AirPods Pro 2 Hearing Aids not available in Canada

I contacted Health Canada Bureau Of Licensing Services and if I interpret their response correctly, AirPods Pro 2 are approved (as of Dec 11/24) as class 2 medical devices. Availability is dependent on the provinces.

Has anyone had any luck?

Here is their response to my inquiry -

“On December 11th, 2024, Health Canada issued two Medical Device Licences to Apple Inc., authorizing the sale of their Hearing Aid Feature and Hearing Test Feature, which are compatible with Apple’s AirPods Pro 2. These types of hearing aids are Class II medical devices in Canada and require a Medical Device Licence to be sold in Canada.

 Provinces and territories decide how licensed medical devices are accessed in their province or territory including, in the case of hearing aids, whether a prescription is required. Please contact your provincial health department for information regarding access to hearing aids and the applicable regulations.”

Yes! Read the same. Health Canada Medical Devices Directorate replied to my inquiry and said they issued licences to Apple on Dec 11/24. And that now it is up to the provinces to decide accessibility. Will write to Alberta Health in the New Year

@donaldfromottawa

There is no way to download AirPod Pro 2 firmware update containing HA functionality. The HA feature set is enabled by the iOS firmware in your iPhone. It ‘knows’ where you are, and is programmed to not activate HA if you’re in Ottawa (or elsewhere in Canada🇨🇦). However, once activated, the feature set will persist. A quick trip across the border to Massena might suffice. The HA features are active in both my iPhone and iPad following a trip to the US last month.

My experience with the ferry attempt between Active Pass and Tsawwassen - it worked! I had to try several times, but once I got into the right area (US waters) suddenly the "take hearing test" appeared. I was very excited until I realized that the ferry noises wouldn't let me do the test, as there was too much rumbling. But once I got back to the parking lot at Swartz Bay, I was able to do it in my car. So delighted! I wasn't sure on the ferry whether the connection would still be there on land, but it was. And to my untutored brain, the effectiveness of the air pods pro 2 as hearing aids seems just as good as my Costco ones were. Hope this encourages someone else.

I have also disabled automatic updates, just in case that would send me back to square one.

This was done with a new iPhone 16E, and the air pods pro 2 were ordered from Amazon a couple of months ago. IOS version 18.5.

I had tried all over Victoria, trying to find one of those places where you get the "welcome to the US! You are roaming!" message, but couldn't find one. The expert said he thought it might be because they were now using GPS, so they knew exactly where I was, as opposed to which tower I was close to, if that makes sense.

Recently wrote to Ontario Health Ministy - this is what I just got back......

Thank you for writing to the Honourable Sylvia Jones, Minister of Health, about using Apple Airpods

as hearing aids. The Ministry of Health appreciates that you took the time to get more information.

In Ontario, audiologists and speech-language pathologists are governed under the Regulated Health Professions Act, 1991, and the Audiology and Speech-Language Pathology Act, 1991.

Under these acts, the College of Audiologists and Speech Language Pathologists of Ontario (CASLPO)

is responsible for ensuring its members are competent, skilled and

qualified to practise in Ontario. As part of its duties, CASLPO may make regulations and set standards of practice on a variety of subject matters.

We encourage you to contact CASLPO as they are best suited to answer your questions:

CASLPO

601-175 Bloor Street East, North Tower

Toronto, Ontario  M4W 3R8

Telephone: 416-975-5347

Toll free: 800-993-9459

Email: caslpo@caslpo.com

We hope this information is helpful. Thank you again for writing.

Sincerely,

Correspondence and Corporate Support | Correspondance et soutien ministériel

Ministry of Health | Ministère de la Santé

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?

I did this on the weekend and it worked. I had already upgraded to 18.1. I just restarted my phone once I got down there and when I connected my airpods the hearing aid features showed up in the settings automatically. I did the hearing test and enabled it in the settings and it kept working even when I got back to Canada. So far it is working great.

I wrote to Health Canada regarding the hearing aid function and they wrote back that they approved this use and issued licenses to Apple allowing this function mid December 2024. They recommended writing to Health Ontario as they will also have to approve the hearing aid function! I wrote to Health Ontario Feb. 12th and have not received a response as of yet. Why we have duplicate levels of health administration seems like overkill. I’m sure other Provence's have their own health administrations as well, multiple duplications!!! Makes you wonder why health care is so expensive!

I'm in BC. I managed to activate the hearing aid function yesterday on the ferry between Swartz Bay on Vancouver Island and Tsawwassen on the mainland.

There's a point for about 15-20 minutes before you get to Tsawwassen when the ferry passes through US territorial waters. I followed the ferry position on Maps and put in my airpods when we got to US waters. They showed up in my iPhone settings with both the hearing aid function and the hearing test active.

When I got home I opened up iPhone mirroring on my iMac and they showed up there too.

Some people here mistakenly label the AirPods Pro's transparency and noise cancellation functionalities as the hearing aid functionality. It’s like Live Listen, which has existed for a very long time, whereby you could use your iPhone to pick up sounds and relay them to your AirPods. These functionalities are fine but not the same as the hearing aid functionality.

The only way to get the hearing test and the hearing aid functionality is with IOS 18.1 and up and AirPods Pro firmware 7B19 and up, in a country that allows OTC sale of hearing aids.

I tried to set up my AirPods Pro 2 with firmware 7B21 with an older iPhone 1ù2 with IOS 17.7.1 yesterday, and YOU DO NOT GET the hearing test and the hearing aid functionality.

There is a lot of misinformation being spread here about this.

Going to repost this info from rasg detailing how you can use your iPods as “unofficial” hearing aids now as long as you use an older iOS version for set up. This worked well for me.

