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...I've been holding off on the ear balloon dilation for FDA approval. I was hoping to avoid out of pocket costs. I can't believe it still hasn't been approved.
Hi lttleldyver,
The procedure you mention is often termed balloon Eustachian tuboplasty (BET), although a number of similar names have been applied. A device used to perform this technique just very recently was cleared for use in Europe and is already available in the Nordic countries.
As for FDA approval, that is pending, and, barring a Priority Review, Accelerated Approval, Fast Track Designation, or Breakthrough Therapy classification, which seems quite unlikely, the remaining wait could be considerable.
Be aware that unlike balloon synoplasty, which generally, although not always (e.g., cases of progressive or recurrent sinus disease), only needs to be performed once, preliminary findings on BET have left it unclear how long it can be expected to provide effective relief.
Best of luck.
Regards,
DocVikingo