Authors: Ruijie Wang¹; Lei Xu¹; Tianyi Liu²; Shanxian Gao²; Li Yin²
¹Shandong Provincial Second People’s Hospital; ²Zhejiang Nurotron Biotechnology co., ltd
Background: To evaluate the effectiveness of remote programming for domestic cochlear implant (CI) systems and provide clinical trial evidence to promote remote hearing rehabilitation services.
Method: Twelve subjects implanted with the domestic Nurotron cochlear implant who had been using the device for more than six months (average age 45.58 ± 10.85 years) were enrolled. Each participant underwent one online remote programming session and one in-person traditional programming session in random order. The clinical efficacy of remote programming was assessed using aided hearing thresholds, speech recognition rates, and subjective questionnaires. A non-inferiority test was applied to analyse the difference in outcomes between remote and traditional programming.
Results: The aided hearing thresholds across all frequencies and the speech recognition rates in quiet environments met the predefined non-inferiority margins (Δ = 4/5 dB or 5%). Subjective questionnaire scores indicated good user acceptance, demonstrating that remote programming was non-inferior to traditional programming in both objective and subjective evaluations.
Conclusion: Online remote programming of domestic cochlear implants demonstrated comparable effectiveness to conventional in-person programming for hearing improvement and speech recognition, exhibiting good feasibility and clinical utility. The remote programming function has the potential to enhance the rehabilitation experience for CI users, particularly benefiting those in medically underserved areas or with limited mobility.
