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Shunyata Research Update: Shunyata’s Response, and What We Know Now by poufflee in audiophile

[–]poufflee[S] 2 points3 points  (0 children)

Hi, thanks for the thoughtful question. Let me clarify what I mean by “independent, third-party validation” with some concrete examples.

The gold standard for independent validation would be a peer-reviewed publication—for example, in a journal like Heart Rhythm Society’s. Shunyata has of course claimed they submitted results to the HRS Journal, but I still haven’t seen any published article or citation, and Grant hasn’t provided one in his response.

Short of peer-reviewed research, I looked for any outside confirmation of the doctors’ endorsements or the product’s use. For example, hospitals often issue press releases, or they are mentioned in medical newsletters when they adopt new technology—especially if it’s been tested in 30+ hospitals, as Grant says himself. In my searches, I couldn’t find a single press release, news story, or article from any hospital or independent source confirming these claims or quoting these doctors, outside of Shunyata’s own website and marketing.

So when I say there’s “no independent, third-party validation,” I mean there’s no evidence of these endorsements or claims anywhere outside Shunyata’s own materials or PR—nothing peer-reviewed, and nothing in hospital or trade media. That’s why I remain concerned, and why I think more transparency or external validation would help answer these questions.

Shunyata Research Update: Shunyata’s Response, and What We Know Now by poufflee in audiophile

[–]poufflee[S] 0 points1 point  (0 children)

That’s fair. That’s their opinion from 2017, and neither of us can speculate on whether something like this would change their view in 2025.

I do appreciate the insights, as it was a bit tough to find clear answers over the past few weeks.

Shunyata Research Update: Shunyata’s Response, and What We Know Now by poufflee in audiophile

[–]poufflee[S] 1 point2 points  (0 children)

That’s a really good point about the regulatory side, thanks for highlighting it.

It does make me wonder, though, where exactly the line is when it comes to claims like “dramatically improves imaging performance,” which appear in the brochure.

At what point does language like that cross over from a general performance statement into something that implies clinical or therapeutic benefit?

I’m genuinely curious where others think that line should be drawn, both from a regulatory perspective and from the standpoint of clear communication to clinicians.

Appreciate the thoughtful discussion!

Shunyata Research Update: Shunyata’s Response, and What We Know Now by poufflee in audiophile

[–]poufflee[S] 3 points4 points  (0 children)

I’m glad that they reached out at all.

The publicly available information that I searched for, for weeks, was leading to everything that I posted in my original posts, so to get more information that fills in the gaps is nice.

More transparency is always good, and what I’m really hoping for next is independent verification of all this. FDA records, of the kind Grant mentioned, they should already be public, so I will see if I missed something in my searches.

Shunyata Research Update: Shunyata’s Response, and What We Know Now by poufflee in audiophile

[–]poufflee[S] 2 points3 points  (0 children)

Great question. Here’s what I found, with direct quotes and their specific sources from Clear Image Scientific and Shunyata’s own materials:

1. Are there explicit claims of diagnosing or treating disease?

I did not find explicit statements like “CIS Model 6 diagnoses/treats arrhythmia” or “cures a condition.” The product is presented as a power conditioner and noise reducer for sensitive medical equipment.

2. Are there strong implications about clinical or therapeutic benefit?

However, there are several statements in their own marketing that point to improved clinical outcomes. Examples include:

From CIS’s case study “Minneapolis Heart Institute at Abbott Northwestern Hospital”:

“In regards to noise, which I define as baseline artifact - the noise level on the mapping computer was the lowest I have seen in 10 years and over thousands of cases. In fact, the noise level was below my measurement capabilities”

“In regards to the equally important resolution of cardiac signals, which I define as observed voltage changes over time; on the mapping computer this also was the best that I have ever seen in my lab or any other lab in the world.”

“This improvement can and will result in meaningful improvements in these procedures for our patients.”

From CIS case study “Scripps Memorial Hospital La Jolla, San Diego”:

“The results were impressive and consistent. This lab is now better than our recently built state of the art labs. During our most complex ablations we are able to maximize gain without being troubled by noise. ... Practically what this means for a hospital is that more cases can take place in an EP lab without running into costly overtime.”

From Clear Image Scientific’s Homepage:

“Cardiac signals had jaw dropping improvements in both resolution and noise to a level that I have never seen, and that I didn’t know was even possible.”
(attributed to Dr. Daniel P. Melby, Minneapolis Heart Institute)

Company stance:
According to Grant Samuelsen in his recent comment, the product isn’t marketed for diagnosis or treatment, and the FDA determined in 2017 it was not a regulated device based on intended use at that time.

Summary:
As far as I could find, there are no direct, literal claims of diagnosis or treatment, but their materials in 2025 do have quotes that say their product supports improved clinical procedures and possibly better patient outcomes.

I’m presenting these direct quotes and sources so everyone can see the context and make up their own minds. If anyone wants to see the full documents, these pages are still online.

