Morton Sara, Dwyer Bob, Dwyer Noel, Holden Laura, Iannuzzi Krista, Lewis Kristen, Nelson Morgan, Brown Christine, Agrawal Smita, Stein Amy, Passmore Carla, Galster Jason, Zlomke Sarah, Firszt Jill
Austin Ear, Nose & Throat Clinic, Austin, TX.
Advanced Bionics, LLC, Valencia, CA.
Otol Neurotol Open. 2025 Jul 14;5(3):e073. doi: 10.1097/ONO.0000000000000073. eCollection 2025 Sep.
To evaluate the efficacy and safety of remote cochlear implant (CI) programming. The primary efficacy objective was to demonstrate that speech recognition in quiet after remote fitting is no worse than speech recognition in quiet after in-person office fitting. The primary safety endpoint was the absence of unanticipated adverse device effects related to remote programming.
Prospective within-subjects interventional study at 5 US centers.
17 CI recipients (12 electric-only [EO] hearing; 5 with aidable residual hearing) with a minimum of 6 months of CI experience.
Programming conducted in person and remotely via a smartphone application.
Speech recognition, fitting duration, and subjective questionnaires.
In the EO cohort, mean AzBio speech recognition for in-person created programs was 89.28% (SE = 3.48), compared with 91.94% (SE = 2.76) for programs created remotely. The combined EO and aidable residual hearing cohort's mean speech recognition for programs created in person was 89.04% (SE = 2.66) versus 90.99% (SE = 2.09) for remotely created programs. The observed value for EO and pooled cohorts was <0.001, indicating that speech recognition in quiet after remote fitting is no worse than that after in-person fitting. Absolute differences in fitting durations between programming methods ranged from 3 to 11 minutes. The total time spent for a typical CI office visit ranged from 1 to more than 4 hours for 88.3% of study participants.
Remote programming provides noninferior outcomes to in-person programming and represents an important step toward improving the accessibility and affordability of obtaining audiology services by eliminating the need to travel. Participants and audiologists rated remote programming positively.
评估远程人工耳蜗（CI）编程的疗效和安全性。主要疗效目标是证明远程调试后安静环境下的言语识别能力不低于现场办公室调试后安静环境下的言语识别能力。主要安全终点是不存在与远程编程相关的意外不良设备影响。
在美国5个中心进行的前瞻性受试者内部干预研究。
17名人工耳蜗植入者（12名单纯电刺激[EO]听力；5名有残余可助听听力），至少有6个月的人工耳蜗植入经验。
通过智能手机应用程序进行现场编程和远程编程。
言语识别、调试时间和主观问卷。
在EO队列中，现场创建的程序的平均AzBio言语识别率为89.28%（标准误=3.48），而远程创建的程序为91.94%（标准误=2.76）。EO和有残余可助听听力队列的组合中，现场创建的程序的平均言语识别率为89.04%（标准误=2.66），而远程创建的程序为90.99%（标准误=2.09）。EO和合并队列的观察值<0.001，表明远程调试后安静环境下的言语识别能力不低于现场调试后的能力。编程方法之间调试时间的绝对差异为3至11分钟。88.3%的研究参与者进行一次典型的人工耳蜗办公室就诊所花费的总时间为1至4个多小时。
远程编程与现场编程的效果相当，并且通过消除出行需求，代表了朝着提高听力服务的可及性和可承受性迈出的重要一步。参与者和听力学家对远程编程给予了积极评价。
