Medical Devices: Bah!

Because HAs are classified as medical devices, users have limited access to normal market support. Instead of Consumer Reports, we have our own specially trained (and financially motivated) professional to explain things. Instead of commonly agreed upon measures of performance, we get flashy marketing phrases unique to each company. Instead of conducting hearing tests after the device is fitted, we are sent out for a week at a time to determine what kind of adjustments might be needed.

Are we really served well by this arrangement?

Hearing aids are classified as medical devices, because they are medical devices. Just like antibiotics are a medicine, and contact lenses are prescribed by a qualified professional.

You could make the same argument about the entire health care industry in the US. The entire system is a for profit system. When you go visit your doctor and there’s a video running about health care in the lobby, who do you think paid for the TV? Who do you think sends the DVDs they play? Who do you think provides the ‘free’ samples?

Pretty much all medical professionals in all fields are influenced by industry forces. Much like our politicians are bought and paid for by various lobby groups, special interests, and corporations.

Not really true, there are plenty of places one can go and read detailed peer reviewed journal articles and academic papers covering a wide variety of ways that hearing loss is being treated and advancement in the field.

The last medical study I read on this said that typically a patient can take 6-52 weeks to obtain maximum benefit from their hearing aids. This means that whatever they get on day one is academic; their brain will continue to adapt to the technology over time, often weeks and months. It would be meaningless to conduct a ‘test’ on the day of fitting to conclusively prove the effectiveness of the hearing aids. It would be like giving a driving test to a teen who just got behind the wheel for the first time that day.

Correcting a hearing loss (which BTW is completely different from correcting a vision problem as an example) takes weeks and months for the brain to utilize the hearing that is still working, together with the artificial sound from the hearing aids. Often a patient has waited years with the problem, teaching the brain how not to hear, and failing to provide the proper stimulation for parts of the brain that deal with hearing.

There are tests that can be done to prove the benefits of a hearing aid, but where would these be if hearing aids were not a medical device? You seem to be arguing for deregulation of the industry, and moving towards off the shelf hearing aids at Walmart. In that world, where are the hearing professionals who are going to help with rehabilitation and meeting goals and satisfaction levels.

Well let’s see. Under the current system, most patients can take advantage of a free hearing test; whereas most medical testing costs hundreds to thousands of dollars. The patient is usually given a state mandated 30 day satisfaction guarantee, along with generous exchange opportunities in the first 2-3 months. Many clinics go above and beyond what the law requires and offers 45-60 day trials.

It’s not often you can buy a custom designed product, try it for 60 days and return it for a complete refund. It’s not often you can meet with a licensed, trained, and qualified person with 10-20 years of experience, and get free advice without obligation.

As I have said before, the issue in America isn’t that hearing aids are considered medical devices (as they are in most industrialized countries), the issue is that we have a capitalist system, for profit private health care, and little to no back up plan for poor or low income families who need help.

Don’t blame the industry for the failings of the American health care system.

“… there are plenty of places one can go and read detailed peer reviewed journal articles and academic papers covering a wide variety of ways that hearing loss is being treated and advancement in the field.”

Information not readily available to consumers. We must rely on Audiologists to digest and spoon feed us. This forum is best I know of on the Internet.

ZCT: "The last medical study I read on this said that typically a patient can take 6-52 weeks to obtain maximum benefit from their hearing aids…˝

Yeah. Maybe for a 75 year old first timer.

“It would be meaningless to conduct a ‘test’ on the day of fitting to conclusively prove the effectiveness of the hearing aids. It would be like giving a driving test to a teen who just got behind the wheel for the first time that day.”

Again, first timers. Straw man argument.

“You seem to be arguing for deregulation of the industry, and moving towards off the shelf hearing aids at Walmart.”

Absolutely. When I buy an automobile, I research my options and start visiting dealerships. I don’t go to an office where somebody shows me a picture, sells me a car, delivers it a week later, and then explain how if I’m dissatisfied it will take 6 to 52 weeks to appreciate the product.

You missed a part. You only have a 30 - 90 day evaluation period to commit to buying the automobile even though it can take up to a year to appreciate it.

Sorry mate, but that’s a pointless comparison.

How about you compare the average time it takes to have a working understanding of a second language after immersion.

Your mental plasticity and habituation will be different from the next person your age, and will vary even further based on exposure levels, motivation and the adjustment of the aids.

There are several outcome based analyses, look at the Glasgow test or COSI for a couple of examples. Unfortunately the responses seem to vary depending on how and when the questions are asked.

