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In October 2015, the President’s Council of Advisors on Science and Technology (PCAST) delivered Aging America & Hearing Loss: Imperative of Improved Hearing Technologies, which targets America’s worsening hearing loss epidemic. The report proposes a number of regulatory changes, at the level of the Federal Trade Commission (FTC) and Food and Drug Administration (FDA), which PCAST believes will “decrease the cost of hearing aids, spur technology innovation, and increase consumer choice options.”

One of the most controversial proposals is the creation of a new category of “basic” category of hearing aids meant for over-the-counter sale. PCAST argues that this “would allow entrepreneurs and innovators to enter the market and open a space for creative solutions to improve mild-to-moderate, age-related hearing loss with devices that can be sold ( . . . ) at the local pharmacy, online, or at a retail store for significantly less.”

So far, a number of key stakeholders have weighed-in, with professional societies (representing audiologists and hearing aid dispensers) and the Hearing Industries Association (HIA) voicing opposition to over-the-counter hearing aid sales, and the Consumer Electronics Association (CEA) and Hearing Loss Association of America (HLAA) supporting the recommendation.


UPDATE: The Academy of Doctors of Audiology have issued a position statement, which has clarified their stance. They are officially supporting the recommendation for over-the-counter hearing aids, with qualifications. The graphic above has been updated to reflect this.

What are the forces behind this polarization of opinion on over-the counter hearing aids, and are the positions taken by these organizations representative of the opinions of audiologists and consumers, respectively?

On the surface, the controversy would appear to be simple. Hearing professionals, and the organizations that represent them, have been clear in their messaging; if over-the-counter hearing aids become a reality, there will be a number of negative consequences for consumers. When consumers forego an expert hearing assessment they run the risk of missing the detection and treatment of underlying medical conditions. Consumers are also more likely, they argue, to achieve poor outcomes via self-treatment with over-the-counter devices. The HIA states that “Failure to adequately address hearing loss can have profound negative consequences including an increase in dementia risk…” If consumers are fitting their own hearing aids, how will they know if their hearing loss has been addressed adequately?

Consumers, on the other hand, need more affordable hearing solutions, and the current hearing care industry has not been able to deliver affordable solutions due to the high cost of traditional hearing aids and the unavoidable cost of professional care. To make matters worse, most consumers cannot rely on medical insurance or government subsidies to assist in the purchase of hearing aids.

The Hearing Loss Association of America (HLAA), the nation’s leading organization representing people with hearing loss, supports over-the-counter hearing aids, but also advises consumers not to forego professional hearing care:

While HLAA supports this groundbreaking report from PCAST, access to technology or hearing aids by consumers is not a substitute for following good hearing health care practices. We encourage people to see their primary care physician and their hearing health care provider for regular checkups. [PCAST’s] recommendations ( . . . ) serve to break down barriers and provide greater access to a variety of solutions for people with hearing loss.

Dig a little deeper, and complexities emerge.

Last week we surveyed 180 hearing professionals and over 130 hearing aid consumers to find out whether their positions were in-line with the positions taken by their representative organizations. We asked the question: Should the FDA Support Over-The-Counter Hearing Aids? 

We expected to strong majority of consumer support for over-the-counter hearing aids. What we found was roughly 67% for, 28% against, and 4% undecided. The results were in the expected direction, but without a clear consensus. For hearing professionals, we expected to see the vast majority voting against the measure, but we found a small pocket (roughly 12%) of support for over-the-counter hearing aids. Below we will explore the numbers in visual detail, and also highlight some of the written comments submitted by consumers and hearing professionals.

Percentage Yes/No For All Groups Surveyed

Over-the-counter hearing aids - all percentages

We are including those who identified themselves as a friend or family of a hearing aid consumer, and those who identified themselves as a hearing aid industry professional, but please bare in mind that our sample size was relatively small for these two groups (as seen in the graph below).

Total Number Yes/No For All Groups Surveyed

Over-the-counter hearing aids - overall participants

Below, we’ve combined hearing aid consumers with friends and family of hearing aid consumers and hearing aid industry professionals with audiologist/hearing instrument specialist. The difference between the 2 groups is clear, but again, a clear consensus does not exist within either group.

