The Institute of Medicine’s (IOM) Committee on Accessible and Affordable Hearing Healthcare will hold a 4th public meeting to review standards and continue discussing a range of hearing health issues on November 13, 2015, specifically the recent controversial report of the President’s Council of Advisors on Science and Technology (PCAST) which will be presented by PCAST member Christine Cassel. Among several recommendations, the PCAST advised FDA to create a new class for the over-the-counter (OTC) sale of hearing aids, and the withdrawal of FDA’s current draft guidance document regarding Personal Sound Amplification Devices (PSAPs), instead referencing this new category as “devices for discretionary consumer use.”
Regulation of PSAPs in Question
The Hearing Industries Association (HIA) has reported on a September 28, 2015 teleconference that was conducted by the Institute of Medicine’s (IOM) Committee on Accessible and Affordable Hearing Healthcare. IOM’s teleconference examined a Voluntary Standard for PSAPs, which is under consideration by the Consumer Electronics Association (CEA).
HIA reports that it provided a white paper on “Patient Care and Positive Outcomes: The Focus of Hearing Health” to both groups to emphasize the sophistication of hearing aid technology (compared to PSAPs), the importance of hearing professionals ensuring proper patient care, and the importance of FDA regulation to guide hearing aid dispensing and device quality.
According to HIA, the September 28 IOM teleconference included a talk from a CEA representative regarding the ongoing efforts to develop a Voluntary Standard for PSAPs (ANSI/CEA-2051). The CEA representative explained that a standard would address some of the concerns regarding low-quality “junk” PSAPs that are widely available on the market today. Such a proposal, however, would do nothing to address the fact that PSAPs are a consumer product that is not regulated by the FDA, says HIA. Moreover, a Voluntary PSAP Standard, if it were developed, could be ignored without consequence by any PSAP manufacturer. Additionally, a Voluntary PSAP Standard could not possibly reach a level of universal public awareness, nor could it match the consumer protections provided by mandatory FDA device standards which are applied to all hearing aids. Furthermore, a Voluntary PSAP Standard would do nothing to address concerns related to the detection of Red Flag conditions by a hearing professional.
The Institute of Medicine (IOM) Continues to Examine a Range of Hearing Health Issues
The IOM’s Committee on Accessible and Affordable Hearing Healthcare is currently examining many issues related to hearing healthcare access and affordability. The committee has held four public sessions, including the September conference call, and will develop its recommendations in closed session. The IOM’s first, second, and third meetings on accessible and affordable hearing health issues were covered by The Hearing Review. The fourth public meeting of the IOM’s Committee on Accessible and Affordable Hearing Healthcare is scheduled for November 13, 2015, and registration is open on the IOM’s Meeting Web Page. More information about the November 13 IOM meeting is also available on Hearing Review‘s Event Page.
A final report from the committee is 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.
Source: Hearing Industries Association; Institute of Medicine (IOM)