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Mary Beth

New Med-El Synchrony internal implant FDA approved

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The other Synchrony implants are Mi1200

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61B53792-AEE4-41F0-B0D5-995B613B35C2.png

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What added benefits are there - do you know?

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I am not sure if there are added benefits or if it is another option for surgery approach (like the pin is an option already).

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Yes, I'd guess that it's not all that different or it wouldn't just be a PMA supplement.  Just curious, really, it won't end up in my head!

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@Mary Featherston

Since I have been implanted all CI items have been supplements on the same FDA number.

Sonnet

Rondo 2

Maestro 6 with ASM 2

Maestro 7 with triphasic pulses

Synchrony

I am not sure how that all works.

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@Mary Beth 510(k) submissions are kind of complex.  Med-El probably submitted the whole system, because you can't just use a processor, you have to have the implant, the processor, and the software that makes them work and lets you map them.  That means that individual components that get released (like Rondo2) will be added to the PMA so that they are regarded as part of the system.  Given Med-El's focus on backwards compatibility, I can't imagine how any new component would be other than an addition to the original PMA.

If they created an entirely new cochlear implant that doesn't work with these components, then it would probably require its own submission, but that would be a fairly radical departure from the way they manage this business (at least that I've seen).  Even then, if the device is deemed substantially similar it could probably be released on the original 510(k).

Navigating regulatory submissions in various countries around the world is increasingly complex, and particularly so for companies like Med-El that make implanted devices that remain in the patient's body.  Our products are all Class I and Class II and subject to similar, but less onerous, regulatory strictures.

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It is thicker in one section.

 

DC8F95FB-41F4-460B-99E2-16AA529EE037.jpeg

E65E871C-D391-4EBE-AD1C-441C945D2BDB.jpeg

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There must be some benefit or I doubt they'd make it bigger.

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I agree.  I asked on Med-El’s official FB page and Verena is checking on it.

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@Joan

Here it is

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@MED-EL Moderator

 

Are you able to tell us what the difference is in the FDA approved Synchrony ST implant compared to the Synchrony implant?

Thanks

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Hi @Mary Beth, Thanks for checking in on this: we are waiting for an answer and will let you know once we hear back :)

Thanks, 

Mary 

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Thank you Mary!

@MED-EL Moderator

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Hi @Mary Beth

 

Sorry for taking so long to get back to you on this. 
 

The implant housing of SYNCHRONY ST is slightly thicker than the Mi1200. In addition, only the Mi1200 is available with a pin fixation.

Although the Mi1210 SYNCHRONY ST cochlear implant was approved by the FDA, at this time there are no immediate plans to release this product in the US.

Thanks for your patience, and sorry again for the delay in replying :). 

Kind regards, 

Mary 

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@MED-EL Moderator

Thank you Mary!

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Does anyone have more information about the "Mi1250 Synchrony 2" implant that received FDA approval on 06/04/19?

See screenshot of FDA premarket approval database below. More details also here: https://fda.report/GUDID/09008737366780 - device is listed as "in commercial distribution" status.

mi1250.PNG

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@Luke

I saw this public FB post mentioning the Synchrony 2 from the ACIA pediatric conference in Miami that just wrapped up.

 

F1D59E01-3E13-44BD-A4C6-E15E690E7104.png

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@Luke

https://s3.medel.com/documents/AW/AW34408_20_Surgical-Guide-SYNCHRONY-ST-EN-English_web.pdf

 

This is the Synchrony ST.  There may be a guide like this for Synchrony 2.

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Yes, I saw the same post on Facebook. I could not find any guide or data sheet like there is for the Mi1200 and Mi1210. From the FDA approval it reads like the electrode array leads do not anymore exit sideways but centered from the receiver/stimulator unit. That likely required a PCB and packaging redesign so I wonder if the internal electronics have also been updated. But googeling for "Synchrony 2" and/or "Mi1250" does not bring up anything except on the FDA pages.

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@Luke

If I see anything, I will post a link.  You too okay?

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Thanks. I found the same image in a July 19 press release on FDA approved SSD & AHL indications, which did, however, not mention anything regarding an Mi1250 implant. Below is a higher resolution snapshot from the PDF. What's interesting is that the wires still seem to exit on the left side of the electronics enclosure as before, but are then routed in the silicone around the enclosure towards the center where the electrode carrier is attached. Maybe there was no PCB/electronics redesign after all...

screenshot.PNG

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