Berrettini Stefano, Cuda Domenico, Minozzi Silvia, Artioli Franca, Barbieri Umberto, Borghi Cristian, Cristofari Eliana, Conte Giorgio, Cornolti Davide, di Lisi Diego, Fetoni Anna Rita, Fiori Simona, Genovese Elisabetta, Girotto Giorgia, Majorano Marinella, Marsella Pasquale, Marzetti Emanuele, Nicastri Maria, Paludetti Gaetano, Quaranta Nicola, Trevisi Patrizia, Zanetti Diego, Cinquini Michela, Forli Francesca, Ghiselli Sara
Otolaryngology Audiology and Phoniatrics Unit, Pisa University Hospital, Pisa, Italy.
Department of Otolaryngology, AUSL Piacenza, Italy.
Acta Otorhinolaryngol Ital. 2025 Feb;45(1):47-57. doi: 10.14639/0392-100X-N3081.
Cochlear implant (CI) is a well-established treatment for adults with sensorineural hearing loss and without benefit from hearing aids. The Italian guidelines date back 15 years; given the expansion of indications for CI, including single side deafness and asymmetrical hearing loss, it became necessary to establish updated guidelines.
Thirteen experts and 2 patient representatives selected the key questions and drew up recommendations. The document was developed following GRADE methodology. The methodological team of the Mario Negri Pharmacological Research Institute performed systematic reviews for each question and supported the overall process.
Five key questions were identified and recommendations formulated, with subgroups and considerations on implementation.
Though the systematic research of scientific literature found a scarcity of randomised trials and an overall poor conduct and reporting quality of primary studies and systematic reviews, strong or conditional recommendations in favour of CI have been formulated for different subgroups of patients. Further studies should enrol a larger number of participants and use consistent instruments to evaluate hearing outcomes, in order to increase the comparability of results and data pooling with meta-analysis.
人工耳蜗植入术（CI）是治疗成人感音神经性听力损失且使用助听器无效的一种成熟疗法。意大利的相关指南已有15年历史；鉴于人工耳蜗植入术的适应症不断扩大，包括单侧耳聋和不对称听力损失，有必要制定更新的指南。
13名专家和2名患者代表选定关键问题并拟定建议。该文件是按照GRADE方法制定的。马里奥·内格里药理研究所的方法学团队针对每个问题进行了系统评价，并支持了整个过程。
确定了五个关键问题并制定了建议，包括亚组以及关于实施的考虑因素。
尽管对科学文献的系统研究发现随机试验较少，且初级研究和系统评价的整体实施及报告质量较差，但已针对不同亚组患者制定了支持人工耳蜗植入术的强烈或有条件建议。进一步的研究应纳入更多参与者，并使用一致的工具来评估听力结果，以提高结果的可比性以及与荟萃分析进行数据合并的能力。
