Food supplement induced residual hearing preservation in partial insertion -cochlear implantation (FIPPI-CI)

Introduction With the introduction of partial insertion at our clinic, the hearing of patients with good low-frequency residual hearing can be well preserved. However, some patients continue to lose their residual hearing as it is observed in classical cochlear implantation. During times of environmental stress, reactive oxygen species levels can increase dramatically due to increase of metabolic rate and decrease of cochlear blood flow. This can result in significant damage to cells. Antioxidant systems may either prevent these reactive species from being formed, or remove them before they can damage vital components of the cell, and thus protect the remaining hearing.Objective In this double blind randomized placebo-controlled clinical trial the effect of antioxidant, a specific combination of vitamins β-carotene (converted in the body to vitamin A), ascorbic acid (vitamin C), trolox (vitamin E) and the vasodilator magnesium (Mg), together named ACEMg, is investigated regarding its effect on residual hearing.Methods Patients with residual hearing in the low frequencies take the oral supplement twice a day for a period 105 days, starting one-day prior cochlea implantation. Our primary objective is to compare the residual hearing preservation 3 months after initial fitting, compared to the preoperative residual hearing in the low frequencies, between the ACEMg treated and a placebo group.Results As this is a double blind study and recruitment is ongoing, we do not know at this time which patients have received the ACEMg combination and which have received the placebo and can therefore present analysis on the residual hearing but not on the ACEMg effects. A first interim analysis shows good residual hearing at all insertion depths.

Publication History

Article published online:
24 May 2022