial and what about the outcomes?
       
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    12. ErikaS

      ErikaS Member Benefactor Hall of Fame

      Location:
      Pennsylvania, USA
      Tinnitus Since:
      09/2022
      Cause of Tinnitus:
      Ear infection/Ultra High Frequency SSHL in Right Ear
      Did anyone catch these inconsistencies though? In the study, they show Figure 1 of the device used and explain what was targeted (trigeminal electrical stimulation). The device in the study is like a headset and looks more like the device advertised for other conditions. With what they are advertising as "Beethoven" for tinnitus, it is a completely different device than what was used in the study, AND Beethoven apparently targets auricular vagus nerve stimulation.

      So, we have a study with a headset looking device targeting trigeminal nerve stimulation, and then you have an advertised device that is an in-ear device that targets auricular vagus nerve stimulation.

      Someone please correct my confusion if I am at all wrong.
       
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    13. Jonno02
      Frustrated

      Jonno02 Member Benefactor

      Tinnitus Since:
      2012. Worsened 2022.
      Cause of Tinnitus:
      Primarily loud music. Secondary - ETD + TMJ
      It’s the same principal as Susan Shore’s device; same target nerve. It’s thought that maladaptive neuroplasticity is the root of tinnitus, so why wouldn’t it also be the answer?

      Lenire stimulates an entirely different nerve.
       
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    14. Nick47

      Nick47 Member Benefactor Hall of Fame

      Location:
      UK
      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      I thought it was the same target.

      Surely we need a bigger 2nd trial before drawing any conclusions.

      I wonder how many of these will pop up. 'dr. Shore's device will be left on the shelf at this rate. I think another prototype is in clinical trials at Brai3n currently.
       
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    15. AUTHOR
      AUTHOR
      Vadimus

      Vadimus Member

      Tinnitus Since:
      04, 2023
      Cause of Tinnitus:
      Otosclerosis, benzo withdrawal, SSRI
      I too was confused that the device in the study looks nothing like the product on their website.
       
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    16. ErikaS

      ErikaS Member Benefactor Hall of Fame

      Location:
      Pennsylvania, USA
      Tinnitus Since:
      09/2022
      Cause of Tinnitus:
      Ear infection/Ultra High Frequency SSHL in Right Ear
      Like I said above though, what device are we dealing with here. The study one that supposedly targets trigeminal nerve stimulation that looks like a headset device of some kind in figure 1 in the study, or their advertised “Beethoven” that are in-ear devices that target auricular vagus nerve stimulation? Am I the only one seeing this huge discrepancy? Lol.
       
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    17. Jonno02
      Frustrated

      Jonno02 Member Benefactor

      Tinnitus Since:
      2012. Worsened 2022.
      Cause of Tinnitus:
      Primarily loud music. Secondary - ETD + TMJ
      The website photo is a 3D render. Looks almost like an artist’s impression. Possibly either they don’t quite know the final form of the device yet or they don’t want to give too much away to potential competition.

      The one in the study kinda looked like a pair of glasses to me? At this rate we’ll all look like a futuristic person from Back To The Future with our bimodal sunglasses, Michigan headsets and Lenire tongue zappy thing.
       
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    18. AUTHOR
      AUTHOR
      Vadimus

      Vadimus Member

      Tinnitus Since:
      04, 2023
      Cause of Tinnitus:
      Otosclerosis, benzo withdrawal, SSRI
      I just emailed NU EYNE and got this answer:
       
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    19. ErikaS

      ErikaS Member Benefactor Hall of Fame

      Location:
      Pennsylvania, USA
      Tinnitus Since:
      09/2022
      Cause of Tinnitus:
      Ear infection/Ultra High Frequency SSHL in Right Ear
      Thanks for reaching out. Everything is freaking "3 years away" or more.
       
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    20. GlennS

      GlennS Member Podcast Patron Hall of Fame

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      Loud music
      8-adb32be77984.s3.amazonaws.com%2Fpublic%2Fimages%2F10c893c0-95d1-4afb-aeeb-88d6d9db337b_448x285.gif
       
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    21. ZFire
      Pacman

      ZFire Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      2012 (mild) & 04/2021 (severe)
      Cause of Tinnitus:
      Ototoxicity (2012) Unknown-likely noise induce (2021)
      And here lies the problem once more. People believing that these tinnitus questionnaires are valid means to assess the effectiveness of tinnitus treatments...
       
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    22. AUTHOR
      AUTHOR
      Vadimus

      Vadimus Member

      Tinnitus Since:
      04, 2023
      Cause of Tinnitus:
      Otosclerosis, benzo withdrawal, SSRI
      Another e-mail from Nu Eyne team. I checked with them about the first study and inquired about the amount of funding needed:
       
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