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PSAPs: Our Role in this Disruptive Environment - Regulatory Issues and Research Findings

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1.  From a regulatory perspective, which of the following determines whether a product is a medical device? Adverse effects clearance Intended use Registered patent Quality standards certification

2.  The 2009 and 2013 FDA Guidance document restricted PSAPs from using specific verbiage in which of the following? Product registration and packaging Patent registrations and user manuals Adverse effects and quality standards Promotional materials and labeling

3.  The three main factors attributing to poor hearing aid penetration rates outlined in the PCAST report were: Competition, access, and poor practice protocols Competition, restricted availability, and insufficient application of evidence based practices Cost, restrictive state laws, and portable audiometric results Cost, access, and inadequate distribution models

4.  It was the opinion of the PCAST report that the FDA guidelines addressing PSAPs: Should be withdrawn and redefine PSAPs as discretionary products for adults with perceived mild to moderate hearing loss Should be withdrawn and redefine PSAPs as appropriate products to be dispensed through a credentialed dispensing professional Was moving in the right direction given the need for establishing a deregulated class of over-the-counter devices Had no significance and that the guidance document could stand on its own

5.  Part of the difficulty of interpreting PSAP vs hearing aid research is the: Lack of low end and high end hearing aid performance data Lack of low end and high end PSAP performance data Access to a wide range of commercially available PSAPs with no established performance and/or quality standards Application of various objective measurement techniques that makes it difficult for practical comparison

6.  Based on the FDA 2013 guidance document, PSAPs are: Suitable for perceived mild to moderate hearing loss in adults A version of an OTC hearing aid illegal Intended for enhancing environmental sounds

7.  The most critical difference between the two presented studies comparing probe-mic measurements of PSAPs versus hearing aids was: The application of different intensity levels to measure device output Use of different prescriptive formulas to calculate targets The established definition of what constitutes meeting target The use of different speech babble signals for speech mapping

8.  In terms of ability to meet prescribed real-ear targets PSAP vs hearing aid probe-mic performance data suggests: Hearing aids outperform PSAPs overall PSAPs outperform hearing aids overall Hearing aid and PSAPs performance is the same PSAPs perform as well as hearing aids for any configuration not exceeding moderate degrees of hearing loss

9.  Published data comparing unaided versus aided speech-in-noise performance measured in soundfield at a +5 signal-to-noise ratio reveals: Hearing aid and PSAP performance is exactly the same Hearing aid performance clearly outperforms PSAP performance across the board Some PSAPs show comparable scores to hearing aids while some do not None of the above

10.  With the passage of the OTC Hearing Aid act: PSAPs will be automatically merged in with the new class of OTC hearing aids PSAPs will be on their own with specific requirements to post warning messages on the outside of the product box PSAPs will remain an independent category regulated by the FDA None of the above