Treatment comparison

tDCS vs TMS for depression: the Flow headset or clinic TMS?

The FDA approved the Flow FL-100 home headset on December 8, 2025. US prescriptions began September 1, 2026. It is tDCS, not TMS.

FDA indication, verbatim: “FL-100 is intended for the treatment of moderate to severe major depressive disorder in the current episode, either as monotherapy or as an adjunctive treatment, in patients 18 years and older who are not considered treatment refractory to medication.”

Match the options to your history Review care-finding resources

The short answer

tDCS and TMS are different technologies. The Flow FL-100 sends a weak, steady current through two forehead pads at home. TMS uses a magnetic coil in a clinic.
The FL-100 is FDA-approved, not just cleared. Premarket approval (PMA P230024) came on December 8, 2025, and US prescriptions began September 1, 2026.
Its label excludes people “considered treatment refractory to medication.” The trial behind it left out anyone whose depression had failed two or more antidepressants.
In that trial, 57.5% reached remission on active treatment versus 29.4% on sham, by the MADRS scale at 10 weeks. The FDA still called the benefit modest.
Flow lists $2,200 for the first 10 weeks and $325 per 4-week refill. It is HSA and FSA eligible, but not in-network with insurers.
If several antidepressants have already failed, the options built for that history include clinic TMS, the SAINT protocol, and SPRAVATO. Ask a clinician which fits.

Side by side

Flow FL-100 vs clinic TMS, question by question

On a smaller screen, scroll the table sideways to see both columns.

Question	Flow FL-100 (tDCS, at home)	TMS (in a clinic)
What it is	A prescription tDCS headset. Two saline-soaked pads on the forehead pass a weak, steady 2 mA current.	A magnetic coil held against the head sends brief, rapid pulses that stimulate nerve cells in a targeted area.
FDA status	Approved December 8, 2025 through premarket approval, PMA P230024. The approval covers this device only.	The first depression device was cleared in 2008. Each system has its own clearance, such as NeuroStar or the SAINT system (September 1, 2022).
Who the label covers	Adults 18 and older with moderate to severe major depressive disorder in the current episode who are “not considered treatment refractory to medication.”	NeuroStar: adults with major depressive disorder who did not get satisfactory improvement from prior antidepressant medication in the current episode.
Who the pivotal trials enrolled	Adults with a current episode. Anyone with an inadequate response to two or more antidepressant trials was excluded.	Adults who had not benefited from earlier antidepressant treatment, off antidepressants during the trials.
Where it happens	At home, guided by a phone app. A clinician prescribes it and can review usage and weekly symptom scores.	In a clinic, office, or hospital, delivered by clinic staff under a physician’s prescription.
Schedule	30-minute sessions, 5 a week for 3 weeks, then up to 3 a week. The app allows one session a day.	Weekday sessions for 4 to 6 weeks, each 3 to 40 minutes by protocol. Accelerated protocols fit many sessions into about a week.
Common side effects	Skin redness, itching, burning or tingling under the pads, and headache.	Discomfort where the coil sits, scalp or face muscle twitching, mild headache, and lightheadedness.
Serious risk to know	Skin burns were reported when dried-out pads were used.	Seizure is rare: under 1 in 1,000 patients in NeuroStar labeling.
Label says do not use	Open wounds or damaged skin at the pad site, or metallic skull reconstruction at the pad site.	NeuroStar: conductive or magnetic-sensitive metal implanted in the head within 30 cm of the coil.
What you pay	$2,200 for the first prescription and $325 for each 4-week refill, per Flow. Not in-network with insurers.	Billed per session, often as a 36-session course. Plans set their own criteria and prior authorization.

TMS details come from NIMH, NeuroStar labeling, and the SAINT clearance. Other TMS systems have their own labels. Flow prices are as posted on Flow’s US help center (updated September 1, 2026) and were checked September 22, 2026.

FDA status

What the FDA approved, and what the approval does not cover

The FDA approved the Flow FL-100, a tDCS headset, for depression. It went through premarket approval, the pathway for Class III devices. The decision date was December 8, 2025.

Some pages that rank for this comparison still say tDCS is not FDA-approved for any use. For this one device, that statement has been out of date since December 2025.