Percentage Yes/No For Combined Consumer and Industry Groups

Over-the-counter hearing aids - overall percentages

Data was gathered via Hearing Tracker’s consumer and provider newsletter-subscribers, via consumer and professional members of the HLAA, and via hearing-industry groups on LinkedIn. Subscribe to our newsletter. Haven’t had your say on OTC hearing aids? Have your say now. Don’t feel like taking the survey? Leave a comment at the bottom of this page.

What are They Thinking?

Looking at the graph above, one begins to wonder 1) Why would an audiologist or hearing-industry professional support over-the-counter hearing aids? and 2) Why would hearing aid consumers, or their friends and family, be against more open-access to hearing devices? Thankfully, we gathered over 200 thoughtful written comments from survey participants, providing answers to these questions. Here are a few selections, categorized by type of individual, and whether they were for, against, or undecided about over-the-counter hearing aids:

Hearing Industry For Over-The-Counter Hearing Aids

OTC hearing aids are akin to reading glasses and should be available for do-it-yourselfers who are tech savvy. More affordable options will lower the price of currenlty overpriced hearing aids. Consumers want options.

FDA is a barrier to hearing healthcare; deregulate hearing aids.

We need to promote a model with the audiologist at the center of assessment and treatment, however the patient should have access to the full range of treatment options.

Makes logical sense for consumers who want to practice self care and who want affordability. Also in line with advancements such as apps.

Create competition, lower costs, address needs of a significant number of people who cannot afford or do not need professional appraisal and assistance.

There is little evidence to suggest a substantial risk to the health and welfare of consumers who adopt hearing aids for early stage, age related hearing impairments without medical intervention. There IS, however, extensive evidence to support the facts that major barriers to adoption of hearing technology exist in the form of high cost and inconvenience. Further evidence supports the early adoption of hearing assistance to improve patient outcome in terms of listening performance, depression, irritability, fatigue and cognitive state. With the current average time from self-identification to adoption of traditional hearing devices hovering around 9 years, it is clear that entry options which overcome the primary barriers to adoption (i.e., cost, inconvenience & performance) should be available to consumers if consumer outcomes are to be optimized in the long term.

Technology marches on… you cannot stop it.

We have OTC reading glasses so I do not see an issue for the same type of thing for people with mild to mod loss. But we have to educate the public or companies will take advantage of the fact that you cannot “see” hearing loss. Easy for purchasers of reading glasses to know if they help or not…not so easy with hearing. That being said, we need to open the door to innovation because we are not only talking OTC hearing aids but apps, etc. Even FitBits might someday provide hearing enhancement. (Hearables). Audiologists should embrace ALL technologies.

For most people, there isn’t a medical condition that would be negatively impacted by self-treating with an OTC hearing aid. As long as people treated them like OTC reading glasses, I don’t see a problem. There will still be a need for audiologists for people with more severe difficulties and people who need lots of support for their device. The OTC devices will have to be durable, though: water resistant, no flimsy cases, internal wiring that stands up to being dropped onto a lap or a carpeted floor, etc. None of these “mail-order” quality pieces of junk amplifiers that stop working in a month!

Cost is a major factor in the reduced access to hearing technology. Low-end, easy-to-use options may prove to be another available option for patients with milder levels of hearing loss.

To make hearing aids more main stream

With the caveat that they need some kind of standard specifications for selection by the consumer.

People deserve the choice

The FDA mission statement indicates that the organization ” …is responsible for protecting the public health by assuring the safety, efficacy and security of …medical devices, …and products that emit radiation.” There is no reason why hearing aids cannot be made both efficacious and safe in an over-the-counter format. Current device category restrictions are confusing to consumers, impair adoption and stifle innovation. The maintenance of a comfortable, high margin distribution cartel should not be a reason to limit access to new technologies and improved hearing performance. In fact, there is no reason why this category of devices could not also be available through professional channels in order to surmount some of the current barriers to adoption and create patient relationships at an earlier stage in the progression of hearing impairment. Creation of a new category of hearing aids that requires suitable standards of performance and quality will improve access to solutions, promote innovation and ultimately bring more patients into the hearing healthcare funnel, at an earlier stage, as hearing difficulties progress beyond the range where OTC solutions are effective.

