Resaphene Suisse AG: Breakthrough in Tinnitus — Tinniwell

Not sure if this has been covered already. Just thought I would share. Am interested to hear what the more informed members think. Thank you.

https://www.biospace.com/article/releases/resaphene-suisse-ag-breakthrough-in-tinnitus-therapy/

 

• "Tinniwell is essentially an MP3 player but one which is equipped with special functions. Using headphones with active noise cancellation, the tinnitus sufferer can configure the device to their ear noise very precisely with respect to character (tone or sound), frequency (pitch) and volume." source

• "Since subjective tinnitus is caused by hyperactivity of the nerve cells, tinnitus therapy with tinniwell makes use of one of the most remarkable capabilities of the human brain: the so-called neuroplasticity. This stimulates surrounding, healthy brain areas and thus uses the effect of lateral inhibition: the targeted activation of adjacent nerve cells, which include the perception spectrum outside of tinnitus, inhibits the activity of the cells responsible for the tinnitus tone." source

The idea of neurofeedback and "tailor-made notched music" method is not new. They call everything regarding tinnitus treatments a breakthrough.

• "The treatment takes place through special therapeutic headphones with built-in, individually adjustable heating. The light warming helps to stimulate the vagus nerve, producing a pleasant relaxing effect." source

I'm wary of tinnitus treatments like this one. Tinnitracks, Tinnitus Pro, Tinniwell... We also don't know if it's safe for every tinnitus patient to wear in-ear earbuds or headphones.

 

What do you think of Susan Shore's device?

 

*Sigh*..........just *Sigh*

That's all I have to say about that!

 

I want to sell my MP3 too.
Who wants it? This thread is reserved only for MP3 market.

 

Resaphene Suisse AG: Charité Ethics Committee in Berlin Approves Study on Tinniwell Tinnitus Therapy

The Charité's ethics committee has approved the double-blind study on the tinnitus therapy device tinniwell with Resaphene Suisse AG, ISIN CH0367465439, WKN A2JG91. A total of 60 people took part in the study and the head is Prof. Dr. med. Birgit Mazurek commissioned. The results are expected for Q4 / 2020 or Q1 / 2021.

The double-blind study has the same design as a first clinical user observation by Dr. med. Johannes Ebbers. This documented an average relief of 54% within 4 weeks; in one patient the tinnitus was even 100% healed in time. Based on the above facts, Resaphene assumes similar results in the double-blind study. If this is achieved, the tinniwell can become the new global standard in tinnitus therapy. There is currently no known competitor who can deliver comparable therapy results. It is estimated that over 100 million patients are affected in the target markets of Europe and the US.

If the study is successfully completed, the management of Resaphene assumes the participation of further institutional investors or the sale of intellectual property to a hearing aid manufacturer as part of an exit strategy of the previous shareholders. No binding contracts have yet been concluded for this.​

This is the website of the company:

https://resaphene.ch/en/

Maybe German people can know more about this. Like @Autumnly states above this just seems to be a neurofeedback device. "There is currently no known competitor who can deliver comparable therapy results" Hmmm I mean Neuromod kinda does... Don't quite know what to make of this. Still unlike some more questionable trials about tinnitus, this one is double-blind. So I guess that's something

 

@Nonomat

This solution comes a bit out of the blue. Don't know what to think of it as well. Perhaps anyone else know more about Tinniwell?

 

"Resaphene Suisse AG, based in Roggwil, Switzerland, is a medical technology company that was founded in 2015 and has been selling a tinnitus therapy device under the name tinniwell since 2016."

Yeah well I think that's all I need to know....

 

It looks to me more like Notch Therapy:

Clinical studies at the University of Münster confirm the effectiveness of frequency-filtered music in tinnitus therapy.​

Then they talk about lateral inhibition, which is a key mechanism in notch therapy.

 

Hasn't this been proven mostly ineffective by now?

 

Not really. There is some modest success. See https://www.ncbi.nlm.nih.gov/pubmed/25951605

There are more studies on notched therapy that you can peruse on pubmed.

It's not a silver bullet, but it does appear to help a fraction of sufferers.

 

I'm tired of German sources completely ignoring any other research that's currently going on, keeping the reader as uninformed as possible while only promoting German producers of at best moderately effective treatment approaches.