Ultimately, you are the final arbiter in a very personal experience, if they don’t work for you, don’t pay for the aids/service.

As usual, someone thinks that a simple fix will change the world for the better.

So does anyone REALLY believe that changing the classification of hearing aids will revolutionise the world?

OTC aids are already available and self-programmable aids are already available so exactly what new product offering or service will magically appear if hearing aids are suddenly treated as non-medical devices?

Albert Einstein said: “A scientific theory should be as simple as possible, but no simpler.”
Maybe we could rephrase this as: “A complex industry sector should be as simple as possible, but no simpler.”

I suspect that the key issue that many US posters have is price. If they can’t afford hearing aids they want to take out their annoyance on someone - often in this forum.

Well, the US is the definitive free-market capitalist society : in return for a lot of freedom Americans have to pay for almost EVERYTHING they want, consume or need. If you don’t like this aspect of American life please use your vote - and don’t blame dispensers, manufacturers etc for the way your society works.

Here in Europe we have far less freedom, few firearms, many public sector ‘workers’, very high taxes, very overcrowded countries … and in return we generally have free health care including free hearing aids.

Nobody over here seems to be demanding that hearing aids be reclassified as non-medical-devices. What would be the point? What would a European gain from such a move? Would they even understand the argument?

My 8 year old aids have features that were missing on the self-programmable aids I tried.

Are you really trying to say that 10 year old technology aids are similar to the modern aids available today??

Are you really trying to say that 10 year old technology aids are similar to the modern aids available today??

Not really.

However do you think that having more capable aids would really change the argument?

In fact making very complex self-programmable aids available could be self defeating in most cases.

Sure maybe you and a few here would do fine with a very complex product - but many would simply mess up big time. So who will take responsibility for hearing damage and/or support costs at this point?

Anyway, forget all the arguments about ‘your rights’ … there is no current workable business model to allow the supply of top-end self-programmable aids to the relatively small number of users who seek such products.

Sure, ‘grey markets’ and ‘back doors’ will exist, in the same way that car obsessives can reprogram the settings in their car computers. However don’t expect to see mainstream user-programmable highly complex aids in your supermarket any time soon.

And to be frank, it’s fairly pointless writing endless posts in this forum moaning about the situation. Accept the fact that you will need to use the grey market - or train as a dispenser - in order to obtain the kit that you want.

I know I could do at least as well ( & probably better) than my professional did no my last visit. I just got my right aid back from repair, and we agreed that both aids needed to be reset to start from scratch.

After they were reset, he ran the feedback adjustments. I mentioned the aids sounded unbalanced, but he wanted to try something else.

He then started soundpoint on his laptop and had me pick a setting, which was near one corner of the screen. He would not do any other adjustments. I even suggestind running SoundPoint again because I noticed it started at the center of the screen and I ended up at one edge.

I now need to return because my left aid is too low. I was suspecting a problem with it before the right aid died.

He now will need to stay late while I drive the 25 miles to his office…

All true…with the aids available today.

Aids on the market now are designed from the bottom up to be fitted by a trained professional using sophisticated software. There is no other market for manufacturers to sell to other than licensed professionals, both by law and by custom.

With modern technology aids do not have to be designed and sold that way. Aids could be designed for simple self adjustment by simple remote ( $15 cost) controls…no computer necessary.

Above applies to the majority of loss types. Not severe, not profound, not complex losses. These will require trained pro’s. IMO Ed

“Audiologists made fewer serious fitting errors than did hearing-aid specialists, but in about two-thirds of all of the fittings, patients ended up with incorrect amplification.”

If the hearing test is good enough to program HAs by, why isn’t it good enough post-fitting to make sure the correction is sufficient? Follow up like that would be helpful to both the dispenser and the user.

I don’t remember the age range on the sample group but I’d bet good money the average age wasn’t 75 or over. Fact is, whether you want to believe me or not, it takes time for the brain to get used to hearing aids, and the longer the loss has been going on, the longer that is likely to be.

Clearly you are confused about the definition of a straw man argument.

I stand by the statement (with medical facts on my side) that the results of a test of hearing aid effectiveness on day one would be a lot different to results after adaptation to hearing aids.

That’s because a car is not a device designed to help you with a medical deficiency. A car is an item that can be evaluated objectively in terms of performance and subjectively in terms of artistic design.

Hearing aids are designed to assist with a permanent hearing deficiency caused by damage (generally) to the hearing nerve.

While getting used to a new car is a real thing, it’s nothing like completely learning to hear again via an artificial device.

