If you spent any time on LinkedIn this week, or reading the news, (or if you have a bunch of friends who sent it to you because they know this is news you’d be interested in), you saw it. Oura is being sued.
The accusation: The ring does not really track your sleep. In fact, the law firm’s press release says, “The “sleep score” is alleged AI guesswork off peripheral signals… no more reliable than a coin flip.”
And, once again, the headlines really do not disappoint in grabbing attention with half-truths.
“The whole category is about to face a reckoning.” One post called it “a watershed moment”. Another announced that “this cracks the foundation of the smart ring market”. A few of them got Oura’s valuation wrong by about six billion dollars while they were at it.
I read the complaint. (OK actually I read about 5 pages of the complaint and had Claude review the rest of it.)
Two things before I go further:
Oura sent me a ring a while back, which I have been wearing since February. Many companies send me products to try out. This article is not sponsored, and I disclosed the same thing when I interviewed their Chief Medical Officer earlier this year.[1]
Also, I am not a lawyer. I took two classes at UVA Law while I was getting my MBA and this, I know, does NOT make me a lawyer. What follows is my opinion as someone who has spent twenty-five years building and commercializing medical devices (and honestly just living in the US and watching how our legal system works), not a legal opinion.
My opinion is that this looks like another nasty example of people using the court system to squeeze money from a company, rather than to remedy an actual injury. And I do not think it is a coincidence that it popped up right as Oura is preparing to go public.
The named plaintiff, Madison Surber, bought an Oura Ring 4 Gold for $513.68 on or around May 22, 2025. The legal argument they are pursuing is just false advertising.[2]
First, Oura advertised specific accuracy figures. The Ring 5 product page claims “95% Sleep Staging Accuracy Compared to clinical sleep lab.” They also use phrases like “Built for accuracy.”
Second, she paid extra because of it. She saw the accuracy claims, believed them, and would not have bought the ring, or would not have paid $513.68 for it, if the marketing had been accurate.
Third, the complaint says those numbers are not what independent research shows. It leans on a 2025 study that reported 53.18% accuracy on sleep stage detection. So, they’re using one study to refute another study without ever actually testing how accurate it was on the client? I feel like they’ve already spent enough money, they could have just done a comparative sleep study on her. Wonder if they did, but now they don’t want to use it? Oura, y’all should look into that in discovery.
The fourth part I noticed, which I find particularly odd, is that they’re saying the ring can’t detect the physiological signals real sleep labs use. OK, that’s like suing a laser beam for not being a light bulb. Oura never claimed to use EEG to get sleep stages. Just because a doctor hand noting an EEG readout is the gold standard doesn’t mean there aren’t other ways you can try to measure or extrapolate data. Most of the Machine Learning diagnostic space is about connecting the dots to other types of measurements to build an algorithm.
Interestingly, the filing never claims it mislabeled or misdiagnosed her sleep stages specifically. It never claims any harm from this except that she paid money for it and it maybe wasn’t AS accurate as she thought. The filing only says, “it became apparent to her that it was not tracking her sleep or sleep quality as advertised.”
The claimant also never seems to have attempted to reach out to Oura and get a refund or bring this up with them in any way prior to sending a letter from a lawyer asking for what I’m assuming was way more than returning her ring in exchange for a $513.68 refund. You’d think if she had they would have mentioned it, at least in the press release if they didn’t think it was worth putting in the legal arguments.
Speaking of the press release, I will say I think the law firm has done an excellent job writing a scathing press release. You should check it out, it’s quite good. Their team should write movie sizzle reels (maybe they do, they are in LA county). https://clarksonlawfirm.com/oura-smart-rings-false-advertising-class-action/
In case you were wondering. That law firm is Clarkson, and this is pretty much what they do. Ryan Clarkson has prosecuted hundreds of consumer class actions covering artificial intelligence claims, medical devices, greenwashing, and food misbranding, and the firm secured a $250 million settlement in an AI-focused false advertising class action against Apple.[4] They filed the first major privacy class action against OpenAI in 2023.[5] It seems their whole operation is going after large tech companies in the California court system.
I’m not actually here to tell you whether they’re in the wrong or whether Oura is. This definitely isn’t going to be one of these articles where I break the case down argument by argument the way I did with WHOOP and the FDA warning letter.[6] That was a case where all of the details of the regulatory reasoning mattered to everyone building in this space.
To me, this one isn’t about whether they have a good argument. It’s about the fact that any company operating in the United States could see themselves in a similar situation. If you sell products to consumers in the US, you could have a law firm eyeing you up as another good opportunity for a (maybe not-so quick) buck.
Well, nothing in life is 100%, but I have two solid answers for you:
I’ve said it before, and I’ll say it again. Industry standards.
I’ll back up first and say that this particular case might not have been saved by any industry standards, but they can make things easier when you can just tell people you test to a certain standard.
