FDA Releases Final Rule for OTC Hearing Aids

August 16, 2022

Today, the Food and Drug Administration (FDA) released its final rule [PDF] establishing a regulatory category for over-the-counter (OTC) hearing aids. Access to OTC hearing aids is intended to increase the availability and affordability for adults aged 18 and over with perceived mild to moderate hearing loss. Companies may begin selling these devices as early as mid-October.

ASHA is conducting a detailed analysis of the regulations and will summarize the guidance and potential practice implications for members. However, upon initial review, ASHA is pleased with many of the included provisions. The output limit has been lowered to 111 dB SPL, or 117 dB SPL if the device is equipped with activated input-controlled compression, and devices are required to have a user-adjustable volume control. Additionally, device insertion depth has been more clearly defined (the device must remain 10 mm or greater from the tympanic membrane) and the language used in the warnings and other important information that shall appear outside and inside the packaging has been simplified. ASHA appreciates the FDA clarifying, and agreeing, with our interpretation that the rule does not preempt state laws requiring an audiological evaluation for minors.

ASHA submitted comments to the FDA on its proposed regulations [PDF] emphasizing the importance of an audiological assessment prior to the fitting of any type of hearing aid and urging for consideration of several revisions that would more clearly define, and strengthen product requirements to ensure consumer safety and device efficacy. ASHA is concerned that the final regulations do not contain a gain limit and that there is little to no mention of the benefit of seeking consultation from an audiologist prior to purchasing a hearing aid or if the user does not experience expected benefit from the device. ASHA is building partnerships with allied professional groups to educate the public on the benefits of consulting with an audiologist.

Audiologists are encouraged to begin utilizing the resources in ASHA’s OTC Hearing Aid Toolkit to prepare for incorporating these devices and/or the individuals utilizing them into their service delivery model. There are also resources to educate the public on the importance of safe and efficacious hearing loss treatment and appropriate use of OTC hearing aids, promote the value of audiology services, and collaborate with other health care professionals to ensure that we are supporting best practice, overall health, physical safety, and quality of life for those that we serve. Check back regularly as resources will be updated to reflect the final regulations.