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AudioStream adapter for Rondo 3 shows up on FCC site


Mary Beth

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Getting closer in the US

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I checked the FDA site a while ago but only saw the HearCares app in process so that’s getting closer as well. There were a few other items but wasn’t able to totally identify them (one seemed to be surgical related). 

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I saw that the HearCare app and Maestro 10 were FDA approved in November.  I have not heard of a US roll out date yet.

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I've heard from an audiologist that not all clinics will be opting into the HearCare system and that any remote programming care must be done by a provider in your state because different states have different laws and certifications. That being said, I am looking forward to these additions!

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There seems to be some features of the HearCare app that are not dependent on clinics opting in.  Obviously to get full benefit from the HearCare app, clinics would need to participate.

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Is this MedEl’s first FCC entry?  I’m curious because it doesn’t look like they’ve had any other items go through the FCC.  Would this approval override an FDA required approval?  One would think there’d be entries for Sonnets, Audiostream v1 and such no?  It also looks like this approval process began back in October.  This doesn’t support bidirectional streaming does it?

 

 

Re: HearCare.  It will always depends on the clinic / hospitals.  Each has their own set of procedures.  Many do not support or have the ability/billing to support telehealth type stuff.  These same places also do not support ABs remote thing either.  I know MEEI/MGB in Boston will never allow it, while another hospital across the city is in discussions how it could be used and what system they may need in place but likely won’t go forward within the next 5-10 years on it.

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Med-El has had several items go through FCC approval.  When I searched online I saw the list and dates.  Just recently the AudioStream adapter has been added to the list.  Here is a screenshot of part of the list.  It will still need FDA approval.

IMG_6318.jpeg

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Thanks!  Not familiar with the FCC site so no clues if this was a one off or something.  Do the FDA approvals come soon after the FCC approvals?

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@John F

Timing varies with FDA approvals.  The website I check updates each Monday.  There is always a period of time after FDA approval and before the item is available to order in the US.  When it is available, you will definitely know.  Smile.  Until then, it only guesses.

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  • 2 weeks later...

FCC and FDA are two totally different, and unrelated entities.

FCC compliance will be related to the fact that the Audiostream adapter is a communication device, but the FCC complaince would run independently of the FDA approvals.

Not sure if FDA would require FCC compliance before they tick their boxes or if that could run in parallel. Typically, these compliance organizations all operate in total darkness of one another and the manufacturer is required to ensure they comply to whatever is necessary prior to releasing product to market.

Some guy in South Africa posted on FB the other week that he had one he was trialling, presumably SA compliance regulations are much more lax than everywhere else!

 

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