Hey everyone,
I am trying to launch my own shopify store - https://audilife.us/ but I cannot get a payment provider to approve the products I am selling. Does anyone know a way around this please? I have had my first sale and cannot receive payouts. The products are registered to sell in the US but all payment providers are very strict on the products I am selling which are hearing amplifiers, bluetooth hearing amplifiers.
I would be very grateful for any help!
Thank you
Zac
Look at your own product titles, that is almost certainly what is blocking you. You describe them as hearing amplifiers, but the store lists TWS Bluetooth Digital Hearing Aids, CIC Rechargeable Hearing Aid, Rechargeable BTE Hearing Aid, and the copy talks about mild to moderate and moderate to severe hearing. An underwriter reads that as an FDA regulated medical device, and Shopify’s own restricted list names hearing aids under medical devices, so this is not one provider being awkward with you.
The FDA line here is drawn on claims, not on hardware. A personal sound amplification product stays a consumer electronic only for as long as it never claims to address hearing loss. Any explicit or implicit claim that a product addresses or improves hearing loss makes it meet the device definition and pulls in the hearing aid rules. Same electronics inside the shell, and your own copy is what decides which bucket you land in.
That leaves two roads and they do not mix. Either rewrite every title, description, collection name and FAQ line so nothing references hearing loss or a degree of it, sell them as situational amplification, then reapply. Or keep the hearing aid positioning and go to a processor that underwrites regulated medical devices, which usually means higher rates, a rolling reserve, and them asking to see your FDA registration.
If you take the rewrite road, do the whole catalogue before you reapply, including the FAQ and the meta descriptions, because underwriting looks at the live site and not just what you typed into the application. What did the provider actually tell you, a decline with a reason or still pending review?
Thank you for the reply lumine! Very helpful. I have received information that these are OTC hearing aids and do not need prescription so I will need to specify that across all titles etc. as you mentioned.
Have you sold these before?
I’d be careful with changing the wording just to get the payment provider through.
If these are genuinely FDA-authorized OTC hearing aids, then I’d keep the medical-device positioning accurate rather than removing “hearing aid” claims and presenting them as ordinary Bluetooth amplifiers. A payment provider can still classify the underlying product as regulated even after the copy is changed.
Before reapplying, I’d get the documentation together:
The exact manufacturer/model numbers
FDA establishment/device information or the documentation showing the products are legally marketed as OTC hearing aids
Supplier/manufacturer invoices
Your U.S. warranty, returns and customer-support information
Any testing/compliance documentation the manufacturer provides
The exact decline reason from the payment provider
Then ask the provider a very specific question:
“Do you support U.S. OTC hearing aids if the merchant can provide the required regulatory and supplier documentation?”
That gives you a much clearer yes/no than repeatedly submitting the store and hoping the review changes.
And no, I wouldn’t claim I’ve personally sold these if I hadn’t. The important part here is identifying whether the products are actually compliant OTC hearing aids and whether the processor underwrites that category, not simply changing the wording on the website.
If you can share the exact decline message Zac received (with private information removed), that would tell us a lot more about where the actual blockage is.
Thank you Alex very helpful! I received this message from Shopify - since then I have no got confirmation with the SKU on the FDA website that they have all been registered as OTC hearing aids and do not need a prescription. I will send an export of my products with the SKU and the screenshot of the verification clearing mapping the SKU with the FDA website image that shows they have been registered as OTC hearing aids. This should solve it! Thank you
Yes, that’s the right direction. 
I’d just make one small change before sending it to Shopify: don’t rely on the SKU screenshot alone.
Create a simple mapping for each product:
Shopify SKU → Manufacturer/Model → FDA listing → OTC classification
That way the reviewer can immediately see that the exact product being sold corresponds to the FDA-listed device, rather than having to figure it out themselves.
I’d also include the manufacturer/supplier name and any documentation you have showing that you’re authorized to sell those products in the US.
The FDA database does contain registered/listed OTC hearing-aid devices and model numbers, so having that evidence is definitely useful.
One other thing: I wouldn’t change your product wording just to make the products look like ordinary electronics. If they’re legitimately OTC hearing aids, keep the product information accurate and use the FDA documentation to support the classification.
If Shopify specifically asked you to provide this evidence, I’d send it as one clean package rather than sending screenshots one by one. That gives the reviewer everything needed to match the catalogue against the documentation.
Hopefully that gets the review moving. Let us know what Shopify says after they review the evidence, that result would actually be useful for anyone else selling OTC hearing devices.
Appreciate it mate thank you so much! Very helpful
No worries mate! Glad I could help
Hopefully the FDA documentation clears things up with Shopify and you can get those payouts released soon. Keep me posted on how it goes.
