Surgical Reduction of the Inferior Turbinates for Nasal Obstruction

Inclusion Criteria:

1. Patient is >=6 and <=17 years old.

2. Patient has had symptoms of nasal obstruction for >=6 months.

3. Patient has nasal obstruction symptoms unresponsive to at least 8 weeks of documentedmaximum medical management (as described in Section 4.1).

4. Patient has bilateral hypertrophied inferior turbinates without other abnormalitiescontributing to nasal obstruction (by nasal evaluation and examination).

5. Patient and parent /guardian agree to participate in the clinical study and tocomplete all required visits and evaluations.

6. Patient (or guardian) must sign IRB approved informed consent form.

Exclusion Criteria:

1. Patient has clinically significant identifiable structural deformities other thanturbinate hypertrophy that may contribute to nasal or upper airway obstructionincluding:

2. Septal deviation

3. Concha bullosa

4. Enlarged adenoids or tonsils (lingual, palatine, or sphenoid)

5. Nasal polyps

6. Nasal valve collapse.

7. Patient has been diagnosed with obstructive sleep apnea not originating from theturbinates.

8. Patient has active or chronic upper airway infection that may contribute to nasalobstruction (not including chronic rhinosinusitis).

9. Patient has active coagulation disorder or patient is receiving anti-coagulants, whichcannot be safely stopped for 14 days (7 days prior to surgery and 7 dayspost-surgery).

10. Patient has systemic disease affecting the nasal passage(e.g. Wegener'sgranulomatosis).

11. Patient is receiving or has received immunotherapy (any type) within 12 months ofenrollment.

12. Patient has a nasal septal perforation.

13. Patient has had any previous turbinate surgery.

14. Patient has had any previous nasal surgery.

15. Patient has had any sinus surgery within 6 months of enrollment.

16. Patient has had an adenoidectomy within 3 months of enrollment.

17. Patient is pregnant or potentially pregnant.

18. Patient or caregiver is incapable of understanding or responding to the studyquestionnaires.

19. Patient is participating in another clinical study during the 12 month enrollmentperiod.