Vagus nerve stimulation (VNS) devices have gained widespread acceptance for treatment of resistant epilepsy and depression.

The increasing number of procedures has resulted in an increasing number of iatrogenic injuries to the vagus nerve, which can have a significant effect on vocalization and quality of life.

We determined the relative frequency of laryngeal adverse effects reported to the US Food and Drug Administration (FDA) after VNS implantation and to analyze associated VNS device problems.

This retrospective cross-sectional analysis queried the FDA Manufacturer and User Facility Device Experience database of adverse events in the US between 1996 and 2020.