Performance and Safety of Otinova® Ear Spray

Inclusion Criteria:

• Male or female ≥ 5 years old

• Clinical diagnosis of otitis externa based on otoscopic exam: a.Defined as a clinical score of at least 1, on a scale from 0 to 2 (none,mild/moderate, severe), for at least one of the OE signs (swelling, erythema andotorrhea)

• Ability to correctly administer Otinova as spray (not requiring tamponade), asjudged by the Investigator

• Subject agrees to refrain from water immersion of the ears during the investigation

• Subject agrees to refrain from using other ear treatment products during theinvestigation

• For pediatric patients, provision of informed consent by subject and legal -Subject,and if applicable legal representative(s), are willing to comply with the protocoland attend all investigation visits.

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.gmalignant OE, abscess, granulation, polyps, congenital disorders)

• History of malignant tumors in the external ear canal, or currently receivingchemotherapy or radiation therapy

• Known allergy or sensitivity to any component of the device

• Use of topical or systemic antibiotics, corticosteroids or other treatment thatcould 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 makeinvestigation procedures inappropriate

• Participation in another clinical investigation within 30 days of screening