Balloon sinuplasty and diving

[DocVikingo]

...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

 

[jimbeeler]

I have had two sinus surgeries separated by about 20 years. Have not had the balloon procedure. I have non-allergic rhinitis (I have allergic reactions to lots of stuff but am not officially allergic to anything). The one thing that has been a miracle cure for me is flushing out my sinuses twice a day (morning and evening). It just keeps stuff cleared out so nothing builds up and develops an infection. I use the squeeze bottle rather than a neti-pot. The extra push from the squeeze bottle helps clear stuff out.

Even after the surgery I still occasionally had infections. It might not work for you but since I started the flushing, I have had zero sinus infections and have had no problems clearing my ears.

Jim

 

[afdgf]

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

In order for a device (which is what the balloon is) to be approved by FDA, it must first undergo clinical trial. The clinical trial of the balloon dilation of eustachian tube has now been started in Pennsylvania. It is not clear if they are doing a phase 2 or a phase 3 trial, but at least something is now started. Until both the safety and efficacy trials are completed and the reports turned in to FDA, the device cannot be approved in the US. There are basically two kinds of trials that are normally done. The common one that is reported in the news media is the pharmaceutical trial. The other type is the device trial. (There are also behavioral trials for a third type.) Technically what is being tested in the trial is the device (the procedure is also being tested but is not referred to in the same way).
what happened in my case is that I paid for the balloon dilation of the Eustachian tube out of pocket (BTW the cost is the same whether you do one or both ears), but I only am paying the co-pay for the rest of Dr. Weeks, the hospital, and the anesthesiologist who were all in plan on my insurance.
In addition to what DocVikingo added, I hope this helps to explain things.

 

[afdgf]

I wanted to report back now that I had the balloon dilation of both of my eustachian tubes on September 10 and I just came back from a week in Key Largo during which I did the Deep Diver course with four deep dives and two reef dives (for fun). I was able to clear my ears on all dives for the first time in my life, without taking any prednisone at all. Dr. Weeks is a miracle worker. If you on the East coast, the person there is Dr. Dennis Poe out of Harvard. Weeks is in San Diego.

 

[DocVikingo]

Splendid news, afdgf.

Cheers,

DocV