Hearing help is too expensive

We need to promote a model with the audiologist at the center of assessment and treatment, however the patient should have access to the full range of treatment options.

Unmet consumer need

Technology and software have come so far.

Hearing Industry Undecided about Over-The-Counter Hearing Aids

Affordability is an issue and technology is evolving. Sure we in the industry can talk about patient safety but if a client does nothing that’s not safe either. We should look at a way of screening for red-flag issues for people looking at a “premium PSAP” as their gateway solution.

Amplification for hearing loss without some supervision or instruction will lead to misleading claims of performance and could discourage consumers from seeking further help. That being said the current regulations are too restrictive and reduces access to hearing help to too many people due to costs.

Hearing Industry Against Over-The-Counter Hearing Aids

Poorly fit hearing aids won’t work at best and can damage hearing at worst.

Consumers may become frustrated after trying several OTC hearing aids that are not appropriate for their hearing loss and give up on amplification. They may feel (at that point) that “hearing aids don’t work”. When, in fact, they have not been properly fitted for their hearing loss. An audiologist would be able to not only measure their hearing and ears, but also counsel them with regard to hearing speech in noise. Also, a professional could check to see if their hearing loss is simply the result of ear wax.

These devices seldom fit the hearing loss and give people the impression that all hearing aids are not going to work.

If affordable access to hearing care is the primary concern, then do away with the medical referral for medicare and allow direct access to audiologists.

In order for patients to get optimal use of their hearing aids they should be specifically programmed according to the patients hearing loss. The fitting of hearing aids should also be verified and validated which cannot be done over the counter.

If the government wants to reduce the cost to the end consumer, they should provide a medical benefit through Medicare (monetary contribution, ability to purchase through a 3rd party buying group, etc.). By the time an individual has noticed an age-related hearing loss, they do not have a mild or a moderate loss, rather they have a moderate-to-severe or greater degree of loss, which cannot be helped by such devices.

I have seen patients come into my clinic with hearing tests provided by retailers at “big box stores” who should have referred for ENT management and did not. These patients were misdiagnosed (hearing loss was exaggerated to make them hearing aid candidates) and red-flags for medical management were ignored. In one case, patient had a tumor on his auditory nerve. Had these patients not come into my clinic for a second opinion, this dangerous management of their care could have escalated into serious health problems. Patients should seek care from a qualified healthcare professional (audiologists) when discussing amplification to ensure they are treated ethically and appropriately.

Hearing aids are medical devices used to treat hearing loss, which is a medical condition. Hearing aids should be dispensed by professionals who are trained in the diseases of the ear and the intricacies of today’s sophisticated hearing aids.

Hearing loss requires professional care. And high outputs put consumer safety at risk

Hearing aids are a medical device that need to be dispensed by appropriately trained individuals….and that is only the first step. Over the ensuing years of ownership…this same hearing care specialist needs to carefully monitor and adjust the hearing aids to maximize the user’s experience and utility of the product.

It will kill the hearing healthcare industry and provide increased general dissatisfaction due to improper fit and poorly adjusted circuitry.

As an audiologist, I cannot support self care for hearing needs. OTC devices cannot be adequately programmed by someone who is a trained, licensed and certified professional and the user runs a tremendous risk of causing further hearing impairment or another physical injury.

People have enough difficulty with devices that are properly fitted by a hearing care professional. It is a recipe for failure.

People with hearing loss differ in so many ways, selling hearing aids over the counter takes away their right to be appropriately fit by a professional. As an Audiologist I feel that we are trained to deal with hearing loss and treatment options. OTC aids will diminish our standing as professionals.

Hearing Healthcare is not about a product, it is about total Healthcare and rehabilitation of restoring not only hearing sounds but the cognitive process.

