If trials aren't predictive of wild success who's motivated to pay the startup cost?
Mass production of a prototype involves committed investment. Everything has to be done upfront with the assurance the initial investment will be recovered and profits made. Design schematics, injection molds, custom parts, QC, marketing/advertising materials, safety testing, trademarks, patents, UL certification, packaging, etc... Not to mention all the governmental and medical regulatory hoops, hurdles and liability concerns.
Once on the market, if it gets poor reviews they'll have to push this product on gullible tinnitus sufferers just to recoup the initial investment. (sound familiar?)
Or maybe this device is a simple TENS unit paired with a programmed mp3 player, minimal startup cost and little risk.
Go big or go home. We don't need more gimmicks. If it works, great! Let the good times roll.
Hope it works, don't we all!