07 · The First Brain-Stim Addiction Clearance

Short-Term Smoking Cessation

For adults who have failed at least one quit attempt.

H4BrainsWay coil
(BrainsWay H4, 2020 — first TMS system cleared for any addiction)Clearance

In 2020, BrainsWay's H4 coil became the first brain-stimulation device cleared by the FDA for any addiction. The coil targets bilateral lateral prefrontal cortex and insula — the circuits that drive craving and habitual use. Treatment is delivered alongside brief smoking-cue exposure to engage the relevant network.

Coverage by health insurance for this indication is more variable than for depression, but the protocol is short — three to six weeks — making cash-pay an option for many patients.

FDA status

FDA-cleared (BrainsWay H4, 2020 — first TMS system cleared for any addiction)

Standard protocol at IPMG TMS

3 weeks of daily sessions + follow-up · H4, 10 Hz, with brief cue exposure

  • 28% vs 12% (4-week continuous quit rate)
    Pivotal multisite RCT, 262 chronic smokers with at least one prior failed quit.
    Zangen et al., World Psychiatry 2021
Eligibility

Who this is for.

  • Adults who smoke and have failed ≥1 quit attempt
  • Patients seeking a non-pharmacologic adjunct to behavioral support

Eligibility is finalized at consultation. We screen carefully for contraindications — see the Safety page.

Talk with the IPMG TMS team.

A consultation is the right next step. We will review your prior treatments, confirm whether you meet the FDA-cleared criteria for this indication, and walk you through what your insurance covers.