Barbara Maurizio, Filippi Chiara, Tarentini Silvia, Covelli Edoardo, Monini Simonetta
ENT Clinic, NESMOS Department, University Hospital Sant'Andrea, Sapienza, Rome.
Acta Otolaryngol. 2020 Mar;140(3):236-241. doi: 10.1080/00016489.2020.1714076. Epub 2020 Jan 31.
Severe-to-profound sensorineural hearing loss (spSNHL) is mostly relying on the use of a cochlear implant (CI). The present study reports on the auditory outcome from a group of subjects affected by spSNHL who received an AMEI application. Nine out of 43 subjects who received a fully-implantable AMEI were initially candidated as off-label (primary off-label group or POLG). Twelve subjects showed over time a decrease in bone conduction threshold (BCT) in the operated ear (Secondary Off-Label Group or SOLG): SOLGa with no detectable BCT (9 subjects), SOLGb with residual low-frequency BCT (3 subjects). The auditory assessment included pure tone audiometry and speech audiometry in quiet and noise. A significant PTA5 difference was found at activation in SOLGb group and at the last fitting in SOLGa Group in respect to the label control group. No significant difference was found between POLG group and control group. Speech audiometry in noise revealed a significant lower gain in all three groups in comparison to the control group. The adoption of an AMEI in unconventional indications could be beneficial also for subjects with spSNHL, although this solution can in some cases only be transient before performing CI surgery.
重度至极重度感音神经性听力损失（spSNHL）主要依靠使用人工耳蜗（CI）。本研究报告了一组受spSNHL影响且接受AMEI应用的受试者的听觉结果。43名接受完全植入式AMEI的受试者中有9名最初被确定为使用未获批准的医疗器械（原发性未获批准的医疗器械组或POLG）。随着时间的推移，12名受试者患侧耳的骨导阈值（BCT）下降（继发性未获批准的医疗器械组或SOLG）：SOLGa组无可检测到的BCT（9名受试者），SOLGb组有残余低频BCT（3名受试者）。听觉评估包括纯音听力测定以及安静和噪声环境下的言语听力测定。在SOLGb组激活时以及SOLGa组最后一次调试时，与标签对照组相比，发现PTA5有显著差异。POLG组和对照组之间未发现显著差异。噪声环境下的言语听力测定显示，与对照组相比，所有三组的增益均显著较低。在非常规适应症中采用AMEI对spSNHL患者也可能有益，尽管在某些情况下，这种解决方案在进行CI手术之前可能只是暂时的。
