Post Market Clinical Follow up Results of the Steady State Coherent Bio-modulator Patch for tinnitus

To follow up with a survey for the safety and performance of the coherent biomodulator patch as a device for tinnitus when in clinical use.

A survey with 20 questions was emailed to device users a few weeks after fulfilled treatment. Collected data from 927 responders from February 2017 to July 2020 was exported and analyzed. The treatment time was 3 weeks, and the patches were changed daily and placed behind one year. The analysis was performed in order to investigate the possibility of subgroups and if the effect of one or more treatments are different, and is the relief dependent on how long the users have had troublesome tinnitus, the age of the user, and the severity of the tinnitus.

Most users were 45 years and older with a gender ratio of 1.65 men vs women. In general, the users reported highly bothersome tinnitus with 82% answering frequently to a lot before treatment. This follow up survey showed that 33% experienced any kind of improvement. The majority of those that reported improvement came from the subgroup of 4-10 years suffered from tinnitus. A very low frequency of side-effects was reported with no new risks or unexpected issues.

When considering the intended purpose of the steady state coherent biomodulator and the provided information in this survey, the device remains suitable for the intended tinnitus users.