Although this approach may provide an “adequate” solution for some hearing impaired people, much like getting eyeglasses at Sears or other low cost sources, it does not allow these people to learn about nor experience a complete and comprehensive evaluation that’s explained to them, or prescriptively set hearing aids (REAL) which can only be performed in an office, or regularly scheduled follow up support/counseling/cleaning and maintenance to ensure long term satisfaction and value, or auditory rehabilitation ensuring the client’s brain is learning to effectively adjust to and utilize the new world of sound the aids provide. It simply is a cheap rip off of quality care that may seem more expensive on the front end, but when delivered with integrity, is an exceptional value to people in the long run.

What if the patient has a reversible hearing loss or medical condition? Hearing aids are potentially damaging to hearing if not set appropriately.

Making over-the-counter hearing aids available to the general public without examinations of ears and understanding the many causes of hearing loss can create serious problems if untreated medical conditions are present. Even hearing difficulty caused by a simple obstruction of ear wax will not be seen and can result in the failure of the device to provide any help. Other conditions such as otosclerosis as well as more involved ear pathologies will be missed by the purchaser of an over-the-counter device.

Absolutely not! As an audiologist, this is an affront to my profession! Hearing aids are not a personal listening device, they are medical equipment, and therefore need to be treated as such. Instead, more needs to be done to stop internet sales of hearing aids and require all hearing aids to be sold by qualified audiologists and hearing instrument dispensers only.

This is a danger to consumers. iPods and iPhones with ear buds tell part of the story. Power junkies will not know when enough is enough and may end up damaging hearing even further.

Hearing Aids are not one size fits all. It takes a skilled audiologist to fit hearing aids appropriately. If anything is sold over the counter, it should be a general amplifier or hearing assistive technology, and not be deemed a hearing aid. Hearing aids should be fit to a prescription. This cannot be accomplished over the counter. It is an insult to the audiology community to believe that something sold over the counter could provide as much benefit as a hearing aid fit by a professional who has a doctorate degree in audiology. Hearing loss is a medical issue and should be treated as such. There is research that is beginning to show a correlation between untreated hearing loss and cognitive decline. It isn’t just about volume, but devices fit to meet a patients hearing loss, listening needs, and lifestyle. There are already too many individuals with hearing loss who are being treated inappropriately by those without the proper education. As hearing loss is a medical issue that can have cognitive and social implications, there should be a movement away from OTC hearing aids and hearing aid dispensers, not towards them so that patients and their hearing loss can be treated appropriately from the start.

It is imperative to have the expertise of a trained hearing care professional in the diagnosing and fitting process with amplification. Due to the way in which our cognitive processing determines how we hear, each individual is so vastly different from one another that selling over-the-counter hearing devices will make them significantly less effective.

I believe it would hinder appropriate treatment for hearing loss. I’ve seen many patients who will wear hearing aids that are not giving them enough volume just because it’s a cheaper option. With the research now showing links between hearing loss and dementia, I believe that our society can’t afford for more individuals with hearing loss to wear inappropriate amplification.

Hearing loss can be the first sign of greater health concerns. It would be in the best interest of the individual to have their hearing evaluated by a professional to rule out other health issues before going directly to amplification.

Because I have not found a single patient happy with OTC hearing aids and they end up feeling all hearing aids do not work and give up seeking help. Also I have had patients with ear infections, earwax and other medical issues get them who needed to be treated medically and did not need a hearing device. The number one complaint of people with hearing loss is background noise and I have purchased many of the devices and they are extremely noisy and have no technology in them to handle background noise.

For so many years the government felt the need to ‘protect’ the public from ill-fit hearing aids. Why now the wild swing the other way? We as an industry and profession have worked so hard to uplift the professional fitting of hearing aids; we can’t just let this agency or administration destroy that. Should there be less expensive hearing aids available, YES, but let us be the ones to continue to present and fit these to patients. OTC will degrade the whole industry, take away what we have worked so hard for the past 30 years.

Patients already have issues with hearing aids that are fit appropriately. Allowing patients to buy very basic devices OTC will exacerbate the problem of patients not hearing and understanding well with their aids. I feel that the primary reason for this is that consumers are not well educated on what their options are and the differences between hearing aids and amplification devices. They view hearing aids as still being very basic amplification devices, when they are not, in fact that. There is also a lot of follow up care that goes into a successful hearing aid fitting. Having aids OTC would eliminate that type of follow up care for those patients that choose to purchase aids that way. This is detrimental to the consumer, as well as to the industry.