Oura actually has a lot of well documented clinical evidence that they have shared publicly, so they’re doing most of what they should be. Their validation studies are published and they recently put out a detailed technical FAQ walking through how they measure and where the numbers come from. You should check that out too! https://ouraring.com/blog/how-oura-measures-sleep-and-validates-accuracy/
What Oura does not appear to have is conformance to a published industry standard.
It looks like one exists specifically in consumer sleep tracking. I found it in a google search. ANSI/CTA/NSF-2052.1-A defines terminology for wearable sleep monitors. 2052.2 covers methodology of measurements. 2052.3-A covers performance criteria and testing protocols, and there is a separate standard, 2092, for snoring detection.[7] These were developed by the Consumer Technology Association, which is an ANSI-accredited standards developer, working with the National Sleep Foundation. The first one published in September 2016. 2052.3 even sets up two separate compliance categories, one for sleep versus wake determination and one for sleep stage determination, and lets a manufacturer state that a device “Meets the CTA Standard.”[8]
What I didn’t find in my search was ANY company saying they follow this standard. I went looking for a consumer wearable publicly claiming that mark. I could not find one. So, I don’t know. I don’t know if they’re following it internally with some of their testing, if they looked at it and decided it was a bad standard for some reason, or if companies know it’s good and just can’t be bothered. I asked Oura, but to be fair I gave them only a few hours to get back to me. If I hear, I’ll let you know.
Beyond sleep, the consumer side also has standards for step counting and for heart rate, plus a general framework for validating digital health metrics under real-world conditions.[9] That is all I found. There is nothing comparable for blood pressure, for ECG, or for most of the biomarkers this industry is now collecting and building product features on, unless you’re filing to be a medical device, then there are standards. (we can argue how good those standards are at another time!)
I have been arguing for industry-led quality standards in this space since February, when I revisited Tom Hale’s op-ed on whether we need a third FDA pathway.[10] I made the case then that it was a consumer protection issue and a market transparency issue. I am adding a third reason now, CYA.
A tested, published, adopted standard is a legal asset. It converts “our marketing was accurate” from a battle of expert witnesses into a document you can hand a judge. Back to the standard that already exists, maybe someone reading this can reach out and educate me on it? I’d love to know why no one seems to be using it!
We are not going to skip past the fact that Oura has a marketing problem here, because they do. They misspoke when they said they had 95% accuracy in sleep staging.
Oura’s own FAQ, published August 23, explains that the 95% figure refers to sleep versus wake detection, where the ring reaches 90 to 96% agreement with polysomnography. Their words: “This is what the 95% figure refers to.”[11] Four-stage classification, which is what most people mean when they say sleep staging, runs roughly 76 to 79% in healthy adults. It’s unclear, but I think maybe a fair assumption, to say that the original marketing didn’t specifically call out with a footnote or asterisk the clarification on that figure for the advertising in question. So, it seems the marketing team may have conflated being able to say asleep versus awake with sleep staging, which is really about distinguishing between the types of sleep, not whether you are asleep at all.
I wouldn’t call that fraud as much as a mistake, and also an avoidable process failure.
In the medical device world we handle this with two things that work together.
The first is a claims matrix. It is a maintained document that catalogs every claim the company intends to make, the specific evidence supporting each one, whether that evidence comes from your own product testing or from external research, the population that data was generated in, and the exact wording you are comfortable using to express it. Any new data, claims, opinions, legal guidance (like new FDA wellness guidance) will mean updates and version changes to the claims matrix.
The second is the review structure around it. Marketing materials do not go out until the right people have looked at them, and the right people typically means regulatory, marketing, and legal in the room together, with clinical involved when the claim is performance-related. Everybody reviews and agrees on approved wording.
This can feel onerous, but it helps add guardrails for exactly this type of issue Oura is now facing.
Would this have caught the Oura issue? I don’t know, I have no idea what Oura has in place internally. They may well have a review committee and a claims process, and things still may have slipped through. A functioning claims matrix most likely would have flagged that the 95% figure was tied to sleep/wake evidence and that “sleep staging accuracy” was the wrong header for it or said that it should only be used with an easily readable footnote for clarification, or whatever their team decided they were comfortable with. And a review committee might have caught what an individual working on an ad might have missed or forgotten to add.
As a fun side quest, I have a guide for managing claims available for paid subscribers here:
It gives guidance on the why, what, and how of setting up and maintaining a matrix and how to get your company to use it properly.
Well, actually I have no idea what will happen with this court case. It could get thrown out, it could settle out of court, or it could go to court and one of the sides wins.
Here’s what we do know:
This case isn’t going to magically make wearables more accurate or better at reporting their results.
Class action suits don’t really make anyone but the law firm significant money.
