The Hearing Industries Association (HIA) announced that it has issued a formal Response to the October “letter report” of the President’s Council of Advisors on Science and Technology (PCAST).
The PCAST technology panel presented its letter report to the Institute of Medicine’s (IOM) Committee on Accessible and Affordable Hearing Health Care for Adults in November 2015. The IOM Consensus Panel has been examining a wide range of issues related to hearing healthcare access and affordability, and is now in the process of developing recommendations, with a final report expected in May 2016. The recommendations of an IOM Consensus Panel may be considered by various institutions and regulatory agencies; however, they are not binding on any institution or agency.
In its formal response to the PCAST letter report, the HIA explains that while supporting PCAST’s overreaching goal of providing greater access to hearing aids, it disagrees with the Council’s recommendations regarding the creation of an Over the Counter (OTC) class of “basic” hearing aids, and proposal that any company should be allowed to promote unregulated electronic products to address hearing loss.
HIA states that it agrees with PCAST that people with hearing loss should have full access to hearing aids, and that each individual should be able to select the professional to conduct necessary evaluation and testing. Individuals should also be permitted to purchase the device through any legal distribution channel. In its response, HIA references the dramatic impact that “disruptive” hearing aid distribution models have already had on hearing aid access and affordability, including the rapid expansion of hearing aid sales at Big Box stores, through the Internet, and with major national pharmacy chains conducting pilot programs in the hearing aid market. All of these channels include the involvement of a hearing professional in diagnosis, fitting and follow-up, which would not exist in an OTC market, or if Personal Sound Amplification Products (PSAPs) were marketed to treat hearing loss.
In responding to PCAST’s recommendations in favor of OTC hearing aids and unrestricted PSAP claims, HIA notes that the Japanese hearing aid market is already fully deregulated, with OTC hearing aids available for purchase at various retail stores such as electronics stores, jewelry stores, and over the Internet. In this unregulated market, only 15% of people with hearing loss use hearing aids, and only 36% of people express satisfaction with the performance of the hearing aids. These figures fall far short of existing American hearing aid usage rates (30% of those with impaired hearing) and satisfaction rates (82%). HIA states that it does not believe this market should be replicated in the US.
HIA’s formal response also emphasizes the importance of FDA regulation of medical devices, including hearing aids, in protecting consumers. These regulations ensure that people with hearing loss are not encouraged to self-diagnose and self-treat their condition, and that hearing aids will meet mandatory quality standards. HIA explains that unregulated consumer products would be exempt from all of the FDA regulations that protect consumers. The risks are evident in Europe, where PSAPs are sold without regulatory controls, with many models generating sound in the dangerous 120-135 dB range. Studies in Hong Kong demonstrate that many OTC hearing aids fail to meet the basic needs of people with hearing loss.
HIA’s response also states its that it finds the analogy PCAST makes regarding OTC hearing aids and OTC reading glasses to be inappropriate.
For additional details regarding HIA’s Response, please contact Andy Bopp, HIA at: [email protected].
For additional views and responses to the October 2015 PCAST letter report, please refer to related articles in Hearing Review.
Source: Andy Bopp, HIA