The wearables category already contains multitudes, from exercise-focused smart watches and sleep tracking smart rings to smart femtech and semi-invasive blood glucose monitors — to name a few of the gizmos we’ve tracked over roughly a decade of novel personal hardware launches. But the space is set to get even more active, with a new wave of neurotech: wearable devices targeting the brain.
The neurotechnology category tends to be associated with brain implants. But wearable neurotech refers to therapeutic medical devices that apply brain stimulation from outside the body — through the skin and skull — not via any physically invasive process as a treatment for a range of chronic health issues.
Think head-mounted wearables that allow the user to self-administer treatment for psychological conditions such as depression (Flow Neuroscience) or period pain & PMS (Samphire Neuroscience). Other target applications include anxiety, insomnia and even post traumatic stress disorder (PTSD). Metabolic disorders like obesity and Type II diabetes could even be treated using wearable neurotech.
Both are applications on the roadmap of Neurovalens, a U.K.-based startup that’s been developing its non-invasive brain-stimulating technology for over a decade.
The market for wearable medtech remains small but it looks to be on the cusp of a growth spurt over the next few years as long-running efforts to commercialize R&D are poised to translate into a pipeline of products — assuming the necessary regulatory approvals flow.
Meet the “little zapper” for depression
TechCrunch spoke to a user of Flow about their experience of its wearable therapeutic. This person, who we’ll call Alex (not their real name as they preferred to remain anonymous), has suffered from low mood for several years. This eventually led them to find out about Flow’s device and get in touch with the company to ask to test it. They’ve been using the product since February 2024.
Flow’s wearable, which has an RRP of €459, is designed to treat depression using a form of electrical brain stimulation called tDCS, or transcranial direct current stimulation. The device applies low current stimulation to the user’s head via a pair of conductive pads that rest on the forehead. Daily treatments are suggested for an initial period of several weeks, after which Alex said they stepped down to a couple of sessions per week. They told us they continued to use Flow at a weekly cadence after that.
An FAQ on the company’s website recommends that if the product is “helpful” for the first 10 weeks of treatment the user continue “for at least another 6 to 12 months, even if you have become symptom-free.”
Discussing their experience with Flow, Alex said the wearable has been helpful and a lot less unpleasant than taking antidepressants.
They had previously been prescribed drugs several times but decided to stop medicating after it led to weight gain, low libido and feeling generally numb/dissociated. Even the process of getting off the drugs had been deeply distressing for them. But Alex said Flow’s device provided a very different treatment experience, with none of the nasty side-effects.
“Just the process of putting the thing on, feeling the little zapper, sitting quietly for half an hour, doing all the little things associated with it is also very calming,” they told us. “It feels like little ants biting at your forehead… [or] one of those muscle stimulators for sports, where it kind of zaps your muscle.
“My experience was I went from a despondent situation, to moving through a more active depression which manifested itself as anger, into a fairly relaxed state at this point, which is unusual for me.”
When we checked in a few months later to see how Alex was doing, they’d finally stopped using Flow. Why? “Feeling slightly better” came the quietly understated response.
A different kind of treatment
One big promise of non-invasive neurotech is that it could offer an alternative treatment for conditions like depression that don’t always respond well to drugs. But how can an electronic device have a therapeutic effect on the human brain? The basic theory is that stimulating the brain’s activity in a targeted way can influence how a person feels by changing the electric signals that brain cells use to talk to each other.
“Brain cells communicate with electrochemicals,” explains Cambridge University’s Dr. Camilla Nord, an assistant professor, head of the university’s Mental Health Neuroscience Lab and author of a book (The Balanced Brain) on the science of mental health. “So one way we can change activity in the brain — and thereby someone’s thoughts, mood [etc]… is by changing the chemistry. That’s what drugs like antidepressants, antipsychotics do.
“The second way we can change it is by changing their electrical signals — and that, in varying ways, is what brain stimulation does.”
While pharmaceuticals are a more established pathway for influencing mood and mental health, there are many drawbacks to taking medication — from ongoing cost; to not easily/being able to stop once you start; to a whole host of potential side-effects.