If you don’t believe me, we have a very similar case to compare:
In May 2015, a class action was filed in the same federal court alleging that Fitbit’s sleep tracking did not work as advertised. The theory was structurally the same as the one now aimed at Oura: the device used an accelerometer, an accelerometer measures movement rather than sleep, therefore the sleep claims were false.[12]
In March 2020, the court approved a settlement and awarded roughly $7 million in attorney fees, trimming about $300,000 off the request after Fitbit argued the amount was disproportionate to what the class actually recovered. Class members who filed a valid claim received checks for $12.50.[13]
If Oura settles, and I would not be surprised if they do, it will not be a concession that the science is wrong. It will be based on a spreadsheet. Legal costs can run into the millions before anyone argues the merits in court, and a company heading into a public offering would rather not carry an open fraud allegation through its roadshow. Everyone involved understands this. Most likely the law firm is counting on it.
I HATE that this is how our legal system is used. I have no way to fix it, but I wish someone smart could solve that issue. Meanwhile we have to understand the US legal system and be as prepared as possible for these types of risks.
It’s up to you and your company to decide your level of risk aversion. Put in the Standard Operating Procedures you think are needed to properly balance risk and the dreaded “process overhead” of review.
As a final note: I talk to many companies that don't think they're medical device companies (and often they're not, for now). The discussions tend to be about creating and following an SOP around claims review, or what else they can do to derisk. These are companies with no mandate to submit anything to the FDA, but a very public mandate to treat their customers well.
If you’re in wearables, consumer tech, or AI - it helps to look at the gap between how you operate today and how a medical device company operates. Once you understand the gaps, you can decide what systems you might want in place to both derisk your company and be able to tell your customers that your products are safe, accurate, and effective.
Blythe Karow is a strategic management consultant and founder of The Karow Advisory Group. The insights shared here reflect Blythe’s strategic expertise navigating the complex world of MedTech and wearables. Imagine what that same thinking could uncover when applied to your business.
How Blythe can help:
Commercialization & Market Readiness Reviews
Product & Business Strategy
U.S. Market Entry Planning & Education
Strategic Advisory for MedTech, Wearables, and HealthTech
Blythe Karow, “Interview with Oura’s CMO, Ricky Bloomfield – Can you guess what we discussed?” The Device Files, March 4, 2026. https://blythekarow.substack.com/p/interview-with-ouras-cmo-ricky-bloomfield
Surber v. Oura, Inc. et al., No. 3:26-cv-08686 (N.D. Cal. filed Aug. 20, 2026). https://clarksonlawfirm.com/wp-content/uploads/2026/08/COMPLAINT-26-cv-08686-Surber-v.-Oura-Inc.-et-al.pdf. Purchase details at ¶ 17, challenged claims at ¶ 31, core allegation at ¶ 4, damages theory at ¶¶ 21, 118, 167, purchase narrative at ¶ 60, demand letter at ¶¶ 154, 166.
Clarkson Law Firm, “Oura Smart Rings False Advertising Class Action.” https://clarksonlawfirm.com/oura-smart-rings-false-advertising-class-action/
Clarkson Law Firm, “Ryan Clarkson.” https://clarksonlawfirm.com/people/ryan-clarkson/
P.M. et al. v. OpenAI LP et al. (N.D. Cal. filed June 2023).
Blythe Karow, “The Wearables Breakdown, Part 2. Fight the Power: Is WHOOP Really in the Wrong in This FDA Battle?” The Device Files, July 23, 2025. https://blythekarow.substack.com/p/the-wearables-breakdown-860
National Sleep Foundation, “NSF / CTA / ANSI Standards.” https://www.thensf.org/nsf-cta-ansi-standards/
ANSI/CTA/NSF-2052.3, Performance Criteria and Testing Protocols for Features in Sleep Tracking Consumer Technology Devices and Applications, § 6.2.
ANSI/CTA-2056 (step counting), ANSI/CTA-2065-A and 2065.1 (heart rate), ANSI/CTA-2108 (validation of digital health technology-derived metrics under naturalistic conditions).
Blythe Karow, “Revisiting Tom Hale’s December WSJ Op-Ed: Do We Still Need to Talk About a Third FDA Pathway?” The Device Files, February 4, 2026. https://blythekarow.substack.com/p/revisiting-tom-hales-december-wsj
Oura Team, “Standing Behind Our Science: How Oura Measures Sleep and Validates Accuracy,” August 23, 2026. https://ouraring.com/blog/how-oura-measures-sleep-and-validates-accuracy/
Brickman v. Fitbit, Inc., No. 3:15-cv-02077 (N.D. Cal. filed May 2015).
“Fitbit Settlement,” Courthouse News Service, March 2020. https://www.courthousenews.com/fitbit-settlement/. Class member checks of $12.50 mailed beginning October 26, 2020, per Top Class Actions.
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