TABLE 4.
Change in middle ear function assessments from baseline to 6-week in randomized participants with abnormal baseline assessments
| Status | Balloon Dilation | Control | Between Arm P Value |
| Tympanic membrane position | |||
| Improved | 66.7% (10/15) | 0.0% (0/12) | <0.001a |
| Not improved | 33.3% (5/15) | 100% (12/12) | |
| Within arm p valueb | 0.002 | – | |
| Valsalva maneuver | |||
| Improved | 47.1% (8/17) | 14.3% (2/14) | 0.068a |
| Not improved | 52.9% (9/17) | 85.7% (12/14) | |
| Within arm p valueb | 0.005 | 0.157 | |
| Tympanogram type | |||
| Improved | 57.1% (8/14) | 10.0% (1/10) | 0.006c |
| No change | 42.9% (6/14) | 60.0% (6/10) | |
| Worsened | 0.0% (0/14) | 30.0% (3/10) | |
| Within arm p valued | 0.008 | 0.625 | |
Results are presented as % (n/N). Tympanic membrane position improvement is defined as a change from retracted at baseline to normal at follow-up; N is participant. Valsalva maneuver improvement is defined as a change from a negative to a positive result; N is participant. Tympanogram type improvement is defined as a change from type B at baseline to type A or C at follow-up, or a Type C at baseline to a type A at follow-up; N is Eustachian tube.
aP values are based on the two-sided, two-sample Fisher's exact test for the difference between randomized arms at 6-week follow-up.
bP values are based on the two-sided, paired sample McNemar's test for the difference within each randomized arm.
cP value is based on the CMH χ2 test (row mean scores) for differences between randomized arms.
dP values are based on the Wilcoxon signed-rank test for differences within each randomized arm.