Hearing aid design flaws on the rise

Hi I am new to the site. I really am sorry if there is another forum on this topic, I haven’t been able to find one using search function.

My first 4 behind ear hearing aids back in the 80’s lasted 5-6 years before the first failure occurred that includes several accidental drownings in bath or shower. These hearing aids were thoroughly tested because of different regulation regarding quality control that were in place back then regarding medical devices.

I joined because I am a lifer for using hearing aids and I been encountering more sever and catastrophic design defects that is costing massive out of pocket costs above and beyond the initial cost of purchase, along with a drastic increase in the frequency of design defects which further increases the profit level as companies try to maximize profits. I have a problem with this in that hearing aids costs are extremely inflated compared to other tech of equal level that is not a medical device as is. Example amplified cell phone with voice correcting technology costs on average 100-200 dollars yet hearing aids with the same level of tech costs $1000-$2000 on average. The initial cost is so over inflated that it is insane to have a medical device fail so frequently. We are defiantly NOT getting what we paid for.

I had to use medical assistance to get a set of hearing aids so I didn’t have many choices. the hearing aid i currently use is identical in both ears and looks exactly like the diagram in the following link minus the boot that fits over the battery housing.
http://www.resound.com/us/Download%20Document%20Library/ReSound%20Ziga/User%20Guides/7080_MK602118rA.pdf

I am conscientious about how much tax payers have to pay in my name and I am frustrated for I have had these hearing aids fail or break 3 times in 2 years because of design flaws which were result of cutting corners to make a bigger profit and were not tested at all to ensure that the hearing aid works as intended.

the average bill for repairs starts around 300$. I have a suspicion that it actually was significantly higher because these were catastrophic failures. Since it was MA(tax payers) Who paid the bill, I did not get to see how much the actual cost of repair was. Problem is, the frequency of breaks is driving up the total cost for the hearing aids being paid in a 5 year period, therefore technically its not the lowest bidder for government contract for the cost is spread out over time. Yet when the initial bidding was done they only listed the initial cost of hearing aids to win the contract, THEY DID NOT INCLUDING THE COST OF FREQUENT REPAIRS DUE TO DESIGN FLAWS IN THEIR BIDDING!

following is main cause for damage and failures:
The kind of moisture that does the most damage is moisture coming from the skin(sweat) for it contains several ingredients that are catastrophic to the sensitive inner workings of hearing aids. the 3 main ones that come to my mind is acid, oil, and salt. Plain water from rain or the tap doesn’t have these properties so it doesn’t have as damaging effect as sweat.

Now I want to point out the design defects. Take a look at numbers 4 and 5 on the diagram on the linked page. those are the mic holes they are on both sides, because it was cost cutting(increases profit) to make one hearing aid casing for both ears. So in order to use 1 housing for both ears the mic holes is on both right and left sides of the SAME CASE (4 holes all together), which means that 2 funnel holes rest right against sweaty skin funneling sweat into the internal housing. Because the rest of the housing is water resistant once the moisture gets inside it nearly imposible to dry it out quickly enough before damage is done. Why does it take so long to dry out you ask : Here is the answer the only evaporation point for the internal workings is the mic hole and the oil in the sweat slows evaporation.

The other major defect is the battery housing which #8 points too on the diagram I linked to. It does not seal tightly to prevent moisture from penetrating. Every single night when I go to bed, I open my hearing aid battery compartment before putting it in a dry-aid container to see that it is completely soaked in sweat from the days use. (I never had this problem with my hearing aids from the 80’s)

I have absolutely no problem pointing out these major design flaws out in that these design flaws would have been picked up with in the first half Hour of testing being worn by a person taking it through its paces in the real world.
I picked these flaws out before I ever got them. I had no choice because all the options available to MA clients had similar DEFECTS. and the alternative is to be practically deaf.(severe hearing loss)

current medical device law has a major loophole that allows companies to bring products to the market without testing because the one brought to the market is similar to another but not the same.

