ADHD Devices and Video Games: What FDA Authorization Means

FDA authorization tells you a device’s labeled use. It does not tell you it beats other treatments.

An FDA-authorized ADHD device can have a real, specific use without solving every problem caused by ADHD. EndeavorRx has evidence for improvement on a computerized attention test. Monarch eTNS has an FDA-authorized use, but a larger 2026 trial did not find a clear symptom benefit over sham treatment.1234 Families need both the current label and the current research before deciding whether to spend money or add another task to the day.

The question is practical: Which difficulty are we trying to change, and how will we know whether this product helped?

Key takeaways

• FDA authorization applies to one device and one labeled use. It does not rank a device above medicine, parent training, or school support.
• EndeavorRx is labeled for ages 8 to 17. Its strongest evidence is better scores on a computerized attention test, not proven change in daily behavior.
• Monarch eTNS is labeled for ages 7 to 12 who are not taking ADHD medicine. A larger 2026 trial found no clear symptom benefit over sham.
• Non-drug treatments can still have side effects and take real effort from the family.
• Confirm the current label, price, and supply in writing, and set one daily-life goal with a review date.

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These products do different things

EndeavorRx is a prescription digital treatment delivered through a video game. It adjusts its challenges as the child plays. It does not record brain waves or deliver electricity. Monarch external trigeminal nerve stimulation, or eTNS, sends small electrical pulses through a forehead patch to branches of a nerve. It is used during sleep under caregiver supervision.12

Neither is EEG neurofeedback, which records brain activity and uses that signal for feedback. Nor does research on a prescription game establish that an ordinary commercial game treats ADHD. The exact product matters, including its version and instructions.

What FDA words do and do not mean

FDA review answers a regulatory question about a particular device and intended use. It does not rank that device above medication, parent training, school support, or every other treatment.

EndeavorRx received De Novo authorization in 2020. Its December 2023 clearance expanded the age indication from 8–12 to 8–17. Monarch received De Novo authorization in 2019; its Gen 2 system received 510(k) clearance in January 2024.1289 Older announcements can therefore miss important changes.

The current U.S. product comparison

Checked September 28, 2026. Regulatory authorization and a working ordering page are different things. Confirm details again before paying.

The age ranges in the table describe labeling. They do not mean every person of that age is a suitable candidate. The diagnosis, main impairment, other conditions, treatment history, and family preferences still matter.

EndeavorOTC is a separate adult product with its own FDA clearance and instructions. It is not simply a way to buy the children’s prescription product without a prescription.14

What EndeavorRx studies actually measured

The main U.S. randomized trial, STARS-ADHD, included 348 children ages 8–12 who were not taking ADHD medication. Children used either AKL-T01, the study name for EndeavorRx, or a digital word game. The schedule was about 25 minutes a day, five days a week, for four weeks.3

The primary outcome was a computerized attention score. Average improvement was 0.93 in the treatment group and 0.03 in the control group. The study’s statistical comparison favored treatment. The FDA review looked at seven other rating scales filled out by parents and clinicians. None showed a clear difference between the groups. Beyond the attention test itself, two analyses that counted children who improved did favor treatment: one for daily impairment and one for parents’ view of attention.38

That distinction matters. A primary outcome is the main result a trial is designed to test. A responder analysis counts people who cross a selected improvement threshold. Different analyses can produce different answers without proving broad recovery.

Ask a provider to name the outcome behind a claim such as “improves focus.” Does it refer to reacting to targets on a screen, a parent’s rating, or completing schoolwork? Each can be useful, but they answer different questions.

