Why Can't Industry Design an Affordable Hearing Aid? - Page 1
Forum section: electronics / general

author: Sionyn
author_rank: Frequent Contributor
timestamp: October 26, 2012, 10:49:54 pm
content: "Tricia Romano writes in the NY Times that over the last 10 years, purchasing a hearing aid had become even more difficult and confusing than buying a new car and almost as expensive. 'I visited Hearx, the national chain where I had bought my previous aids. There, a fastidious young man spread out a brochure for my preferred brand, Siemens, and showed me three models. The cheapest, a Siemens Motion 300, started at $1,600. The top-of-the-line model was more than $2,000 for one ear. I gasped.' A hearing aid is basically just a microphone and amplifier in your ear so it isn't clear why it costs thousands of dollars while other electronic equipment like cellphones, computers and televisions have gotten cheaper. Russ Apfel, an engineer who designed a technology now found in all hearing aids, says there is no good reason for the high prices. 'The hearing aid industry uses every new thing, like digital or a new algorithm, to raise prices,' says Apfel. 'The semiconductor industry traditionally reduces the cost of products by 10 to 15 percent a year,' he said, but 'hearing aids go up 8 percent a year annually' and have for the last 20 years."http://well.blogs.nytimes.com/2012/10/22/the-hunt-for-an-affordable-hearing-aid/

author: IanB
author_rank: Super Contributor
timestamp: October 26, 2012, 11:16:05 pm
content: You need to append "in the USA" to your question.In other parts of the world where governments are involved in healthcare provision they set reasonable price mandates on vendors to prevent artificial price inflation. But in the USA the government has various kinds of "medical device" legislation that sets testing and liability requirements to help make things more expensive, and allows manufacturers to collude with insurance providers to inflate prices as much as they can.

author: EEVblog
author_rank: Unknown
timestamp: October 26, 2012, 11:35:11 pm
content: Don't modern hearing aids have some form of advanced DSP in them?And possibly an ASIC to get the size down in modern devices?Dave.

author: IanB
author_rank: Super Contributor
timestamp: October 26, 2012, 11:39:32 pm
content: Maybe they do have complex electronics, but so do cell phones. I don't see why one should cost vastly more to design and manufacture than the other?

author: mikeselectricstuff
author_rank: Super Contributor
timestamp: October 26, 2012, 11:40:41 pm
content: Quote from: EEVblog on October 26, 2012, 11:35:11 pmYes, but they make enough of them that the NRE won't be a big part of the cost

author: Psi
author_rank: Super Contributor
timestamp: October 26, 2012, 11:40:53 pm
content: Yeah, modern hearing aids can be very advanced with DSP/ASIC for all sorts of filtering and intelligent signal processing.Some have bluetooth pairing to your phone for phonecall audio and so you can adjust a vast amount of settings for audio gain, volume and filtering by using an app.I think they may do advanced beamforming as well, using multiple microphones to track the locations of sounds and amplify the voice of someone in front of you but not ambient noise.

author: poptones
author_rank: Frequent Contributor
timestamp: October 26, 2012, 11:42:33 pm
content: WHAT?

author: prenato
author_rank: Regular Contributor
timestamp: October 27, 2012, 12:20:30 am
content: Even in Europe, my family tells me these devices are very expensive, so I wouldn't say it is just an issue in the USA. Also I suspect they are substantially more complex than "just a microphone and amplifier in your ear" (I once interviewed for a job at a company that made these; seemed more complex than that:) . That said, the price does seem a bit out of proportion for what they do, considering complex devices like cellphones are so cheap these days for example. We need some Chinese companies to enter this market to see some competition (maybe they have already?)

author: george graves
author_rank: Super Contributor
timestamp: October 27, 2012, 12:47:32 am
content: From what I understand, the same is true for wheelchairs - over charging. There a special place in hell of the guy who got insanely rich off of people that lost the use of their limbs.

author: tom66
author_rank: Super Contributor
timestamp: October 27, 2012, 01:07:38 am
content: Same for mobility scooters -- I saw one entry level model with an RRP of £2,500! It's just a pile of lead-acid batteries, a motor, and a chair, in essence. Oh, and it was made in China, like all good things.

