OBJECTIVES:
Primary Objective The primary objective will be a decrease of inconvenience with at least 10% for at least 50% of the subjects.
Secondary Objectives
The secondary objective will be to:
To evaluate if the patch can improve the tinnitus patient's quality of life and sleep quality.
METHODOLOGY:
Study Design:
An open safety and performance clinical investigation of the antinitus patch in patients with manifested tinnitus.
Treatment Duration:
1 patch per day for 3 weeks
Primary Endpoint:
Tinnitus severity questionnaire (TSQ)
Performance Parameters:
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)
Primary Objective The primary objective will be a decrease of inconvenience with at least 10% for at least 50% of the subjects.
Secondary Objectives
The secondary objective will be to:
To evaluate if the patch can improve the tinnitus patient's quality of life and sleep quality.
METHODOLOGY:
Study Design:
An open safety and performance clinical investigation of the antinitus patch in patients with manifested tinnitus.
Treatment Duration:
1 patch per day for 3 weeks
Primary Endpoint:
Tinnitus severity questionnaire (TSQ)
Performance Parameters:
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)