MED-EL Elektromedizinische Geraete Gesellschaft m.b.H., Innsbruck, Austria.
Acta Otolaryngol. 2021 Mar;141(sup1):63-81. doi: 10.1080/00016489.2021.1888486.
The Auditory Brainstem Implant (ABI) is based on the classic cochlear implant (CI) but uses a different stimulation electrode. At MED-EL, the early development activities on ABI started in the year 1994, with the suggestion coming from J. Helms and J. Müller from Würzburg, Germany in collaboration with the Univ. of Innsbruck Austria. The first ABI surgery in a neuro-fibromatosis (NF2) patient with the MED-EL device took place in the year 1997. Later, the indication of ABI was expanded to non-NF2 patients with severe inner-ear malformation, for whom a regular CI will not be beneficial. Key translational research activities at MED-EL in collaboration with numerous clinics investigating the factors that affect the hearing performance amongst ABI patients, importance of early ABI implantation in children, tools in pre-operative assessment of ABI candidates and new concepts that were pursued with the MED-EL ABI device. The CE-mark for the MED-EL ABI to be used in adults and children down to the age of 12 months without NF-2 was granted in 2017 mainly based on two long-term clinical studies in the pediatric population. This article covers the milestones of translational research from the first concept to the widespread clinical use of ABI in association with MED-EL.
听觉脑干植入体（ABI）基于经典的人工耳蜗植入体（CI），但使用不同的刺激电极。在 MED-EL，ABI 的早期开发活动始于 1994 年，德国维尔茨堡的 J. Helms 和 J. Müller 提出了这一建议，他们与奥地利因斯布鲁克大学合作。1997 年，在一名神经纤维瘤病（NF2）患者中进行了首例使用 MED-EL 设备的 ABI 手术。后来，ABI 的适应症扩大到了内耳畸形严重的非 NF2 患者，对于这些患者，常规的 CI 不会带来益处。在 MED-EL 与众多诊所合作进行的关键转化研究活动中，研究了影响 ABI 患者听力表现的因素、儿童早期 ABI 植入的重要性、ABI 候选者术前评估的工具以及使用 MED-EL ABI 设备探索的新概念。2017 年，基于儿科人群中的两项长期临床研究，为 MED-EL 的 ABI 颁发了用于成人和 12 个月以下儿童（不包括 NF-2）的 CE 标志，主要用于该设备的广泛临床应用。本文涵盖了从最初概念到 MED-EL 广泛应用 ABI 的转化研究的里程碑。
