The Over the Counter [OTC] Hearing Aid Act of 2017 (S 670) is expected to be passed today by the Senate Health, Education, Labor & Pensions (HELP) Committee as part of the larger Medical Device User Fee Amendments (MDUFA) package which pertains to how medical device companies will pay fees to the US Food and Drug Administration (FDA) when registering their devices with the Agency.
Introduced in March by Senators Elizabeth Warren (D-Mass) and Chuck Grassley (R-Iowa), OTC Hearing Aid Act is bipartisan legislation designed to make hearing aids for those with mild-to-moderate hearing loss available over the counter. A companion bill (HR 1652) led by Representatives Joe Kennedy III (D-Mass) and Marsha Blackburn (R-Tenn) has also been introduced in the House. The bill largely mirrors legislation (S9) introduced by Senators Warren and Grassley in late 2016, and would require the FDA to propose a rule that would establish an OTC hearing aid category for adults with “perceived” mild-to-moderate hearing loss within 3 years of passage of the legislation, and finalize a rule within 180 days after the close of the comment period.
The proposed legislation would also require the FDA to write regulations ensuring that this new category of OTC hearing aids meets standards for safety, consumer labeling, and manufacturing protections, providing consumers the safe option of an FDA-regulated device at lower cost. The Act would also supersede other state laws restricting OTC device distribution, and provide for a study of the devices relative to consumer satisfaction after 3 years.
One of the most controversial aspects of the bill has been the language pertaining to OTC devices being used for “mild-to-moderate” hearing losses—or conceivably a hearing loss up to 70 dB, which many believe would not avail itself to a “do-it-yourself” healthcare approach. The American Speech Language Hearing Association (ASHA), Hearing Industries Association (HIA), and other organizations have maintained that self-directed treatment and OTC hearing aids should be recommended only for people with mild hearing loss, for whom the risks of failed intervention are outweighed by the potential benefits.
“Hearing loss is a medical issue that requires patient care and service from a hearing professional to ensure the best outcomes,” noted HIA Chairman Brandon Sawalich of Starkey Hearing Technologies. “HIA and the other hearing health organizations that have expressed concern about the OTC hearing aid bill will continue to work with members of Congress to ensure that patient safety is the top priority.”
Although the bill is expected to pass through the committee today, it’s still possible the bill could encounter resistance and/or be modified to restrict the devices from covering more severe ranges of hearing loss.