Info on new Cochlear BAHA implant - set to debut 9/1/10

[leapyrtwins]

This is a statement from Cochlear that was passed along to me.  Thought BAHA candidates - as well as current wearers - would find this very helpful.

"On July 15th Cochlear received FDA clearance for our new Baha implant, not abutment.  The new Baha implant, B13000, will be available for order starting September 1st.  The new implant features a secure implant to abutment connection and has a newly designed coated titanium abutment screw, designed for a more consistent result over the life of the implant.

In October 2009 Cochlear released a new abutment. As of last October, Oticon processors cannot fit on our new abutment (they will snap on but will not stay on for an extended period of time). Cochlear's Baha philosophy is also "backwards and forwards compatibility."

With that said, Cochlear patients with the "old" abutment and implant will be able to wear new processors going forward, as would Cochlear patients who have the "new" abutment - they too can wear "older" processors if they so wished to do.  When we obtain FDA clearance for our systems, we validate our processors on our abutments.

With that said - Cochlear does not have validation for using a Oticon processor on our "older" abutment.  Again, the Oticon processor will not fit on our new abutment/implant.  Cochlear's abutement has always been, an internal snap coupling whereas Oticon's device is an external snap coupling. The external snap coupling design, reduces the amount of clearance for potential skin overgrowth."

Jan

[saralynn143]

Thanks, Jan. Interesting.

Sara

[ombrerose4]

Jan, I'm not quite sure I understand what the B13000 is? Is it an implant that works differently than our current BP100? Is it something that current BP wearers will need in the future? I'm confused,lol!

[leapyrtwins]

Lauren -

I understand your confusion, I was confused myself.  In fact, I may still be confused    but here goes.

The way I understand it B13000 refers to the implant part of the BAHA system, not the processor.  The implant part is basically the titanium rod that goes in the skull plus the attached connection for the abutment.  The abutment is the part that is screwed onto the connection.  The processor is then attached to the abutment.  The processor is the tiny hearing aid (Divino, Intenso, BP100).  So in the end, there are 3 parts of the "system".  

Apparently Cochlear BAHA recipients who have their implant surgery 9/1/10 or thereafter are getting the new implant part.  This is consistent with other changes that Cochlear has coming down the line (check out this thread http://anausa.org/forum/index.php?topic=13165.0 ) which will make their implant parts and abutments inconsistent with Oticon's.

From what I gather, Cochlear has decided to make their systems theirs and theirs alone because they are concerned that a combination of Cochlear parts with an Oticon processor was never cleared by the FDA.  And, in what they feel is the best end result for the patient, they are objecting to that non-FDA approved combination and are taking steps to prevent it from happening. 

So in effect, patients who choose Oticon's BAHA system cannot switch to Cochlear's BAHA system and vice verse.  

In addition, Cochlear has started to modify their BP100 - and are now for some reason referring to the modified version as the BP3.  Yet another thread to check out http://anausa.org/forum/index.php?topic=13166.0

The coupling has to do with the way the different processors attach to the abutment.  Cochlear uses an internal coupling - which basically means their processors have,  and will continue to have, a little "stem" so that they will "snap" onto the abutment.  Oticon uses an external coupling - their processor wraps around (kind of "hugs") the abutment.  The external coupling leads the processor to sit much closer to the skin on the skull.

If you weren't that confused before, I'm sure you are now 

Jan

[saralynn143]

That's very helpful, Jan. I understood about the abutment and the processor, but did not get the connection part. Now it makes much more sense how Cochlear is able to make their BAHA system proprietary.

Sara

[ombrerose4]

Thanks Jan, I understand much better now. I will also check out those links. Thanks for the info!

[leapyrtwins]

Wow!  You guys impress me - it took me forever last evening to figure this out enough to post something that makes sense.

Glad to know I'm smarter than I thought I was LOL