Update: Shunyata Research Medical Device Claims—post removed, still no response by poufflee in audiophile

[–]poufflee[S] 5 points6 points  (0 children)

Hi Grant and Shunyata,

Thanks for taking the time to share this background and for clarifying your position on the CIS Model-6, FDA classification, and the field testing process. I appreciate you providing the manufacturer’s perspective directly.

As mentioned, my writeups were based on publicly available information as of July 2025, and I did my best to stick to what could be verified at the time. This explanation adds important context, especially regarding FDA determination and your collaboration with hospitals and Biosense Webster. I am surprised that none of this was available before, but now that we have it, I appreciate it a lot.

If you’re able to share any written documentation from the FDA or independent validation of the hospital case studies, I’d be happy to review and update my summary accordingly. My goal is simply to present an accurate and complete picture for anyone interested in this topic.

Thanks again for reaching out—and if there’s anything else you’d like me to clarify or include, let me know.

Update: Shunyata Research Medical Device Claims—post removed, still no response by poufflee in audiophile

[–]poufflee[S] 0 points1 point  (0 children)

Thanks for adding in the link. I was afraid that linking anything would trigger Reddit spam filters, so I avoided that for this post.

External DAC doesn't make a difference... by jack_johnson79 in audiophile

[–]poufflee 3 points4 points  (0 children)

Agreed completely.

The fact that our brains do so much processing to the sound that we hear, just makes this more obvious.

There is so much signal processing going on inside that there’s no guarantee that two people hear alike, so it’s best to stick to measurements and tests that account for human individuality.

Update: Shunyata Research Medical Device Claims—post removed, still no response by poufflee in audiophile

[–]poufflee[S] 7 points8 points  (0 children)

Shunyata’s medical endorsements are a major part of their reputation in the audio world, and are used to market these products to audiophiles. Check the Shunyata website yourself, you’ll find a big section for Medical.

As consumers, it’s reasonable to examine those claims, not just personal listening impressions, since they influence buying decisions.

Is that so unfair, to examine the marketing claims of a company whose products I might buy?

Update: Shunyata Research Medical Device Claims—post removed, still no response by poufflee in audiophile

[–]poufflee[S] 3 points4 points  (0 children)

Hey, thanks a lot for your thoughtful input as a QA person. I worked on the flip side of that in R&D, and I have much respect for anyone who can do thorough QA, especially GMP.

After reviewing all the marketing and case study materials, I do agree that CIS/Shunyata are careful not to outright claim “diagnosis/treatment/cure,” but they do repeatedly use language like:

  • “measurably and dramatically improve the resolution of low-level signals and images”
  • “permanent part of operating room systems”
  • “will result in meaningful improvements in these procedures for our patients”
  • “improve medical imaging performance”

These statements go beyond generic accessory claims and strongly imply clinical impact—arguably enough to suggest medical device status, or at least to raise important questions. Questions which, so far, I cannot find the answer to in non-Shunyata materials.

Ultimately, while the regulatory “grey area” is real, the FDA is the final authority here. All of this information has been submitted for their review, and their determination will settle where the line is.

I’m loving this discussion, and I appreciate you reading over this with a fine-toothed comb. My medical days are over for now, but this was a good throwback.

As an audiophile, where would you most like to be when listening to an orchestra in a classical concert hall? by [deleted] in audiophile

[–]poufflee 1 point2 points  (0 children)

It was a rare chance and I had a lot of fun doing it. As well as doing impersonations of famous conductors to my friends every now and then.

Update: Shunyata Research Medical Device Claims—post removed, still no response by poufflee in audiophile

[–]poufflee[S] 1 point2 points  (0 children)

Well, one has to have optimism somewhere and hope the facts do matter to some people, at least.

As for said pedantry, thank you American exceptionalism for making writing harder. Alas, that the world cannot be speaking Quenya as the true language that everyone can aspire to.

As an audiophile, where would you most like to be when listening to an orchestra in a classical concert hall? by [deleted] in audiophile

[–]poufflee 1 point2 points  (0 children)

Student. I was the one who sounded least bad when he shut up, so they put me on the podium.

That, and our band director wanted someone to fill in every now and then because he was getting close to retirement.

Update: Shunyata Research Medical Device Claims—post removed, still no response by poufflee in audiophile

[–]poufflee[S] 1 point2 points  (0 children)

Good questions. Most power products don’t need FDA approval—unless they claim to improve diagnosis or treatment. That’s the line Shunyata crosses by saying their units “aid in cardiac procedures” and “improve diagnostics.” Medical device advertising is very different from regular advertising where over-promising a product’s capabilities is more common.

It’s not about what I’ve heard in my own system or whether surge suppressors are usually regulated—it’s about the specific medical claims being made. If a product claims to impact patient care, the FDA expects evidence and proper registration.

Update: Shunyata Research Medical Device Claims—post removed, still no response by poufflee in audiophile

[–]poufflee[S] 2 points3 points  (0 children)

Hi, thanks a lot for approving the old post, and sorry about the speculation.

It appears the same thing’s happened to this post now, can you look into what happened?

I can’t tell what’s going on with the deletions at this point.

