Hypothermia as a potential therapeutic approach to reduce the risk of hearing loss and the need for a hypothermal device to investigate this question in a clinical study

The permanent bilateral hearing loss caused by ototoxic therapies is still an unsolved medical and socio-economic problem with a large impact on society and, of course, on private life and work productivity. Patients who receive a high dosed cisplatin regimen have at least a 50% risk of hearing loss. Most of the severe side-effects are under control nowadays but ototoxicity is still a major problem and even leads to discontinuation of anticancer therapy sometimes. The goal of a hypothermal approach will be a reduced cisplatin uptake in the inner ear and a reduction of cisplatin associated hearing loss. The efficacy of hypothermia was already shown in animal studies, but until now no clinical study has been carried out because the concept of hypothermia application to the inner ear is quite new and there are some problems in applying hypothermia to the inner ear of living human subjects. However, the current project overcomes these problems with the innovation of a custom-made channeled ear mold which will be connected to a cooling water circulation. The design has to address the following requirements: a very close contact to the ear canal and eardrum will be crucial towards an effective heat absorption, possible cooling duration of at least 1 hour, comfortable fit and must not harm the eardrum or the skin of the ear canal, and the production material has to be biocompatible. We present a prototype made of 3D printing of biocompatible flexible silicone. This prototype could be used for clinical studies to investigate the effect of hypothermia to reduce the risk of hearing loss during ototoxic therapies.

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Artikel online veröffentlicht:
10. Juni 2020