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How concerning is this judgment?

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Advanced Bionics LLC to Pay Over $12 Million for Alleged False Claims for...13

Advanced Bionics LLC, a Valencia, California-based manufacturer of cochlear implant system devices, has agreed to pay more than $12 million to resolve allegations that it misled federal health care programs regarding the radio-frequency (RF)...

While doing research on which cochlear implant to choose I ran on to this judgment against . I’m not sure how significant/harmful this misleading statement about “radio-frequency (RF) emissions generated by some of its cochlear implant processors" is. This certainly doesn’t give me a warm and fuzzy feeling about AB. Any thoughts?

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I’m certainly no engineering whiz, but it does rather conjure up coverups in other industries and/or companies, Big Tobacco, leaded gasoline, Love Canal, Flint MI water, diet pills … it wouldn’t be the first time that an “inconvenient” truth was swept under the carpet. I would also not get a warm-fuzzy with a company that deliberately misleads, mis-states, lobbies to influence, or creates a corporate culture of profit over quality of life (think Enron’s backroom dealing with CA’s energy grid providers).

As far back as 2021, AB was in trouble for selling knowingly defective CIs8 - some 50% of devices sold, many to children. I don’t know how a company could retain any crediblity after such blatant abuse of their patients.

I just chose for my surgery Nov 30th. This would not have changed my decision. These sorts of issues could be anywhere and we may not know. Now that they have been fined for it, they will be more careful. Maybe the extra oversight will be a good thing. I like the technology and the way it pairs with the Phonak Link . AB is owned by the parent company that makes Phonak, and they are mainstays in the hearing aid world.

In reply to @1Bluejay

@1Bluejay said:

I don’t know how a company could retain any crediblity after such blatant abuse of their patients.

have always been known for faulty internal parts going back years, that need to be replaced. That’s one of the reasons why I chose Cochlear.

This just affect the external device HW, not the internal HW. Not a big deal. this tells me is willing to cut corners on a $12k device… does not look good at all for a company that have way too many recalls…

Disclosure: I am team yellow! (Cochlear Ltd)

I’m sure it was the internal hardware that needed to be removed and replaced.

This article states revision surgery was required.

HiRes Ultra Series Recall: Failure Rates and Revision Speech Recognition...7

Compared to manufacturer reporting, a high number of patients experienced hard failures of the Ultra (V1) and Ultra 3D (V1) devices. Early identification of failures is possibly because of the diligent use of electrical field imaging testing. Most...

Thanks for all your replies. It seems this problem may not be a decision changer but it is indicative of other problems has had over the years. There are things I like about AB’s implant and I have used phonak hearing aids for years. But I would be kicking myself if I chose AB then had problems. It is going to be interesting to hear what the surgeon has to say on the 17th.

In reply to @eam4094

@eam4094 said:

It is going to be interesting to hear what the surgeon has to say on the 17th.

Hey, even if your surgeon recommends , go with your GUT. You never know what goes on behind the scenes. Sometimes surgeons get kickbacks or perks when they recommend a vendor.

My gut tells me to stay away from AB. They deserve the loss in business they should be getting. It’s unacceptable, unprofessional and criminal to knowingly peddle a medical device with FLAWS.

Like, go make a fast buck selling rubber crutches or screen doors on subs, ok?

Aren’t kickback illegal for medical device but I suspect people in the US choose because it is made/designed in the USA…

Technically I bet kickbacks are “illegal” here in the US but vendors will offer other perks like expensive dinner out, golf date, or maybe even a supply of clinician coats embroidered with their logo. I’ve seen that at clinics where they promote a single brand (even if they can be arm-twisted into fitting you with another brand).

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