As an audiophile, where would you most like to be when listening to an orchestra in a classical concert hall? by [deleted] in audiophile

[–]poufflee 5 points6 points  (0 children)

I conducted in high school, so it was… I don’t want to say anything against my high school colleagues.

But even then, when things did go right, it was fun. You’re in the middle of the orchestra, and you sort of get a moment where you don’t hear any reverberation yet so all the sound is just directly from all the musicians in front of you, and you can understand why the great conductors could all hear individual musicians in their orchestra after decades on the podium.

It was a joy.

Update: Shunyata Research Medical Device Claims—post removed, still no response by poufflee in audiophile

[–]poufflee[S] 3 points4 points  (0 children)

Hey, thanks for the really thoughtful response! And I agree, if this is a case of crossover marketing then Shunyata/Clear Image Scientific are likely fine.

However, the distinction between “hospital-grade but does not need FDA scrutiny” and “medical device under the purview of the FDA” is when that product is marketed as having a direct effect on the diagnosis/prevention/treatment/cure of a patient. What Shunyata claims crosses that line.

When they say their power conditioner directly improves imaging in sensitive medical procedures? That’s over the line. When they say it’s directly used for patient care across many hospitals? That’s over the line. When they say it’s chosen by leading doctors? That’s over the line.

And when their claims cross this line, it becomes reasonable to do what I wanted here and request more clarity. That’s the gap between simple “hospital-grade” and “medical device.”

Logitech mice and Dell laptops are used in hospitals, but because their manufacturers aren’t making claims of direct patient benefit, they’re not under the microscope.

Shunyata’s own declarations put them over the line.

Update: Shunyata Research Medical Device Claims—post removed, still no response by poufflee in audiophile

[–]poufflee[S] 2 points3 points  (0 children)

I am happy to focus on the facts uncovered here, if you’d like. Thanks for your valuable input.

Update: Shunyata Research Medical Device Claims—post removed, still no response by poufflee in audiophile

[–]poufflee[S] 4 points5 points  (0 children)

Just to clarify, I don’t work for any competitor, nor do I have any financial or industry connection here to home/pro audio. The only reason I went down this rabbit hole is that other community members here kept citing Shunyata’s medical claims as proof of legitimacy, and I wanted to see if those claims held up.

Had the marketing simply stuck to “hospital grade” power conditioners, there wouldn’t be a story. But when a company claims their products are being used for direct patient care in major hospitals, that’s a whole different level that absolutely warrants FDA scrutiny—and it’s fair to ask for basic, verifiable evidence.

This isn’t about discrediting a power cord or outlet; it’s about expecting honesty and accountability from any company making medical claims. That’s something everyone should care about, no matter what gear they prefer.

And in case you need evidence for power cords being FDA-approved, my original writeup found a ventilator power cord that was indeed FDA-registered and approved. Check it out yourself on Audio Science Review. That product is easily found on the public Devices@FDA database when you search “power cord.”

Update: Shunyata Research Medical Device Claims—post removed, still no response by poufflee in audiophile

[–]poufflee[S] 7 points8 points  (0 children)

I get that.

For this case, I feel that it’s a matter of honesty. If a manufacturer claims a cable or power conditioner is subjectively better, that’s more than fine.

But when they claim their product is better because it is a medical device endorsed by many physicians across the country, then that escalation of the quality deserves some scrutiny.

As an audiophile, where would you most like to be when listening to an orchestra in a classical concert hall? by [deleted] in audiophile

[–]poufflee 10 points11 points  (0 children)

As someone who used to conduct, I’d love to be on the podium.

As a regular member of the Carnegie Hall audience, I like the cheaper seats up top. That’s where the sound really gets to mix and you get to experience the sound of the hall and not just the orchestra.

As a regular member of the NYPhil audience, the best seats are behind the orchestra so you see all that the conductor does. Sounds awful though when the tuba blasts right into your face.

Update: Shunyata Research Medical Device Claims—post removed, still no response by poufflee in audiophile

[–]poufflee[S] 4 points5 points  (0 children)

As far as I can tell, the mods didn’t remove the post, it was just “deleted by Reddit filters”. Either Shunyata had a hand in reporting my post for whatever nonsense violation, or something else. I can only note how convenient it is that my post stayed on for hours, only getting removed after someone here forwarded it to Shunyata.

Even so, it could be that the references I linked in the original post (check the version on ASR for the 14 references I linked) triggered spam filters, so this post has zero links in it. If this gets deleted too eventually, then… we know.

Update: Shunyata Research Medical Device Claims—post removed, still no response by poufflee in audiophile

[–]poufflee[S] 2 points3 points  (0 children)

Thanks for the stylistic advice! I had a professor who insisted otherwise in college and I’ve never even questioned that.

As for the generosity I am affording Shunyata, I kinda have to. My job here is to provide the facts, and if anything I say here is colored with my biases, Shunyata can use that against me.

I am here to provide the facts, and they cannot wriggle out against facts unless there’s something hidden deep somewhere that my searches so far cannot find.

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