Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SafKan
This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator.
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Total duration of subject participation will be 1 day with a follow up call within 2-4 days after the procedure. Total duration of the study is expected to be 3 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Mild (1), Moderate (2), or Complete (3) occlusion of the ear canal based on the Degree of Occlusion Scale in one or both ears
Informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
You may not be if
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data