Patients buy these “hearing aids” then come to audiologist to fix them because they don’t work. When you try to explain why they don’t understand. Then they tell people they bought these “hearing aids” and they have never worked. So this exacerbates the idea that hearing aids are not worth the cost because they don’t work.

Consumers Against Over-The-Counter Hearing Aids

Not like buying a toaster. You need a professional! Over the counter dentures would not help anyone , this won’t either. It will hurt the people who actually need them .

Hearing aids are not a one type/size fits all. There are different options and accommodations available and its important that the wearer is well versed on what to expect. You will have people that don’t fully understand hearing loss or hearing aids selling them to people.

A simple increase in volume is not adequate for most with hearing loss. The loss is different across the different frequencies of sound. Some people may turn the OTC hearing aids up too loud in an attempt to improve what they hear. This usually just distorts the sound, and could lead to further hearing damage. I am all for more affordable hearing aids, but please keep a knowledgeable person involved in their fitting and adjustment.

All hearing aids need to be properly fitted by a professional.

Fitting and programming is crucial to successful hearing aid use.

Consumers Undecided about Over-The-Counter Hearing Aids

Well, I support the principle of the idea but hearing loss is unique to each individual and quite complex. Being able to find and adjust a hearing aid to address a person’s situation is beyond the skill of the most individuals. My audiologist has spent many hours fine tuning my aids to give me the best hearing experience possible. Many audiologists have a Phd. What I would like to see is the price for hearing aids come down to be affordable to a wider range of people. The industry has something of a mystique built around the marketing, pricing and dispensing of hearing aids. As an example, 4 years ago when I was shopping for hearing aids, I found 1 brand and model that I liked. Then I went to a different supplier and found the same brand and same model for $1,000 LESS than the first supplier.

Patients need access to genuine audiologist assessment and care. Patients need properly fitted aids. Patients need protection from too-loud amplification. Enforcement/oversight of predatory hearing aid distributors is currently very insufficient, on the one hand. On the other hand, PSAPs are valid instruments that should be reasonably available. I, with an 80dB hearing loss, found a $300 Personal Sound Amplification Device/System that worked better than my old hearing aids and nearly as good as new Oticon hearing aids ($6,000). I wore it for a few months and it worked remarkably well. Then I bought it for my elderly family member who had arthritis and he liked its large size (big headset shape) and large dials and lack of earmold, which never worked for him. He wore it to our wedding and it really did work better than audiologist-fitted hearing aids ever did for him. I am concerned about a lack of national standards–no hearing loop installation standards as in Europe, no caption call standards (they miss entire sentences, no joke), no smartphone dB measurement data to compare across instruments, etc. We need rigorous and enforced standards, including over the counter hearing aids.

I agree that people may go this route when they would not go via the current system. I also understand how many people do not have hearing aids that should. My main concern is that anyone paying $500 for a PSAP, who ends up dissatisfied and unhappy with the results will bad mouth all hearing aids to others. I know several people who have purchased PSAPs, who think they have hearing aids. Most feel they are not worth the cost. I would say that if the device was in the $100 range, it might be OK.

There needs to be a warning included explaining that these are not intended for those with profound loss; otherwise folks like me may not get the best hearing aid(s) for their needs.

The great majority of hearing aid professionals do not follow any best practices they just want to make a huge profit by selling expensive hearing aids and then saying good bye. At least this has been my experience. Also I have recently seen 3 of my elderly friends buying expensive hearing aids that ended up on a shelf because the hearing professional who recommended and sold them could not (would not) do too much about the issues that these customers had with the hearing aids (proper fit, whistling, etc.). You don’t have to go too far, just check how many professionals on Hearing Tracker say they follow best practices. So if this is the case, why should one go to a hearing professional and pay many thousands of $s to buy something that will not help them? Why does one need them if they do not provide added value? I do understand why they argue against OTC hearing aids, they will lose sales. If they do not want that to happen, then they should follow best practices and become professionals instead of just being salesman.

