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
Frequently Asked Questions
Without the malleus and incus bones, it becomes difficult to stabilize a prosthesis since these bones normally serve as important connection points for hearing restoration devices. Scar tissue on the stapes footplate can further complicate repairs, requiring laser dissection to correct. However, the absence of these bones limits conventional surgical options for effective prosthesis placement.
The Malleus Replacement Prosthesis (MRP) is a device developed in France designed to replace the malleus bone when it has been removed. It can be inserted into the external auditory canal, allowing a Total Ossicular Replacement Prosthesis (TORP) to connect from the MRP to the stapes footplate. This provides a new stable connection that can improve hearing restoration outcomes in complex cases.
As of now, the Malleus Replacement Prosthesis (MRP) is not FDA approved in the United States. Efforts have been made to inquire about its potential US release date, but approval timelines through the FDA process remain unpredictable. Therefore, the device is not currently accessible for patients in the US.
Yes, laser dissection is often used to correct scar tissue on the stapes footplate, which can improve conditions for hearing restoration surgery. However, even with this technique, the lack of malleus or incus bones makes it challenging to stabilize a prosthesis effectively in complex cases.
Yes, ongoing research such as the study led by Dr. Neil Sperling and French surgical teams focuses on innovative solutions like the Malleus Replacement Prosthesis. These advances aim to improve hearing outcomes in patients with complex ossicular damage, though regulatory approvals are required before widespread clinical use in the US.
Patients should consult with experienced otologic surgeons who can evaluate their individual clinical situation, discuss available treatments including experimental options, and inform them about emerging prostheses like the MRP. Personalized assessment is crucial as each case, especially those lacking key ossicles, requires tailored approaches.
