Inhibition with RU and ME increased eosinophilia in the bone marrow compared to controls (p < 0.05). Eosinophilia in bronchoalveolar lavage fluid increased in the sensitized groups compared to controls, but there were no differences between the sensitized groups. CD3+ and CD4+ cells were increased in the nasal mucosa as a result of treatment with RU and ME.

Objective: A new topographical filter in a dermal administration patch that organizes water molecules has been suggested as an alternative treatment for manifested tinnitus. The aim of this study was to evaluate this patch in a pilot study. Materials and Methods: 12 patients were included (10 completed) in an open study all receiving treatment with daily changed patches. The objectives were to evaluate safety and performance of the patch during and after treatment. The primary objective was to evaluate the tinnitus severity (by Tinnitus Severity Questionnaire, TSQ) and tinnitus annoyance (by Visual Analogue Scale, VAS). The secondary objective was to evaluate if the patch could improve the patient's quality of life (by SF-36 Quality of life questionnaire) and sleep initiation time (self-rated). Results: At visit 4, after 21 days of treatment, an improvement (decrease in TSQ score) was seen in 5 responder patients, which was sustained at the post-treatment visit. A marginal increase in TSQ score was seen also initially in 5 non-responder patients, 4 of which were responders post-treatment. The rated tinnitus annoyance, quality of life and sleep initiation time did not show significant changes. The safety evaluation did not present any safety concerns. Conclusion: This small pilot study indicates that it can be reasonable to recommend on a risk-benefit and safety perspective treatment with the dermal patch to patients with tinnitus as a consumer product based on the lack of other effective alternative treatment. Further and larger studies, and also proven experience, are recommended for stronger evidence.

Objective: The objectives of this study were to evaluate the performance and safety of an innovative passive light photon driven microscopic biomodulator patch as an alternative medical device for tinnitus relief. Materials and Methods: Eighty-two (82) patients were randomized to receive either an active (biomodulator) patch or a placebo patch, for a 3-week treatment period. Patch performance (evaluated with questionnaires related to tinnitus and quality-of-life) and safety were assessed after 3 weeks of treatment (Week 3) and at a follow-up visit 4-weeks after end of treatment (Week 7). Results: The biomodulator patch was safe and well-tolerated and was efficacious, with significant difference (p < 0.05) between the groups at Week 7; active patch had 30% responders compared to 10% for placebo, measured as a decrease from baseline in at least 2 points in tinnitus annoyance visual analogue scale (VAS, 0-10). Tinnitus handicap inventory (THI, 0-100) improved by mean -16 points significantly (p = 0.0005) for the active responder group, but with no statistically significant changes for the placebo group or between the groups. Well-being questionnaire also improved for the active responder group, but not statistically significant. The placebo responder group did not improve in well-being. Other tinnitus related symptoms did not show significant changes. There was no statistically significant difference in performance between the active (biomodulator) and placebo groups directly at the end of treatment (Week 3). Conclusion: In a cost-risk-benefit rationale according to this study it can be reasonable to recommend the biomodulator patch for treatment of tinnitus. Improvements were shown at Week 7 (4 weeks after the end of treatment period).

Taken under consideration the lack of easy-to-use alternative and the low risk profile, this patch device could highly be recommended to try for tinnitus relief as a conclusion based on the clinical studies and post market surveys. Further studies of how this bio-modulator more specific act on the auditory system, how long this may sustain and if there can be subgroups of patients or variations in the treatment time, delayed onset, number of patches, and frequency for more efficiency needs to be considered.