Are these FDA-certified as hearing aids? null

These are not FSA approved hearing aids but are FDA certified as OTC hearing devices. Some of the previous answers I believe have been misleading

Hi Dalinar, Both the CRE-C10 and CRE-E10 are FDA-registered devices. Regards, Erin

Yes they are FDA cleared medical devices, part of the new OTC class of hearing aids.

“Are these FDA-certified as hearing aids?”

This question is for: Sony - Self-Fitting OTC Hearing Aids - Black

Asked by Dalinar 3 years ago

These are not FSA approved hearing aids but are FDA certified as OTC hearing devices. Some of the previous answers I believe have been misleading
Answered by Whatdyousday 3 years ago
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Hi Dalinar, Both the CRE-C10 and CRE-E10 are FDA-registered devices. Regards, Erin
Answered by SonyListens 3 years ago
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Yes they are FDA cleared medical devices, part of the new OTC class of hearing aids.
Answered by ChicaChicaSlimGabey 3 years ago
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