On August 16, the US Food and Drug Administration (FDA) issued a final rule to improve access to hearing aids. The rule establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild-to-moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist.

Consumers could see OTC hearing aids available in traditional retail and drug stores as soon as mid-October, according to the FDA.

Close to 30 million adults in the US could benefit from hearing aid use, yet many hearing aids are expensive. The final rule aims to stimulate competition and facilitate the sale of safe and effective OTC hearing aids in stores and online across the US. The OTC category established in the final rule applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild-to-moderate hearing impairment. Hearing aids that do not meet the requirements for the OTC category (for example, because they are intended for severe hearing impairment or users younger than age 18) must be prescribed.

The FDA finalized the rule after receiving and reviewing more than 1,000 public comments on the proposed rule issued, on Oct. 20, 2021. Comments submitted by consumers, professional associations, hearing aid manufacturers, public health organizations and advocacy groups, members of Congress, state agencies, and other stakeholders are summarized in the final rule, along with the FDA’s respective responses.

In response to public comments and to assure the safety and effectiveness of OTC hearing aids, the final rule incorporates several changes from the proposed rule, including lowering the maximum sound output to reduce the risk to hearing from over-amplification of sound; revising the insertion depth limit in the ear canal; requiring that all OTC hearing aids have a user-adjustable volume control; and simplifying the phrasing throughout the required device labeling to ensure it is easily understood. The final rule also includes performance specifications and device design requirements specific to OTC hearing aids.

Read the full FDA announcement, here