The U.S. Senate recently passed the Over-the-Counter Hearing Aid Act of 2017 with a unanimous vote of 94 to 1 in favor. This is potentially big news for those suffering from mild to moderate hearing loss because it includes over-the-counter hearing aids as part of the devices regulated by the FDA. Essentially, it can mean lower costs for hearing aids and an improvement in the quality of life for those who have not been able to afford hearing aids due to the high cost. The act was introduced to the Senate by Elizabeth Warren (D-MA) and Chuck Grassley (R-IA). The bill is supported by the Hearing Loss Association of America (HLAA).
Specifics of the Over-the-Counter- Hearing Aid Act of 2017
According to the details of the written bill, which was introduced to The House on 3/21/2017, the bill amends the Federal Food, Drug, and Cosmetic Act to require the FDA to categorize hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids. The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription.
State and local governments may not establish or continue in effect requirements specifically applicable to hearing products that are not identical to FDA requirements and that restrict or interfere with the servicing or sale of over-the-counter hearing aids.
The FDA must update and finalize its draft guidance on hearing products. The guidance must clarify which products are medical devices.
Benefits for People with Hearing Loss
People with mild to moderate hearing loss stand to benefit greatly from the passing of this legislation because it will make hearing aids more easily accessible and much more affordable than they have been in the past. It is estimated that about 86% of people who need hearing aids never are able to get them because of the high cost. They usually wait for many years to seek treatment and by that time, the hearing loss is so significant, it has negatively impacted their lives for a long time. (Source). Barbara Kelly, executive director of the HLAA expresses her gratitude and approval of the bill, “Senators Warren and Grassley and Representatives Kennedy and Blackburn – among many others – have worked tirelessly to ensure passage of this bill. Their efforts are sure to make a significant difference in the lives of millions of people with hearing loss.” (Source). Vern Buchanan (R-FL) co-sponsored the act and after the passage of the vote, he said, “This bill could help improve the quality of life for nearly 50 million Americans who struggle to hear everyday conversations. Many people who need the hearing aids cannot afford the high price tag of $4,000 or more.” (Source). The Hearing Loss Association of America supports this bill because they believe that OTC hearing aids will be more accessible as well as being more affordable. More people who need them will seek out help if hearing aids are available OTC.