PSAPs with hearing aid labels; is any PSAP following FDA guidelines?

I have been looking at PSAP devices over some time. I tried many of them. Some of them, even though they do not mention the word ‘hearing aid’ on the internet, has ‘hearing aid’ written on them. One example is:

I have attached a picture from the package which clearly says ‘Hearing Aid’.

I got another one from Walmart Online (could not get the link; seems like is down now).

Aren’t these products violating the law? The over-the-counter act has not come into effect, has it?

Also, none of the PSAPs I tried out follow the FDA guidelines, especially the ones regarding labeling.

Are all these rules and guidelines a joke now? Why is no one (say the federal government or FDA) doing anything about this?

I’m sure the FDA is not funded enough to enforce all regulations equally. So they have to prioritize. Going after PSAP sellers that call their PSAP “hearing aids” is probably not at the top of their priority list.

"To clearly distinguish between PSAPs and hearing aids, FDA relies on the intended use of
each product to determine whether it is a medical device or an electronic product. The
intended use may be established by labeling or promotional materials. Labeling or
promotional materials that make claims, or include language that suggests the use of a
PSAP for hearing impaired consumers, establish an intended use for the electronic product
as a medical device, which would therefore be subject to the regulatory requirements for a
hearing aid, as described in this guidance. Examples of such labeling claims and language
that would establish an intended use as a medical device include:
• a description of the types and severity of hearing loss
• a description of listening situations that are typically associated with and indicative
of hearing loss
• wording to suggest that the product is an alternative to a hearing aid. "

Frankly, if they work to improve your hearing enough to use them, what difference does it make what they are called. More and more people are buying stuff on-line. If the devices can be returned for a refund if they don’t suit the user then I don’t think there is a problem with nomenclature.