For the crazy prices we are forced to dish out these medical devices need better custom designing and Thorough testing before ever being released to the public. Medical devices need to be as free from design flaws as possible and have rock solid reliability. These devices should not fail for its entire life of use our lives depend on these devices that the haring world takes for granted. Last thing you want is say having a hearing aid fail just before you go through a cross walk and your not able to hear the car screeching its breaks, who is about to hit you.

I’m not sure how to respond to this without sounding completely patronising, but have you ever thought the ‘holes’ might be necessary for the aid to function.

Without Testing: that’s just nonsense - products aren’t always perfect, but do you really think manufacturers would invest a few million in releasing an untried product.

I do believe there is no reason for you to worry about your level of patronising considering your qualification as professional, your number of postings, the number of won fights, …

But have you ever considered the possibility of the existance of non-audios who are in a similar manner qualified as professonals in the design of ruggedized eqipment who deny the necessisty of this moisture sensitive "holes? or the existence of others knowing about DSP and appropriate costs for these devices? …

There is imho no need to further thr “healthyness” of this business with techno bubble.
Purgatorio

There’s a significant difference between presenting the facts involved in this whole industry and peoples’ individual perception as it relates to them: but that’s an argument for another day…

Ok, if you want to take it from the ground up, basic engineering form design involves a spatial construct of all the elements needed for the design to function properly. within each of the elements you have engineering trade-offs.

Take the battery compartment as an example: you said - they wick sweat in, the Engineer says: there must be air-flow to allow the battery to function. OK lets use a gore-tex filter and seal the door: two months later that is covered in grease an the aid loses power after an hour. Also Mrs Jones cannot open it so easily with her arthritic fingers any more. Who was correct, you or the engineer who introduced the design flaws?

…patronising at its best … isn’t it?

Ok, let’s take that for granted. (Yaaawn)

Ok, and an other engineer with less submerged (hihi!) phantasy says, lets not seal the batt compartment but the electronics. That might save it from sweat and under water hearing is for the whales (God save them!). Besides, the OP refered especially to the symmetric mic vents, where the inner ones each -stemming from the cost reducing symmetry- are unnecessarily over-exposed to sweat.

… would hail to more inventive battery change regimes offering more convenience (and precision in contact and insertion) and robustness then the current designs do.

I’d say, me and the more creative engineer are right and “the engineer who introduced the design flaws” is obviously wrong (disregarding the truth that current batts need air). FLAWS are never “right”.

Btw, I forgot to mention the current hype about “water resistant” HAs! This is a misnomer or euphemism (as you like it) escamote from the so called “haute horlogerie”, which adhere to a pricing ethos related to that of the HA industry, where this same term is similarly misleading. But still these design efforts strive to appreciate the moisture problems and do not try to hide them behind “correct engineers”.

HOHs may be engineers themselves.
Purgatorio :stuck_out_tongue:

Corey,
If you are having as many moisture problems with your HA as you seem to be having, I would get a dry and store and start using it instead of just using a dry aid container. you might see a drop in the number of repairs.

I believe that Um Bongo has a background in electronic device design & volume manufacturing, so his opinions count.

I have a background in mobile phone design & manufacturing, so hopefully I can provide some useful input too.

Any poster who tries to suggest that modern electronic consumer products are carelessly designed is totally and utterly wrong. A typical engineering team might be SEVENTY people. They are highly skilled and aren’t messing around.

The idea that consumer products are not tested is also ludicrous. Totally ludicrous.

This forum does have some posters who are qualified engineers - but who do not appear to have worked in the very special environment of a major product design & development team. Sorry, but engineering experience gained in a ‘small’ environment will not give you the full wide-ranging experience of a major product development.

The bottom line: Hearing aids, mobile phones, computers are designed & developed by skilled teams (not individuals) who carefully optimise product performance, function, reliability, usability, style etc … without being instructed to maximise profit, cheat the client etc!