Device:Flow FL-100, made by Flow Neuroscience AB of Malmö, Sweden. FDA product code JXK.
Prescription only: the approval order restricts sale and distribution to prescription use.
US availability: Flow announced its US launch for September 1, 2026. Patients get a prescription from their own clinician or through Flow Care, a telehealth service staffed by independent licensed clinicians.
Age: 18 and older. The approval does not include anyone under 18.
Use: alone or added to an antidepressant, for a current episode of moderate to severe major depressive disorder.

The phrase that matters most: “not considered treatment refractory”

The indication does not define the phrase. The trial behind it did. EMPOWER excluded anyone with an inadequate response to two or more antidepressant trials at an adequate dose and duration.

It also excluded people who had ever had ECT, TMS, or another brain stimulation treatment. It excluded anyone who had taken ketamine or esketamine for depression, or had been hospitalized for depression.

The FDA said so directly. Excluding people with two or more failed antidepressants limits “the evidence for use of the FL-100 in a more treatment resistant population.”

What the FDA flagged as uncertain

The FDA described “a moderate level of uncertainty of benefit.” It named three reasons: unblinding, no pre-set threshold for a meaningful change, and conflicting results in other studies.
On the main scale, active treatment beat sham by 2.3 points. The FDA wrote that the clinical meaning of that gap “has not been established.”
Its benefit-risk summary called the benefit “modest,” but enough to outweigh risks it judged low, mild, and short-lived.

The at-home confusion

Is Flow a TMS device? No. Here is the difference in plain terms.

Searches like “Flow TMS” and “at home TMS” mix up two different technologies. The Flow headset is tDCS. TMS is a clinic treatment that uses magnets.

tDCS: a gentle, steady current

Two saline-soaked sponge pads sit on the forehead. A battery headset passes a 2 mA current between them for 30 minutes. The FDA summary says the current may change how excitable nearby nerve cells are by shifting their resting state.

TMS: strong, fast magnetic pulses

A coil is held against the scalp over a mood-related area. Brief magnetic pulses pass through the skull and induce small currents that stimulate nerve cells there. People usually feel a light tapping on the head. No anesthesia is needed.

Who runs the session

With the FL-100, you do. The app sets the schedule and caps use at one session a day. With TMS, clinic staff position the coil and run each session.

What a search result may not tell you

The FL-100 approval is device-specific. Other tDCS headsets sold online are not covered by it. Ask for the FDA number and indication of any home device.

Which fits your treatment history

Questions to take to a clinician, sorted by what you have already tried

This section does not choose a treatment for you. It shows where each label draws its line, so you can ask sharper questions.

No antidepressant yet this episode, or one still underway

This is closest to the group the FL-100 trial enrolled.

EMPOWER took people on no antidepressant, or on a steady one for six weeks. Ask:

Does my current episode fit the FL-100 label, and how severe is it?
Would the headset be used alone or added to my medication?
Who reviews my weekly scores, and what result would change the plan?

One antidepressant has not helped

The two labels overlap here, and insurance rules differ.

The FL-100 trial did not exclude one failed trial. NeuroStar’s TMS label covers people who did not improve on prior antidepressant medication. Ask:

Am I considered treatment refractory to medication, and why?
Would my plan cover TMS now, or does it require more medication trials first?
What does waiting for another trial cost me in weeks?

Two or more antidepressants have not worked

You are outside the group the FL-100 approval rests on.

This site is written mainly for people in this group. The options built for this history include clinic TMS, the SAINT protocol, and SPRAVATO. NIMH notes that ECT is still considered the “gold standard” for treatment-resistant depression. Ask:

If the headset is offered, what evidence supports it for my history?
Which of TMS, SAINT, SPRAVATO, or ECT fits my history, and why?
What records do I need for prior authorization?

Find a clinician who can review your history Open the appointment checklist

The evidence

What the trials showed, with the sham arm in view

Every number below comes with its sham comparison where one exists. The 57% remission figure in launch coverage means more beside the 29.4% sham rate.

Flow FL-100: the EMPOWER trial

EMPOWER randomized 174 adults in the UK and Texas. The plan was 36 home sessions over 10 weeks. Half had active stimulation and half had sham. The FDA reported these week-10 results for 87 active and 86 sham users:

Hamilton scale (main outcome): scores fell 9.4 points on active and 7.1 on sham, a 2.3-point gap.
Hamilton response: 54.4% on active versus 26.9% on sham.
Hamilton remission: 44.9% versus 21.8%.
MADRS remission, a score of 10 or less: 57.5% versus 29.4%.
Blinding: 77.6% of the active group guessed their arm correctly, against 40.7% of the sham group.

