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The U.S. Food and Drug Administration has recently paved the way for hearing aids to be sold over the counter, removing the obligation to get a prescription or medical exam before purchasing most devices.

This is great news for consumers south of the border. But what are Health Canada and provincial regulatory authorities waiting for to follow suit?

Hearing loss is the fastest-growing, and among the most prevalent, chronic conditions in our aging society. It’s a major cause of cognitive decline, dementia, depression and falls, and often leaves people feeling isolated, which severely affects their quality of life. The world can be a scary and lonely place if you don’t hear well.

Over 70 per cent of Canadians aged 20 to 79 have some measure of hearing loss or tinnitus, according to Statistics Canada. In people over 70, hearing loss is almost universal.

Only a small fraction of those who could benefit from hearing aids – about one in five – actually use them, for a variety of reasons.

Stigma is a powerful deterrent: There is nothing like a hearing aid to make you feel or look “old,” even in an era when most everyone has something stuck in or on their ears, from AirPods to Beats by Dre. There can also be a fair bit of stubbornness involved – a conviction that, clearly, everybody is mumbling, and your own ability to hear is not the problem.

But the single biggest barrier to people getting the hearing help they need is cost.

Hearing aids – which amount to pretty basic technology – are shockingly expensive, ranging from about $995 to $4,000 for each ear in Canada. To make matters worse, the cost is often not covered by insurance programs, public or private.

Then there is the inconvenience of mandatory testing by an audiologist and a prescription.

With restrictions lifted, it is predicted that there will be a wave of innovation unleashed, and prices in the U.S. could drop precipitously to as low as US$300 to US$500 for a device.

That would definitely make hearing aids more accessible, especially to people with mild to moderate hearing loss.

Current manufacturers, a small oligopoly, are warning that the liberalization of rules will result in ineffectiveness, poor quality and even dangerous devices, which is unlikely. Of course, they don’t like to talk price, other than to say hearing aids require testing, fitting, maintenance and more.

They’re right, of course – the device itself is only part of the equation.

Hearing loss is usually gradual and insidious. You adapt by cranking up the TV, by avoiding loud restaurants and crowds and by nodding a lot in a non-committing way.

Hearing tests are needed to figure out what kind of hearing loss you are suffering from, and some professional guidance can help to pinpoint the best device for you.

There is a dizzying array of options, and having a device that fits and works well is key. It’s essential that there is a maximum volume, and limits on the maximum insertion depth into the ear canal – rules the U.S. FDA has mandated. In some instances, medical consults are and will remain a must. Sudden hearing loss, fluid leaking from the ears, vertigo, pain and ringing in the ears must be guarded against.

The question that the U.S. addressed (and that Canada has yet to) is whether it is essential to be tested by an audiologist and to get a prescription. The regulator’s answer was “no.”

There are some decent online hearing tests, and most people need fairly straightforward help in the form of devices that simply provide amplification of sound.

Of course, there will still be a role for audiologists – hopefully an even bigger one if more people can start to afford help for hearing loss.

What needs to change is the business model. At the moment, Canadians have to go to a hearing clinic to get tested, get a prescription and then purchase hearing aids at grossly inflated prices. A CBC investigation in 2013 found that it costs about $150 to manufacture a hearing aid, which is sold to an audiology clinic for between $400 and 600, and then sold to consumers for anywhere from $1,000 to $4,000.

They can get away with this because there are very few manufacturers, which often own the clinics, and the mandatory testing-and-prescription requirements in Canada hold consumers captive. Services need to be unbundled so a consumer can get a hearing test and then go buy the device that suits them at a pharmacy or big-box store.

The current rules are paternalistic, and as a result, individuals who are hard-of-hearing are being exploited and denied essential care. It’s well past time for Canada’s regulatory authorities to allow over-the-counter hearing aid sales.

The pleas of consumers have fallen on deaf ears for far too long.

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