By the way, comments such as “Yaaawn” are totally uncalled for in this forum. We have major arguments here which can become very heated … but we remain polite.

The idea that consumer products are not tested is also ludicrous. Totally ludicrous.

I couldn’t agree more. I worked in R&D for a couple of years developing Pager technology in the mid 80s. The average testing phase was in the range of 18 to 24 months before the product was released to the public. Todays electronics are much more sophisticated and complex than those of 20 years ago and therefore undergo more sophisticated and complex testing producing a very reliable product.

Makes me miss pagers…

Sorry, Post in wrong forum !

I’m not going to argue with you about ruggedisation, other than to ask you why one of the most popular mobile phones is made from glass which requires you to put a plastic case over it. And if you have ever had to shout a warning across a whitewater river to a kayaker with a 70 dB loss, it’s even less of a question.

I’m sure that the ‘engineers themselves’ would probably appreciate that hearing aids need to be ‘life-tested’. I’d suggest you’d see that as part of the design process.

Having a go about the number of posts and ‘winning’ arguments is all very good, but it doesn’t fundamentally alter the paradigm of the current industry, which is largely based around the work of a man called Lars Kolind. He observed that this kind of industry can either operate in a low quality ‘fast and dirty’ model or a high quality ‘expensive and trustworthy’ one. He opted for the latter and put the supply pricing up on all the product coming out from Oticon at the time. The benefit of the latter model is that people can be trained to provide decent quality CE marked product through a reputable supply chain.

So, hearing aids can be produced more cheaply, but the current ethos of the industry isn’t based on that. Take it up with Oticon - Kolind has left now.

I am somewhat disappointed about the level of taking a very punctual write up by some posters with decent open mindedness. I personally perceive it ludicrous (yes!) that the cavalry mounts to prosecute one little red indian -who dared to mention disconsent- by alleging statements he never made. Trying to make myself clear:

  • I really do not care about anyone’s background in the forum nor will I bring mine into play: I try to focus on the semantics/pragmatics of the written statements.

  • I do not share, but try to respect the biggest part of corey’s and other’s opinions.

  • I was however seduced to oppose to a guru’s inappropriate opinion about some -proven unnecessary- holes and his playing with being argueably not patronising. BTW, no word has been said about these holes since!

  • Never did I state any sympathy for the untestedness claim of corey (indeed, I consider “life testing” part of product development, perhaps not exactly of “design”) nor did I mention anything about careless design by teams being as big as you like!

  • When some people are annoyed about my ironically (hihi!) expressed fading attention when reading platidudes about engineering, but in the same posting can not get enough of using the word “ludicrous” about other people’s (evidently emotional) statements, I still offer them my honest pleed for pardon for hurting their feelings with my evil word “yaaawn” (sic!).

  • I do not back the opinion of developing teams being generally allowed to sacrifice economic principles in favor of what you like. I rather adher to them being encouraged to “maximise profit”. Certainly “cheating” is abolished and product quality is a necessary asset (Yaaawn, OK?).

  • I am also not participating in a discussion abot ruggedisation, although it is interesting on its own why and in which parts of a modern smartphone “glass” is used (its the fingers and not the tightness) and why they did not use a titan but a plastic frame (please do not let it be price/quality rather style/performance, … :wink: ).

  • Another discussion I will not join is about the SPL of white water and the distance coverable by shouting in this setting.

  • As you can read I ascribed a certain ethos (call it strategy if you prefer) in pricing to the HA industry and did not particularly complain about it -just pointed to their relation to (really) high level DSP-, but I am just not quite sure if it serves the customers best. Nevertheless I feel incapable of discussing this theme too.

  • The number of postings and winning debates have nothing which correlates to ethos (of companies), only (positively?) to patronising (so perhaps … take it up yourself?).

  • Finally, I will try to answer any argument but I am annoyed by handling unfounded presumptions.
    Purgatorio

N.B.: I think, seb is the one who made this thread hopefully helpful.

I am unfamiliar with a change in quality control law since the 1980s. Perhaps you could share these regulatory changes with us?

