MED-EL Elektromedizinische Geraete Gesellschaft m.b.H., Innsbruck, Austria.
Acta Otolaryngol. 2021 Mar;141(sup1):82-105. doi: 10.1080/00016489.2021.1888496.
The cochlear implant (CI) as a treatment option for single-sided deafness (SSD) started with a clinical study looking in to the influence of cochlear implantation with a MED-EL device on incapacitating unilateral tinnitus in SSD. The study began in 2003 and was conducted by P. Van de Heyning and his team in Antwerp, Belgium. The first CI in SSD without tinnitus in Germany was implanted by J. Mueller and R. Jacob in Koblenz in 2005. Translational research activities took place since then to evaluate the CI as a treatment option for SSD not only in adults but also in children. They assessed the hearing performance of SSD patients implanted with CI, importance of long electrode arrays in SSD patients, degree of acceptance of CI by SSD children, importance of early CI implantation in SSD children in developing language skills, music enjoyment by hearing with two ears and evidence on spiral ganglion cell body distribution. In 2013, MED-EL was the first CI manufacturer to receive the CE mark for the indication of SSD and asymmetric hearing loss (AHL) in adults and children. In 2019, MED-EL was the first CI manufacturer to get its CI device approved for patients over the age of five with SSD and AHL, by the FDA in the USA. This article covers the milestones of translational research from the first concept to the widespread clinical use of CI in SSD.
人工耳蜗植入作为治疗单侧聋(SSD)的一种选择,始于一项临床研究,该研究旨在探讨 MED-EL 设备植入对 SSD 患者失能性单侧耳鸣的影响。该研究于 2003 年由比利时安特卫普的 P. Van de Heyning 及其团队开展。德国首例 SSD 无耳鸣患者的人工耳蜗植入由 J. Mueller 和 R. Jacob 于 2005 年在科布伦茨完成。此后,开展了转化研究活动,以评估人工耳蜗植入作为 SSD 治疗选择的效果,不仅在成人中,而且在儿童中。他们评估了植入人工耳蜗的 SSD 患者的听力表现、SSD 患者中长电极阵列的重要性、SSD 儿童对人工耳蜗的接受程度、SSD 儿童早期植入人工耳蜗对发展语言技能的重要性、双耳听力的音乐享受以及螺旋神经节细胞体分布的证据。2013 年,MED-EL 成为首家获得人工耳蜗治疗 SSD 和成人及儿童不对称性听力损失(AHL)CE 标志的人工耳蜗制造商。2019 年,MED-EL 成为首家获得 FDA 批准其人工耳蜗设备用于 5 岁以上 SSD 和 AHL 患者的人工耳蜗制造商。本文涵盖了从最初概念到人工耳蜗在 SSD 中广泛临床应用的转化研究里程碑。