My Mission to create a better "Snug Fit" (For CI and HA).

Good point RoseRodant. I'll make sure no latex is used on this. I know some people who are allergic to it too.

Well, I got my first plastic prototype made over this week and and I'm loving this. Unfortunately the only plastic my friend had for his 3D printer is black so it's made of black plastic right now. I'm shooting for clear but this is just to give it some thorough testing.

What's great is when you use this you don't feel it at all. It's not even touching your skin anywhere when you wear it unless it's about to fall off such as if you shake your head really fast or angle your head in a position that it would normally come off (Such as bending down). Only then will the holder make contact with your flesh anywhere and stop it from falling off.

It's not hard to put on or take off. That was another issue I ran into while testing the design out. At first it was kind of hard to put the processor on. But now I've got it so I can put it on and take it off easily. You just have to sort of angle it a certain way when you put it on or take it off.

My next issue it to find a way for it to attach to the various CI processors and BTE Hearing aids. Because they are all shaped differently. I need to find a universal method to attaching them to the processors and HA that won't harm them. No one would want to glue anything to their processor or HA. How I have it attached to mine is I attached it to one of the color shells that come with the N5. I have a friend that has a Freedom so I'll check her's out to help me work it out for them.

I also noticed that a simple modification to this design will also hold eye glasses and prevent them form coming off.

So, as soon as I work these things out I'll start sending some prototypes out to some beta testers. The first ones may not look at that great as far as the color of them. But I want to get some people to test it out so I can find any alterations it might need. Then I'm going to contact some companies that can make them out of clear plastic.

I said I was going to give them very extensive testing. Yesterday I was in a little wrestling match with a friend (All in good fun) and it didn't fall off. So I'm very excited about this. It's a great feeling when an idea comes together.

Ron
 
RoseRodent said:
Definitely my biggest ask for anything you make would be latex free. I am so allergic to latex that I can't go in for surgery unless I am first on the list and they have taken all latex outside the room 3 hours before they start. Too many of these products are made from latex content because it's durable, stretchy and cheap.
Click to expand...

yes, I had the same problem with earmold allergies. For years, I would scratch my ears raw. My audiologist would fuss at me and tell me not to pick at my ears. But I couldn't help it. When I switched audiologist, It was he who told me that I may be allergic to some earmold. That's was when my ears began to heal up for the first time in years. So it is very important we have options.
 
Lighthouse77 said:
yes, I had the same problem with earmold allergies. For years, I would scratch my ears raw. My audiologist would fuss at me and tell me not to pick at my ears. But I couldn't help it. When I switched audiologist, It was he who told me that I may be allergic to some earmold. That's was when my ears began to heal up for the first time in years. So it is very important we have options.
Click to expand...

I have latex senstivity, when i had the CI op, my wrist and ankle were banded with red ID tag and warning, everything in the op was latex free, even the BP cuff, my room was removed of latex stuff and notice on my door warning nurses not to wear latex gloves. Did you know that sygrines are made of latex? Seems every thing contains damn latex . I was the first on the list to have the op.
It's same with Ear mold... I have been told off number of times for "squeaking" my ear as i forget to turn the HA off and it makes alot of noise... would i bother with off switch if my ears was so itchy!! It's often left raw and i often get severe ear infections. Last time i had ear infection it was so bad that my face swelled up.
I have hypo allergic earmould, they are made of silcone.
 
Ron,

Please do not look for "beta testers". These are class 2 medical devices and controlled by the FDA. It is a federal offense to offer medical devices to the public without the proper approvals.

You can generally do what you want to your own stuff, but as soon as you give to someone else you are a manufacturer. You could end up with serious fines or imprisonment. Research what you are doing first. Are you familiar with 21CRF Part 11?

I realize that you are doing this with the best intentions, but intentions do not make it legal.

C1
 
you are silly, it is no different than people coming up with ideas with critter clip and such for hearing aids. Or in my son's case, a cheerful eye patch for lazy eyes. He isn't making medical devices at all. He is simply coming up with ideas how to keep cochlear implant to stay on.
 
CrazyOne said:
Ron,

Please do not look for "beta testers". These are class 2 medical devices and controlled by the FDA. It is a federal offense to offer medical devices to the public without the proper approvals.

You can generally do what you want to your own stuff, but as soon as you give to someone else you are a manufacturer. You could end up with serious fines or imprisonment. Research what you are doing first. Are you familiar with 21CRF Part 11?

I realize that you are doing this with the best intentions, but intentions do not make it legal.

C1
Click to expand...

That does not apply to what I'm doing. But I appreciate the warning.

Ron Jaxon
 
overthepond said:
I have latex senstivity, when i had the CI op, my wrist and ankle were banded with red ID tag and warning, everything in the op was latex free, even the BP cuff, my room was removed of latex stuff and notice on my door warning nurses not to wear latex gloves. Did you know that sygrines are made of latex? Seems every thing contains damn latex . I was the first on the list to have the op.
It's same with Ear mold... I have been told off number of times for "squeaking" my ear as i forget to turn the HA off and it makes alot of noise... would i bother with off switch if my ears was so itchy!! It's often left raw and i often get severe ear infections. Last time i had ear infection it was so bad that my face swelled up.
I have hypo allergic earmould, they are made of silcone.
Click to expand...

