Electrical vestibular nerve stimulation (VeNS): a follow-up safety assessment of long-term usage

Author:

McCulloch Erin1ORCID,Kumar Goothy Sai Sailesh2ORCID,McKeown Jason134ORCID

Affiliation:

1. Neurovalens Ltd. , Belfast , UK

2. Department of Physiology , RD Gardi Medical College , Ujjain , India

3. Wellcome-Wolfson Institute for Experimental Medicine, Queen’s University , Belfast , UK

4. Center for Brain and Cognition , UC San Diego , San Diego , USA

Abstract

Abstract Objectives 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. Methods 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. Results 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. Conclusions 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.

Publisher

Walter de Gruyter GmbH

Subject

Drug Discovery,Pharmacology,General Medicine,Physiology

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