The uneven guessing is why the FDA spoke of unblinding. Two analyses that balanced the guesses put the gap at about 2.0 to 2.1 points. Quality of life on the EQ-5D scale did not differ between groups.

Not every home tDCS trial agrees. A 2024 trial in Brazil gave 210 adults unsupervised home tDCS with the same device for six weeks, with or without a digital therapy program. It found no significant benefit over sham. The FDA summary includes this trial and cites conflicting results as one reason for uncertainty.

TMS: sham-controlled and real-world results

An NIMH-funded trial at four US university clinics treated 190 antidepressant-free adults. Remission reached 14.1% with active TMS versus 5.1% with sham after up to six weeks.
In 42 US practices, 307 outpatients had failed an average of 2.5 adequate antidepressant treatments. Clinicians rated 58.0% as responders and 37.1% as in remission. This study had no sham arm.
SAINT, an accelerated five-day protocol, was tested against sham in 29 adults with treatment-resistant depression at a planned interim analysis. Four weeks later, depression scores had fallen 52.5% on active versus 11.1% on sham.

Why these numbers cannot be subtracted

The trials studied different people, on different scales, at different times.

EMPOWER excluded the treatment-resistant patients that TMS trials were built around.
EMPOWER measured at 10 weeks. The TMS studies measured at the end of an acute course, or 4 weeks after SAINT.
Remission cut-offs differ by scale and by study.
No trial on this page compared the two devices head to head.

Access, cost, and coverage

How you get each one, and who pays

The FL-100 has a posted cash price. TMS is priced by each clinic and usually runs through insurance. That difference shapes the paperwork more than the price does.

Flow FL-100

Prescribed by your own clinician, or after a Flow Care telehealth visit.
Filled by Coassist, a digital pharmacy that handles payment and home shipping.
First prescription: $2,200 for the headset, two boxes of pads, and 10 weeks.
Refill: $325 for one box of pads and 4 more weeks.
HSA and FSA eligible, per Flow. Some plans ask for a letter of medical necessity.
Not in-network with insurance plans. Flow suggests asking about out-of-network reimbursement.

Flow’s price page does not mention clinician visit fees. Ask whether the evaluation and follow-up visits are billed separately.

Clinic TMS

Ordered by a physician and delivered in a clinic or office.
Plans usually require prior authorization and records of past medication trials.
Aetna, for one, asks adults for two failed antidepressants from different classes plus a failed augmentation trial.
Aetna covers up to 30 weekday sessions over six weeks, then 6 taper sessions.
SAINT and other accelerated protocols carry separate billing and coverage questions.

Our TMS cost and insurance guide walks through pricing a full course. The SAINT cost guide covers the accelerated protocol.

Schedule and safety

What a treatment week looks like, and what the labels warn about

A week on the Flow FL-100

Weeks 1 to 3: five 30-minute sessions a week. After that: up to three a week.
Each session needs a fresh pair of pads, moistened with saline, never tap water.
A weekly self-rated questionnaire tracks symptoms in the app.
Your clinician can see your usage and scores on a clinic portal.

A week of clinic TMS

Standard courses run five weekday visits for 4 to 6 weeks.
Sessions last 3 to 40 minutes, depending on the protocol.
Accelerated protocols such as SAINT pack several sessions into each day for about a week.
Travel and time off work are part of the real cost.

FL-100 safety, from its labeling and trial

Do not use it over open wounds or damaged skin, or over metallic skull reconstruction.
Talk with the prescriber first about pregnancy, current suicidal thoughts, metal in or near the brain, seizures or epilepsy, and skin conditions on the scalp or forehead.
Skin redness under the pads affected 63.5% on active versus 18.5% on sham. Headache was similar in both groups: 42.4% versus 35.8%.
Two people had first-degree skin burns, both after using dried-out pads. Both healed.
The FDA found no serious adverse events attributed to the device, and no mania in the trial.
The labeling warns never to change your depression treatment without your clinician.