Drugs also aren’t equally effective for everyone, if they work at all. And, even if they do, no one wants to have to be taking any form of medication, even a painkiller, forever – unless they literally have no choice. So the case for neurotech wearables to expand treatment options looks strong — provided device makers can demonstrate that their products are safe and effective.
To the uninitiated, the idea of applying electricity to the brain might sound a bit scary. But, asked about potential risks, Nord says the amount of neurostimulation used in commercial devices is so mild it shouldn’t be a cause for concern.
“My understanding of the level of brain stimulation used in these commercial devices [is] they are not something to have safety concerns about,” she suggests. “These are very, very low levels of electrical brain stimulation – if they’re changing neuronal activity it’s likely to be at safe levels if you’re using them for a short amount of time, which is how they’re recommended for use.”
Whether there might be any risks related to usage duration – i.e. using non-invasive neurostimulators for long periods of time – is less clear. “To some degree, we can never fully know,” she posits. But long term drug use may have its own risks, too.
Another big potential plus-point for neurotech vs pharmaceuticals is that a treatment that’s lower risk can be tried earlier — before resorting to prescribing medication. Drugs may also require a full diagnosis before they can be dispensed. Whereas wearable neurotech could open up a market for earlier health interventions — allowing treatment to be applied sooner in a disease’s progression with the chance of better outcomes for patients.
Technical & regulatory complexity
While neurotech has clear potential, there is a lot of complexity attached to this kind of medtech. Part of the reason the neurotech landscape is so complex is the variety of techniques that can be used to influence the brain’s activity. Broadly speaking this includes transcranial magnetic stimulation (TMS), electrical current stimulation (CES), and even – research indicates – ultrasound (TUS).
So far, most commercial activity has focused on a form of CES called transcranial electrical current stimulation (aka tDCS). But there are several other electrical approaches being explored. Applications for non-invasive brain stimulation are also growing – but the main areas of interest so far are mental health and neurological issues.
Commercializing neurotech research into medical devices is far from simple due to a fragmented regulatory environment, too: In the U.S., the Food and Drug Administration (FDA) is an overloaded one-stop shop, while in Europe a decentralized system of private accredited bodies handle safety testing and audits. The rules for how medical devices are prescribed and reimbursed also differ between markets.
On top of that, there is some historical baggage to contend with – as a result of brain stimulation having a long but not always illustrious history. Legacy devices unsupported by science do explain some of the lingering scepticism about non-invasive neurotech therapy. But in recent years, the FDA has been looking to tighten up its rules for approving electrical neurostimulation for certain applications.
This is a course corrector for earlier waves of products that were brought to market in the U.S. from the late 1970s onwards under less rigorous standards. In 2019 the FDA finalized a reclassification of CES for treating insomnia and anxiety — moving these use-cases to a lower risk category (Class II) but also applying some special controls.
The 2019 FDA order also addressed CES devices targeting depression. These were maintained as Class III (high risk) under its revised rules but there’s now a more involved pathway to get to market, known as Premarket Approval (PMA). Device makers must amass U.S. clinical evidence that will be reviewed, and ensure the hardware meets safety standards, before they can seek approval for a commercial launch.
A full PMA application process can take years. And while some devices targeting anxiety and insomnia have been cleared by the FDA since the 2019 rule changes, the regulator has yet to approve any CES devices for depression under its revised pathway.
Safe to say, the first depression-targeting neurotech wearable that gains FDA approval will be able to lay claim to a major credibility boost.
Modernized and strengthened rules for approving neurotech medical devices set the category up for a reputational reboot – provided startups can deliver to the upgraded standards.
Getting regulatory sign-off is not the end of the journey, though. Healthcare supply systems also assess novel treatments with a focus on costs — meaning they need to be able to demonstrate value for money. Again, different markets and healthcare systems may approach these cost-benefit assessments very differently, amping up the admin work for startups wanting to sell to multiple markets.
