Primary Objective The primary objective will be a decrease of inconvenience with at least 10% for at least 50% of the subjects.
The secondary objective will be to:
To evaluate if the patch can improve the tinnitus patient's quality of life and sleep quality.
An open safety and performance clinical investigation of the antinitus patch in patients with manifested tinnitus.
1 patch per day for 3 weeks
Tinnitus severity questionnaire (TSQ)
Tinnitus severity questionnaire (TSQ) and numerical rating scale (NRS) measuring tinnitus annoyance.
Quality of life and sleep quality
Safety Parameters: Adverse Reactions
Estimated Enrollment: 16
Study Start Date: October 2010
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (Aktin)
Investigation of the antinitus patch in patients with manifested tinnitus.