From October 2016 to July 2017, all patients with chronically decompensated tinnitus were informed about the "Tinniwell" treatment device in the ENT specialist practice of Dr. med. Johannes Ebbers and invited to participate in the observational study. All patients underwent an oto-neurological examination, including ear microscopy, tonal audiometry, videonystagmography, an initial clinical neurological examination, and magnetic resonance imaging of the skull.

Exclusion criteria included the discovery of an organic cause of tinnitus ("symptomatic tinnitus") and refusal to participate in the study.

A total of thirty patients were recruited. One study participant discontinued the study without providing reasons after two weeks. Thus, 29 study participants could be evaluated. The oldest study participant was 72 years old, and the youngest was 17 years old. 14 participants were male, and 15 were female.

The study procedure

At the beginning of the "Tinniwell" treatment, each study participant was interviewed using the Tinnitus Mini-Questionnaire according to Göbel and Hiller, and the tinnitus severity (score) was determined. In seven patients, the psychovegetative tension level was additionally measured using the heart rate variability method (HRV). The selection of these seven patients was random and depended on the availability of the examination device. Subsequently, the patients were instructed on how to use the "Tinniwell" device. Participants were encouraged to use the "Tinniwell" treatment device for at least 30 minutes daily over the following four weeks. A longer treatment duration was explicitly desired. Light activities such as reading, walking, and light housework or gardening were permitted during the therapeutic application. After four to six weeks, the tinnitus score was re-evaluated, and if necessary, another HRV measurement was carried out. Additionally, participants were asked about the criteria of "usability", "recommendation level", "music preference", and "therapy mode".

Results

In contrast to a previous study by Dr. med. Johannes Ebbers, a more or less significant improvement in tinnitus perception (measured by the questionnaire score) was observed in all patients. Not a single participant experienced a deterioration. One patient completely lost her tinnitus. The average tinnitus score (maximum achievable value: 24 points) decreased from the initial 15.5 points to 7.3 points. This corresponds to a reduction from an average moderate tinnitus to a mild tinnitus.

Expressed in percentages, the tinnitus decreased on average by 52.9%. The results varied between a reduction of 100% (complete disappearance) and a 20% improvement.