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

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.

 

This is incredible if it's real. Bonus points for us in Europe as well. Do they have a donate button? Lol.

 

jurek.olszewski@umed.lodz.pl

That is the email of the author of the study.

 

It would be interesting to find the degree of hearing loss and response rates. Looks very impressive!

 

This sounds fantastic, but aren’t they saying the next trial is going into 2026?

 

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?

 

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.”

 

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.

 

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.

 

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.

 

Where are you seeing "50% had a complete elimination of tinnitus after treatment"? Your post read 27.4%.

 

I always knew the cure would be magnets...

 

Sorry, you are right. It included intermittent tinnitus (which means moments of silence I guess).

 

How does this work? 24 patients (only) had bilateral tinnitus?

 

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."

 

I participated in the study in early 2017. No effect for me. There was no control group and the study was not blinded. I would not put too much trust in it.

 

Thanks for letting us know!

I think we shouldn't shoot studies which did not work for someone specifically. I see quite often studies which supposedly provide statistically significant difference, then one individual tries it, didn't work, and because of that no one is interested any longer in the study. We know that there are subgroups of tinnitus which are not defined yet - also this study has some non-responders (you were part of that). That doesn't say anything about the potential that it offers though.

I wrote to the researchers to see if I can participate and some additional questions but no response. I also checked the Polish trial pages for any information on a trial but I couldn't find any. Still I think these findings should not be ignored straight away.

 

They must belong to the Susan Shore school of R&D timelines.