author: LEECH666
author_rank: Frequent Contributor
timestamp: October 27, 2012, 01:28:50 am
content: Quote from: poptones on October 26, 2012, 11:42:33 pmI chuckled a little. Guess I am going to hell.

author: Conrad Hoffman
author_rank: Super Contributor
timestamp: October 27, 2012, 02:40:15 am
content: IMO, it doesn't matter what they do, the volume is high enough (no pun intended) that they shouldn't cost more than $100USD... per pair! With DSP and whatever else you want. A total rip off and insurance doesn't even cover 'em.

author: NiHaoMike
author_rank: Super Contributor
timestamp: October 27, 2012, 03:32:57 am
content: Maybe start an open source project? If we use the pocket radio/MP3 player/cell phone type form factor, it shouldn't be very difficult. Have it operate from standard AA cells and use a low power processor like the EnergyMicro ARM chips. It would also help if it had uses besides a hearing aid such as an electronic stethoscope or guitar effects unit.

author: GEuser
author_rank: Frequent Contributor
timestamp: October 27, 2012, 04:00:27 am
content: You'll notice in the society databases that when a cheap but good hearing aid actually gets developed that theDivorce Ratewill go up dramatically , so there might be a bit of a conspiracy going on

author: sacherjj
author_rank: Frequent Contributor
timestamp: October 27, 2012, 04:04:20 am
content: The ones that dad got over 5 years ago were small enough to almost hide in the ear. They were able to measure the loss of hearing across the frequency band and tailor the amplification to match the loss in the ear.This was done by programming the device. So there is some type of custom DSP with configurable gain and feedback detection and avoidance. Really cheap hearing aides can overload and get into a feedback loop loud enough that you can head the squeal if you are close.

author: jeremy
author_rank: Super Contributor
timestamp: October 27, 2012, 04:29:38 am
content: Medical device certification is ridiculously, stupidly, ridiculously expensive. Companies like Siemens have to pay this and it is a significant barrier to entry for smaller competitors, so prices rarely come down unless there is a revolutionary new technology. This certification process makes it pretty difficult to do open-sourcey stuff too. I'm not saying the regulation should go away (it is very important), but it does cost a ton.In their defence, I know that elsewhere in medical devices some things are designed with the intention that insurance companies will be paying, not necessarily the end user directly so they prioritise functionality rather than price. Given the economics of these devices, it seems as though it is either assume that insurance will pay or don't build the device at all. If Siemens made a crappy but cheap hearing aid (which somehow got through certification) and people started getting hit by cars because they couldn't hear them, you could run that entire multinational company into the ground in a few weeks (esp. in the medical litigation environment of the USA).So the priority is to make the best device possible and worry less about the price. And as mentioned earlier, lots of NRE in these things and not enough buyers.

author: poptones
author_rank: Frequent Contributor
timestamp: October 27, 2012, 04:35:25 am
content: Taadaa! The world's first open source hearing aid.

author: RJSC
author_rank: Regular Contributor
timestamp: October 27, 2012, 04:40:57 am
content: Basically "everything healthcare" is overpriced.Why does ECG machine cost more than a digital storage oscilloscope?Is has a good differential amplifier, but than the sample rates are low, and the LCD and processing board are the same or cheaper...The answer is simple, everyone working in healthcare, be them the chemists/pharmaceuticals, medics, ans EE's who design healthcare devices think they have the right to line their pockets just because it's for your health and you'll pay or die: it's like selling water bottles at 50$ in the middle of the desert...Here every medic charges 60€ plus for a private appointment which lasts 5 or 10 minutes, and they are VAT free...You can get an appointment for a tenth of that on the public hospitals, but it takes 1 or 2 years to get to your turn on some specialties and 1 to 3 months where the waiting list is shorter. This is because medics do not want to work on the public sector since they charge on 10 hours of private appointments the same the public sector pays them for a month.

author: poptones
author_rank: Frequent Contributor
timestamp: October 27, 2012, 05:11:16 am
content: http://youtu.be/wshyX6Hw52I

author: Mechatrommer
author_rank: Super Contributor
timestamp: October 27, 2012, 05:13:40 am
content: audiophoolery has been discussed extensively in this forum so why wonder?

