OTC hearing aids vs prescription: what is the difference?

Last updated September 3, 2026.

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.

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