Relief for chronic tinnitus – without pharmaceuticals (tinnitwell study)
Results of a clinical observation study with the “tailor-made notched music” method

• the first study was only based on 29 patients
• they measured tinnitus severity using Göbel and Hiller’s Tinnitus Mini Questionnaire (for whatever reason they didn't use THI or TFI), 0 points = no distress, 24 points = maximum distressed
• they don't mention for how long the patients had had tinnitus only that they had "decompensated tinnitus"
• "significant improvements in the amount of tinnitus perceived (measured using the questionnaire score) were observed for all patients"
• "After a four-week Tinniwell treatment, the stress index had decreased by an average of 45.6%. The energy reserve had increased by an average of 15.5%, the psycho-emotional state had improved by 22.5%, and the biological age had decreased by 6.3 years (13.1%)." [psycho-emotional state??? energy reserve???]
• "The average tinnitus score (highest possible score: 24 points) dropped from an initial 15.5 points to 7.3 points. This corresponds to a reduction in tinnitus from average moderately severe tinnitus to mild tinnitus. Expressed in percentages, on average the tinnitus decreased by 54.1% [They mean tinnitus distress, right? They don't mention tinnitus loudness/volume]

 

Yeah, I guess I have to start to differentiate. Tinnitus trials =/= Good news.

 

https://www.businesswire.com/news/h...ene-Suisse-AG-Charité-Ethics-Committee-Berlin

 

If the device is being sold since 2016 what is the point in conducting the clinical trials now? Was the device improved?

Anyone here who tried the device?

 

It's a similar scenario with the Aurex 3 device. Back in the news lately accompanied by statements about how the offering "will" control/treat tinnitus. One checks the website, reads the fancy paper promising an FDA cleared "consumer variant available in 2019", and then of course nothing - notwithstanding the fact that 2019 was last year.

 

I just got a reply from them. I asked them if anyone got worse in the study, they replied no. And it's already in the market for 2479 euro.

 

They have a medical device currently in double-blind study with results due Q4 / 2020 or Q1 / 2021, yet right now they'll sell us same medical device for nearly 2.5K euro?

Can someone please explain to me what the heck is going on.

 

Aw man, you play keys? I used too, and drums. Not anymore ......

 

A curiously worded press release, using quite emphatic language:

[my emphasis]

"By monitoring Resaphene in 250 patients from January 2019 - February 2020, 4 phases of therapy have now been identified. In phase 1, tinnitus becomes louder during or immediately after treatment. This can only occur after 2 days or 5 weeks. This is the indication that the therapy is working on the patient. In phase 2, the tinnitus tone drops and becomes quieter. Phase 3 is a big surprise for the patients because the tinnitus now partially disappears during the day. In the final phase 4, it also disappears at night. It is then recommended to continue the therapy for a further 3 weeks at the last known frequency, since the tinnitus will then permanently disappear. A premature termination leads to the tinnitus being present in its old appearance again within a week. Overall, phase 4 was observed after 3-4 months with a daily therapy duration of two hours.

In the past, two studies were carried out at the University of Münster on the topic of Tailor-Made Notched Music Training. In the second study, the subjects were advised to stop the therapy if the tinnitus worsened. According to our knowledge, this was the reason for the poor results from this study. An improvement in the patient's tinnitus is always preceded by a worsening."

 

This sounds like Lenire.

 

That's exactly what I was thinking.

 

There is a study showing that the average relief of 54% is demonstrated after 4 weeks. In addition, we were named test winner in the field of tinnitus therapies by the specialist magazine Webgesundheit.

The price for the rent of 6 weeks is 379 euros (financing from 6.57 euros per month possible).

they made the offer to me.

 

Is it for tonal tinnitus only? I read it is based on matching tinnitus frequency.

 

tinniwell can determine the personal tinnitus frequency and suppress it with counter-sound.
that's what it says in the flyer.

 

Hi, anyone has more news about Tinniwell? It is German technology so that makes it more attractive and reliable. Anyone who has tried it or know someone who has? Best regards!

 

They sell the device for 2479 euros, rental only available for Austria, Germany and Swiss citizens for around 600 euros for 4 weeks.

 

Resaphene Suisse AG: FDA approval process for tinnitus therapy tinniwell continues

Roggwil, July 13, 2022 - Due to the COVID pandemic, work for the FDA approval of the tinniwell was stopped at the beginning of 2021. This has now been
resumed and Chief Medical Officer Thomas Rauterkus has been commissioned to
manage the project. The aim is to complete this project within 12 months and
thus gain entry into the medical technology market in the USA.​

What an unprofessional press release. Comparing yourself with Neurolink while you did an unblinded trial of 29 participants and are now seeking FDA approval.