Just a few thoughts and some background info on what the...

Just a few thoughts and some background info on what the Clinical Trial might be about ...

Starting with a bit of (controversial) discussion of how BOSE completed their clinical study to first get the DeNovo approval for their (just released) Hearing Aids.


https://www.medtechdive.com/news/hearing-industry-calls-bose-self-fit-hearing-aid-study-flawed-in-complaint/560992/

I posted this on HC at the time it was released - wondering at the time if the approval would be overturned.

It seems FDA didn't listen to the HIA (Big 5 anyone?) and went ahead with the DeNovo approval.

This appears to be the reason (510(k) Exempt) that Nuheara and Olive have since got FDA listing for products without clinical trials


As for the Regulatory Frameworks in Australia - this part of @YourDudliness post seems to be most relevant.



As well as the study done by the University of Melbourne, Nuheara have also worked with the National Acoustics Laboratory (NAL) and have used the NAL2 standard as the hearing test on the BOOST and subsequently the MAX.

They look like they could be one body that might do the Research side of a Clinical Trial ...




One of the interesting things about a trial, is that Nuheara have reminded us many times that they already have 5 years of data (collected from all bud wearers) that is a great resource in understanding use and users of hearables. I'm wondering if its possible that the study could be more "Statistically Driven" (data driven) than actually involve longitudinal study of people. Or if it might just be an "on the spot" study like the one BOSE did for their DeNovo clearance.

I guess we will will find out more detail next week.

Whatever it is, the aim of a Clinical Study is to get Regulatory Approval - and it must be something beyond the approvals we already have.

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