AirPods Pro 2 Hearing Aids Not in Canada

Thanks for sharing this response from your MP.

So a product that is designed and sold (both in the US and Canada) for the dedicated purpose of improving hearing recognition (and likely called a “hearing aid”) is allowed to be sold and used in Canada - because it is cleverly characterized as a “hearing amplifier”.

Yet an internet OS update for long available AirPods is “blocked” for Canadians because this “software code”makes our AirPods into “medical devices” - and now our AirPods are miraculously seen by our “health guardian bureaucrats” in Health Canada as a “hearing aid” and therefore a “medical device”. And thus subject to Federal and Provincial regulatory control.

A clever sleight of hand - likely unlawful - pushing the boundary of medical device protectionist and anti-competitive practice beyond any logical or purposeful limit.

Why the difference? Health Canada realizes there is no practical way they can block the mail or citizen transmission of OTC hearing aids into Canada - without an extremely costly and heavy handed enforcement process.

Think trained hearing aid sniffer dogs at airports and border crossings. Maybe further x-ray inspections and training to recognize clandestine hearing aids tucked away in your luggage! How about having to remove your US purchased OTC hearing aids at Canada Customs upon returning to Canada after a vacation and having them inspected by trained Health Canada “experts” to determine if they are “hearing amplifiers” or “hearing aids”.

Yah - you get the picture (and sarcasm) I trust.

But if all Health Canada has to do is to misuse Canada’s control over the airwaves within Canada to “block” the download of this “dangerous to the Health of Canadians” latest OS update - then it’s Golden! Let’s do that! That will provide at least 5 more years of market protection to the audiologist and hearing device industry in Canada. While Health Canada “considers” the pros and cons of deregulation of this market segment, just like the US has done over the last 5 years before they concluded the BENEFITS to American citizens outweighed any concerns. Is Health Canada really going to arrive at the opposite conclusion?

If this OTC hearing aid sale issue has been resolved to the benefit of US citizens, after strict review by US health experts, you figure Health Canada might move quickly to a similar decision? Or to at least, in the interim, back off of their patently misguided blocking of the latest AirPod OS upgrade within Canada? Close to 100 other countries recognize the obvious - the improved functionality is not making the AirPod into a “hearing aid” or “medical device”, and the upgrade has not been blocked from their citizens.

This sort of regulatory over-reach breeds contempt and cynicism of the important work that Health Canada performs each day.

It is also somewhat disappointing to know that for whatever reasons, Apple has been complicit in this madness by going along with the Health Canada position.

We must all write to Health Canada and also bring this to the attention of the media. The rationale of Health Canada will not withstand scrutiny from the public once known. I for one will be writing to CBC Marketplace because I believe this bureaucratic bungling is just the type that falls within the role that the TV show tries to fulfill on behalf of the public.

Thoughts?

Look at the long list of countries where the Apple Airpod Pro hearing aid functionality is available. It includes many third-world countries but not Canada. This is nothing short of outrageous.

In Canada, corporate lobbies always win over consumers: the Big Three telecommunication companies are still charging an arm and a leg for internet and cell phone coverage, the big chartered banks are still charging high interest rates on credit cards and forcing a three-week pay cycle to change the due date every month and screw consumers with late payment fees, the audiologist and hearing aid lobby is still preventing consumers from purchasing over-the-counter hearing aids, 2 years after they have been made available in the US.

As I said, this is nothing short of outrageous.

Last year, I purchased the Sony CRE-C10 from BestBuy US and had them shipped to Shipito for re-shipping to me in the Montreal area. Last month, I bought the Sony CRE-C20 from Amazon US, and it was again shipped to Shipito for re-shipment to me in the Montreal area. To install the Sony app for these OTC-ITE hearing aids, I had to create a US Apple ID, log out from my Canadian Apple ID, and use a VPN to be able to get the Sony app from the Apple store while logged into my US Apple ID, set up my hearing aids with the app, log out of my US Apple ID, log in to my Canadian Apple ID to have access to all my purchases (music, movies, books, etc.).