The U.K.’s publicly-funded National Health Service (NHS), for example, relies on a body called NICE (the National Institute for Health and Care Excellence) to evaluate both clinical efficacy and cost effectiveness of potential treatments. While the U.S. has a far more fragmented cost assessment process as a result of the larger role private healthcare plays.
Achieving reimbursement is the holy grail for a medical device maker as it unlocks the opportunity to reach serious scale. But there’s no shortcut to get there.
Since March last year Flow’s wearable has been made available to patients and clinicians in the U.K.’s NHS via a series of pilot programs. It’s also started to have its hardware reimbursed in some European markets.
Co-founder and CEO Erik Rehn won’t be drawn into predicting how long the next big step for Flow, of FDA approval, might take to obtain. But he credits the startup’s initial B2C approach – of selling its wearable to interested consumers in Europe (where it has obtained a CE mark under regional medical device rules) – with giving it enough runway to work towards heading over the pond as a reimbursable medical device in the future.
“There’s this big gap between getting regulatory approval and reimbursement,” Rehn tells TechCrunch. “A lot of companies have a medical device idea, they develop it, they run the clinical trials to get approval, but then what? It can take years from that point to actually get it to a reimbursed state to actually earn money. And how do you survive that?
“We solved that by having a strategy where we could sell directly to consumers. But that’s not possible in all cases. It might need to be a prescription device…. depend[ing] on the indication you’re using it for – but also the technology, and also the regulatory framework on the market where you are.”
“To have the really big impact in the long term we need to go B2B,” he adds. “We’d need to get reimbursement. We’d need to get this as a first line of treatment. And that’s much harder than just having the medical device approved.”
Flow’s strategy requires the startup to execute a long, slow switch from B2C to B2B – as it amasses usage data, traction and evidence for its novel wearable — to gain buy-in from healthcare systems far more accustomed to pushing pills on patients than head-mounted gadgets.
“It’s taken a long time,” admits Rehn. “I hoped it [would] be much faster. But I think, realistically, this is how long it takes to change how something is treated.”
Beyond placebo
Whether the sense of relaxation the person we spoke to earlier, Alex, was able to achieve within a few weeks of trying Flow’s non-invasive neurostimulation is a direct result of the therapeutic electricity the device applies or whether some kind of placebo effect could be involved — including as a result of mindful product design (Flow’s app encourages the user to get into a routine of reflective self-focus, for example) — is harder to determine.
Placebo is a phenomenon that refers to the brain’s ability to change a person’s experience with expectations.
Alex told us they believe Flow’s product worked for them. But they also wondered aloud whether it was placebo?
Rehn says Flow is able to demonstrate the product’s efficacy in trials that control for the placebo effect. And — specifically — he says it can demonstrate that it’s the electrical brain stimulation component which is having a therapeutic effect.
“So far we only looked at the brain stimulation — there’s no CBT [cognitive behavioral therapy], involved [in our clinical trials],” he stresses. “Because it’s the headset that we sell. So we want to be really sure that we have evidence for the treatment.
“That’s the kind of evidence that we’re going to the regulators with.”
Discussing the role placebo might play in non-invasive brain stimulation, Dr Nord confirms there is no way for regular users to be sure. “These forms of brain simulation that are being used [commercially] – for the majority – they have a basis in science. They have the potential [to make] these changes in the brain. And then, therefore, a potential to have the effects that they claim to be having.
“But when you personally have experienced these effects – no, you can’t say whether it has happened through that [placebo] pathway,” she says.
A person experiencing relief from a debilitating condition like depression may not much care about the exact mechanism making it happen – whether it’s their own neurons convincing them to shift perspective or a legit change in brain activity flowing from active neurostimulation. But for healthcare systems and regulators – and therefore for medical device builders – it obviously does matter.
Knowing a treatment is better than placebo is a standard clinical requirement that enables healthcare service providers to take decisions that properly consider risks and costs. So a direct-to-consumer strategy can only be a stepping-stone for any medtech startup.
Add to that, the really big prize this new wave of wearable neurotech builders are shooting for is to get their devices established as therapeutics within traditional healthcare supply systems where they can scale impact and have the chance to drive a more proactive approach to tackling complex concerns.
