In iOS 18.1 the long awaited Air Pods Pro 2 Hearing Test and Hearing Aids feature is (as of 18.1 release date) not available in Canada. When will it be available and is there any specific was as users we can make this happen?
[Re-Titled by Moderator]
iPhone 13 mini, iOS 18
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.”
welwyn wrote:
Well, the latest update is 18.1.1. However, the hearing aid capability is simply NOT available in Canada yet. When will it be? No answer
No one participating in this forum would know the answer to that question. You will need to wait until Apple and the Canadian government work through whatever they need to work through.
au Québec, une vieille loi ( la loi des professions, qui date d'une cinquantaine d'années) empêche les audiologistes et orthophonistes de vendre des appareils auditifs) et c'est pour cette raison qu'ils s'en dissocient. Le lucratif marché est réservé aux audioprothésistes, qui n'ont pas le droit d'avoir un employeur qui n'est pas audioprothésiste - ça explique pourquoi Costco vent des appareils en Ontario et pas au Québec.) Je viens d'installer iOS 18.3.1 et la fonction d'aide auditive n'est toujours pas disponible. Il paraît qu'un court séjour aux USA permet d'activer la fonction mais disons que le climat politique actuel ne me donne pas trop le goût de franchir la douane :-(
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
---- ATTENTE POUR ACTIVATION DES AIRPODS PRO 2 AU QUÉBEC ----
High,
I just read the correspondance from Berbyq with the ON gouv. posted here.
A few weeks ago I made a similar enquiry asking the ''Ordre
des orthophonistes et audiologistes du Québec'' what was oldling up the local approval of the listening aid pro 2 in Quebec. here is there answer:
Bonjour Monsieur -------,
Effectivement, Santé Canada a approuvé la fonction "appareil auditif" dans les
Airpods de Apple vers la fin de 2024. Cependant, l'Ordre des orthophonistes et
audiologistes du Québec n'a aucun lien avec le fait qu'Apple n'ait pas encore
déployé la mise à jour du logiciel permettant d'activer cette fonction, tant au
Québec que dans toutes les autres provinces canadiennes. En effet, l'OOAQ n'a
pas pour rôle de donner son aval au sujet de la disponibilité de ce type de
produit ou de sa vente au Québec, notamment parce que la distribution et la
vente de prothèses auditives sous prescription ou en vente libre ne fait pas
partie des activités des audiologistes ou des orthophonistes du Québec.
En complément d'informations, l'OOAQ a un énoncé de positon sur les appareils
auditifs en vente libre, que vous pouvez consulter au lien suivant:https://www.ooaq.qc.ca/decouvrir/a-propos/enonce-position-appareils-auditifs-vente-libre/ ainsi qu'une page web dédiée
au sujet: https://www.ooaq.qc.ca/consulter/audiologiste/appareils-auditifs-vente-libre/
Bonne journée,
Joanie Farmer, M.P.A Audiologiste
/ Conseillère aux affaires professionnelles
Ordre des orthophonistes et audiologistes du Québec
630, rue
Sherbrooke Ouest, bureau 800
Montréal,
Québec, H3A 1E4
mulholland4 wrote:
In iOS 18.1 the long awaited Air Pods Pro 2 Hearing Test and Hearing Aids feature is (as of 18.1 release date) not available in Canada. When will it be available and is there any specific was as users we can make this happen?
[Re-Titled by Moderator]
Unfortunately it’s now up to the various provinces to approve. If you read that email I got from my mp it said in part:
“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.”
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 because the sale of OTC hearing aids is still banned in Canada. We must assume that Apple considers the hearing aid functionality introduced with IOS 18.1 to qualify the AirPods Pro as a hearing aid under Canadian law. Therefore, because the sale of OTC hearing aids is still banned in Canada, Apple prevents Airpods Pro users from using this functionality.
I doubt it's Apple. It's the same with the UK, France, Spain and Australia. No OTC hearing aids in the Uk. Mine work as hearing aids as I am still running IOS 17.7.1 and they work really well for me.
Lucster wrote:
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.
I tried to make that point early on in other threads. No one wanted to listen. Perhaps you'll have better luck. I hope so.
Au sujet des air pods 2 voici ce l'ordre des audiologiste au Québec m'ont récemment répondu concernant l'absence d'acces au logiciel d'activation :
==================
Bonjour Monsieur *****,
Effectivement, Santé Canada a approuvé la fonction "appareil auditif" dans les Airpods de Apple vers la fin de 2024. Cependant, l'Ordre des orthophonistes et audiologistes du Québec n'a aucun lien avec le fait qu'Apple n'ait pas encore déployé la mise à jour du logiciel permettant d'activer cette fonction, tant au Québec que dans toutes les autres provinces canadiennes. En effet, l'OOAQ n'a pas pour rôle de donner son aval au sujet de la disponibilité de ce type de produit ou de sa vente au Québec, notamment parce que la distribution et la vente de prothèses auditives sous prescription ou en vente libre ne fait pas partie des activités des audiologistes ou des orthophonistes du Québec.
En complément d'informations, l'OOAQ a un énoncé de positon sur les appareils auditifs en vente libre, que vous pouvez consulter au lien suivant:https://www.ooaq.qc.ca/decouvrir/a-propos/enonce-position-appareils-auditifs-vente-libre/ ainsi qu'une page web dédiée au sujet: https://www.ooaq.qc.ca/consulter/audiologiste/appareils-auditifs-vente-libre/
Bonne journée,
Joanie, M.P.A
Audiologiste / Conseillère aux affaires professionnelles
[Edited by Moderator]
Sorry, I’ve lost track of this discussion so maybe this has been posted already. But I contacted Health Canada Medical Devices Directorate and this is part of their reply -
“On December 11th, 2024, Health Canada issued two Medical Device Licences to Apple Inc., authorizing the sale of their Hearing Aid Feature…..”
It goes on to say that it is up to the provinces to determine accessibility to these devices. So what next?
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?
If you travel to the states with your AirPods the feature enables right away…..and they still work when you get back!
im thinking an update might wipe it out so I’m avoiding this update. The hearing function is awesome.
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.
This is very helpful only under headphone accommodation I am not offered the option of using an audiogram. I have done the Mimi test and associated the audiogram with the Health app but still don’t get that option.
iPhone 12 Pro Max 18.2
Airpods Pro 2
Canadian resident obviously
The Hearing Aid Feature is not supported in Canada yet. Neither is the UK where I live. If you have an iPad or iPhone running IOS 17.7.1 or older you can them working and access and add your audiogram and USE your audiogram as long as you set them up with is older than 18.1.
You can get access if you have an older Apple iPad or iPhone.
This will probably depend on if/when your province also approves their use. I know that in BC there are regulations that require a licensed tech to dispense “medical devices” such as hearing aids. I’ve emailed our BC minister of health to learn of the timeline for approval but no response yet.
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 because the sale of OTC hearing aids is still banned in Canada. We must assume that Apple considers the hearing aid functionality introduced with IOS 18.1 to qualify the AirPods Pro as a hearing aid under Canadian law. Therefore, because the sale of OTC hearing aids is still banned in Canada, Apple prevents Airpods Pro users from using this functionality.
AirPods Pro 2 Hearing Aids not available in Canada
