Interesting article about Medical Grade Claims

Shadowfax said:
This came up on my feed today and since I work in the field of Agency Approvals I found it interesting. There seems to be some gray areas on both sides.

www.headphonesty.com

Audiophile Brand Allegedly Used Fake Hospital Endorsements to Hype Up Their Cables and Conditioners

An engineer dug into the company's hospital claims and forced them to respond publicly.
www.headphonesty.com www.headphonesty.com
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It appears I'm late to this post. I was sent a link yesterday and would like to address the questions originally posted on reddit. I work in the field quite a bit and don't get to forums very often.

Regarding the Reddit post that turned into a AI style re-post on headphonesty.

It's a difficult decision to respond to mis-information being spread on the internet. There's usually nothing to be gained by replying to anonymous posts like the one referred to. The original poster made a series of wholly inaccurate, inflammatory statements that were eventually sent to us. It looks like that post then migrated into an AI style article; I don't know what else to call that. Two surgeons I've worked closely with in the electrophysiology/heart surgery community replied to the misinformation with their experience. Those responses weren't copied over, so I’ll add them below my reply.

Anyone can post uninformed accusations on-line with relative impunity. In this case, someone claimed their ‘investigation’, that did not include contacting us, proved Shunyata/CIS does not have necessary FDA approval'. The entire FDA premise is factually wrong. I know this in part because our products were at FDA for almost two years before we were told they did not fall under FDA purview-- they explained why..

- FDA approval is not required for CIS products to be used or tested in medical settings any more than it is for other passive, removable power taps (see Surgeon's explanation below). The OP originally demanded answers about FDA, then transitioned to questioning the measurement results after my response. There's a lot of context unsaid here, but I'm trying to be brief without being accused of avoiding addressing something.

- CIS products met all electrical standards for testing and application during the period CIS products were tested in EP labs between 2016 and 2020 and the start of covid. On-site testing was done with biomedical oversight and in cooperation with surgeons and clinical staff at every lab I visited. Our sole interest in testing was to collect data and qualify for partnership in the medical space.

- We have not tested CIS products in EP labs since COVID disrupted our cooperative testing with Biosense Webster(BSW), but will resume if an opportunity for collaboration surfaces. Although CIS products were recently certified for medical use in Europe through DEKRA, we have not tested products there yet, or claimed to.

The OP implied that we manipulated or crafted measurement results and data. Although he cited no specifics, I assume he's referring to the measurement data posted on www.clearimagescientific.com see - case studies.

-The OP's speculation ignores the fact that the measurements and endorsements were posted with the intention that they be shared and vetted within the medical community. The measurements posted were fact checked and shared beginning in 2016. We posted what was sent to us as is, which explains why the measurements are still there.

- All of our testing in EP was vetted by the senior science officers from the largest supplier of electronics for Electrophysiology, Biosense Webster (BSW) a J&J company based in Haifa, Israel. This was done prior to CIS signing a 2 year contact with BSW for testing in early 2018. I traveled with their team of science officers multiple times to US labs for almost two years.

- At their invitation, I also visited BSW headquarters and animal labs in Israel twice for product testing. It would be implausible to suggest we faked tests and feedback generated within an interconnected community of medical experts, science officers and surgical teams. BSW only signed a contract with us after vetting all we had done prior.

There was one final insinuation I'd like to clear up, that we perhaps conjured an HRS Journal submission: Fact: The principal biomedical and surgical team at Deborah Heart hospital performed a meticulous series of tests using CIS products. They considered the results significant enough to submit them to the Heart Rhythm Society Journal. As with many HRS submissions, their test results were not subsequently published. The submission was then shared with us as a data point given its granularity. The idea that we would make up data with everyone's name attached to it, while at the same time inviting scrutiny from prospective partners, leaves a fairly big gap in logic. Like many emerging disciplines, top EP surgeons and labs interact with one another on a regular basis.

Finally, I'd like to thank the two surgeons who sacrificed time out of their schedule to post their experience with our products in the original reddit thread. I've copied their posts below fwiw. Hopefully, this satisfies some of the pointed curiosity.

Regards,

Grant Samuelsen
Shunyata Research
Clear Image Scientific

From the original Reddit thread:
I’m a practicing cardiac electrophysiologist posting in a personal capacity. I have no financial relationship with Shunyata Research or Clear Image Scientific (CIS).