author: jeremy
author_rank: Super Contributor
timestamp: October 27, 2012, 05:19:33 am
content: Quote from: RJSC on October 27, 2012, 04:40:57 amThis I have actual, personal experience with. Not saying there isn't price gouging, but to assume that everyone is just trying to rip off sick people is a bit hyperbolic. Also, an ECG is not the same class of instrument as a hearing aid.1. Because end users aren't meant to buy them (and shouldn't). One shouldn't use them outside of a specially designed environment as the noise floor will be too high for diagnostic purposes.2. They absolutely cannot break and absolutely cannot get things wrong. In an ICU you want to worry about people, not whether the soldering on op amps was good enough, or a person vomiting on it will short it out. Liability is HUGE.3. Thought certification was expensive? Try getting certification for a piece of emergency equipment.4. Cal is expensive (cal people have their own certifications too)5. Modern processing algorithms are complicated, especially in diagnostic systems (lots of DSP for noise, wavelet, HMM, NN, etc).6. (sucks, but true) A reliable ECG readout can potentially clear a clinician from malpractice (saves $$$$$$$). See point 2.I can build an ECG for less than $20, doesn't mean it should be used by a doctor or in a hospital. But really, you can get a solid ECG for about $10k-20k. This is definitely in the price range of a mid-range digital storage scope? The rigol/siglent/etc is hardly a piece of medical diagnostic equipment, I don't think you can really compare them.Think medical is expensive? If I told the optics guys I know that I wanted to buy a $20k DSO they could probably just give me the money from spare change out of their pockets

author: HackedFridgeMagnet
author_rank: Super Contributor
timestamp: October 27, 2012, 05:45:54 am
content: Quotewhere do I meet these 'optics guys'?

author: SeanB
author_rank: Super Contributor
timestamp: October 27, 2012, 05:59:57 am
content: Most of the cost is the markups and testing/certification in the chain in my guess. Low volumes ( 100k units a run per model, versus 100 million a year for a cheap cellphone) and the need to custom encapsulate each one for the user will make them pricier. Ultra low power and ultra small size will also drive the price up as you need to package the interior origami style on a flex PCB, and you will have to supply an expensive low volume programmer/ hearing analyser with every 100 units or so. Has to run for a day or 5 on a single zinc air battery of 30mAh or less capacity, no rechargeable cell is small enough to fit.This probably will push the per unit cost up to around $100 at the manufacturer, the rest being distributor, retailer markups and cost of certification per country and per healthcare provider ( they vary hugely across the world and from area to area).BTW, low cost Chinese made orthopaedic equipment is coming into the market, wheelchairs, walking aids and such, quite well made and very cheap, and not subsidised ( which makes them more expensive for some reason) with prices for a frame being $20, crutches $10 and a wheelchair being under $100, the mobility scooter is the most expensive, $500, including charger, batteries and delivery from the local distributor.

author: jeremy
author_rank: Super Contributor
timestamp: October 27, 2012, 06:00:55 am
content: Plenty of places:http://www.cisco.com/,http://www.alcatel-lucent.com/,http://www.huawei.com/en/, etc. Bits and bytes gotta get through the ocean somehow.

author: EEVblog
author_rank: Unknown
timestamp: October 27, 2012, 06:04:56 am
content: Quote from: Conrad Hoffman on October 27, 2012, 02:40:15 amSure, there is likely some "whatever the market will bear" pricing happening, but I suspect the volumes aren't that huge in the scheme of things.This site says there are 1.5M sold per year (presumably in the US)http://www.eldoradohearing.com/faq.htmQuoteDave.

author: EEVblog
author_rank: Unknown
timestamp: October 27, 2012, 06:08:27 am
content: This site says only 6M are sold worldwide each year:http://www.netsquared.org/blog/amy-sample-ward/solar-powered-hearing-aids-change-worldAnd more specific US based numbershttp://hearinghealthmatters.org/hearingnewswatch/2012/hearing-aid-sales-rose-by-3-last-year-with-california-leading-the-way/Dave.

