Sinuclean Nebules 45 for Treatment of Pediatric Exudative Otitis Media

Inclusion Criteria:

• Documented diagnosis of mono or bi-lateral exudative otitis media, performed the dayof recruitment or in the week before, with endotympanic effusion present for at least 3 months, and hearing loss.

• The diagnostic criteria is type B tympanogram for at least one of the two ears.

• The criteria is integrated by a) tonal audiometry to demonstrate bilateral ormonolateral deficit (loss of more than 20dB averaged to 0.5-1.2 and 4Khz in the bestear with pure tone audiometry); for 1-3 yo subjects the audiometry is behavioural b)otorhinolaryngologic examination in endoscopy for the otologic, rhino-sinusal andpharyngeal districts.

Exclusion Criteria:

1. Outcomes of adenotonsillectomy

2. Velo-palatal insufficiencies, cleft lip and cleft palate.

3. Hearing loss of perceptual, and mixed type.

4. Clinical conditions (systemic diseases or other) that may interfere with theevaluation of safety and clinical effectiveness of the product under investigation,for example: diabetes mellitus, heart disease, chronic renal failure, active systemicinfections)

5. Assumption, during the study of drugs that may interfere with the assessment of theproduct object of clinical investigation.

6. Possibility of needing treatment during the study with drugs that are not allowed, forexample: antibiotics in long-term prophylaxis, immunosuppressants, corticosteroids.

7. Regular intake of steroids in the four weeks preceding the date of the admissionvisit.

8. Viral or allergic rhinitis, with active effusion.

9. Down Syndrome

10. Diagnosis of immotile cilia syndrome

11. Condition of immune deficiency disease or otherwise.

12. Cystic Fibrosis.

13. Dental malocclusion

14. Other diseases of other organ systems, which, in the opinion of the investigator, mayinterfere with the purpose or the study procedures.

15. Not vaccinated subjects, with no clinical history of varicella who have been incontact, in the 4 weeks before the admission visit, with people who may be sufferingfrom chicken pox or Zoster.

16. Psychic condition incompatible with participation in the research.

17. History of intolerance or allergy to the components of Sinuclean Nebules.

18. Medical and surgical intervention that may prejudice the complete execution of thetrial, in the 4 weeks preceding the signing of informed consent.

19. Imminence of a medical-surgical procedure that can jeopardize the completion of thetrial.

20. Participation in the course to other clinical investigations, or terminated within 30days of the start of this trial.

21. Previous randomization in the study

22. Be first- or second-grade relative of a member of the Site study staff.