Antinitus – Clinical studies

For regulatory and development technological reasons, we continuously work with follow-ups as well as clinical studies carried out by specialised medical doctors. We do this to ensure that the safety and efficacy of our patches meet our expectations and the requirements for medical devices.

We are determined to continue our research and further studies to help people suffering from tinnitus. In this regard, we intend to allocate further finance from the proceeds of Antinitus sales towards new innovations and technologies in the field of tinnitus treatment.

Conclusions of tinnitus research in general

– The intention of the Antinitus treatment is to provide long-term relief from tinnitus or even permanently, but the result is highly individual and can vary a great deal.

– Tinnitus affects a significant proportion of the population and is a global problem.

– For some, tinnitus is a strong burden to carry with high negative impact on their quality of life.

– Even a slight alleviation in tinnitus is of value for the affected one, and it is only he or she who could determine and value this ease.

– Tinnitus is a difficult to treat and there is currently no universal cure.

– Treatments used today are expensive, time consuming, some with harmful side effects, and all with lack of clear scientific evidence.

– Treatments of today is mostly given to rather severe cases and with often long lead time before initiation. People with mild to moderate tinnitus love few treatment options.

– As tinnitus largely is subjective it is also a challenge to find objective methods of measuring improvements, and there are very few studies previously reported in literature that could be of guidance.

Clinical Investigation I

The Aktin I study

Atkin I is our first study. The study was conducted at a Clinical Research Unit at Karolinska Universitetssjukhuset, Stockholm, Sweden.

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Clinical Investigation II

The Aktin II study

The study was conducted at two outpatient clinics specialising in ear, nose and throat disorders, (Dr Peter Åhnblad at Sickla ÖNH-centre, and Dr Anders Nordkvist Läkarhuset +7, Göteborg).

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Conclusions

The intended use of the Antinitus patch is to relieve tinnitus inconvenience.

It is a low risk product, and any adverse effects that may develop are expected to be rapidly reversible when one ceases to use Antinitus. The product is made of skin-friendly material and is easy to use; see “Claims” below. The risks mentioned in the risk analysis are considered acceptable.

The studies show that Antinitus meets its intended use and that Antinitus is considered to fulfill Essential Requirements and to be a safe product.

Claims

Antinitus relieves the tinnitus inconvience
See Clinical Investigations.
Antinitus is composed of skin friendly material.
Aktin I: One skin reaction and one skin sensitivity experience without visual skin reaction. The skin reaction disappeared after stop of Antinitus therapy. Aktin II: Totally 16 patients reported skin reactions which is a common finding with patches. The reactions were reversible. The material used in Antinitus is biocompatible.
Antinitus is easy to use.
Antinitus is a patch applied as an ordinary plaster. No patient noted any problem to attach Antinitus behind the ear.

What is tinnitus?

Tinnitus is the perception of sound that is not generated by an outside source. Tinnitus is a sensation that is inherent in almost all of us and we can, for various reasons, become aware of.

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How does Antinitus work?

The patch contains a raster that creates an organized signal, which is expected to regulate the auditory system.

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