Later U.S. studies widened the evidence, with important limits:

• An adjunctive study included 206 children ages 8–14, some taking stimulants and some taking no ADHD medication. They received two treatment periods separated by a break. Ratings of impairment improved, but everyone received the device. Without a control group, the study cannot show how much improvement the game itself caused.15
• An adolescent study enrolled 162 participants ages 13–17. Of these, 146 provided the primary attention-test assessment. Attention scores improved after four weeks, but this was also an uncontrolled study.16

These studies were funded by Akili, the product developer. Industry funding does not erase a result. It makes clear reporting, suitable controls, and confirmation by other research groups especially useful.31516

Newer digital-treatment research adds a mixed picture

Two Japanese trials reported in 2025 studied SDT-001, a Japanese-language adaptation of the technology, in ages 6–17. Their different comparison groups help explain why study design matters.

The blinded exploratory trial randomized 216 participants between the therapeutic device and a similar single-task game. A separate 46-person observation group was not randomized. Symptoms improved in both game groups, without a statistically clear advantage for the therapeutic device on the main symptom comparisons. Favorable comparisons with the observation group were later analyses and cannot carry the same causal weight.17

A subsequent trial randomized 164 participants to the device plus usual psychosocial care or usual care alone. Its analysis of 163 participants favored the device on clinician-rated inattention after six weeks. The study was open label, meaning people knew the assignment, and it did not use a comparison game.18

Both studies were sponsored by Shionogi. Together, they say digital treatment is worth more study. They leave open how much the game itself helps, and whether daily life improves. Their participants and care settings do not change the U.S. product label. A positive trial with a less closely matched comparison also does not make a null blinded trial disappear.1718

Why the newer Monarch trial changes the conversation

The original sham-controlled eTNS trial randomized 62 children ages 8–12 who were not taking ADHD medication. After four weeks of nightly treatment, symptom ratings favored active stimulation over sham. That small study helped support the original FDA authorization.219

Conti and colleagues then conducted a larger trial at two U.K. sites, published in 2026. It randomized 150 young people, ages 8–18 at consent, including participants taking stable stimulants and those off medication.4

Active and sham devices were used overnight for four weeks. The sham delivered brief, low-frequency stimulation rather than being completely inactive. Masking of families and researchers appeared largely successful.4

The primary ADHD symptom score, based on parents’ reports and scored by an investigator, showed no clear advantage for active treatment: the adjusted difference was 0.83 points, with a 95% confidence interval from -2.47 to 4.13. There was also no clear symptom advantage at six months. Analyses restricted to younger children or those off medication did not identify a convincing benefit.4

A confidence interval describes the uncertainty around an estimate. This result does not prove that the true effect is exactly zero. It does weaken confidence that the device produces the symptom benefit suggested by the smaller trial.

The partly active sham is a limitation. It could affect the size of the contrast. At the same time, a more convincing sham helps control expectations. This is a reason to examine the whole design, rather than declare either study the final word.

The trial population was broader than the U.S. label. A family’s decision should reflect this newer evidence even while the existing FDA authorization remains in place. A journal article does not itself revoke a clearance.

Gen 2’s clearance concerns hardware and usability changes. Its FDA submission relies on the earlier clinical evidence; it does not establish a new, stronger treatment effect.9 A newer device generation and newer proof of benefit are separate things.

Side effects and the work of treatment

A non-drug treatment can still have side effects and take substantial effort.

For EndeavorRx, the current instructions advise pausing for problems such as frustration, headache, dizziness, nausea, eye strain, or joint pain. Persistent problems should be discussed with the child’s clinician. A seizure means stopping treatment and contacting the clinician. Photosensitive epilepsy, color blindness, and physical limits that affect device use deserve discussion before starting.10

Monarch must not be used by children with an implanted heart device or nerve stimulator, or with metal or electronic implants in the head. The patch should go only on healthy, unbroken skin. Families need the prescriber’s screening and the correct instructions for their exact system.2 Reported problems include headache, fatigue, and sleep disturbance; no serious adverse events were reported in the larger trial.4 That finding does not guarantee that every child will tolerate it.

Ask the child what the routine feels like. A game can become another demand after a difficult school day. A forehead patch can complicate bedtime. A parent may have to handle setup every evening. These costs belong in the decision alongside dollars and test scores.