author: Unknown
author_rank: Unknown
timestamp: October 27, 2012, 07:23:18 am
content: Once an open source hearing aid reaches working prototype stage the funding for certification should be the easiest thing in the world shouldn't it!?If there were volunteers to design it, I am sure as hell that there would be volunteers to finance certification.

author: poorchava
author_rank: Super Contributor
timestamp: October 27, 2012, 08:08:08 am
content: It's not only US. Similar situation takes place in Poland where I live. In general all types of disability-reducing equipment (dunno the right english term for those devices) such as: hearing aids, automatic insulin pumps for those with accute diabetes, all kinds of joint/bone implants/replacements, electric wheelchairs are ridiculously expensive and so are doctor appointments. All the time you can hear/see some campaigns to raise funds for rehabilitation or special equipment for some heavily disabled person (mostly kids with some inborn defects).As probably everywhere in the EU we have public healthcare, for which we pay heavy money (added to monthly tax) and which is in most cases totally useless. In general it takes at least two weeks to get a meeting with general doctor/ first contact doctor who then directs you to specialists (or not because on the contrary to what would be logical, those general md's are usually rather incompetent). Getting an appointment at pediatritian orthopedist or dermatologist takes anywhere from a week to a month. Some more specific or hard specialists take more than two months (cardiologist). And the best thing: waiting period for getting CT/MRI/PET/USG/ECG done by public healthcare can be as high as 12 months.That's why most of larger private companies found a private medical healthcare for their employees (my eployer too).

author: G7PSK
author_rank: Super Contributor
timestamp: October 27, 2012, 08:25:12 am
content: My mother in law just bought a pair of digital hearing aids from a firm called "Specsavers" they did not work the switch and volume control would not turn on either one after a week of them not working she asked me to look at them which is when I found out they were not on and could not be turned due to the force that would be required to turn the knobs would break them.She rang Specsavers who made an anointment to adjust them 2 weeks down the line, she came back to me saying that they were now squealing, I looked at them and found that whoever adjusted them had sheared the knobs on their shafts such that they now spun freely doing nothing at all. She rang specsavers who made yet another appointment a week away at which they said there was nothing wrong with the hearing aids, at this point I advised my mother in law to get a full refund, Specsavers at first tried to refuse a refund claiming that each individual hearing aid is made for the customer, and it was over 30 days from purchase, in the end they caved in and gave a full refund of £1200-00 yes twelve hundred pounds for what is a mass produced piece of tat that starts off as a cone shape the fitting to the ear is just making a mold of the ear then heating the plastic case and forcing the unit into the mold while heating it with hot air. The whole process's most likely only takes twenty minuets to complete and it was during this stage that they managed to bond the control shafts on the ones that my Mother in law purchased.

author: SeanB
author_rank: Super Contributor
timestamp: October 27, 2012, 10:16:16 am
content: Poorchava, same here. Not going to use public healthcare unless I have a death wish. Local hospital has a little problem, no linen for the last year, no washing machines ( no money allocated both to run them and to fix the broken ones, so external laundry is making a killing) and you go there to die. They found a body in a service corridor, dead for at least 6 months, had gone missing from the ward that long ago. Go for medicine and you get pot luck, if not in stock they will give what they have, so instead of AZT you will get paracetamol or vitamin pills, or you get somebody else's script.Private medical aid and a semi state hospital is another matter. Adequate to excellent service ( depending on which one you go to) and proper care, though always there are bills to pay. I go to the GP and he is competent, friendly and helpful ( and overworked but not to the point of my last one who had a heart attack at 30 at work, so now he has moved closer to his home and works at a local branch with less load) and who bills $35 roughly per visit. Pharmacy knows me by now, " you know your medical aid does not cover all this bill, only a portion" -"Yes" and I pay. Only good thing is medicine has a fixed exit price to the consumer.

