Taipei: Taiwan's Industrial Technology Research Institute (ITRI) has announced the development of a groundbreaking noninvasive in-ear vagus nerve stimulator, marking the country's first digital therapeutic technology designed for generalized anxiety disorder (GAD). The innovative device aims to offer a nonpharmacological treatment option for individuals suffering from anxiety, with plans to launch it into practical use within the next three to five years, as revealed by ITRI project manager Hu Chang-lin in an interview with CNA.
According to Focus Taiwan, the stimulator functions by activating the parasympathetic nervous system through vagus nerve stimulation via the ear, which is associated with inducing relaxation. In addition, the wearable device is equipped to monitor physiological signals such as heart rate variability (HRV) and photoplethysmography (PPG), leveraging this data to fine-tune stimulation parameters. The system integrates with a digital therapeutics app, enabling users to track their stress levels and treatment progress. The information is also uploaded to the cloud for analysis, providing doctors with valuable insights into patients' conditions.
Research by the Ministry of Health and Welfare, as cited by ITRI, indicates that approximately one in four individuals in Taiwan experiences psychological distress. With over 2 million people having sought medical treatment for mental health conditions, only a small fraction-about 1-7 percent-have received psychological therapy covered by the National Health Insurance program. While medication remains the predominant treatment method, it often comes with concerns over side effects and challenges in drug tolerance. Furthermore, the stigma surrounding mental illness deters some from seeking treatment.
Hu emphasized that the ITRI technology is not intended to replace existing therapies but rather serve as a supplementary treatment option. It could be initially used alongside medication, potentially reducing patients' dependency on pharmaceutical solutions. While noninvasive transcutaneous auricular vagus nerve stimulation (taVNS) has been explored internationally, many existing products lack real-time physiological monitoring, a feature that ITRI's device seeks to address.
The device has passed electrical safety and biocompatibility testing and is currently in the application process for clinical trials. Hu noted that ITRI anticipates the regulatory review to extend up to 1.5 years. The institute also aims to make the technology accessible for home healthcare, with a target price comparable to a home blood pressure monitor. Plans are underway to collaborate with medical and wearable device companies to commercialize the product following clinical validation.