Energous Product Announcement: Where's the Approval?

Earlier today Energous put out a press release about an apparent FCC approval for an anticipated personal sound amplification product (PSAP) that may be on the market in as little as three months. Despite his being a re-announcement of an already delayed product, and contact only, it send the WATT stock shooting up from under $4.80 to nearly $9.50 before settling back down closer to $7.00 at close, a healthy ~50% gain. Interestingly, it's basically a year to the day when they announced the FCC Part 18 approval for their mid-range wireless charger, that still is not announced as for sale, which got it a big price spike before a long slow decline. As this was 3am pacific time, my post was fairly cursory, and since then I've had some discussions with others who follow Energous and a few interesting points have come up.

As noted earlier, no FCC approval could be found for such a device for Energous or the manufacturers SK Telesys or Delight. Now I'd expect there to be something, somewhere - Energous push things pretty far IMO in how they exaggerate, but they really avoid doing anything blatantly illegal. Given this, I'm interested to know what that FCC approval is, if the company can provide any more details on that - the type of approval, and approval number, anything.

Interestingly, this is a personal sound amplification product PSAP - not a hearing aid. A hearing aid requires FDA approval, a PSAP does not. From the FDA:

PSAPs are intended to amplify environmental sound for non-hearing impaired consumers. They are intended to accentuate sounds in specific listening environments, rather than for everyday use in multiple listening situations. They are not intended to compensate for hearing impairment or to address listening situations that are typically associated with and indicative of hearing loss. 

Products making these (hearing aid) or similar claims should not be considered PSAPs. In addition, products that are sold as an “over the counter” alternative or substitute for a hearing aid should not be considered PSAPs. Because PSAPs are not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body, they are not devices as defined in the FD&C Act.

The link also has a very clear definition of hearing aids, and the regulatory pathway expected of them.

So a very clear and specific difference between a hearing aid, and a PSAP, and while the press release starts by talking about a PSAP, it then goes on to say:

Like hearing aids, PSAPs are used by the hearing impaired to assist with hearing loss, but they are available without a prescription and tend to be lower in cost than hearing aids.

So they are making claims that these devices are to be used for mitigating hearing loss, which makes them hearing aids, not PSAPs, and subject to FDA approval. Now confusion is often useful when you want people to draw incorrect conclusions from statements, but when you get into a regulatory environment like the FDA, you have to be careful and precise. So which is it Energous?

It's also very hard to find out anything from either of the partner companies on the product itself. SK Telesys isn't a hearing aid company and there's a single Energous related press release that I can find on their page (and nothing else, for any product, for a company that's 21 years old...). Delight have a website with more information, but not much more. They clearly advertise as a hearing aid (not a PSAP), no mention of FCC or FDA approval (it has Bluetooth, FCC approval is mandatory, it's a hearing aid, so FDA approval mandatory), and it's dated from the original June 2018 announcement.

Now there's even a PDF for download, however you enter an email, click send now and then see this:

And when you click the only button you have - nothing. So a 6 month old webpage, with minimal information, that contradicts some of Energous' statements, and that I can't find necessary FDA or FCC approvals for. No ordering page, no description of commercial outlets to purchase from, no release date.

Not much more to say, with so little to go on, the coming weeks will tell. The roller-coaster of Energous continues. Now to keep an eye on when insiders sell and see if they take advantage of this spike.

(Repeating the seemingly obligatory statement - I have no financial position, short or long, in Energous or any related company. Nor have I ever had any such positions.)