FDA Hearing Aids rebranded as cheaper OTC models

https://forum.hearingtracker.com/t/sony-and-ws-audiology-announce-partnership-on-otc-self-fitting-hearing-aid-business/70933 (member archive)

How severe a loss can the OTC version of these aids fit? Maybe they’re only available as LP aids and quickly top out on available amplification even though they might have other higher-end features?

Well there’s a couple of models to choose from, this from the Sony website,

Sony CRE-C10 Self-fitting OTC Hearing Aid1

Find everyday balance with the CRE-C10, Sony’s Self-Fitting Over-the-Counter Hearing Aids that blend comfort and technology to reconnect you to what matters most.

I currently wear Oticon OPN-S with HP receiver for my moderate to Severe loss. My first post here so, I haven’t uploaded an Audiogram but will soon.

I have become increasingly unhappy with the Oticon’s because they seem to have had a lot of phantom issues and durability problems. Including: 3 replaced Receivers in one year, shutting off and turning on without command, uncommanded level changes, etc.

So, I began to look at the Resound line again (formerly wore ReSound). After a bit of digging around, I found that the Jabra Enhance Select 200 OTC aids are the same as the as some models of the ReSound Omnia and ReSound One series HA’s.

It appears that they ship with different Receivers based on what you buy.

Here is the data from their FDA and FCC information:

I am assuming that the MM (Mild to Moderate?) receivers are the type that ships with the Select hearing aids as that would comport with the approved for Perceived Mild to Moderate hearing loss in the OTC guidelines. However, the sales data for the Select 200 has an entry in the website that states that the 200 series are suitable for moderate to severe hearing loss.

In the ordering process, I took the Hearing test and, at the end, the results stated that my hearing loss was too severe for these hearing aids.
Now I am a bit of a rebel and don’t like being told no. My current hearing aids (The Oticon’s ) have a problem with the left device and it’s in the shop. So, I decided that I would buy a pair of OTC hearing aids as a “backup” . I intend to monkey with these and even plan to have ask my audiologist change the receivers if she will (obviously, I will pay her for this and don’t mind doing so) if that is necessary.

At the end of the day, it would appear that the Hearing Aid industry is walking a tightrope with OTC products and is probably on the hairy edge of a revolt from their partners for prescriptive devices. I can’t blame the audiologists since they have a business to run and investments of people, equipment and facilities to pay for. However, we may be headed for a collision course on the order of “right to repair” because these devices appear to be the same devices we buy from an audiologist. Except in this case, the cost is 1/3 the cost of the retail price of a full service shop.

I realize I have made a lot of assumptions here and am willing to be corrected. I am interested in what this community thinks of my “science Project”.

Well, being a new user, I can only embed one document per post. I will add the others if anyone is interested in separate posts.