In all fairness. A cell phone does not cost $100 - $200. When you buy an iPhone 4S, it costs $199. Then there’s an activation fee, a two year contract, a data contract, a smart phone fee. On Verizon, as an example, the bare minimum you are getting billed for is about $90 a month. So that’s $2,160 you’re on the hook for, and that’s before they up sell you things, or bill you for exceeding your texts or data, or minutes. A moderate user with unlimited talk and text, and a medium data plan is going to be well over $3,000 in the contract period. And stuff you don’t use can often get stolen from you and not rolled over even if you paid for it. And when that shiny new iPhone 5 comes out, they’re going to charge you for the phone, tack on another two years of commitment, and probably charge you a $200 early upgrade fee too. Oh, and if you ever want to change your plan, you’ll probably find that the new plans are not quite as good as the old one, but if you want to change a single option, you are forced into the new plan which was never part of your original agreement with them.

Conversely a typical hearing aid purchase includes free testing, free adjustments, free clean and service, for many years with a trained, licensed and qualified hearing professional, who is a little more expensive to hire than a cell phone salesperson.

Well that is a flaw of American health care, not hearing aid companies. They just operate within the confines of the society they are operating in. ReSound probably gives those same hearing aids away for free in the UK, via the NHS.

You are talking about one device out of a sample size of millions, an extrapolating ‘facts’ that are simply an opinion. Maybe that design is a lemon. Does it mean that all hearing aids from all companies in the world are the same?

I’ve seen hearing aids that last over ten years without problems.

Starkey introduced the first fully comprehensive warranty back in 1973, and over the years most hearing aid companies have adopted the concept of a fixed repair charge. They charge one fee, and that includes any repair from a catastrophic repair to a minor repair. Through this system some repairs will lose the company money, and some will make the company money. But it protects you from sending in a repair, and the lab simply telling you that you have to buy a new hearing aid.

Some manufacturers do however put a limit on how long they will offer repairs on hearing aids, which I think is a bad idea.

Also it should be noted that it is not uncommon for a repaired hearing aid to return with a full one year warranty. It is also not uncommon for the hearing aid to be sold with a three year warranty.

So for many patients even if the aid does break in the first three years, the repair is free. If it breaks in year four, it is repaired for (let’s use your number) $300, and now is warrantied again for another 12 months. Compare that to other electronic products. What do you think Apple is going to say if you walk into their store and tell them your four year old iPhone just broke? How about your TV? You think they are going to repair it for $300 and give you another year of warranty?

Your experience might be different simply because the organization was trying to save money by negotiating a shorter warranty.

In recent years most hearing aid companies have gotten on board with nano-technology that protects hearing aids from moisture. This is a wonderful development. Last year some manufacturers introduced a dual layer nano technology that also repels oils. The outer layer catches the oil, the the lower layer repels moisture.

It seems that many manufacturers are working on the whole waterproofing concept.

You are making several assumptions here. I don’t know why this company chose to do things the way they did. But it is a stretch to simply assume it must have been for cost cutting purposes and extrapolate from there.

But I agree, it seems pretty dumb to stick a hole next to the mastoid. Of course you could argue that even if the mic hole was on the back of the aid, hair can still transmit sweat into the mic, which is why there should be a nano-coated membrane to protect it, which there is on many hearing aids today.

When you bought batteries in the 80s, they were mercury batteries. These cause significant environmental problems, so they were largely dumped by the industry. The replacement is a zinc air battery. Essentially a membrane on the top of the battery allows air in, which starts the chemical reaction that produces the electricity. As far as I understand it batteries perform better if they have access to air ongoing, so creating a completely waterproof seal on a battery door would starve the battery of air, which may not be a good idea.

What makes you think they don’t test hearing aids? Speaking of the company I am most familiar, I know that they do extensive testing of all their hearing aids. They have focus groups, and patients participating in real life trials. They even track local (America) and global stats on failure rates, even down to monitoring what people are calling in about. So if I call in about a battery door issue, and so do 50 other professionals I don’t even know, it’s immediately red flagged, and passed as feedback back to the design team.