author: vk6zgo
author_rank: Super Contributor
timestamp: October 27, 2012, 11:20:23 am
content: I have worked with these things,& they are more than" basically just a microphone and amplifier in your ear".Each Hearing Aid is programmed individually by an Audiologist,(They are Professionals,so expect to be paid as such),following a full hearing test,so that has to be factored in.The Audiometers they use have to be sent to an approved Standards Lab for checking each year--additional expense.The earmould is custom made to fit,so as to be a good seal for sound energy ---this is imperative for "in the ear" devices,as they can oscillate uncontrollably if any earphone signal gets back to the microphone.All this is hands-on work adding to the cost!If the thing fails,a Tech has to pull it apart,remove all of your scungy earwax,replace extremely tiny parts (board level ),check to see if its program has been corrupted,check through the Audiologists notes in case there is an update,perform an acoustic sweep in a special test unit,deal with several irate clients at the counter,sign off on your Aid,& then send it on its way.Compared to a mobile phone,or computer,these things are tiny,they are all slightly different shapes & sizes,so the connections between such things as microphones & earphones all vary widely.Even the last generation of analog Aids had complex programs covering Dynamic Range,Frequency Response,Noise Floor,AGC,& other stuff,all of which had to be set by the Audiologist,then adjusted following user reports.And what people do to them!Every couple of weeks you will get several in which have been eaten by dogs,dropped in the sea (fishermen),or dug into sandpits (A children's favourite).Hearing Aid manufacturers do not have the economies of scale that people making things like Ipods have,as they produce many different models to fit the extremely diverse needs of their clients,so even before any further mods at point of sale,you will find "umpteen" different versions.

author: G7PSK
author_rank: Super Contributor
timestamp: October 27, 2012, 11:31:33 am
content: The in ear models being sold now are just one chip so there can be no repairs the chip is enclosed in a plastic moulding that sits in the ear. The pricing is simply on what can we squeeze the customer for, remember that many of them are older people who do not understand electronics etc, so are easily ripped off.

author: jeremy
author_rank: Super Contributor
timestamp: October 27, 2012, 11:39:23 am
content: Quote from: HAL-42b on October 27, 2012, 07:23:18 amMedical certification is not a once-off thing, you don't just write a cheque and then get a tick. When things go wrong, there *has* to be someone who is responsible (in the legal sense) for taking the blame and to fix it. Taking the blame may involve lawsuits. Licenses for these things (depending on where you are I guess, not really sure) are not necessarily perpetual so you need an organisation to keep this sort of thing up to date and regulation changes mean that devices may have to be changed. Also, you will notice on a lot of equipment a little sticker or logo that says "Rx Only", meaning that it is illegal for the final buyer to not be a medical professional (a doctor can give it to someone, but the someone can't go and just buy it). Certain device classes must be "Rx Only" to pass certification and/or avoid legal liability.And *everyone* would have to make their own hearing aids from the ground up, because if any lawyer catches a whiff that you are selling something "medical" (or even giving it away for free), they will sue your pants off because legally "medical devices" have special restrictions. You can get people to sign a document saying that they won't sue you, but it is useless as in this area you can't actually sign away the things that would actually protect the medical professional (depends where you live of course).A bunch of sphygmomanometers and ECGs and other things are allowed on ebay only because they are marketed as "personal monitoring devices", and so using them in an actual medical context (aside from being stupid and irresponsible) leaves the door wide open to malpractice lawsuits. You *can't* make something diagnostically useful and safe for $10, even the biopotential amplifier frontend I have on my desk now (literally just a single channel differential amplifier with programmable gain, few analog filters, no processing or display or anything, not rated for diagnostics) has about $300 worth of circuitry just for patient HV isolation.I don't mean to be a wet blanket, if anyone thinks that they can pull this off then I reckon go for it! But you are entering an environment that has been specifically developed for large corporations, and a big chunk of the setup is kind of justified. Rest assured that some people are trying to make it better, but it's a hard problem just like healthcare (see the other posts in this thread) and people in the field I regularly speak to (engineers/scientists/clinicians, not managers or marketers) care more about diagnostic accuracy and treatment effectiveness than price. I guess I am more in the hospital side of things than the consumer side, so ymmv.Compared to pharmaceuticals, the price of small electronic devices is lost in a rounding error; I have seen small children go through $20,000 of antibiotics in a single day. And then they put them in an overcrowded room with a bunch of other sick kids (close tax loopholes to pay for more hospitals? never!) and the money is down the toilet.

