Prototype Device for Electrical and Magnetic Stimulation of the Ear in the Treatment of Tinnitus

Discussion in 'Research News' started by InNeedOfHelp, Jun 19, 2022 at 11:29 AM.

    1. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      Assessment of Subjective Tinnitus Treatment Results Using a Prototype Device for Electrical and Magnetic Stimulation of the Ear-Preliminary Study

      Background: The aim of the study was to evaluate the effectiveness of subjective tinnitus treatment in patients with cochlear sensorineural hearing loss with magnetic ear stimulation using a prototype device. Since the 1970s, studies have been conducted on the use of electrical stimulation of the ear in the treatment of tinnitus. The available literature contains various hypotheses about the influence of electrical stimulation of the ear on tinnitus.

      Material and Methods: Preclinical studies were performed for 100 patients, 40 women and 60 men (124 ears in total), aged 38–72 years, treated for tinnitus. A subjective assessment of the loudness of tinnitus was performed, and the frequency and intensity as well as hearing threshold were determined using a prototype device for electro-magnetic stimulation of the ear. The treatment cycle consisted of 10 five-minute stimulations performed daily 5 times a week.

      Results: Before treatment, persistent tinnitus was found in 100 ears (80.6%) and periodic tinnitus in 24 ears (19.4%). Immediately after treatment, persistent tinnitus was present only in 50 ears (40.3%) and periodic tinnitus in 40 ears (32.3%). Complete resolution of tinnitus was noted in 34 ears (27.4%). On the other hand, the examination performed 3 months after the treatment showed persistent tinnitus in 40 ears (32.3%) and periodic tinnitus in 50 ears (40.3%), and complete resolution of tinnitus was recorded in 34 ears (27.4%). Based on the VAS analog scale, there was an improvement in tinnitus in 98 ears (79.0%) immediately after treatment and no improvement in 26 ears (20.0%). The mean VAS scale before treatment was 4.9 points, after treatment it was 2.1 points and 3 months after treatment it was 1.9 points.

      Conclusions: The preliminary research results show the high effectiveness of magnetic stimulation in the treatment of tinnitus with the use of a prototype device for electromagnetic stimulation of the ear. There was no negative effect of the stimulation on hearing or tinnitus.​

      WOW. 50% had a complete elimination of tinnitus after treatment, after 3 months 28% were completely tinnitus free, and in total of 80% of the ears improved! There were no adverse effects and the treatment is non-invasive (placed in the external auditory canal). I'd highly recommend reading the full study. The treatment can be done at home and consists of 10 minutes/a day of stimulation per ear.

      Just adding up that this is a Class IIa device in Europe (medium risk), so only a certificate of conformity is required. There is already a patent registered/approved in 2021, and apparently already a study of 300 participants underway (the first one that finds the study gets a cookie, I cannot seem to find it in the European study database).

      This is not light years away at all.
       
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    2. DimLeb

      DimLeb Member

      Tinnitus Since:
      03/2021
      Cause of Tinnitus:
      Idiopathic Cochleopathy or Maybe Loud Music
      This is incredible if it's real. Bonus points for us in Europe as well. Do they have a donate button? Lol.
       
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    3. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
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    4. Nick47

      Nick47 Member

      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      It would be interesting to find the degree of hearing loss and response rates. Looks very impressive!
       
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    5. JRC1

      JRC1 Member Benefactor

      Tinnitus Since:
      2016
      Cause of Tinnitus:
      medication
      This sounds fantastic, but aren’t they saying the next trial is going into 2026?
       
    6. Joe Cuber
      Irritated

      Joe Cuber Member Podcast Patron Benefactor

      Location:
      California, USA
      Tinnitus Since:
      03/2022
      Cause of Tinnitus:
      My guess is long-term noise exposure from earbuds
      How does one determine whether they have cochlear sensorineural hearing loss? I have mild hearing loss in both ears... Is it likely caused by SNHL?
       