When a company is offering a three year warranty, it is in their financial interest to be sure that the device does not fail in that time frame. Even if you assume they are ambivalent, simple economics would suggest they would be only shooting themselves in the foot if they launched an untested product to the masses, and then had to pay to repair them at their cost over and over again for the next 1000 or so days.

I don’t think a hearing aid company would survive if they were doing this.

I think you’ve clearly had some bad experienced with your hearing aid. But you are extrapolating those experiences into a general statement of how all hearing aid companies are, and how all hearing aids are.

I’ve seen the global fail rate of the hearing aid company I work with, and you’re talking data from 100+ countries, and hundreds of thousands of units. The rates are pretty reasonable.

No company produces a flawless product. Ever seen a commercial on TV where some lawyer has a class action lawsuit going over faulty hip replacements, or various other medical devices? Some drug company just got in hot water because for the second time in the last few years they accidentally sent out sugar pills instead of contraception pills!

I sincerely hope that your next set of hearing aids is more enjoyable to own and a lot more reliable. In the meantime it might not hurt you to send a pointed letter to ReSound and tell them what you think of their product.

Purgatorio, you seem to be here mainly to practice English.

It would be MUCH better to go to an English or Irish bar in your town and practice with REAL conversation, not on-line with silly arguments about hearing aids.

YES they would. testing in real world is a hefty expense. Also anything that goes wrong in testing has to be re-engineered adding to cost over budget for not getting it right the first time. Also in many cases these flaws are intentional to get ongoing revenue from hearing aids after they are sold. there is big money in frequent replaces and repair. Iif people only replaced or repaired at the end of the 5-6 year life span then there is no additional revenue. “Most” hearing aid companies are doing it for the bottom line total profit. Not because they genuinely want to help people hear better. This does not include the Audiologists themselves.

First off, thought I pointed out I been using hearing aids in the real world for 31 years. And I am of an engineering background/ oriented. I take electronics and others apart for fun. I put them back together if they still work.

I’ve used behind, in ear, FM systems, and robo-ears (ones used for watching TV)

I know the holes are necessary the problem I am having is in the manor of their placement. and also if the hole has to be place in an area of high moisture they are not taking steps to prevent moisture from going in

example in the link I provided the holes should be facing out meaning that there should only be 2 holes NOT 4. the ones resting against the scalp should not be there. the company cut corners by having 1 case for both right and left ear. because the mic holes are on the side of the casing they should have 2 different cases one for right and left where the side against the scalp has no holes. By using the 1 case for both ears the side mic holes are a flaw in design. As I pointed out simple 1/2 hour testing in real world NOT LAB would of discovered these flaws in design.

The reason for 1 case, for both sides, is it cuts down on the number of machinery in plants from 2 assembly lines to one this is what I meant from cutting corners and cost cutting to maximize profit.

The side hole mic points is great idea as long as you have right and left ear models where the cases are mirror of each NO HOLES AGAINST THE SCALP.

nothing on this earth beats real world experience where Murphy law comes to play.

When not enough steps are taken to prevent moisture from entering the necessary holes its a design flaw. You can’t rationally call a hearing aid water resistant without the steps to stop moisture from penetrating. the ones i have are claiming water resistant they are not which is the reason for 3 failures in 2 years.

Look at water resistant watches for example with all the buttons and dials they still manage to keep the moisture out. I have 5 button watch that I take in the bath and soak all around the edge is sealed in a manor that prevents moisture penetration (yet the buttons are in holes in the case), and they only charge around 50-100$ for this. So there is absolutely no reason for hearing aid manufactures excuse for hearing aids that cost in $500-$2000 range or higher to not have the same level of engineering standards.

I am aware batteries need air flow due to gasses put off from chemical reaction inside the battery itself.