Fortunately, I don’t need to repeat this process to fine-tune my hearing aids with the Sony app. Once installed on my iPhone, I can use it even when logged into my Canadian Apple ID.

But isn’t it ridiculous that I must do all this to access good OTC-ITE hearing aids in Canada? One needs to be a bit savvy to do what I did, which is not the case for many elderly Canadians who would benefit most from affordable OTC hearing aids. The more I think of this, the more outrageous it appears to me...

Well, I am a Senior Citizen and I have been waging this battle for 2 years. I wrote emails to my Federal Member of Parliament, Liberal Robert Oliphant, and my Provincial MPP, Liberal Stephanie Bowman, detailing all the information you have provided above, such as how the USA carried out strict test on over the counter hearing aids products and concluded it was in the Public Interest to open up the market. Not here. Both of these Liberal politicians tap danced and provide the same pablum based responses, such has how there were morally outraged at how the hearing aid monopilies in Canada have managed to block access for Canadians. However, after several exchanges when I pleaded with them to do their jobs by doing something tangible to effect a change in legislation, they did NOTHING - they simply ignored my emails (I wrote another email to them yesterday on this Apple issue).

I was fortunate to have contacts in the USA and I purchased a set of JABRA hearings aids for $1,200 - less than half or a third of what I was quoted at Hearing Life and House of Hearing. Note that most of the hearing aids are made in Scandanavia (Denmark is a big producer). The on-line test showed exactly the same hearing deficiences as the in-house test at Hearing Life and House of Hearing. And the service was excellent. I met on-line with an Audiologist and they addressed all my concerns. When I had a small problem with one hearing aid, they shipped me a new pair (through my US contact) - all for free.

This latest scam with preventing Canadian citizens from accessing low cost hearing aids is a complete disgrace, and I promised both Liberal politicians Robert Oliphant and Stephanie Bowman that I would go to the end of the earth to expose their betrayal to the Senior citizens of Canada in favor of protecting a well oiled and financed political lobby.

Big Gordo

Shhh - don’t tell the Canadian health regulatory authorities. They will soon set up inspection facilities to X-ray parcels to find those dangerous OTC hearing aids! Yah - it’s insane. Dictating to Apple “no, no, no - don’t you dare improve the functionality of your top selling product - we can’t block the sale of your iPods in Canada - but we can block your automatic customer upgrade to the latest IOS ! Talk about third world behavior - this is truly over the top. The time has come to stop this anticompetitive behavior - enabled by our very own Government. The media have got to pick up on this story and start screaming like ****.

Both federal and provincial govts will need to deregulate the hearing aid industry. Short answer, don’t hold your breath.

Related article: https://www.cbc.ca/news/health/hearing-aids-over-the-counter-us-canada-1.6622197

Good response lakedogs_2000

I have also written last week to health Canada, it has been a week now with no response, I will now push my mp for answers, keep it up, this is a travesty. Many Cdns will benefit greatly from this low cost hearing assistance, most cannot afford the audiologist priced option.

This would probably work if you have a vpn but my understanding is it might violate the Apple terms of service.

I’ve contacted my MP and MLA and heard back from our mla. He’s looking into the issue.

That’s precisely what it is. IOS 18.1 does install on your compatible iPhone, and firmware 7B21 does install on your AirPods Pro 2, but the hearing test and the hearing aid functionality are unavailable in Canada. I understand that it’s the same in India as well.

I’m sorry Lucster - but this response makes zero sense, particularly after reading all of your other comments on this thread.

You say:

“The update to IOS and the AirPods firmware is not blocked in any way, shape, or form in Canada. What is blocked is the hearing aid functionality of the AirPods Pro by Apple …”

My point is this: you say the “hearing aid functionality is blocked by Apple”. But according to the Apple Store tech supervisor Genius that explained it to me in Vancouver, it is the IOS UPDATE that gives the AirPods that precise functionality!!! That is why the 18.1 update is “not available” in Canada, using GPS locating to prevent access to that update to the firmware for users of AirPods in Canada! Apple may be the one actually doing that - but the person I spoke to that the Government of Canada required that.