TMS safety, from NIMH and NeuroStar labeling

Common: discomfort where the coil sits, scalp or face twitching, mild headache, lightheadedness.
Seizure is rare: fewer than 1 in 30,000 treatments, or 1 in 1,000 patients, in NeuroStar labeling.
Metal implanted in the head near the coil rules TMS out. NeuroStar labeling requires screening before treatment.

Fall and winter

Seasonal depression: where a light box, the headset, and clinic TMS fit

Neither the FL-100 label nor NeuroStar’s label mentions a seasonal pattern. The seasonal treatments NIMH lists are different.

NIMH describes seasonal affective disorder as depression with a recurrent seasonal pattern, lasting about 4 to 5 months a year.
In most cases, symptoms start in late fall or early winter and lift in spring.
Light therapy means a 10,000-lux light box for about 30 to 45 minutes a day, usually first thing in the morning, from fall to spring.
NIMH also lists cognitive behavioral therapy, SSRIs, and vitamin D. Extended-release bupropion is FDA-approved to help prevent seasonal episodes.

If a winter episode is also a moderate to severe major depressive episode, a clinician can say whether either device label applies. If light therapy and medication have already failed across several winters, bring that history to the conversation.

Common questions

tDCS vs TMS: questions people ask

Is Flow a TMS device?

No. The Flow FL-100 is a tDCS device. It passes a weak, steady 2 mA electrical current between two pads on the forehead. TMS uses a magnetic coil that sends brief, rapid pulses to stimulate nerve cells in a targeted area. The FDA approved the FL-100 through a different pathway, with a different label, than the TMS systems cleared for depression.

Is tDCS FDA approved for depression?

One tDCS device is. The FDA approved the Flow FL-100 on December 8, 2025 (PMA P230024) for adults with moderate to severe major depressive disorder in the current episode who are not considered treatment refractory to medication. The approval is specific to that device and that label. It does not extend to other tDCS headsets, and it does not cover depression that has resisted medication.

Is TMS more effective than tDCS?

The trials cannot answer that. The trial behind the FL-100 excluded people whose depression had not responded to two or more antidepressants. The TMS trials enrolled people who had not benefited from earlier treatment. They used different rating scales and time points, and neither compared the two devices. Ask which evidence matches your own treatment history.

What is a major disadvantage of tDCS?

For the FL-100, the FDA named the main limits itself: a modest benefit whose clinical meaning has not been established, uneven blinding in the pivotal trial, and conflicting results in other studies. A 210-person trial of unsupervised home tDCS in Brazil, using the same device, found no significant benefit over sham. Practical drawbacks include skin irritation under the pads, new pads every session, a self-run schedule, and paying out of pocket, because Flow says the device is not in-network with insurance plans.

Can I do TMS therapy at home?

TMS for depression is delivered in clinics, offices, and hospitals, according to NIMH and NeuroStar labeling. The home device the FDA has approved for depression is the Flow FL-100, and it uses tDCS, not TMS. If a product is sold as home TMS for depression, ask for its FDA clearance number and indication.

What disqualifies you for TMS?

Device labeling and insurance rules both matter. NeuroStar labeling rules out conductive or magnetic-sensitive metal implanted in the head within 30 cm of the coil, such as cochlear implants or aneurysm clips, and calls for caution with a history of seizures. Insurers add treatment-history rules. Aetna, for example, asks adults to show an inadequate response to two antidepressants from different classes and to an augmentation trial, each for at least 8 weeks.

Can I use Flow if antidepressants have not worked for me?

The FL-100 label is for people who are not considered treatment refractory to medication. Its pivotal trial excluded anyone with an inadequate response to two or more adequate antidepressant trials. If that describes you, you are outside the group the approval rests on. Ask your clinician why it is being suggested, what evidence supports it for you, and which options are labeled for treatment-resistant depression.

How much does Flow cost compared with TMS?

Flow’s US help center lists $2,200 for the first prescription, which includes the headset, two boxes of pads, and 10 weeks of stimulation, and $325 for each 4-week refill. Flow says the device is HSA and FSA eligible and not in-network with insurance plans. TMS is billed per session, often as a 36-session course, and many plans cover it when their written criteria are met.

Sources

What this page is built on

Figures come from the FDA documents, labeling, abstracts, and help-center pages linked above, accessed September 22, 2026. Trial rates are group averages and do not predict one person’s result. This page is educational and does not replace advice from a treating clinician.