Actually they can seal the door itself and place vent holes on the outside , the vent holes would be inverted funnels so the funnel is inside not out facing away from head water has more problems penetrating holes shaped like that. They can include larger lever edges which will give purchase for leverage to pry it open for those with arthritis.

It’s entirely possible that there are plugs that can be inserted into the holes that would sit up against the head therefore preventing moisture from entering them. Also, there is more than likely some sort of neoprene covering over the mic that would prevent moisture from entering the mics and causing them to cut out in most cases. Of course there would be some people who exceed the norm but in general, most will have little-no issues with them.

As for “cost cutting to maximize profit” I think that’s not the reason. It’s more like having a universal casing so that it maximizes efficiency in manufacturing. Sometimes I’ve had to use a hearing aid I originally configured for a right ear as a left hearing aid. Now if they were specifically L/R I couldn’t switch them. I’d have to send it back and get a different one. Or lets say a patient wants, for whatever reason, to switch a BTE over to the opposite ear. They couldn’t. I’d have to tell them they’d have to buy a new one for the other ear and then there’s be the issue that companies do that to milk more money from the buyer “why couldn’t they just make them so they could go on the right or left ear?!?!”.

The hearing aids go through extensive research regarding design and I am SURE any question you can think of has been thought of and worked through about a million times.

And last time I looked a watch didn’t have a microphone and receiver in it…just some cirucit boards and buttons. And a water-resistent watch is not the same as a water-proof watch (like a deep-mariner) which costs in the hundreds of dollars as opposed to $25 or $40. There are hearing aids you could take off, stick in a glass of water, and take out and wear without any stop in function due to nano-coating. I’ve had patients get in the shower with their hearing aids on and have them work just fine when they got out…just because you have issues with moisture does not mean that it’s everybody that is having the same problem. Products are designed to work for most, understanding that there will always be outliers that need additional help or attention. And honestly, the hearing aids cutting out a WHOPPING 3 times in 2 years is pretty darn good for something that’s in a moisture-heavy, wax-laden environment for 730 days. I challenge you to take a water-resistant radio and stick it in the corner of the shower, turn the water on so that it’s about 100degrees in there for 12-14 hours a day, and come along and pour some dust from your vacuum and some candle wax on it probably 3 or 4 times a week and see how long it takes for the sound quality to diminish or for something to break.

These are tiny, miniaturized electronics that we leave in an environment that is moist, dark, and has waxy and dusty debris in it for 8-16 hours a day, every day, and then are surprised when something gets clogged up or breaks? If you are expecting to wear them without any problems, ever, well you have unrealistic expectations about what a hearing aid is capable of.

appreciate the input. The engineers themselves, what you say most likely is true, but its not the same for their bosses. bosses have a tendency to push the engineers to cut corners that if the boss wasn’t there hanging obvious or not so obvious threats over their heads. I believe engineers would be less likely to include flaws without the boss breathing down their necks, yet even engineers makes mistakes which is why real world testing is so important, Example the first batteries were sealed in air tight compartments not realizing they needed to be vented to prevent catastrophic failure.

I who am not a graduate of engineering, but with a spacial and engineering background, spotted the design flaws as soon as an example was placed in my hands.

thing about hearing is it a case by case basis, especially with the way hearing adapts, so the one fits all approach may not be the best choice, mass production does not always work.

Other thing that makes mass production not the best idea for hearing aids is the number of different environments that a person needs to use one.

example a mass produced hearing aid will work for say an office clerk who is in a controlled environment who never sweats. Yet it will utterly fail in a sweaty construction environment. Yet you have other people that will be in both environment.