author: Unknown
author_rank: Unknown
timestamp: October 27, 2012, 12:34:44 pm
content: vk6zgo I agree with everything you said but I think much of these complications are avoidable on OHSW level and could have been avoided at commercial level as well if it didn't present a conflict of interest for the commercial side.(This stuff should have gone to the other thread in the OHSW section actually)The only thing that needs to be done is to provide every user with a docking station for his/her hearing aid. The docking station connects to a computer via USB and provides charging, functionality check and calibration. So it must have, besides charging circuitry, an audio interface similar to a USB sound card, some logic and a computer software.The software estimates the hearing parameters of the user in a manner similar to the color calibration SW that used to come with CRT monitors. I.e. the user is not required to know anything, he/she just answers binary choice questions on the screen. The software filters out statistical noise and bias and forms a reasonably accurate response curve for the user. Alternatively it may use the more precise (presumably) audiologist data.Once the data is obtained the docking station can program (and verify) any blank device to the user's data. In case of damage or loss it is a simple matter for the user to pop a new device from a blister, program it at the docking station and carry on with life. As devices themselves do not have to go through audiologist they can be much cheaper, say 50$ a pop or lower.The ergonomics side can be solved as well in many possible ways. Third party service, standardized sizes (as in shoes) or mouldable polymers for self application are all possible solutions that have worked comparable fields.

author: Unknown
author_rank: Unknown
timestamp: October 27, 2012, 01:34:24 pm
content: Quote from: jeremy on October 27, 2012, 11:39:23 amI am glad that you seem to be well aware of the logical fallacy there. Having somebody to sue is not a real requirement. Lawyers would love it if you believed that but for them it is preferable if you walked on a wet floor and fell so that they can sue for damages. Your not falling is against their interests. What you want is walking on a dry floor and not falling. What a lawyer wants is you walking on a wet floor and falling and preferably breaking a few bones so he can claim higher damages. So a compromise is reached where a special sign is placed on the wet floor which prevents the lawyer from claiming damages but the danger for you is exactly the same as before. What you need is not somebody to sue, but a reasonable expectation that a solution put forward would work. In other words you need a proven design, not somebody to sue. Anyway enough about lawyers, back to hearing aids....What I propose is a voluntary effort to design a good working hearing aid and to publish the relevant documentation "open source". After that, a separate voluntary effort sets out to gather funds in order to get the design "type certified" by independent 3rd party institution. After that it is the responsibility of every would be producer to prove that his implementation is up to scratch. By all likelihood the volunteers from the previous endeavors would be in the best position to do that with their know how and existing tooling and most importantly their public profile.So I am not proposing that everyone should roll his own, but rather that the benchmark for a very good and well proven one should be known universally therefore the market would not be viable for the crap ones.

author: NiHaoMike
author_rank: Super Contributor
timestamp: October 27, 2012, 01:44:21 pm
content: Quote from: jeremy on October 27, 2012, 05:19:33 amAt one point, TI actually worked with some vendor to sell $50 EKG addons for use with their (first generation) MSP430 watch. It ran on a single coin cell and it had the disclaimer that it is not for medical use.QuoteIt's very easy to get several 100s of kV worth of isolation for less than $20 - it's called wireless. Of course, it would rely on batteries for isolated power, but I would expect consumer grade EKG units to be self contained, battery operated devices. And if battery power is not an option, couldn't you use a small solar panel and some LEDs to send power across a distance inside a plastic box, perhaps with a piece of clear plastic or glass to separate it?I believe there are several open hardware EKGs out there, but I haven't checked lately. But a basic wireless, battery powered EKG would actually be much easier to build than a hearing aid with advanced DSP.

