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Table 1 Overall clinical score

From: Evaluation of the safety and efficacy of a novel product for the removal of impacted human cerumen

1

<3%

Normal - Normal and/or insignificant earwax present in ear canal. Tympanic membrane completely visible.

2

3 – 25%

Minimal - Very little and mostly insignificant impacted cerumen that is not likely to have an effect on normal activities or cause any otologic or non-otologic symptoms; cerumen closer to the 25% impaction level may lead to increased impaction. Tympanic membrane (TM) is visible but still some minor presence of earwax.

3

26 – 50%

Mild - Some excessive impacted cerumen causing partial occlusion of the ear canal usually causing some minor to major otological and/or non-otological symptoms at the 30-50% level. TM partially visible, but somewhat difficult to see.

4

51 – 75%

Moderate - Moderate and excessive impacted cerumen causing partial occlusion of the ear canal causing major to serious complications in otological symptoms and in some cases, serious non-otological symptoms. Partial to very little of the TM visible.

5

76 – 100%

Severe - Severe and excessive impacted cerumen causing partial or complete occlusion of the ear canal; these subjects may have significant qualify of life issues with the complications from the otological and non-otological symptoms. Little if any of the TM is visible.