Makes zero sense that Apple would just voluntarily block the 18.1 IOS update without being told to do so by Health Canada. They would want to introduce this enhanced functionality to ALL of their IPod users!

AirPod pros are no more a “medical device” than they were before. Health Canada is overreaching - and should be called out in the loudest way for their anti-competitive and anti-consumer behavior.

If it’s good enough for the US regulatory authorities - it’s good enough for Canadian regulatory authorities.

I have been fortunate in my life to never have had my freedom taken away from me...until now. And it doesn't feel good. I purchased my AirPod Pro2 devices after reading a New York Times article about the upcoming launch of their ability to be hearing aids. I am beyond distraught because I had a brief three minutes of seeing how great they were at improving my hearing and then "poof", the button I had pushed--Accessibility on the Airpod App on my phone--disappeared and I literally heard it go back to just plain non-hearing aid status...never to return again. I found out the hard way that my GPS was used to block any access to be able to hear better.

To think that in Canada, a seemingly free country, we are unable to purchase something and have it work the way we want it to is blocked is a really, really bad realization. Think of all the lower income people who this would benefit and Health Canada is opting for the Hearing Aid companies (Big Hearing, like Big Pharma in the US) instead of it's citizens who are in need is sobering at the least.

FYI, I have tried to get the hearing features working in Canada by wiping my phone, setting up using a VPN, disabling location services and using a US account but it did not work. I guess they use your GPS location even if you don't allow it.

My next attempt will be a trip to the USA to see if that works.

Here’s the response I got from my MP when I questioned why one company could sell OTC hearing aids while Apple cannot.

Dear Greg,

Thank you for your email.

My office did some digging into your issue, and this is what we’ve uncovered:

The devices listed in the Amazon link are technically considered “hearing amplifiers” and not “hearing aids,” therefore making them available for sale in Canada without being licenced by Heath Canada does not classify this as a “medical device.”

Hearing amplifiers and hearing aids are both devices that amplify sound, but they have different purposes, intended users and regulatory status:

Health Canada regulates hearing aids as “medical devices”, so the federal agency (Health Canada) would have to approve Over-the-Counter models for sale in Canada. Once they have been approved, it is up to the provinces to decide whether such hearing aids could be sold over the counter. For example, In British Columbia, provincial law says only a licenced audiologist can prescribe a hearing aid and prohibits providing anyone a hearing aid without a prescription.

According to the Medical Devices Regulations, Class II, III and IV devices must be licenced before they can be sold in Canada. Class I medical devices do not need to be licenced; however, the devices listed in your Amazon link are not considered to be “medical devices” and, therefore, do not need to be licenced for sale. 

Unfortunately, no company within Canada are able to provide hearing aids Over-the-Counter to our citizens at this time.

I hope this addresses your concerns and please do not hesitate to write to me in the future.

Sincerely,

Frank J. Caputo, MP

Kamloops-Thompson-Cariboo

You mentioned in another post that you can get the "hearing aid functionality" with the Airpods Pro 2 without IOS 18.1 and without regard to where you are located.

Unfortunately, your “scenario” requires a workaround to do a hearing test with an app or to go to an audiologist, pay to get an audiogram and feed it to your iPhone to get it to adapt to your hearing specificities because your “scenario” does not give you access to the full Apple hearing test that comes with IOS 18.1. Furthermore, what you’re getting is very likely more akin to customized EQ than the actual hearing aid functionality that comes with IOS 18.1. How do you know whether you are getting the full hearing aid functionality of IOS 18.1 with your setup???

Your setup is undoubtedly better than nothing for countries that do not allow the sale of OTC hearing aids, where the full AirPods Pro 2 hearing aid functionality is blocked. But it is not a substitute for this functionality for millions who would benefit significantly from it at a reasonable cost.

Why would these millions of individuals be forced to go through any workaround because their country does not allow OTC sales of hearing aids? The issue is not finding a clever workaround that may or may not give users the full AirPods Pro 2 hearing aid functionality, but governments that should put an end to the audiologists-hearing aid manufacturers cartel and allow people to benefit from advances in technology to improve their day-to-day lives.