The US Food and Drug Administration (FDA) has given the green light to over-the-counter (OTC) hearing aids, which will not only lower costs but also enable millions of consumers with perceived mild to moderate hearing impairment to buy the devices directly from stores or online retailers without needing a medical exam, prescription or fitting adjustment by an audiologist.
The hearing aids should be available in traditional retail and drug stores as soon as mid-October when the rule takes effect.
Close to 30m adults in the country could benefit from hearing aids. “Hearing loss is a critical public health issue affecting the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Dr Robert Califf. “This new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighbourhood store or online.”
The OTC category established in this 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) are prescription devices.
The FDA finalised the rule after receiving and reviewing more than 1 000 public comments on the proposed rule issued on 20 October 2021. Comments submitted by consumers, professional associations, hearing aid manufacturers, public health organisations and advocacy groups, members of Congress, state agencies, and other stakeholders are summarised in the final rule, along with the FDA’s respective responses.
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 labelling to ensure it is easily understood. The final rule also includes performance specifications and device design requirements specific to OTC hearing aids.
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