This afternoon the House of Representatives passed H.R. 2430, the Food and Drug Administration (FDA) Reauthorization Act of 2017. Included in this legislation is a provision that requires the FDA to develop regulations related to the sale of over-the-counter (OTC) hearing aids for adults with perceived mild to moderate hearing loss.
The legislation provides specific direction to FDA in the development of the regulations, including the following provisions:
- Requirements that establish or adopt output limits appropriate for OTC hearing aids
- Labeling requirements that include:
- "conspicuous" labeling that the device is only intended for adults
- information on the "red flag" issues that may require prompt medical attention if necessary
- symptoms of medically treatable causes of hearing loss
While the law preempts state and local laws that restrict access to OTC hearing aids, the legislation also contains a private remedies provision, stating that individuals may still exercise their private rights under State or Federal laws related to product liability, tort, warranty, contract or consumer protection laws. The legislation further requires the Secretary of Health and Human Services to submit a report to Congress analyzing any adverse events related to OTC hearing aids.
The Senate is expected to pass similar legislation by the end of July.
ASHA remains concerned with OTC hearing aids, and is poised to engage FDA during the development of these regulations. ASHA has advocated that OTC hearing aids be intended for use in mild hearing loss only, and that strong protections be put into place to ensure that they are not used by children. Most recently, ASHA has worked with Congressional allies to strengthen the report language in H.R. 2430 that indicates that hearing loss is a medical condition.
For additional information, contact Ingrida Lusis, director of federal and political advocacy at email@example.com.