On Wednesday, the Food and Drug Administration (FDA) released a new guidance document indicating that it will not enforce the medical evaluation and recordkeeping requirements (21 CFR §801.421(a) and (d)) prior to the dispensing of certain hearing aid devices to individuals 18 years of age and older, specifically Class I air conduction and Class II wireless air-conduction devices. The current regulation requires that all prospective hearing aid users have a medical evaluation by a licensed physician within six months prior to the hearing aid dispensation. However, individuals 18 years of age and older can waive this requirement through a signed statement.
The impetus for issuing the guidance was the FDA's conclusions that:
- Approximately 30 million people suffer from hearing loss in the United States.
- Only about 1/5 of the people who could benefit from a hearing aid seek intervention.
- The current regulations regarding conditions for sale provide a barrier to access.
- The vast majority of individuals obtaining hearing aids waive the medical examination requirement.
The FDA's decision was shaped in part by the recommendations of the President's Council of Advisors on Science and Technology and a study conducted through the National Academy of Sciences, which showed that the medical examination requirement and waiver were providing little benefit for users 18 years and older, while posing a barrier to access. In addition to re-evaluating the current regulation, the FDA also will consider a regulatory framework for hearing aids that can be sold to consumers over the counter.
It should be noted that the existing labeling requirements still will be enforced including i) the notice to prospective users that good health practice requires a medical evaluation, and ii) the warning statement to hearing aid dispensers to advise a prospective user to consult with a licensed physician.
The guidance does not cover Class II bone-conduction hearing aids and those hearing aids labeled for prescription use only. Also, it does not include users younger than 18 years old.