Performance and Safety of Otinova® Ear Spray

A Prospective, Post-Market Clinical Follow-up Investigation to Verify Performance and Safety of Otinova® Ear Spray When Used in the Treatment of External Otitis Symptoms

The purpose of this study is to assess the performance and safety of Otinova® Ear Spray when used in the treatment of external otitis symptoms.

After being informed about the study and potential risks, all patients giving written informed consent will receive treatment with Otinova® Ear Spray for 7 days, twice daily.

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 and otorrhea)

• Ability to correctly administer Otinova as spray (not requiring tamponade), as judged 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 the investigation

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