FDA Takes Important Step to Support Consumer Access to Hearing Aids

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FDA Takes Important Step to Support Consumer Access to Hearing Aids

Wed, 12/07/2016

The Food and Drug Administration (FDA) announced today that they do not intend to enforce the requirement that individuals 18 and up receive a medical evaluation or sign a waiver prior to purchasing most hearing aids.

Eric Mann, M.D., Ph.D., clinical deputy director for the FDA, made the announcement at a public meeting hosted by the National Academies of Science, Engineering, and Medicine (NAS) to discuss their report Hearing Health Care for Adults: Priorities for Improving Access and Affordability. The announcement is in direct response to Recommendation 3 in the NAS report to "Remove the [FDA's] Regulation for Medical Evaluation or Waiver."

HLAA is the only consumer-group sponsor of the NAS report and supports the 12 recommendations contained in it.

HLAA Executive Director Barbara Kelley commented, "We applaud the FDA's decision to remove this requirement and believe it is a step forward to remove barriers and make hearing health care for consumers more affordable and accessible."

In making the announcement, Dr. Mann also said that the FDA is considering another of the report's recommendations which would create a new category for over-the-counter hearing devices.