Consumers For Over-The-Counter Hearing Aids

Anything that makes hearing aids more accessible to more people is a good thing.

It can be the gateway for those who need hearing help to take the first step.

My hearing aids cost $6500. We need to make hearing aids affordable.

Some older people don’t like going to the doctor and don’t want an expensive high quality hearing aid. They just want something to get them by.

Hearing aids as they are dispensed now cost too much. I believe technology and software could be created that allows for user adjustment of settings without having to be adjusted only by highly-paid “specialists.”

We live in a “I want it, and I need it now” society. The current methods take weeks to get hearing aids, is time consuming and doesn’t work well if you are homebound or in a nursing facility. Doesn’t matter if this is your first or tenth pair. Consumers should be able to get them if all they need is simple amplification. They are too costly, and insurance often won’t pay, or will pay just a pittance of their cost.

Because who can afford $4,000 to $6,000 for hearing aids, they are not covered by most insurances yet I need them to work!

The hearing aid industry needs to be forced into being more competitive, innovative and responsive to consumer needs.

I am a hard hearing person, use hearing aids every day and had a lots of problems with the last pair I bought(very expensive) and now j have Kaiser as my insurance company but they do not cover hearing aids and it’s totally unfair.

The cost of hearing aids at the dispenser is exorbitant, Perhaps I can afford them through this alternative although I question the service component that is so important when it comes to fine-tuning and fixing…

There are so many who can not afford hearing aids.

People with mild to moderate hearing loss are not inclined to spend the dollars necessary to purchase HAs (especially from an free standing audiology office as opposed to big box and other methods) but they could benefit from PSAPS as their loss progressed the would, hopefully explore upgrading to full featured HAs.

People with only a small vision loss have the option of buying cheap, over the counter eye glasses. I think people with a small hearing loss should have the same option.

Hearing aids sold by commercial audiologists are too expensive. On the other hand hearing aids sold over the counter will not have any expert available to show the customer how to use them (some people can’t even insert ear plugs correctly) or to ascertain that they fit correctly or need any adjustment. So it’s not altogether a simple answer.

Hearing aids are too expensive for most people. It’s better to have something than nothing.

Getting started with “beginners” hearing aids will significantly reduce the typical time lag between patients knowing they need a hearing aid, and when they can finally get them. Statistics suggest that time is 7 to 10 years.

Because I suffer from severe to moderate hearing loss and can’t afford hearing aids so I just remain nearly deaf.

Existing distribution structure of hearing devices has not served the American hard of hearing public. Over the past 4 decades, the percentage of HOH population using hearing aids has not changed in a significant way. New ways of distribution must be created as a matter of better public policy.

As long as the ability to further damage the ear is eliminated these should be treated like reading glasses which are widely available OTC.

Hearing aid dispensers charge too much and have abused their monopoly.

Because I think patient’s needs are more important than the needs of traditional Physicians, Audiologists, Manufacturers and Dispensers. The current system is a racket. The costs prohibit access to hearing aids for a large group of people.

It would reduce the total cost to the motivated patient and would not prevent anyone from seeking a doctor’s advice.

It will provide hearing assistance for those who cannot afford the exorbitant cost of hearing aids!

Innovation drives evolution and price reduction, hearing technology has no exception from this. If prices remain high, there is a large % that will never be able to benefit from hearing aids.

Prescription hearing aids are too expensive if electronic hearing assistance devices will do the job. On-line hearing test programs seem to follow the same procedures as do “professional” audiologists even if the results are not quite as precise.

So many people who need hearing aids never purchase them. It may be cost or vanity. For many with severe loss they need the assistance of an audiologist in choosing brands, models, and programming.

Today’s hearing aids are out of the reach of the majority because the cost is too high. We must allow alternatives for these people with low cost and easy access. We cannot wait for insurance coverage. The gold standard will always be licensed fitters and audiologists but for those with fixed income access is most important. I personally know many paso users who love their cheap devices.

Competition would hopefully drive the price down for all hearing aids.

Because the cost of hearing aids is out of reach on millions of people that needs them. Hopefully this will bring the cost down and break the big six hearing makers monopoly.

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