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It seems to me that the Neuromonics folks are acting responsibly in allowing the use of ADP outside Australia only in the setting of clinical trials [and in limiting its use within Australia to two or three clinics wherein - as I understand it - they closely monitor progress].

True, the formal international clinical trials process is taking longer than I personally would have liked, but I must admit considerable admiration for any "for-profit" business that refuses to make claims about a product until it can justify those claims by virtue of independent controlled testing in a clinical trials setting. You know, the only reason most pharmaceutical companies do clinical trials is because they are required to do so by the FDA (and similar entities abroad). No such trials are required for homeopathic preparations, herbals, and the like - because they do not fall under the umbrella of the FDA. So when you see an ad for, for instance, Dr. John's Ear Drops with claims that it can cure tinnitus or for "low intensity laser" - the manufacturers are not required by law to back up those claims with anything more than an anecdotal success or two (out of thousands of failures?). And you really don't see a whole lot of those manufacturers doing formal blinded controlled clinical trials on a voluntary basis, now do you?

But here we have the Neuromonics people, who could easily release their product today and make a bundle based upon some preliminary (favorable, to be sure) non-blinded testing not yet backed up by a series of legitimate formal independent blinded controlled clinical trials, saying: "Let's wait until we can support what we strongly believe our product can do with some solid blinded controlled data. And if the trials show that it's worthless, then we go back to the drawing board."

Refreshing approach, no?

sp

I know for certain that ADP is in clinical trials in the US, but I do not know where. I do know that there are several independent university sites and that Neuromonics is not conducting the trials - their only role is in preparation of the spectrally altered music. Unaltered music with the same delivery system is being used for controls. And the studies are prospective, randomized, and double-blinded. (You cannot tell if you are listening to spectrally altered music or not.) I think that there is also a broad band sound plus counseling arm to the studies, but that arm is obviously not blinded.

sp

Op asked:

1.) Is Neuromonics shooting for FDA approval?

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I imagine so.

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2.) If they obtain FDA approval, will that mean that insurance companies are more likely to cover the costs?

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Not in my opinion. After all, the devices used in TRT have FDA approval. But you have to know what buttons to push to get insurance companies to cover TRT. What will make insurance companies cover ADP is demand and results. I suspect that the Neuromonics folks figure that there will be a lot of demand. TRT demand would be just a drop in the bucket in comparison. That is, if ADP works!

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3.) Do you have any idea when they plan to complete trials in the US

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No.

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and whether they plan to "retrofit" TRT centers to introduce their treatment?

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Why would they want to do that? As I understand it one of the main thrusts of ADP is how easy it is for an audiologist (any audiologist) to treat patients - and how (comparatively) few contact hours are required.

sp

If ADP is more effective than TRT, then likely TRT clinicians will offer it just like most other audiologists. What's to panic?

sp