author: G7PSK
author_rank: Super Contributor
timestamp: October 27, 2012, 01:49:29 pm
content: What certification is in all honesty really required a hearing aid can not be life threatening in any way, they can have no worse health affects than an iPod or similar. The main thing is personal vanity of the wearer otherwise they would use something like thishttp://www.ebay.co.uk/itm/Loud-N-And-Clear-Personal-Sound-Amplifier-Hearing-Aid-/190448649859?pt=UK_Health_Beauty_Mobility_Disability_Medical_ET&hash=item2c579fc683

author: Unknown
author_rank: Unknown
timestamp: October 27, 2012, 02:46:36 pm
content: Hearing Instrument Consumer Protection Act.(225 ILCS 50/1) (from Ch. 111, par. 7401)(Section scheduled to be repealed on January 1, 2016)Sec. 1. Purpose. The purpose of this Act is to protect the hearing-impaired public from incompetent and dishonest dispensers of hearing instruments who could endanger the health, safety and welfare of the People of this State. The Federal Food and Drug Administration has recommended that State legislation is necessary in order to establish standards of competency and to impose stringent penalties for those who violate the public trust in this field of health care.(Source: P.A. 89-72, eff. 12-31-95.)[...]Read on:http://www.ilga.gov/legislation/ilcs/ilcs3.asp?ActID=1305&ChapAct=225%26nbsp%3BILCS%26nbsp%3B50%2F&ChapterID=24&ChapterName=PROFESSIONS+AND+OCCUPATIONS&ActName=Hearing+Instrument+Consumer+Protection+Act.TLDR edit:- The hearing instrument dispenser shall give at no charge to every person fitted and sold a hearing instrument the "User Instructional Brochure"- When the hearing instrument is delivered to the consumer or purchaser, the serial number shall be written on the original receipt or contract and a copy shall be given to the consumer or purchaser. If a used hearing instrument is sold, the receipt and the container thereof shall be clearly marked as "used" or "reconditioned"- All hearing instruments offered for sale must be accompanied by a 30-business day return privilege.- *** A hearing instrument dispenser shall not sell a hearing instrument unless the prospective user has presented to the hearing instrument dispenser a written statement, signed by a licensed physician ***- If the prospective hearing instrument user is 18 years of age or older, the hearing instrument dispenser may afford the prospective user an opportunity to waive the medical evaluation required by this Section, provided that the hearing instrument dispenser:(i) Informs the prospective user that the exercise of a waiver is not in the user's best health interest;(ii) Does not in any way actively encourage the prospective user to waive the medical evaluation; and(iii) Affords the prospective user the option to sign the following statement:"I have been advised by .................(hearinginstrument dispenser's name) that the Food and Drug Administration has determined that my best interest would be served if I had a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing instrument. I do not wish a medical evaluation before purchasing a hearing instrument."And it goes on like that ... In short, to sell and fit hearing aids in the USA you need to be certified. Fair enough. No idea how it is in my own country but it should be something similar (if not copied verbatim).

author: jeremy
author_rank: Super Contributor
timestamp: October 27, 2012, 02:52:48 pm
content: Quote from: HAL-42b on October 27, 2012, 01:34:24 pmI agree with you, but the problem is that the law is not written this way (or so I have been told by people much smarter than I). Legally, there is no such thing as a proven design; the only option is for someone to stick their neck out otherwise you don't pass certification. It's the same thing as signing off on a job in a plant or on a mine site; if everything hits the fan and someone dies, you are going to have a few unhappy people knocking on your door regardless of whether you did it "correctly" or not.Quote from: HAL-42b on October 27, 2012, 01:34:24 pmThis is the entire problem! There would be no producers that could sell the device for less than several hundred because their legal liabilities would still be huge and technician/audiologist costs would be the same. And each manufacturer would have to maintain their own ASIC masks, not exactly a cheap endeavour either.For reals, this area is a legal minefield and that slows everything down to a trickle. It's a pain in the butt, but that's the way it is.The rest is sorta OT, but anyway:Quote from: NiHaoMike on October 27, 2012, 01:44:21 pmYep, they worked with BM to produce a heart rate monitor; this is not the same thing as an ECG and the information output is not very useful unless you are going for a jog and want to make sure you are running hard enough.QuoteBatteries are not an option because these devices need to be used 24/7. I guess you could use solar power and LEDs, but the amount of fiddling to get any efficiency and to not be laughed out of cert would probably make it not worth it. Long range inductive wireless power is out because of interference and people tend to shy away from wireless because it is easy to interfere with. The correct way is to use isolation transformers, but these need to be tested, rated, etc and that costs money.I see you are talking about consumer grade, however there is really no such thing as a consumer grade ECG as the information they give out is mostly useless to a consumer. Perhaps there is some confusion here; ECGs are for quantitatively examining thePQRST complexto look for signs of heart conditions like myocardial infarction (heart attack), arrhythmias, etc.

