The comprehensive Food and Drug Administration (FDA) bill that includes the Over-the-Counter Hearing Aid Act of 2017 will be presented to the full House and Senate for a vote in the coming weeks. The Hearing Loss Association of America (HLAA) is in full support of the bill and has issued an Action Alert to encourage consumers—especially those affected by hearing loss—to take action by writing to their senators and congressmen to vote in support of this groundbreaking legislation, the HLAA announced.
The bipartisan legislation introduced on March 21, 2017, by Senators Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass) and by Representatives Marcia Blackburn (R-Tenn) and Joseph Kennedy III (D-Mass), will create a new category of hearing aids that will be available over the counter (OTC), and remove unnecessary and burdensome requirements that reportedly create barriers for consumers who could benefit from hearing aids. The legislation has been bundled as part of the larger Medical Device User Fee Amendments (MDUFA) package which pertains to how medical device companies will pay fees to the FDA.
The HLAA reports that the Over-the-Counter Hearing Aid Act is important to consumers because:
- Approximately 30 million Americans could benefit from hearing aids, yet only about 14 percent use them, often citing high cost as the reason—hearing aids currently cost an average of $2,400 each. It’s been said that many consumers with mild to moderate hearing loss who could benefit from hearing aids are not taking steps to get hearing help.
- The top six hearing aid manufacturers account for 98% of all hearing aid sales (and only one of those companies is US-based). Those in opposition to the bill, in effect, are willing to sacrifice innovation and patient choice to protect the status quo, according to HLAA.
- Innovation is pushing its way into the hearing healthcare market and has the potential to create more variety and better products. Competition from prospective companies, who have essentially been prevented from entering the market due to strict regulations and the current structure, has the potential to drive down cost for not only OTC hearing aids, but for all hearing aids.
- According to census data, there are fewer than 20,000 hearing aid dispensing professionals in the United States. There simply are not enough hearing healthcare professionals to care for 48 million people with hearing loss. People in rural areas and nursing homes are often left behind.
OTC hearing aids will encourage more people to make hearing health a priority, which includes screening and testing, says HLAA. The consumer group believes that hearing health is not prioritized to the same degree that vision and dental health are, despite the high risks associated with untreated hearing loss. In fact, most physicians do not include hearing screening or hearing testing in their annual, preventive care visits. Further, hearing aids are not covered under Medicare or by most private insurers.
HLAA Executive Director Barbara Kelley said, “This is just one piece of the big picture to make hearing aids more affordable. HLAA has advocated—as have many other organizations—for Medicare and insurance coverage for many years, with little progress and little hope that it will become a reality anytime soon. However, the Over-the Counter Hearing Aid Act may be a viable alternative for people who want to do something about their hearing loss but who can’t afford to.”