Within a few weeks to months the subjectively perceived tinnitus reduces significantly.

ForgTin® research since April 2017

The story of ForgTin® began when Klaus Grübl, inventor of the current ear hook, started to experiment with his own tinnitus after 19 years of “incurable” tinnitus and made an accidental discovery. In his first self-experiments he bent the hook of his glasses with the effect of a continual pressure on certain areas/points of his ear. In the course of time Klaus Grübl experienced his tinnitus more and more silent and by now he has nearly entirely forgotten his tinnitus.

In further developments the hook was further optimised and today the ForgTin® is a high-tech product made of 3D printed materials that are also used for medical implants. Several silicone pressure elements can be adjusted individually by the user.

Reduction of the tinnitus in the course of the application of ForgTin®

The chart shows a typical curve during the application of ForgTin®. The timeline of the application shows that the patient’s tinnitus changes significantly! (the perception of the tinnitus volume reduces significantly). Patients regularly answer the question „How loud do you perceive the tinnitus currently?“ during the study.

The reduction of the tinnitus volume reduces the strain

The patients are also asked „How straining is the tinnitus currently?“ during the study. With the reduction of the tinnitus volume the strain caused by the tinnitus reduces too, as can be seen in the chart.

30 % of the patients document a reduction of the disruptive ear noises of 90-100 %. 
70 % of the patients document a reduction of 30-90 % (detail study 1)

The volume curve as well as the strain curve changed in the course of time significantly on an average. Intermediate peaks were mostly caused by high temporal emotional stress levels such as deaths, diseases or other emotional stress. Intermediate peaks can also be experienced when the so far prominent tinnitus noise disappears in case of multi-frequency tinnitus and thus a new tinnitus frequency is perceived which is not that loud and disruptive. Finally, it comes to forgetting and flattening of the curve.

study 1

The success of a single subject, the inventor, is not meaningful, of course. In a further step a one-armed study with 20 participants (10 female, 10 male, average age 55, average tinnitus duration 5 years) started. All study participants have worn the Forgtin over a period of 6 months and documented the tinnitus volume as well as tinnitus strain in an electronic diary. All study participants reported about a reduction of the tinnitus volume. 30 % of the study participants indicated that the tinnitus has disappeared nearly entirely during the observation period (improvement over 90 %). The remaining 70 % of the study participants reported about a reduction of the tinnitus between 30-90 %. No side effects were reported by the study participants.

The illustration below shows the progress of the tinnitus of one study participant. There was no control group in the first study.

study 2

In October 2020 a two-armed, randomised, clinical study starts in Upper Austria. The end is planned for August 2021. With this clinical study the effect of ForgTin® will be further examined and compared with a control group that gets no tinnitus therapy in the same period. All participants will be examined medically by a study doctor before, during and after the application of ForgTin®. A primary success parameter for the study is the German version of the Tinnitus Handicap Inventory (THI) questionnaire. The duration of this study is 10 months. Apart from the comparison of the application of ForgTin® with a randomised control group the study examines which types of tinnitus respond especially well to the application of ForgTin®. For this reason, other factors regarding stress, neck and jaw tensions, previous illnesses as well as emotional factors will be included.

On November 16, 2020, the ethics committee of the Medical Faculty of the JKU Linz gave the OK for the start of the study under EK no .: 1229/2020.

This study was also registered with Clinical Trials.gov under the identification number “NCT04623957”.

 

abbildung1_studie1

Illustration: progress of a study participant
x axis: duration, in total 6 months
y axis: volume/strain 0-10

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