AirPods Pro 2 Hearing Aids not available in Canada

On December 11th Health Canada provided Apple with the necessary approvals (from their letter to me “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”.

However, they go on to explain that it is now up to each individual province whether a prescription is required for them. This is an example of ridiculous bureaucracy. If it comes down to each province or territory, why would Health Canada need to be involved in the first place?

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.

Interesting article from yesterday where Apple is quoted as still working with the provinces on this: https://www.thestar.com/life/health-wellness/apple-s-airpods-hearing-aid-feature-is-available-in-106-countries-but-not-canada-here/article_76c5641a-0346-11f0-a88b-9fa7e7f24a0b.html

The quote makes me feel a little more optimistic since it indicates that Apple has not been given a hard no by the provinces yet.

Already forwarded to CBC new c/o Mike Crawley who wrote a piece on this 2 years ago when the USA allowed over the counter hearing aids

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

Good work big Gordo, I have written a letter to health Canada, ignored, also contacted my conservative MP, who seems to be very concerned about this and assured me she will bring it up at Parliament, it is absolutely ridiculous that these are being deprived to Canadians

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.

You’ve probably already heard stories like mine, but living in Canada, not being able to take advantage of the hearing aid feature that hundreds of other countries enjoy. Today I landed on a flight to London, England and immediately the hearing aid feature was available on my phone when I connected to the airport wifi. This is so frustrating. I have been active in contacting CBC Marketplace, no response, Health Canada, Ontario College of audiologists, Saskatchewan Health where I live and continue to get the runaround. I actually own a terrible set of $5,000 hearing aids that I do not wear. They sound awful. My AirPods sound wonderful as they are designed with music fidelity in mind. If I sit down and play my guitar with my $5000 hearing aids, the sound is so awful I want to throw them across the room. Let’s get this fixed. More people need to be active and make the decision makers aware. We need the media to help us out. Anyone have any pull?

I travelled to the US last month. The Hearing Assistance features magically appeared on my iPhone 15 Pro, and also on my iPad.

I was able to do a Hearing Test.

Upon return to Canada, the HA features were still active! And after updating to iOS 18.4.1, they are still there.

So we arrived in Zurich, Switzerland on a holiday. Of course my hearing aid function works here, too and I’m sure it will continue to work as we travel to Italy in a few days. My partner mentioned to me how beautiful the song birds sounded outside the AirB&B we are staying and I said, I can’t hear the birds, other than the low frequency crows. I put in my AirPods and immediately I could hear the birds. It almost brought tears to my eyes how beautiful it sounded. My partner said, why are you being denied this in Canada? I can see the added joy this brings to your every day life.

Here’s unexpected good news: AirPods Pro 2 Hearing Aid and Hearing Test Features Approved to Launch in Canada

I’ve updated to 18.3 and cannot find any hearing aid/test function. I think the various provinces still need to approve.

I wrote to the Quebec Health Minister and my email was transferred to the Quebec Health Ministry.

Here is the response I received today - January 7, 2025 (in French)...

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Monsieur Marcil,

​​​Nous avons bien reçu votre courriel concernant la vente d’appareils auditifs au Québec. Nous portons à votre message toute l'attention requise.

Nous lisons attentivement tous les témoignages, car le bien-être et la santé des Québécoises et des Québécois demeurent notre priorité. Ceux-ci nous sont utiles pour mieux connaître l’impact des décisions, et améliorer les mesures en place ainsi que les services offerts aux citoyens, lorsque cela est possible. 

Plusieurs solutions sont analysées en continu afin d'assurer des mesures adéquates et suffisantes dans l’ensemble du réseau de la santé et des services sociaux.

Veuillez agréer, Monsieur Marcil, l'expression de nos sentiments les meilleurs. 

L’équipe du Ministère

Ministère de la Santé et des Services sociaux

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Let’s hope they follow up by approving the over-the-counter sale of hearing aids designed for mild to moderate hearing loss in Quebec ASAP so that Apple can activate their hearing Aid functionality on the Airpods Pro 2 in this province...

So frustrating and unacceptable. My wife got $4000 hearing aids 5 years and ago and rarely used them as they distorted sound so much. The rechargeable batteries died several months ago and the store where she bought them said the manufacturer no longer supported them and no repair could be done. The audiologists will fight us to the end as their only cash cow is seriously threatened by Apple. I have received nothing but boiler plate brush-offs from the Ontario Ministry of Health. Premier Ford’s office did not even reply.

This why we need Mark Carney as prime minister. One Canada one approval! This pathetic situation of each province having to approve something as basic as this is embarrassing. On the international stage what a bunch of small minded losers we must look like to the rest of the world.