The dividing line: OTC is for adults with mild to moderate loss, self-fitted; prescription is professionally fitted and serves all levels, including severe.
The FDA created the OTC category on October 17, 2022: adults 18+ with perceived mild to moderate loss can buy devices in stores or online without an exam. OTC output is limited by design - severe or profound loss needs the fitted path, with a professional programming the device to your exact hearing map. Pymander's escalation routing is built and tested specifically for this class of decision; see the safety architecture working paper .
What to do
Common questions
OTC hearing aids vs prescription: what is the difference?
The dividing line is how much help you need and who fits it. Over-the-counter hearing aids - an FDA category created October 17, 2022 - are for adults 18 and older with perceived mild to moderate hearing loss, sold in stores and online with no exam, no prescription, and a lower price; you fit and adjust them yourself. Prescription hearing aids come through a licensed hearing professional who tests your hearing, programs the device to your exact loss, and tunes it over follow-up visits - and they can serve all levels of loss, including severe and profound, which OTC devices cannot: their maximum output is limited by design. The honest short version: mild trouble with restaurants and the TV is OTC territory; one ear much worse, sudden loss, ear pain or drainage, or severe loss is professional territory first - some of those are medical problems, not shopping decisions.