Allergy sufferers unite! I have a latex allergy too, and I have experienced earmold reactions - to the point where my ear swelled shut around the mold!

Luckily though, almost all of our hospitals here are completely latex free. They won't even allow latex balloons, they must be mylar. It is wonderful!
 
I went in for a mapping yesterday and found out that Cochlear is working on a new snug fit for the Nucleus 5. So, I'm going to get in touch with them about my design. My mother has a BTE hearing aid and I made one for her. She likes it a lot too. So things are going great with this.

Like I said before. The two best things about this design is you cannot feel it when you use it. So comfort is not a problem at all. What I feel is unique about it is it doesn't "Hold" it to your ear. What it does is prevent it from falling but it's not a "Holder". Think of it kind of like a door stopper that's a few inches away from the door. It isn't touching the door but if you try to open it the door would make contact with the stopper and prevent the door from opening further. This kind of like how this design works. It doesn't hold the ear but it prevents the processor from falling off. I hope that makes sense. LOL

Won't be long now I'll be able to show you all exactly how it works.

Ron Jaxon
 
RonJaxon said:
That does not apply to what I'm doing. But I appreciate the warning.

Ron Jaxon
Click to expand...

Not a problem. I just want to warn you to be very careful. Even band-aids (the kind for wounds not cheap fixes to a problem) are considered Class 1 medical devices in the USA. The wooden popsicle sticks (i.e. tounge depressors) are medical devices (Class 1). Just be very careful to keep yourself out of trouble.

-C1
 
CrazyOne said:
Not a problem. I just want to warn you to be very careful. Even band-aids (the kind for wounds not cheap fixes to a problem) are considered Class 1 medical devices in the USA. The wooden popsicle sticks (i.e. tounge depressors) are medical devices (Class 1). Just be very careful to keep yourself out of trouble.

-C1
Click to expand...

but those involve medicine. What he is doing is not.
 
Lighthouse77 said:
but those involve medicine. What he is doing is not.
Click to expand...

I am sure you are correct.

However, if you do any these actions to something that is classified as a medical device by the FDA, you are a manufacturer under the law.

Medical Device Listing - 21CFR Part 807
Manufacturers must list their devices with the FDA. Establishments required to list their devices include:

manufacturers,
contract manufacturers that commecially distribute the device,
contract sterilizers that commercially distribute the device,
repackagers and relabelers,
specification developers,
reprocessors single-use devices,
remanufacturer
manufacturers of accessories and components sold directly to the end user
U.S. manufacturers of "export only" devices

Overview of Device Regulation

-C1
 
Oh believe me. I do appreciate CrazyOne's warning. A friend of mine is in a small law suit right now that's similar. He won't get into any trouble or anything. The only thing they are battling about is if he'll be able to move forward with his product or not.

On the latex issue. That won't be a problem with this. It's made of the same kind of stuff that most head phones are made of (I'm gonna add some metal that'll allow them to make sleight adjustments if needed. Such as if they need to they can bend it a little for a better fit. Kind of like how people can, if needed, but a little bend in the arm of their sunglasses.

So what you have is a plastic part that will hold it to the processor or BTE, a short flat metal rod. On the end of that is a little plastic (to give it a smooth rounded edge) because this is the only part that'll touch your flesh when it needs to.

One question. Can any of you who have latex allergies use those pads that go on the nose part of eye glasses? Padding isn't needed but if one wants them I was thinking about using those because they are easy to find if they ever need to replace it. The padding can also provide more grip when they want it. But like I said, the padding isn't necessary because it's not touching your flesh all day long. Just like the door stopper I explained in my last post.

Ron Jaxon
 
Ron Jaxon - I'm VERY interested on your design - it would help me a lot.I hope you can make it - if you ever need Freedom beta testers I'm in!
 
Is any of this metal visible or is it all covered? Because if any is exposed you then get into the murky world of nickel allergy instead!

Can I also presume you have checked patent law? To get something covered by a patent you don't actually have to produce it for manufacture, you just need to draw a picture of it up to patent standard and write a specific description of it. You then file the patent so that anyone who wants to manufacture something similar has to pay you for doing so. I think this kills off a lot of businesses. If you aren't going to have the ** to go out and invest in your product and sell it yourself then I'm not sure you can expect the person who does do so to pay you for that. Put your money where your mouth is if you want protection! If I ruled the world ;) I'd restructure patent law so that anyone who had not attempted to manufacture and distribute their product after 5 years lost their protection.
 
On the metal thing. I haven't found the exact metal it'll be made of yet. I got my prototypes that are made of material I've found but manufacturing isn't worked out yet. On the other hand, no metal will ever touch your skin when you wear it anyway so I doubt that'll be a problem.

I'm at the moment working on the patent pending. At least getting that much filed for now. A lawyer friend of mine is sending me information on what I should do. He also said he'd help me make sure what I have won't violate any other patent. So I'm lucky to have some help in that area. Getting things patented isn't cheap.

Ron Jaxon
 
snug fit

hi Ron I have my implant surgery on wednesday ,still with a little pain already,expected my first programming on 3 weeks.one of my biggest concern is the snug fit.as an engineer with an active living I don,t want to loose it. I made few sketchs if iu want me to share with you.
Also have to tell you that the nucleous hybrid had been approved by the fda recently.

you can email me ramonortiz1496@hotmail.com
 
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