Performance and Safety of Otinova® Ear Spray

Exclusion Criteria

• •Duration of OE signs/symptoms longer than 6 weeks
• •Suspected perforated eardrum or eardrum fitted with drainage tube
• •Post-mastoid surgery
• •Prior otologic surgery within 6 months of enrollment (must be successfully healed)
• •Conditions which may make it difficult to evaluate the therapeutic response (e.g malignant OE, abscess, granulation, polyps, congenital disorders)
• •History of malignant tumors in the external ear canal, or currently receiving chemotherapy or radiation therapy
• •Known allergy or sensitivity to any component of the device
• •Use of topical or systemic antibiotics, corticosteroids or other treatment that could affect the study result within 7 days prior to enrolment
• •Pregnancy or lactation at time of enrolment
• •Subjects with any other condition that, as judged by the investigator, may make investigation procedures inappropriate
• •Participation in another clinical investigation within 30 days of screening