FDA Clearances of Auricular, Cranial and Other Forms of Neuromodulation

FDA Clearances of Auricular, Cranial and Other Forms of Neuromodulation

Rapid growth in Neuro-auricular Modulation:

The recent FDA clearance of a wearable transcutaneous auricular nerve field stimulator (tAN) as developed by Spark Biomedical in Dallas, Texas, and featured in Practical Neurology, is one example of the investment by Pharma and Tech based on the increasing interest in neuro-auricular modulation research. The device, and similar devices like it, stimulate nerves on and around the ear.

The microsystem of the ear has been used for millennia in the field of ear acupuncture, and for decades in the fields of Auriculotherapy and Auricular Medicine. The ear is recognized as a window to the brain.[1] The unique innervation of the ear by the major nerve branches of the body, including cranial nerves, offer the anatomo-physiological basis — as recognized by the World Health Organization[2] — for the treatment of mind and body via the ear. The neuroscience underlying and validating these treatments is continuing to catch up and is rapidly growing as evidenced by recent growth in neuro-auricular modulation related research and conferences such as the 2020 taVNS Conference by the Medical University of South Carolina.[3-14] 

Are Healthcare Professionals Keeping Pace?

Unfortunately, many clinicians, therapists and other healthcare and wellness professionals have been too busy in their practices to keep pace with the auricular insights now being advanced by neuroscience — as biomedical devices become just another competitive force on private practice. And, patients often do not understand the distinctions between the treatment outcomes promised by a biomedical device, a drug, or integrative therapy offered by a therapist or healthcare practitioner.

The coming shift in healthcare toward bioelectronic medicine points to the importance in ongoing continuing education. Especially training in neuro-auricular modulation, a field of neuroscience that is now validating the direct application of Auricular Methods (and Auricular Medicine) across all aspects of healthcare (including biomedicine, psychology, manual therapy, acupuncture, chiropractic, and many other related fields of practice).


CIAM | Editor’s Note: Training in neuro-auricular modulation, as used in the fields of neuroscience and Auricular Medicine, has been offered by the Canadian Institute of Auricular Medicine (CIAM) since 2003 — to all healthcare professionals not just physicians and acupuncturists. 



[1] Agnes, Muriel. Auricular Medicine: Window to the Brain. Blurb, 2018

[2] Shang, C. Mechanism of Acupuncture - Beyond Neurohumoral Theory. Medical Acupuncture Journal. 2000; 11(2), 61-70.

[3] Mercante B, Deriu F, Rangon CM. Auricular Neuromodulation: The Emerging Concept beyond the Stimulation of Vagus and Trigeminal Nerves. Medicines (Basel). 2018;5(1):10. Published 2018 Jan 21. doi:10.3390/medicines5010010

[4] Shiozawa P, Silva ME, Carvalho TC, et al. Transcutaneous vagus and trigeminal nerve stimulation for neuropsychiatric disorders: a systematic review. Arq Neuropsiquiatr. 2014; 72: 542-7.

[5] Kong J, Fang J, Park J, et al. Treating Depression with Transcutaneous Auricular Vagus Nerve Stimulation: State of the Art and Future Perspectives. Front Psychiatry. 2018; 9: 20.

[6] Fang J, Rong P, Hong Y, Fan Y, Liu J, Wang H, Zhang G, Chen X, Shi S, Wang L, Liu R, Hwang J, Li Z, Tao J, Wang Y, Zhu B, Kong J. Transcutaneous Vagus Nerve Stimulation Modulates Default Mode Network in Major Depressive Disorder. Biological Psychiatry. 2016 Feb 15;79(4):266-73.

[7] Kurebayashi LF, Turrini RN, Souza TP, Marques CF, Rodrigues RT, Charlesworth K. Auriculotherapy to reduce anxiety and pain in nursing professionals: a randomized clinical trial. Rev Lat Am Enfermagem. 2017;25:e2843. Published 2017 Apr 6. doi:10.1590/1518-8345.1761.2843

[8] Stanton G. Auriculotherapy in Neurology as an Evidence-Based Medicine: A Brief Overview. Med Acupunct. 2018;30(3):130–132.

[9] Alimi D. Medical Auriculotherapy: Scientific Bases, Principals and Therapeutic Strategies.[in French]. Paris: Elsevier–Masson; 2017

[10] Badran B, Dowdle L, Mithoefer O, Austelle C, McTeague L, George M. Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Brain Stimulation. 2017; 11(3):492-500. DOI: https://doi.org/10.1016/j.brs.2017.12.009

[11] Hays SA. Enhancing Rehabilitative Therapies with Vagus Nerve Stimulation. Neurotherapeutics. 2016;13(2):382-394. doi:10.1007/s13311-015-0417-z

[12] Reuben, C. (2005). Acupuncture & auriculotherapy: Valuable natural treatment modalities for addiction. Townsend Letter for Doctors and Patients, 269(81), 84.

[13] Carter, K. O., Olshan-Perlmutter, M., Norton, H. J., & Smith, M. O. (2011). NADA acupuncture prospective trial in patients with substance use disorders and seven common health symptoms. Medical Acupuncture,23(3), 139-135.

[14] McLeod M. Advanced taVNS Conference Archived Presentations: Advanced Transcutaneous Auricular Vagus Nerve Stimulation. College of Health Professions website of the Medical of South Carolina. March 2020. Accessed November 10, 2021. https://chp.musc.edu/research/nc-nm4r/learning-opportunities/past-events-and-archives/tavns-video-archive



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