The bottom line is, due to the reality that a hearing loss involves using a medical device to improve the situation, and given the medical evidence that re-learning to hear again after years of experiencing a significant and progressive hearing loss one cannot realistically compare it to the purchase of a new car other other similar high ticket item.

Seems like a very broken, oppressive system.

One example: Gun Control's Twisted Outcome -

Looking at a typical fitting session…

The presemt standard operation of the fitting process is basically flawed in that the loop between the fitter and the patient is dependent on the patient answering correctly.

The patient is asked to evaluate the fitting adjustment; ie; “Now how does that sound?” How is the patient upon hearing the new adjustment for a few seconds supposed to accurately evaluate the new sound based on just the pro’s voice. Few if any offices have the equipment to simiulate real ambiances…or real life.

This is another reason, I maintain that self fitting could produce at least as accurate adjustment as a professional assuming the patient is sentient and has mental and physical dexterity and the aids were designed to be self fitted.

OK Ed you’ve said it a thousand times…enough already… Ed

How is the patient that has problems hearing high, soft voices supposed to evaluate the new sound based on the pro’s low, husky voice?

I guess it probably would to someone who only reads articles that support their view point.

However, your article rather conveniently brushes aside the tiny issue of homicide. :eek:

I have not researched your article to determine if their statistics are correct on other crimes, but when they skipped over the very important issue of being deliberately killed by another, I got curious. So I turned to Wikipedia and sure enough there is a list of countries by homicide rate:

Unfortunately in the States, while it may be true we are less likely to be a victim of violent crime, you are in fact FIVE TIMES more likely to be murdered than in the UK, and that’s stayed consistently true for about the last decade (or almost as long as the government crack down on firearms in the UK). So would you rather be mugged, or killed?

If you intentionally leave homicide out of the equation when writing a biased pro-gun article, it can sound very convincing. Unfortunately leaving out the homicide rate skews the entire debate, since it seems that in the UK you might get beat up, or have your wallet stolen, or get broken into. But while that ends as nothing but a horrible violent crime, in the US the same scenario ends up in the victim being slaughtered. So now it’s a homicide, and the other aspects of the crime are pretty much ignored. If I steal a guys wallet and then shoot him in the head, I’m pretty sure the prosecution is going to focus on the murder conviction rather than what I was doing prior to pulling the trigger.

Also it is important to note that America has one of the most aggressive criminal justice programs in the world, resulting in more people being locked up in jail than any other country. So it would be pretty easy to argue that guns aren’t the reason for crime stats, jailing anyone who looks vaguely suspicious, poor or a minority, might have more to do with the lowering of violent crime, as opposed to gun laws.

OK Ed you’ve said it a thousand times…enough already… Ed

True … but at least you have drive and passion … unlike 90%+ of the general population.

The main issue, as I see it, is that you over estimate the proportion of users who might want any form of self programming.

Most people can’t even set the clock on their video recorder, so programming hearing aids would really be a challenge!

Without a commercially interesting possible user base, the manufacturers simply have no incentive to provide aids, programming software … or most importantly the required very, very expensive support & hand-holding.

As an example, I once worked at a senior level at a mobile phone company. We made around 850,000 phones a month with a total global staff of 450. We could support the networks and the biggest distributors … but no way did we have the staff to support small shops and certainly not end-users. So how could we ever find enough money - or staff - to support 850,000 NEW end users a month? We would also need to support purchasers from all prior months. Sorry, not possible … unless all support was charged for at cost plus a bit of profit. Say at $100 per hour.

By chance I spent today at a large hearing aid factory: maybe 100 staff with several hundred aids a day being processed. The place would have to be HUGE to deal with end-user support … so how would they find the huge number of extra staff, premises and most importantly the money to support say 1% of their end-users?

Simply won’t … and financially CAN’T happen.

Well I was expecting a rant about $200 hearing aids from Walmart that are magic and self fitting, so I have to say I was refreshed by what you wrote. :wink:

I was working with a patient yesterday and he popped into my head as I was reading what you said.

Some people are not good at articulating how they hear, and so it ends up with some guess work on the part of a hearing professional trying to get things right.

I think the Starkey Soundpoint system is a step in the right direction for giving the patient some significant levels of control over the sound. In a study of the technology 44% of patients found improvement over the regular dispenser settings.

Perhaps companies will take this kind of concept further and it will lead to better fittings down the road. After all better fittings lead to fewer returns, and that creates more profit. So it’s not like the companies are not on board with the concept of helping people get closer to whatever makes them happy.

Can I write them off?