Could the Malleus Prosthesis procedure be done in the U.S?

DOCTOR ROBERT PINCUS FEB 25, 2015 10:32 AM

Question

I had chosteatoma when I was little, and they had to remove all three of the bones in my ear. I recently had surgery when they put in a TORP to try to regain hearing, but it was unsuccessful because there was too much scar tissue on the stapes footplate.

They then told me there was nothing else they could do to free the stapes because there was no malleus or incus they could connect it to.

I recently read a study done by Dr. Neil Sperling where a malleus prosthesis was inserted into the external auditory canal. The TORP was then connected from the prosthesis to the footplate and the results from the study were good.

Is it possible that I could have this procedure here in the U.S?

 

Answer

Thank you for your inquiry.  The clinical situation you describe can be very difficult to repair. A laser dissection can usually correct the scar tissue associated with the stapes footplate, but without a malleus bone, it is difficult (but not impossible) to stabilize a prosthesis.

A very promising solution is the Malleus Replacement Prosthesis (MRP) developed by surgeons in France, who I worked with to report their results.

Unfortunately, this device is not yet FDA approved in this country. I have made a recent inquiry to the company who manufactures it for an estimated release date in the US, but this information is unpredictable due to the FDA’s process.

If I could be helpful to you to further consider your options, I would be happy to do so.

Neil M. Sperling, MD

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