This guidance document describes one part of FDA’s effort to create a flexible and adaptive regulatory approach to the oversight of hearing aids to increase availability and accessibility of these devices.

Hearing loss is estimated to affect 30 million people in the United States and can have a significant impact on communication, social participation, and overall health and quality of life. Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention.3 Several barriers may contribute to the low use of hearing aids in hearing impaired individuals such as high cost, stigma of being perceived as old or debilitated, and value (hearing benefit relative to price).

FDA regulations regarding conditions for sale have also been cited as a potential barrier to availability and accessibility of hearing aids. FDA is issuing this guidance to communicate to consumers, hearing aid dispensers, hearing aid manufacturers, and hearing health professionals that FDA does not intend to enforce certain conditions for sale of hearing aid devices that are required per FDA regulation. Specifically, FDA does not intend to enforce the medical evaluation (21 CFR 801.421(a)) or recordkeeping (21 CFR 801.421(d)) requirements prior to the dispensing of certain hearing aid devices to individuals 18 years of age and older. However, FDA will continue to enforce 21 CFR 801.421(b) and (c), which require hearing aid dispensers to provide prospective users an opportunity to review and to make available the “User Instructional Brochure,” containing specific required labeling, before the sale of a hearing aid.

This guidance is being implemented without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate (Section 701(h)(1)(C)(i) of the FD&C Act and 21 CFR 10.115(g)(2)). FDA has determined that this guidance document presents a less burdensome policy that is consistent with public health. Although this guidance is immediately in effect, FDA will consider all comments received and revise the guidance document as appropriate.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.