    7. PeterPan
      Nerdy

      PeterPan Member Advocate

      Location:
      Sydney
      Tinnitus Since:
      09/2016
      Cause of Tinnitus:
      Heat Exhaustion
      No control again, however:

      “After obtaining the consent of the Office for Registration of Medicinal Products of the Republic of Poland, a randomized, double-blind, placebo-controlled clinical trial has been planned for a large population of 300 patients with subjective tinnitus in the period 01.12.2021 to 28.02.2026.”
       
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    8. AUTHOR
      AUTHOR
      InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      Often with long studies you have primary endpoints (reached after several months) and secondary endpoints reached much later, with readouts in between. It could also be that the study is only in one location and they expect it to take time to get enough patients. Either way, there are often readouts in between and in Europe you don't have to wait the entire 5 years to get your medical device on the market.
      Agree with no control but when 50% has a complete diminishing of tinnitus, it is significant. I don't think someone can diminish tinnitus by a placebo effect, so these figures seem very relevant and valid to me.

      @Hazel, can we get these people on the Tinnitus Talk Podcast? This comes out of nowhere and these results are quite significant and even stronger than the Auricle device.
       
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    9. addot

      addot Member

      Location:
      US
      Tinnitus Since:
      Jan 2013
      Cause of Tinnitus:
      Noise exposure
      This is a pre-clinical study, it's meant to serve only as a proof of concept.

      Placebo/control group testing is more of a Phase 2/3 thing.
      Unfortunately, tinnitus is actually very susceptible to the placebo effect. This is one of the reasons why it's so challenging for potential treatments to do well in clinical trials.
       
    10. addot

      addot Member

      Location:
      US
      Tinnitus Since:
      Jan 2013
      Cause of Tinnitus:
      Noise exposure
      Great find! Thanks for sharing. It seems like a lot of electrical/magnetic ear stimulation treatments are popping up: Dr. Hamid Djalilian is coming up with a device that uses basically the same approach (also in the pre-clinical phase), and OP @InNeedOfHelp found another recent study using what I believe is the same approach in mice.
      This is in keeping with Dr. Djalilian's study, in which 60% of participants reported complete suppression of their tinnitus in response to stimulation. I was cautiously optimistic over that study and am likewise cautiously optimistic over this one. I still think placebo is a real concern, but I do agree that complete cessation of tinnitus seems too large of an effect to attribute to placebo. With all these studies coming up at the same time... here's hoping these folks are on to something and that these early results hold up in clinical trials.
       
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    11. bikerbandito

      bikerbandito Member Benefactor

      Location:
      NYC
      Tinnitus Since:
      09/2021
      Cause of Tinnitus:
      Unknown
      Where are you seeing "50% had a complete elimination of tinnitus after treatment"? Your post read 27.4%.
       
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    12. NewLionel

      NewLionel Member

      Tinnitus Since:
      2019
      Cause of Tinnitus:
      headphones
      I always knew the cure would be magnets...
       
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    13. kingsfan
      Mellow

      kingsfan Member Benefactor Hall of Fame

      Location:
      Southern California
      Tinnitus Since:
      9-17-20 / 10-20-20 / 3-31-21 / 5-23-21
      Cause of Tinnitus:
      turning everything up to 11
      magic-how-do-they-work.gif
       
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    14. AUTHOR
      AUTHOR
      InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      Sorry, you are right. It included intermittent tinnitus (which means moments of silence I guess).
       
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    15. Uklawyer

      Uklawyer Member

      Tinnitus Since:
      03/2020
      Cause of Tinnitus:
      Medication - antidepressants
      How does this work? 24 patients (only) had bilateral tinnitus?
       
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    16. addot

      addot Member

      Location:
      US
      Tinnitus Since:
      Jan 2013
      Cause of Tinnitus:
      Noise exposure
      The results are ambiguous though, so I don't blame you. According to them, before treatment, persistent tinnitus was found in 100 ears, and after treatment, persistent tinnitus was only found in 50 ears. This to me reads like the treatment eliminated tinnitus in 50% of patients. But then they go on to say that tinnitus elimination occurred in 34 ears? What is the difference between these two things?
      Yes, exactly. At the beginning of the methods section, they say that "A total of 124 ears were examined, of which 24 had bilateral and 100 had unilateral tinnitus, 60 ears on the left side and 40 ears on the right side."
       
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