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

  • Erin McCulloch ORCID logo EMAIL logo , Sai Sailesh Kumar Goothy ORCID logo and Jason McKeown ORCID logo
Published/Copyright: March 14, 2022

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.


Corresponding author: Erin McCulloch, Neurovalens Ltd., Belfast, UK, E-mail:

  1. Research funding: None declared.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Erin McCulloch completed this research project as part of her university placement at Neurovalens. Dr Jason McKeown is co-founder and CEO of Neurovalens.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: This project was carried out as a post marketing follow-up study and did not require ethical committee approval as per the guidance developed by the UK Medical Research Council (MRC) Regulatory Support Centre and the UK Health Research Authority (HRA).

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Received: 2021-12-22
Accepted: 2022-02-02
Published Online: 2022-03-14

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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