Quitting smoking is notoriously difficult. Nicotine physically rewires the brain's reward pathways, which is why willpower alone rarely works and why even nicotine replacement therapies have modest success rates. Without assistance, fewer than 5% of smokers maintain abstinence for 12 months.
FDA Clearance for Smoking Cessation
In August 2020, the FDA cleared Deep TMS using the BrainsWay H4 coil as an aid for short-term smoking cessation in adults. This was the first FDA clearance for any brain stimulation device targeting addiction. The treatment targets the bilateral insula and prefrontal cortex, regions heavily involved in addiction, craving, and reward processing.
How the Treatment Works
The protocol is unique. Before each TMS session, patients are exposed to smoking cues like handling a cigarette or lighter to activate the relevant neural circuits. The magnetic pulses are then delivered to those active circuits to help disrupt the addiction pathways. The standard course consists of 18 sessions over 6 weeks: daily sessions for the first 3 weeks, then weekly sessions for the following 3 weeks.
The Clinical Evidence
The pivotal multicenter, double-blind, sham-controlled trial that supported FDA clearance enrolled 262 adults who had smoked an average of more than 26 years and had failed multiple prior quit attempts. In the full intention-to-treat population, the four-week continuous quit rate was 17.1% in the active Deep TMS group versus 7.9% in the sham group. Among patients who completed the full treatment course, the continuous quit rate was 28.4% in the active group versus 11.7% in the sham group.
A 2025 Phase IV registry study of post-marketing clinical use found even stronger results in real-world settings. Among 68 chronic smokers (averaging one pack daily for 28.5 years with five prior quit attempts), 49% of those who completed the first 15 sessions achieved full smoking cessation, verified by exhaled carbon monoxide testing. The study also documented significant reductions in cigarette craving across the full group.
Realistic Expectations and Coverage
Insurance coverage for TMS smoking cessation remains limited in the US, which is the biggest barrier to access. Most patients pay out of pocket. The treatment is best suited for chronic smokers who have failed multiple prior quit attempts and are motivated to quit but have been unable to do so with traditional methods.
Find a TMS Clinic for Smoking Cessation
Not every TMS clinic offers smoking cessation treatment, since it requires the specific BrainsWay H4 coil. Search our directory and confirm with each provider that they have the H4 coil and offer this protocol before scheduling.
Sources
- Zangen A, et al. Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. World Psychiatry, 2021.
- BrainsWay. FDA Clearance for Smoking Addiction in Adults, 2020.
- Tendler A, et al. Deep TMS for Smoking Cessation: Outcomes From a Phase IV Registry Study of the H4 Coil. Transcranial Magnetic Stimulation, 2025. Link
- FDA 510(k) Clearance, BrainsWay Deep TMS System H4 Coil, August 2020.