Clinical trial investigating the effect of antioxidatives and magnesium on residual hearing preservation in cochlea-implant-patientsThis study was funded by the EU as part of the FP7 project “ProHearing”.
18. April 2018 (online)
Studies have shown that a particular combination of vitamins A, C and E as well as magnesium (together: ACEMg) can protect the residual hearing. The potential protective effect of ACEMg on residual hearing preservation in cochlear implanted patients was investigated.
CI patients were treated with ACEMg tablets or placebo 2 days preoperatively and up to 3 months postoperatively. The study objective was to compare the hearing loss at 500 Hz 3 months after first fitting between the two treatment groups.
51 patients were included in the study. Of these, n = 2 were supplied with a Flex16, n = 5 with a Flex 20, n = 10 with a Flex 24 and n = 32 with a Flex 28 from MED-El Elektronische Geräte GmbH. In the intention-to-treat population, 25 patients were treated with ACEMg and 24 patients with placebo. In this group the mean hearing loss at 500 Hz was 30.21 dB (placebo) or 26.00 dB (ACEMg) 3 months after initial fitting, difference: 4.21 dB. In the per-protocol population, a difference of 5.53 dB was achieved, with a mean hearing loss in the ACEMg group of 23.64 dB (n = 11) and 29.17 dB in the placebo group (n = 12). Adjusting the postoperative hearing loss to electrode length and surgeon results in 8.01dB decreased hearing loss in ACEMg-treated patients compared to placebo-treated ones.
Perioperative oral administration of ACEMg tends to protect residual hearing in CI patients. It has to be examined which factors influence the patients' reaction onto the therapy in order to achieve the positive effect in all patients.