Avoid making treatment a test of character. If the child struggles to participate, describe what happened: discomfort, boredom, frustration, a scheduling conflict, or a device problem. Bring that information to the prescriber. Escalating pressure can make it harder to judge both tolerability and benefit.

Current access, price, and instructions

As of September 28, 2026, EndeavorRx’s official site advertised $99 per 30-day prescription. Its route begins with a clinician’s prescription, followed by caregiver payment and activation. Check refill billing and cancellation terms before paying. Hardware costs are separate, and compatibility depends on more than simply owning a phone or tablet.1112

The current Revision V instructions recommend 10–25 minutes daily, five days weekly, for four weeks. The original randomized trial used about 25 minutes daily.310 Follow the prescriber’s plan and the instructions for the current app. Do not assume that extra play produces extra benefit.

Monarch’s official parent page describes sending a prescription to Transition Pharmacy, which then contacts the family. The same page also has a waitlist link, and its parent FAQ says the device is “not yet for sale.” The page pictures the Gen 2 device, but a current public price and shipping time could not be confirmed from that page.13 The useful next step is a written answer from the manufacturer or pharmacy before committing to treatment.

For either product, ask for the total expected cost, including follow-up visits, repeat treatment, supplies, and any hardware. An HSA or FSA eligibility statement does not tell you what your insurance will reimburse. Obtain the plan’s answer for your own coverage.

Company announcements and ownership changes do not answer whether a prescription can be filled today. An active website is also not proof of inventory. This article verified the advertised routes, not a completed purchase.

Turn “let’s try it” into a reviewable plan

The following is an original discussion tool, not a validated rating scale. Complete it with the prescriber before starting.

Choose an observable goal. “Better attention” is hard to judge. “Starts the agreed homework task with fewer reminders” is clearer. Keep the task and observer as consistent as possible, and note major changes in sleep, school demands, or other treatment.

A hypothetical example: A family hopes a digital treatment will reduce repeated prompts during a 15-minute homework period. They agree how to count prompts before starting and bring the same record to follow-up. If the child’s game performance improves but homework does not, that is useful information. It should change the discussion about continued time and cost.

A home record cannot prove causation the way a well-designed randomized trial can. It can still show whether the family’s chosen outcome is moving in the right direction. The clinician can pair it with appropriate symptom or functioning measures.

Ask what happens if the result is mixed. Perhaps the child enjoys the game, scores better on a test, and still misses assignments. Perhaps sleep becomes harder. Decide together which outcomes matter enough to justify continuing. A completed course is information, not an obligation to buy another one.

Keep the broader ADHD plan in view

EndeavorRx’s label says to use it as part of a wider plan. That plan may include therapy, medicine, or school programs. Monarch’s U.S. indication is for children not taking prescription ADHD medication.19 That is a selection limit to discuss with a clinician, not a reason to stop prescribed treatment to qualify for a device.

Device decisions also should not postpone practical help. Behavioral parent training and classroom organization systems address other parts of daily functioning. The ADHD care overview can help organize the broader conversation.

Bring the product name, current instructions, written price, and one daily-life goal to the appointment. Ask: “What benefit is supported for someone like my child, what remains uncertain, and when will we decide whether this has been worth continuing?”

Frequently asked questions

Can siblings share an EndeavorRx prescription?

The manufacturer says the prescription is for the named patient.10 Ask the prescriber about a separate evaluation instead of sharing access.

What records should we keep if we seek reimbursement?

Ask the plan which documents it requires. Keep the prescription, itemized receipt, product name, service dates, and its written coverage response. Keeping records does not guarantee reimbursement.

Related reading on NP FADY

• Neurofeedback for ADHD: What the Evidence Shows Before You Pay
• Change the Pattern, Not the Child: A Parent’s Guide to Behavioral Training for ADHD
• Build the Rails: Classroom and Organization Systems for ADHD

References

1. U.S. Food and Drug Administration. EndeavorRx v3.0, K231337: 510(k) summary and indications for use. Decision December 13, 2023. FDA decision document. Accessed September 28, 2026.

