Neurovalens Ltd., Belfast, UK.
Department of Physiology, RD Gardi Medical College, Ujjain, India.
J Basic Clin Physiol Pharmacol. 2022 Mar 14;33(5):645-648. doi: 10.1515/jbcpp-2021-0395. eCollection 2022 Sep 1.
This retrospective, open-label study was undertaken to assess the safety of repeated, long-term electrical vestibular nerve stimulation (VeNS). The primary outcome for this study was assessment of hearing function as reported by formal audiometry testing.
Assessments were conducted on n=25 long-term users of daily 1.5 mA VeNS. Skin inspection of the mastoid area, otoscope examination of the inner ear, and formal audiometry testing was conducted on n=18 users. All participants completed a survey-based assessment to determine usage of the device, adverse events, and long-term outcomes.
Mean duration of use was 22 months, with approximately 80% of users reporting 1 h of daily, or 1 h of regular (2-3 times per week) VeNS usage. No adverse events were reported. There were no significant findings during examination of the mastoid areas, ear canal, or tympanic membranes. There were no significant findings reported from the formal audiogram assessments.
This appears to be the first study to provide formal assessment to show that repeated, long-term VeNS usage has not generated any significant side effects or adverse events. Results from this study further support previous literature that electrical vestibular stimulation is both safe and well-tolerated.
本回顾性、开放性研究旨在评估重复、长期电前庭神经刺激（VeNS）的安全性。本研究的主要结局是通过正式听力测试评估听力功能。
对 25 名长期使用每日 1.5mA VeNS 的患者进行评估。对 18 名患者进行了乳突区域皮肤检查、内耳耳镜检查和正式听力测试。所有参与者都完成了一项基于调查的评估，以确定设备的使用情况、不良事件和长期结果。
平均使用时间为 22 个月，约 80%的患者报告每天使用 1 小时，或每天使用 1 小时（每周 2-3 次）的常规 VeNS。未报告不良事件。在检查乳突区域、耳道或鼓膜时未发现明显异常。正式听力图评估也未发现明显异常。
这似乎是第一项提供正式评估的研究，表明重复、长期使用 VeNS 并未产生任何显著的副作用或不良事件。本研究的结果进一步支持了先前的文献，即电前庭刺激既安全又耐受良好。