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If you haven’t updated your iPhone to IOS 18.1 you can still use the Airpods as hearing Aids with an older IOS without the geographical lock and for me with mild to moderate hearing loss they work really well. I've been using them for five or six weeks. They won't help you that much if your hearing loss is severe or profound.

If you are not on IOS 18.1 you can set them up straight away. If you have an iPad or an older iPhone that is running an older IOS you could set them up on that. You will need to download the free Mimi app to do do a hearing test OR you can download your audiogram by taking a photo of it.

Assuming you have set them up using Bluetooth after you have taken a hearing test. Go to Settings/Accessibility/Audio Visual and click on Headphone Accommodations. Click on Audiogram and it will ask you which one to use. If you used the Mimi app the test will appear with todays date. Select it. In the next menu you can hear a sample of music and toggle between music with your Audiogram applied and without it so you know your Audiogram is working.

Go to the bottom and click on Transparency Mode and also switch Conversation boost on.

With the Airpods connected to your phone or iPad, your Airpods will appear close to the top of the Settings menu. Click on it. Switch Conversation Awareness on. Switch Loud Sound Reduction on. Go almost to the bottom and do an Ear Tip Fit Test to make sure you have a good seal in your ears.

That's about it but there are loads of settings you can play around with. In the last menu I mentioned you can simply set them to Adaptive Mode which will automatically set Noise Cancellation volume according to your surroundings. Otherwise you tinker with the Background Volume and Hearing Aid Volume manually independently of each other.

Hope this helps. Copy it quick!

I’m in Canada. I have an iPhone 15 Pro and an old iPad, both with 18.3.2. Also have Air Pods Pro 2.

As widely reported by others, the Hearing Assistance features are not visible.

Last month, I went to Florida. Upon arrival, I turned on the IPhone, took Air Pods out of the case, put them in my ears, and opened iOS Settings. The AirPods item had appeared in the list. Opened it, and as if by the magic, the Hearing Assistance functionality had been enabled! I was able to do a Hearing Test. The test reported “little to no loss”. (Odd, since my wife insists that I often don’t seem to hear her very well…). After completing the test, I was able to activate Media Assist mode, which I assume applies some equalization to the audio output when listening to music, videos, or calls. However, there is no button to enable Hearing Aid mode. I surmise that’s because the amount of my hearing loss, per the test, was insufficient.

Out of curiosity, I put the iPhone to sleep and woke up the iPad. Once the AirPods had paired with it, the Hearing Assistance features were enabled on the iPad as well.

i did a second Hearing Test, using the iPad. The results of the second test were almost identical to the first. The two tests results then got synced between the two iDevices (via iCloud), and can both be viewed in the Health app.

Upon return to Canada, I checked to see if Hearing Assistance functionality persisted after crossing the border. It did🥳. Further, I subsequently updated the iPad to 18.4, and was surprised to see that HA is still enabled. I’ve not yet updated the iPhone. That’s on my ToDo list, after doing a backup with iMazing.

Doesn’t appear that a new Prime Minister would be able to help considering that it is the Province that is in control of this issue. https://www.ctvnews.ca/toronto/consumer-alert/article/i-think-its-sinful-to-hold-it-back-consumers-frustrated-apple-hearing-aid-feature-not-available-in-canada/#:~:text=Apple%2520AirPods%2520not%2520clear%2520for,ripped%2520off%252C%E2%80%9D%2520said%2520Jackes.

The issue that needs to be clarified is whether Apple looks at GPS data to determine where you are located when you attempt to configure the AirPods Pro. I could log in to my US Apple ID using a VPN and then download the Sony app and configure my hearing aids—all that from my location north of Montreal. But I don’t know if the Apple process is the same. Remember that when you log in to a different Apple ID on one iPhone, you must first log out of your Canadian Apple ID. If you have the lockdown feature set, you have to wait an hour before being able to log in to your US Apple ID. It’s better to turn off lockdown mode before you begin this process. You can reactivate lockdown mode after you’re done.

I am pretty certain that it's to do with your Apple ID.

It's would have been so much easier if nobody had updated to IOS 18.1 and that's the foirst thing they did often after buying the Airpods specifically to use them as hearing aids.

The Airpods do a great job as hearing aids running any IOS as long as it's not 18.1 and they are not geographically locked. The other "lock" they have is that they will not work as hearing aids at all if your hearing test shows severe or profound hearing loss. It's something to be aware of and I think Apple has had to use the locks in order to get FDA approval in the US.

If you haven’t updated your iPhone to IOS 18.1 you can still use the Airpods as hearing Aids with an older IOS without the geographical lock and for me with mild to moderate hearing loss they work really well. I've been using them for five or six weeks. They won't help you if your hearing loss is severe or profound BUT I do know of a few people with severe loss using them for the music, TV, Facetime and phone call features simply because the sound quality is so good. They might just want a break from their normal hearing aids.

If you are not on IOS 18.1 you can set them up straight away. If you have an iPad or an older iPhone that is running an older IOS you could set them up on that. You will need to download the free Mimi app to take a hearing test OR you can download your audiogram by taking a photo of it.

I have read that rolling back to and older IOS is no longer possible as Apple is no longer signing the backdate but I would love to put it to the test by restoring a back up of my iPhoine but I don't want to mess things up.

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.

What will work is if you set them up with an Apple device that is on IOS 18.01 or older.

It works. I have been using them since September and they work well for somebody with mild to moderate hearing loss. Music was a revelation and I am loving listening to music again.

Go to settings/accessibility/audio visual/headphone accommodations