2. U.S. Food and Drug Administration. Monarch external Trigeminal Nerve Stimulation System, DEN180041: De Novo classification request decision summary. 2019. FDA decision summary. Accessed September 28, 2026.

3. Kollins SH, DeLoss DJ, Cañadas E, et al. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. Lancet Digital Health. 2020;2(4):e168–e178. DOI: 10.1016/S2589-7500(20)30017-0. PubMed.

4. Conti AA, Bozhilova N, Eraydin IE, et al. External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial. Nature Medicine. 2026;32:582–590. DOI: 10.1038/s41591-025-04075-x. Public full manuscript.

5. U.S. Food and Drug Administration. De Novo Classification Request. FDA guidance page. Accessed September 28, 2026.

6. U.S. Food and Drug Administration. Premarket Notification 510(k). FDA guidance page. Accessed September 28, 2026.

7. U.S. Food and Drug Administration. Are There “FDA Registered” or “FDA Certified” Medical Devices? How Do I Know What Is FDA Approved? FDA consumer page. Accessed September 28, 2026.

8. U.S. Food and Drug Administration. EndeavorRx, DEN200026: De Novo classification request decision summary. 2020. FDA decision summary. Accessed September 28, 2026.

9. U.S. Food and Drug Administration. Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System (Monarch Gen 2), K233293: 510(k) summary. Decision January 16, 2024. FDA decision document; current record. Accessed September 28, 2026.

10. Akili Interactive Labs. EndeavorRx Instructions for Use, Part 5011 Revision V. Updated June 2025. Current instructions page; Revision V PDF. Manufacturer source. Accessed September 28, 2026.

11. Akili. EndeavorRx official website. Product and advertised price. Manufacturer source. Accessed September 28, 2026.

12. Akili. Frequently Asked Questions about EndeavorRx. Prescription, payment, compatibility, and support information. Manufacturer source. Accessed September 28, 2026.

13. NeuroSigma. Monarch eTNS: Parents and Caregivers. Ordering information. Manufacturer source. Accessed September 28, 2026.

14. U.S. Food and Drug Administration. EndeavorOTC, K233496: 510(k) summary. Decision June 14, 2024. FDA decision document. Accessed September 28, 2026.

15. Kollins SH, Childress A, Heusser AC, Lutz J. Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. npj Digital Medicine. 2021;4:58. DOI: 10.1038/s41746-021-00429-0. Full text.

16. Stamatis CA, Farlow DN, Mercaldi C, et al. Two single arm trials of AKL-T01, a digital therapeutic for adolescents and adults with ADHD. npj Mental Health Research. 2024;3:30. Study record and author details; full text. DOI: 10.1038/s44184-024-00075-w.

17. Mikami K, Miyajima T, Nishino R, et al. Exploratory study of dual-task digital device in children and adolescents with attention-deficit/hyperactivity disorder. Psychiatry and Clinical Neurosciences Reports. 2025;4:e70089. DOI: 10.1002/pcn5.70089. Full text.

18. Mikami K, Miyajima T, Nishino R, et al. Efficacy and safety of SDT-001, a dual-task digital device, in managing attention-deficit/hyperactivity disorder symptoms in children and adolescents: a phase 3, randomized, standard treatment-controlled study. Psychiatry and Clinical Neurosciences. 2025;79:447–457. DOI: 10.1111/pcn.13833. Full text.

19. McGough JJ, Sturm A, Cowen J, et al. Double-blind, sham-controlled, pilot study of trigeminal nerve stimulation for attention-deficit/hyperactivity disorder. Journal of the American Academy of Child & Adolescent Psychiatry. 2019;58:403–411.e3. DOI: 10.1016/j.jaac.2018.11.013. PubMed PMID 30768393; full text.

This article is for education and is not a substitute for diagnosis or treatment from a qualified health professional. Do not start, stop, or change medication without your prescriber’s guidance. Product labels, prices, and availability can change. Evidence last checked September 28, 2026.

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