The over-the-counter hearing-aid category took effect October 17, 2022. FDA describes its intended users as adults 18 or older with perceived mild to moderate hearing loss. Both the age threshold and the word 'perceived' belong to that scope.
FDA describes air-conduction devices that require no implantation or surgery, allow users to customize settings, and are available without a licensed professional's prescription or involvement. This describes access to the category, rather than the performance of a particular product.
The agency places severe or profound hearing loss outside the intended OTC scope and directs users younger than 18 to prescription hearing aids. It also says hearing professionals can sell OTC devices and provide hearing tests and evaluations. The purchase pathway leaves room for professional care.
For an ENT practice assessing a product announcement, the category and the product call for different questions. The OTC description identifies the intended population and purchase pathway. Claims about comparative performance, individual suitability or an effect on practice demand require their own evidence.
This is an explanation of a framework introduced in 2022, based on FDA's consumer guidance observed October 14, 2026. It reports no new regulatory action and does not determine a named product's regulatory status.
For an ENT practice assessing a product announcement, the category and the product call for different questions.
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FDA category explanation ↗This explainer describes a historical regulatory framework. It does not establish a product’s current authorization status, clinical superiority or treatment suitability.
