FDA Announces Immediate Changes Regarding Medical Waiver Requirement
for Adults Purchasing Hearing Aids
On December 7, while providing comments at the National Academy of Sciences meeting on Hearing Health Care for Adults, Dr. Eric Mann, Clinical Deputy Director at the U.S. Food and Drug Administration (FDA), announced that, effective immediately, the Agency no longer intends to enforce the requirement that individuals 18 and over receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. Dr. Mann’s comments were followed by a formal release and the issuance of a guidance document containing more information. This guidance is effective immediately. The Academy has long advocated for this change and applauds the FDA for their decision.