This is a strong point in which hearing aids can’t effectively be mass produced (to have one aid fits all mentality).

cell phones are different in that most users can control the environment in which they use cell phones people with hearing aids need them in what ever environment they find themselves in. thus there is not as much to specialize(or ruggedize them) the phones

I also pointed out that there were added loopholes regarding medical devices in general that basically allows manufactures to design and sell medical devices without testing because the product made is similar to another product, but IS NOT THE SAME DESIGN… This was mainly pushed by mass producers through lobbying. Now our government is trying to fix it. I feel bad for those who have internal style hearing devices, is many of them were not thoroughly tested.
http://www.safetyresearch.net/2012/02/08/lawmakers-try-to-close-fda-loopholes/

Well I’m going to have to disagree with you about the testing of hearing aids because I have seen, first hand, the testing the devices go through. It may apply to other medical devices, but not hearing aids. Also, you can’t honestly expect a hearing aid to be designed on a case-by-case basis. Talk about expensive. And it’s unnecessary. While your opinion might seem sound, it’s just way off base on this. Most people (and I mean like 90%) don’t need any additional moisture-protection and that includes people with very active/demanding lifestyles.

http://www.safetyresearch.net/2012/02/08/lawmakers-try-to-close-fda-loopholes/
testing of them was dropped so they could get the aids to market faster. the first design was most-likely tested in manor your telling me, but the follow-on variation were not. Some of the variations had extreme changes from the original. That warrants from ground up testing.

when I noticed an obvious flaw in the first model Mayo clinic showed me. I asked to see all the other aids MA approved, they had 5 models available, all different companies. ALL 5 had similar flaws They were not taking steps to stop moisture from entering the necessary holes needed. Or blandantly ignoring water and placing them in places where water literally funnels into the hearing aid by gravity alone. They were all claiming moisture resistant.

the cost cutting by using one case for both ears is apparent, when you have only 1 Assembly line instead of 2 you virtually cut overhead cost in half, especially wages which is the biggest expense. This is ignoring the need of the user(right and left version is better especially if holes are on the side), medical devices should not the life time of the device. medical devices are life savers and are necessary they are not a luxury so you can’t cut corners like you do for other industries.

i have had both mercury and zinc batteries based hearing aids, both hearing aids lasted the same life average, before De-regulations of quality control.(removal of regulation to ensure divice worked as intended throughout its life.)

reason I can’t actually locate the regulations that weaken quality control is the companies involved don’t want it publicly known.(back door dealings) If it had been know by the public from the onset, they would have been in an uproar and stopped it on the spot.

It was watchdog groups that brought the loopholes “similar too” no testing done clause. Which explained the rise in design flaws making it to market. Common sense put 2 and 2 together to get 4. these loopholes were not there in the 80’s

Having trouble finding hearing aid specific ones, but here is an example of the loopholes regarding testing. its easier to track down life threatening ones because people get emotional about it.
http://thomasjhenrylaw.com/blawg/most-recalled-medical-devices-had-been-fast-tracked/

finally got the itemized bill statement from mayo repair $300, The hearing aid company is witholding what was actually wrong with it. My guess is they don’t want regulators or public to know the frequency of the same failure happening. I wish I knew how I can get that info. every time try to get it from the company they refuse or ignore my requests.

believe me, I want to know exactly when the regulations changed too, so I can find those responsible for wrecking my quality of life further and get in their face and tell them how their back door greedy corrupted dealings effected real people in negative ways, where to them the end justify the means.

ok here is 2 regulations the PMA (more rigorous testing this route)
the the 510(k) which bypasses a lot of what pma requires http://www.american.com/archive/2011/february/learning-a-little-about-testing-medical-devices

the 510(k) was introduced sometime after the 80’s to speed up getting medical devices to market.

the MA hearing aid is a striped down version of the original it is NOT improvment over the origional so they should require the PMA route over the 510(k)

I just called mayo clinic the whole pixel line hearing aids was dropped by resound who manufactured them. Resound cut their losses. If it been a solid hearing aid, there would have been no reason to drop the line.

I also found out our state changed policy very recently, within last 2 years, regarding lowest bidder, Think Minnesota got fed up with the quality issue in that ma was footing the bills. One thing I like about our ma they keep statistics on this stuff to help cut corporate fraud which runs up state budget. since MA in Minnesota comes from the general fund…