What about consumer neurotech?
There’s another bundle of brain-targeting wearables to consider which sit outside the medtech category — in a broader but fuzzier wellness device space. These are lifestyle products, marketed and sold directly to consumers, typically with some brain training or tracking pitch. But with no regulatory oversight of claimed benefits it’s harder to understand and verify impact.
While we’ve seen startups experimenting with consumer neurotech plays for years, there are signs the category might be heating up again – judging by recent device launches.
For example, Netherlands-based Alphabeats – which launched its first product in the U.S. in May – is combining an EEG (electroencephalography) brainwave detecting headband with music and other in-app visuals for a focus-tracking and focus-training pitch that’s geared towards professional athletes and sportspeople.
The product is based on research originally conducted by the electronics giant Philips, along with researchers at the University of Tilburg in the Netherlands, according to co-founder Jorrit DeVries, who was also president & chief commercialization officer at the startup when we spoke to him (but has since taken over the CEO role).
Another consumer player that’s set to launch its debut brain-targeting device in the U.S. shortly is Neurable. The Boston-based startup has actually been grinding away in the category for years – spinning out of the PhD research of founder and CEO, Ramses Alcaide.
After years developing algorithms to boost an EEG signal from brain-scanning hardware that’s small enough to be housed in a standard-looking pair of headphone cups, Neurable’s first consumer device is finally headed to market — via a partnership with premium audio brand, Master & Dynamic. The resulting product is a pair of premium smart headphones that will be marketed as an attention-tracking (and focus training) tool for information workers wanting to optimize their productivity.
Brain training itself isn’t a new idea of course. Games claiming to up your mental agility have been touted and sold for years. But such apps don’t have the best reputation, with limited evidence of utility beyond such stuff being good for improving users’ ability to play brain training games.
Startups like Alphabeats and Neurable are hoping to reboot the category thanks to pulling in brain activity data via EEG. Their pitches push the notion that consumers can use their apps to track their brain activity in real-time and get feedback to support them to positively rewire mental habits.
Why does DeVries think the time is right to sell consumers on a wearable for training mental game?
“I think the stigma [around mental health and seeking support for it] is being removed quite rapidly,” he suggests. “Role models like Simone Biles, for example, or Michael Phelps, or all these key athletes that that talk about mental performance and the importance of mental health – so that helps the market tremendously to be able to tap into to a bigger cohort of people that is not worried about what a lot of people think about it.”
Another big change he flags vs earlier consumer neurotech plays is refinements to the wearable technology itself: Alphabeats is bundling a pretty slender headband with its app, which is made by a third party company (BrainBit), also helping it trim product costs.
“The form factor is getting smaller and smaller and more accessible. Prices are being driven down by competition,” he says, adding: “Years ago there were headbands in the market that were at least $1,000 and now we’re offering Alphabet for $499 including 12 months of the service.”
“In five to 10 years from now, it will be very common to get EEG out of earbuds,” DeVries also predicts. “So we want to focus on this platform to become the companion – the mental performance companion – for anybody that needs it.”
In Neurable’s case the U.S. startup kicked off with what Alcaide admits was a “bad strategy” – of focusing on targeting the tech at users of AR and VR. The new product positioning now has the startup leaning into the wellness trend.
Neurable talks in terms of its smart headphones enabling users to take care of their “mental hygiene” – so there’s a clear push to connect to the broader wearables space (which encompasses products like Apple’s Watch, the Oura Ring or the Whoop band, to name a few), where health tracking has been a key selling point.
“We’re definitely going to go the same path as Apple does,” emphasizes Alcaide. “We’re not going to make a medical device anytime soon – we’re just going to help people better understand themselves and their data.”
What else might brain-focused wearables end up targeting down the line? Research continues to turn up some tingling possibilities. A recent study suggested neurostimulation could even be used to dull the emotional pain of heartbreak. So maybe future consumers of neurotech wearables will be weighing the pros & cons of whether they want to give themselves a dose of Eternal Sunshine of the Spotless Mind.
A headband for heartbreak remains science fiction for now — but, well, it’s quite a thought!
