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.
Academy President, Dr. Ian Windmill, PhD, responded to this announcement with the following remarks: “The Academy is thrilled that the FDA has heeded the comments from stakeholders in the hearing health community and has taken immediate steps to improve hearing aid accessibility for patients and remove unnecessary barriers for those seeking hearing health-care.”
The FDA clearly states that their guidance documents, including this guidance on medical waivers for adults purchasing hearing aids, do not establish legally enforceable responsibilities. The information released in guidance documents serves only as recommendations, unless specific regulatory or statutory requirements are cited. In many states, waiver requirements may be written into state licensure rules or statutes. Additionally, payers may require a letter of medical necessity or physician referral prior to the dispensing of hearing aids. This guidance document does not supersede those requirements, but rather opens the door to begin making changes to such policies, regulations, and statutes.