FDA Hearing Aid Regulations. What does it mean?

The hearing aid industry in the U.S. is going through a change and it looks like it isn’t going to be plain sailing.

Recent proposed changes to FDA hearing aid regulations are being opposed by audiologists. What does this mean for those who wear and need hearing aids and will these changes actually mean lower prices.


What changes are being proposed?

The FDA have recently indicated that they will no longer enforce the requirement that anyone needing a hearing aid should first have a medical examination. People can now waive this requirement. However, professionals believe that this won’t have any real impact as most people already waive this exam.


The most contentious change is the proposal to create a new class of hearing aid that can be sold over the counter in much the same way as reading glasses currently are.


This would allow places such as Wal-Mart to enter the hearing aid market. The idea behind this is the hope that hearing aid prices can be driven down and become more affordable to a greater number of people.


From an audiologist point of view this is dangerous ground to be treading. They say that hearing loss is a much more complicated issue and such a simple solution could actually lead to greater problems.


Why are these changes being advocated?

Those pushing for change have long stated that the cost of hearing aids are a prime hindrance to people seeking these devices. At present it is estimated that there are over 30 million people over 60 years of age in the U.S. that suffer from hearing loss. Studies have shown that untreated hearing loss leads to a greater level of social isolation, depression, dementia and even falling down and injuring themselves.


The studies also show that people with hearing loss are also more likely to be unable to work or travel. They tend to be less physically active than normal hearing people.


The price for a new pair of hearing aids can be anything from $4000 to $6000. This cost includes things like the professional examination to determine the level of hearing loss, the actual fitting of the device and the follow up support system for maintenance and repairs.

Hearing aids


Because hearing aids are classed as a medical device then they are subject at present to strict FDA regulations and must prove that they are manufactured and work effectively.


The introduction of Personal Amplification System Products, or (PASPs) has really thrown a curveball into the whole situation. As they are not classed as a medical device then they do not require FDA regulation.


These PASPs are much cheaper than hearing aids. They can range in price from as little as $25 up to several hundred dollars, which is way cheaper than what people are paying for medically approved hearing aids.


These PASPs are becoming increasingly popular. Not just due to the price but also because better technology is being introduced such as increased connectivity to smartphones etc… and  background noise reducing ability.



Why are audiologists opposed to these changes?

Audiologists believe that hearing loss is a much more complicated issue than simply allowing anyone who thinks they need a hearing aid to pop into Wal-Mart and by whatever catches their eye.


They firmly believe that a professional needs to physically look into a patient’s ear to see what is causing the hearing loss in the first place. There may be a more serious medical issue going on or it could be caused by a simple blockage due to wax build up.


They also question how people are going to determine what level of hearing loss they have. It isn’t possible to self determine your level of hearing loss. Free hearing tests are available online but they haven’t yet reached the level of sophistication of the proper audiology test.


Their other concern is that these PASPs devices may actually harm peoples hearing if used incorrectly or if the device is of a poor quality. The link between loud noise and hearing loss is well established. What is to stop cheap, badly made devices from flooding the market if they are not regulated in some form.siemens touching hearing aids


Audiologists favour an over-the-counter hearing aid that must meet standards for safety and effectiveness, and includes warnings that certain hearing problems require professional treatment. Alongside that proposal is one that once people get a medical exam that they are given the audiogram report and can then go to an over the counter provider armed with that information.


What happens next?

Republican U.S. Sen. Chuck Grassley, R-Iowa, and Democratic U.S. Sen. Elizabeth Warren, D-Mass., last month introduced the Over-the-Counter Hearing Aid Act of 2016, to require the FDA to establish rules and regulations for hearing aids that would be very similar to PASPs, but would have to meet certain safety and effectiveness standards.


According to Sen Grassley, this new legislation won’t affect those who require professional help before getting a hearing aid. It will also benefit those who want to buy a simpler device over the counter.


Ursula Chaplin, an audiologist and executive director of the nonprofit Speech and Hearing Center in Chattanooga disagrees. “In my opinion, that is a terrible thing, If you buy an inexpensive cheap hearing aid and expect to hear well with background noise, that is not going to happen,” she said.


Is there a compromise to these changes?

In my opinion there is merit in both camps but due to the seriousness of the issue I would be leaning slightly towards the professional audiologist position.


Those advocating the changes appear to be doing so from both a cost and better access for people position. There is merit in this. Of the estimated 30 million people over 60 years of age in the U.S. with hearing loss, only approximately 30% actually get hearing aids. The cost is seen as a major factor in this.


From a personal point of view, the cost of hearing aids are absolutely ridiculous. Something needs to be done to bring these costs down and make the devices more affordable to all.

hearing aids linked to apple


The other side of the argument has much in it’s favour also. Audiologists are rightly concerned about the hearing health of people. If we allow the market to be flooded with cheap and unregulated devices then we could actually be doing more damage to peoples hearing health in the long run.


It should also be noted here, that even in countries such as the U.K. where people are entitled to free hearing aids if required on the National Health Service there is only about a 40% uptake from people who need them. It is obvious from this that there are issues other than price that prevent people from wearing hearing aids.


I think the situation would be better served if some sort of steering group could be put together before any changes are introduced. Bringing people together to represent all parties (including hearing aid users) could hopefully be able to put together a plan that would have the support of all and ensure that everyone was singing from the same hymn sheet.


If you have an opinion on this then get in touch with your local representative or your local hearing help group. This issue is too important to be left to others. Make your voice heard. Break the silence.


As always, thanks for dropping by. This is your website. Please feel free to leave a comment or opinion below. I will answer them all asap.



11 Replies to “FDA Hearing Aid Regulations. What does it mean?”

  1. Wow what an interesting read. I didn’t know that hearing aids could be such a hot button issue. It surprised me how much hearing aids actually cost and the impact not having one could be on a persons well being. If they had access to less expensive devices and were shown how to use them properly, I’m sure it would take away some of the risks that audiologists are concerned with. Although, this may also cut into their bottom line, and you have to wonder where the line can be drawn between actually wanting to help and their own personal gain.

    1. Hi Brittanie,

      Thanks for dropping by. Your comments are much appreciated.

      These proposed changes to the U.S. law will have a profound effect on the hard of hearing community. Whilst I can certainly see both sides of the argument, I think the hearing health of people must take priority over profit. With other areas of technology we are constantly seeing a reduction in prices. Take smartphones for example. As technology gets better the price of a quality smartphone is a fraction of what they were only a few years ago.

      With hearing aids, the prices are continuing to rise and lots of people are simply priced out of buying a pair. The fear of audiologists is that if the market is flooded with cheap imitations then more harm than good could be done in the long run.

      There needs to be some sort of compromise between what audiologists see as acceptable quality hearing aids and the manufacturers of these devices. It isn’t right that we are playing games with peoples hearing health and their quality of life.

      Hopefully Congress will take a bi-partisan approach when this comes before the house and forces all parties to come together to reach an agreed way forward.

      Thanks again for your contribution.



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