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. |