The FDA today issued a final rule that may improve access to hearing aids by potentially lowering costs for the devices.
By establishing a new category of over-the-counter (OTC) hearing aids, consumers with perceived mild to moderate hearing impairment may purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or fitting adjustment by an audiologist.
According to an FDA release, the rule is expected to lower costs for hearing aids as part of the Biden-Harris administration’s effort to expand access to quality healthcare while lowering costs for such care. The agency said the rule aim to “assure the safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace.”
The action follows President Biden’s executive order on promoting competition in the American economy, which asked for the FDA to allow hearing aids to be sold over the counter with a 120-day deadline for action.
“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”
The FDA finalized the rule on the back of reviewing more than a thousand public comments on the proposed rule, issued Oct. 20, 2021. The 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.
Additionally, the OTC category established applies to certain air-conduction hearing aids intended for people 18 years of age and older with mild to moderate hearing impairment. Devices that don’t meet the requirements of the newly established category are prescription devices. The rule also repeals the conditions for the sale for hearing aids and includes provisions that address some effects of the FDA OTC hearing aid regulations on state regulation of hearing aids.
The effective date for the final rule is 60 days following publication in the Federal Register.
“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Dr. Robert M. Califf. “Establishing 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 neighborhood store or online.”
