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Gotta love the FDA


Adam

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Just found out one of the reasons why it took so long to approve the 2nd mic.

They needed to change some things in the user manual and labeling. I kid you not.

well at least everything is approved now.

 

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Won't be surprise if that changes were something like "Don't insert your fingers into electric outlets" :)

 

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Lol! Which took careful planning I'm sure!! 

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Adam,

According to the PMA section of the FDA website, this supplement to the original PMA was submitted by Med-El on August 22, 2016. It was approved within the FDA's normal 180 day time period for this type of submission.

Sonnet users, like myself, should note that In addition to the time required for product documentation and labeling completion, audiologist training also has to be completed.

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That's understandable. Sure, audi training is a time consuming process. We will wait a little bit more (only because we have no other options:rolleyes:), But I think we can allow ourselves to fret a little bit to make our waiting more entertaining :D

 

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Okay @Cara Mia (playing with our newly discovered feature- smile).  So which mic settings are you most interested in trying out?

Natural- fixed focus to the front (is best when noise is from behind)

Adaptive- focuses in on loudest sound signal

Omni- just like we have now with equal focus all around but with 2 mics, instead of one

Auto-adaptive: stays in omni until a trigger loudness level (set by our audiologists) and then switches to adaptive 

 

Then of course there is windblock.  Options are OFF, MILD or STRONG.

 

Which settings will you ask your audiologist to place in your 4 program slots?

 

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Duplicate

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Oh, Mary Beth, very good questions.

I am greedy here, I am most interested in all setting to try out. Even the omni with a windblock or in auto-adaptive mode feature can be very different from what I hear now.

And it is hard for me to choose what to ask. I would like to try all of that in real life (not within the wall of my CI center). I need more program slots for sure :)

Definitely don't know what to choose better over the other options.... Need to hear it to decide. Sure I want Natural and, perhaps, auto-adaptive is more sophisticated option compare just Adaptive (but maybe I am wrong). Perhaps, I will start with a Mild windblock as I am pretty comfortable with wind without any block and I like to listen to wind....

Ok, guys, help me with that! your ideas?  Don't tag anybody just because I need some time not to feel myself too naughty when doing this.

I am happy today, our new hire has decided to quit! Some my boring duties are back to me, but it is such a relieve.... :)  Much better than endless training with not so much progress... feel so energetic :D

 

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I also like listening to wind and don't get bothered by wind noise often so here is my plan.  I am going to get my favorite program in 4 dual mic versions

-omni

-natural

-adaptive

-auto-adaptive (but not sure which trigger dB to request yet)

That will be 4 programs in 4 slots.  Windblock OFF in each one.

Then use them in my real life and determine which ones I want to keep and which ones I don't.  At the following appt I can add in windblock on the mic settings I am keeping.

That's my plan.

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Very structured plan, Mary Beth. I think I can follow it with the main mic settings activated with Windblock off. Good that we can schedule the adjustment appointment as soon as we need without waiting for several months until the next "standard" visit.

I am curious to try Windblock ON even if I am pretty comfortable with this feature off.

I told you, I am greedy and inquisitive about all of that :)

 

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I will try windblock on also but not at first.  I want to alter one thing at a time.  Smile.

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Strange, 

I thought I saw one submitted later. Anyhow, my info came from an employee. 

Yup, now everybody has to get trained on it

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Sweet thoughts you have, girls...[emoji3]

Sent from my EVA-L09 using Tapatalk

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Agreed Cara Mia. What's a little longer?

 

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Gotta tell ya Mary Beth, the natural blew me away. Absolutely perfect for that application

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I haven't really even thought about windblocker. 

I think what I might do is just roll with it for  a little while, then come up with a more specific plan if I want to tweak anything. 

It will be enough to get used to the programs. Once I get a better feel for what I like, I'll know what to change.

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Cara Mia,

I am out of "standard visits". Maybe they will include a few for adjustments.

curious to hear what the windblock is like. I don't remember that when I was in Arizona

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Adam,

Since I'm still in the first year....does insurance usually only include so many "particular" types of Audiologist appts & then stop paying? 

Thanks for the info.

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No Travel,

when you get implanted, usually activation and mappings for a certain amount of time are included in the cost of the CI.

if I went to my Audi today for anything, we could run it through our insurance. There would still be some out of pocket for me. It really depends on your insurance plan.

i was referring to the mappings after activation where there was no out of pocket at the time of the mapping

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Actually different CI centers in the US handle the billing for activation and subsequent MAPpings differently.  Some include some of them in the cost of the implant.  Some keep those costs separate.

 

At my CI center, those costs were not added into the cost of the implant.  Activation and each MAPping appointment was handled separately.

 

It varies from one CI center to another.

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I hope it all happens soon for you guys. I wish I had known all the stuff you guys do a year ago. I hated wind block. But don't remember the last time it happened. Think it's gone. When wind block kicked in everything went quiet. But it doesn't anymore. As for programs I like omni and adaptive. 

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That's right Mary Beth. I think every stage is handled a little differently. My hospital wanted us to stroke a check for 4,000.00 as a down payment.

yeah like we could do that. We ended up getting help from Voc Rehab, otherwise the surgeries wouldn't have happened.

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