author: Unknown
author_rank: Unknown
timestamp: October 27, 2012, 03:59:36 pm
content: Quote from: jeremy on October 27, 2012, 02:52:48 pmAs an architect I go through the drill quite often. Doesn't help it make any more sense and doesn't serve the client any better either. Some mandarins seem to get a kick out of it. What is very important is to realize that the only thing that gets certified is my following of the building code. Nobody ever tests the building itself!! When a rouge airplane or a tsunami actually tests the building it is realized that the code that I followed was no good at all.This type of certification is called "procedure certification". The actual item is not tested, only the adherence to some procedure or code is. When the procedure itself is faulty you see the result on the news. My pet peeve.A better approach is to "type certificate" as it is done in aerospace industry and some others. You get a representative sample, test the hell out of it and if it pases you stick with it.QuoteFortunately for our original designers their type certificate is at the same time their production certificate and the funds are not out of pocket expenses either. It gets expensive only for the late entrants, a fair advantage in my book.

author: vk6zgo
author_rank: Super Contributor
timestamp: October 27, 2012, 11:24:38 pm
content: Quote from: G7PSK on October 27, 2012, 11:31:33 amEven in the analog models,the main "guts" was a single chip.It's the peripheral stuff,all of which has to be attached to the board,such as,microphone,earphone,volume control,programming socket, phone pickup coil,etc,which uses up the time & patience of the Tech.Try replacing all that stuff,rebuilding the moulding which the customer has wrecked,reprogramming it,testing it,all within the ridiculous 20 minutes or so allocated.Oh,& then do another 90 or so!Some Aids use a remote control for the volume & a few other functions--this just provides a few more avenues of failure.My experience of old people with Hearing Aids is that they are well aware of the performance they want out of their Aids.Some of the old Buggers used to leave the ladies at the counter in tears.

author: Lightages
author_rank: Unknown
timestamp: October 28, 2012, 12:58:01 am
content: I sometimes question the value of hearing aids for many people. I have seen the top of the line hearing aids left out on the table because the person hears better without them. I have seen people with hearings aids not knowing whether they are on or not. I have seen some people actually get a benefit from them. On average they seem ridiculously priced for the technology involved.$2000 per ear for an upper model, and endless battery consumption, all for "i can hear a bit better, but I am not sure"?I have a bluetooth earpiece that cost $25 and does some amazing stuff. It is rechargeable and lasts 6 hours on a charge. Knowing what I know about electronics, I am sure it is possible to make two earpieces with a bluetooth mic, and bluetooth receiver and speaker, and a pocket device that can handle all the processing with bluetooth that could sell for well under $500. Power the pocket device with a lithium cell, make it mini/micro USB rechargeable, and provide a charging port for the earpieces. This can be charged in a car, on a computer, anywhere there is power. Then you have a convenient easy to use and recharge system. Loose an earpiece? Big deal, get another for $25 ear plus fitting cost.I watched my father for years getting nothing from his hearing aids that cost $1800 each. And don't tell me he didn't have a good audiologist. He went to the best in the city.OK, rant mode off.

author: jeremy
author_rank: Super Contributor
timestamp: October 28, 2012, 04:41:14 am
content: Quote from: Lightages on October 28, 2012, 12:58:01 amAgain, your headset was probably produced by the million, does not have medical grade QA, does not need to be reprogrammed, has little to no liability for the manufacturer. You don't think all of that extra stuff is worth a couple of hundred? Yes you can make a bluetooth microphone thing for less than $500 *in parts*. You just can't sell one as a medical device for that cheap and expect to make a long term profit (or break even).And the electronics isn't as simple as just putting a microphone and op-amp together, you need to be able to correct any arbitrary HRTF problems; if you whack 50db gain over 20-20k on there you will just cause them to become deaf in the frequencies they can hear.