In 2016–2017, at our invitation, Mr. Samuelsen (CIS) brought passive power-distribution equipment to our EP lab. Testing occurred during scheduled clinical days under biomedical engineering oversight and standard hospital policies.

Across multiple sessions, we observed a repeatable reduction in baseline electrical noise on our EP recording/monitoring systems under typical clinical loads. In one representative series, baseline noise amplitude decreased from ~0.08 mV to ~0.006 mV with the CIS equipment in place (>10-fold reduction).

Separately, I was aware of—and interacted with—Biosense Webster R&D personnel during their two-year evaluation agreement with CIS that ended when COVID-19 disruptions began. My understanding from those interactions aligns with multi-site field testing during that period.

Why FDA clearance was not required (specifics):

FDA regulates “medical devices” based on intended use, not on whether a product touches a patient. The agency states: “To determine if your product meets the definition of a medical device, you should define the intended use and indications for use of your product.” Products not intended for diagnosis, cure, mitigation, treatment, or prevention of disease are not medical devices under federal law. U.S. Food and Drug Administration U.S. Code

An article becomes a medical-device accessory (and thus a device) only if it is intended to support, supplement, or augment a regulated parent device’s performance, which FDA evaluates primarily from labeling and promotional claims. Passive, general-purpose power-distribution/conditioning equipment without such medical claims is not an accessory. U.S. Food and Drug Administration+1

In hospitals, the use of power strips/relocatable power taps is governed by facility codes (e.g., NFPA 99) and UL listings (e.g., UL 1363A or IEC/UL 60601-1 where applicable). CMS permits their use when those requirements are met—this is a facilities/electrical-safety compliance issue, not an FDA premarket-clearance pathway. CMSHFM MagazineFDA Access Data

This comment is limited to the points above. It is not a publication and makes no claims beyond the measurements we observed locally. I won’t be engaging further in the thread.
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Hi, I am a cardiac electrophysiologist and director of our EP labs. I’ve known Grant since about 2016. He reached out to me regarding the current discussion since we worked together evaluating CIS products in our lab. I have no financial relationships with Shunyata or CIS.

Just for background, in the EP lab we evaluate low level electrical signals in the heart using specialized catheters and recording systems, at times looking at signal amplitudes as low as 0.1 mV or even less. In the EP lab EMI is common due to the large amount of equipment as well as being connected to the hospital electrical grid. Noise is the enemy of good signal analysis at these levels and having a low noise floor is critical. After hearing from another EP physician, I reached out to Grant. We were having noise in one of our labs as high as 0.1 to 0.15mV at the time. He made a trip to our lab to trial an early CIS unit. After Our biomed engineering team evaluated and approved the unit for our use as per their standard for any new equipment that comes into the hospital, we were able to reduce our noise floor to less than 0.01 mV and this was a consistent result.

I am also aware that Shunyata/CIS contracted with Biosense Webster R&D in 2018 to evaluate the CIS units. I independently confirmed this during conversations with individuals at BSW. We did not publish data or papers on these findings, but the difference CIS products made were observable and allowed us to more easily do our work.
 
I've been in the business for a very long time. over 50 years, and there are many bad actors and bad companies in Audio. Shunyata is not one of them. They are good guys. I am not talking about product, anyone can have their own opinions as to what they like and buy , but as a business and to interact with them and their staff is a pleasure.
I have dealt with too many companies to mention and Shunyata, Grant , Richard etc are always straight forward and receptive. They IMO are on a short list of companies to praise and want to do business with. This same "publication" wrote an article about an interview I did , used info and pictures and NEVER contacted me or the video's creator.
A word to the wise
 
BendingWave said:
I've been in the business for a very long time. over 50 years, and there are many bad actors and bad companies in Audio. Shunyata is not one of them. They are good guys. I am not talking about product, anyone can have their own opinions as to what they like and buy , but as a business and to interact with them and their staff is a pleasure.
I have dealt with too many companies to mention and Shunyata, Grant , Richard etc are always straight forward and receptive. They IMO are on a short list of companies to praise and want to do business with. This same "publication" wrote an article about an interview I did , used info and pictures and NEVER contacted me or the video's creator.
A word to the wise
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Was the article about the interview you mentioned above factual?
 
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