FDA Issues Guidance on Sale of Non-Prescription Hearing Aids

The U.S. Food and Drug Administration (FDA) has announced plans to improve consumer access to hearing aids. Previous regulations had impeded individual’s ability to get the medical technology they required.

The FDA has released a guidance, effective immediately, stating that it will not require individuals over the age of 18 to sign a waiver or provide proof of a medical evaluation in order to receive hearing aids.

The new guidance still requires that patients under the age of 18 undergo a medical evaluation before being allowed to purchase hearing aids. New customers must also receive comprehensive information from a licensed hearing aid dispenser before they can buy the devices.

Additionally, the FDA is considering creating a new category of hearing aids for consumers. These over-the-counter devices would be far more cost-effective than most models currently on the market, providing innovative technology at a fraction of the present price.

The FDA is working with the President’s Council of Advisors on Science and Technology, as well as the National Academies of Sciences, Engineering, and Medicine to develop further programs to improve access and affordability for those in need of hearing aids.  The agency is also communicating with other federal agencies and consumer advocacy groups to support an increase in consumer access to needed hearing technology.

Although the guidance is ‘Immediately in Effect,’ the FDA will accept comments from the public on the changes, and revising the guidance as required.

Read the complete text of the FDA’s hearing aid guidance.

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