Update 2 (November 3rd): The “Tech Topic” article titled Clinical Results with a New Wireless Binaural Directional Hearing System by Thomas A Powers PhD and Matthias Froehlich PhD of Siemens Audiology Systems has been released by Hearing Review; and we encourage interested readers to examine this supporting documentation. To this end, we have requested a meeting at their Piscataway NJ headquarters to view the supporting clinical data that substantiates this product claim: As one Very Prominent Ohio Audiologist told us, “It would be quite a breakthrough if their claims were valid… and if so… they should be proud to display the data for all to see!“
Update (October 31st): We have received two supporting documents you can download here: Guidelines for Hearing Aid Manufacturers for Substantiation of Performance Claims (HIA, 2009), and New Binaural Strategies for Enhanced Hearing (Kamkar-Parsi, Fischer, & Aubreville; October 2014 Hearing Review). We are still awaiting “Clinical results with a new wireless binaural directional hearing system” (Powers TA, Froehlich M; November 2014 Hearing Review; in press); and more importantly, the underlying study papers and raw data for the R&D conducted at University of Northern Colorado (2014) and Oldenburg Horzentrum (2013). Separately, Siemens released a puff YouTube video, mirrored here.
We just received the thick product launch package from Siemens USA on their new Binax aids, and right on the envelope were the rather “bold” claims of “binax: The world’s first technology that is clinically proven to outperform normal hearing*” and “binax. Clinically proven*. Better than normal hearing in demanding listening environments” …and then in fine print it states: “Studies conducted at University of Northern Colorado (2014) and Oldenburg Horzentrum (2013) showed that Speech Reception Thresholds (SRT) in cocktail-party situations improved up to 2.7 dB for wearers with mild to moderate hearing loss using binax with Narrow Directionality, compared to people with normal hearing. This corresponds to over 25% improvement in speech understanding.”
Needless to say, and being diplomatic, we believe this is a “bold claim” and we are investigating it closely. We had a long conversation with a very senior audiologist in Piscataway, where we were promised certain documents. However, we still want to look very closely at the methodology, and more importantly, the actual test equipment setup, and the actual auditory test materials. As we undertsand it, “HINT” (Hearing In Noise Test) materials were used, and already we have a problem with that, as “ceiling effects” make data analysis difficult. In addition, there is apparently an HIA test protocol not publicly available for making speech-in-noise claims, which we will also be scrutinizing. Lastly, we have requested a visit to their US headquarters near us to view the raw data and re-crunch the numbers: Last year this author peer reviewed an Ear & Hearing article on aided speech perception by one of the people involved in this project, and we were less-than impressed when we applied engineering-level scrutiny.1 Stay tuned as we open an investigation into this claim: If indeed it withstands our scrutiny, it would appear to be a breakthrough for the hearing impaired.
1. To assure public safety, it is standard practice for our Engineer colleagues to submit their calculations along with their drawings to a registered Professional Engineer for scrutiny; and this is why we have requested access to the underlying data; or as President Reagan famously said, “Trust, but Verified.” When these checks are not properly followed, this can occur, with more here.
2. Preface from Guidelines for Hearing Aid Manufacturers for Substantiation of Performance Claims:
In 1994, the Hearing Industries Association (HIA) developed guidelines for the substantiation of hearing aid performance claims. These guidelines became the basis for “Guidance to Hearing Aid Manufacturers for Substantiation of Claims,” issued by the US Food and Drug Administration (FDA) in August 1994. Subsequently, the FDA “sunsetted” its guidance document, so in 2002 HIA issued a revised document entitled, “Guidelines for Hearing Aid Manufacturers for Substantiation of Performance Claims.” Since then, there have been a number of changes in the applicable regulations and changes in the composition, manufacture, and testing of hearing aids, as well as advances in auditory disciplines. Accordingly, HIA has revised the Guidelines to reflect and incorporate these changed circumstances and technologies.
These Guidelines are designed to assist manufacturers in understanding and identifying the substantiation requirements for hearing aid claims, including performance or user-benefit claims. As part of that goal, these Guidelines outline study procedures that a manufacturer may follow to obtain scientific data to substantiate claims. Manufacturers may also modify the study procedures described below or follow other study procedures, provided that they result in an adequate level of substantiation for the claims being made. Labels, labeling, brochures, web sites, and other similar materials are promotional materials, and like advertising, claims made in these materials create substantiation requirements under the United States Food and Drug Administration’s (“FDA’s”) and the Federal Trade Commission’s (“FTC’s”) laws. Every claim requires some level of substantiation and the manufacturer must possess the requisite substantiation at the time a claim is made. The nature and quantum of the substantiating data depends largely on the claim that is made.
To determine the appropriate substantiation for a claim, identifying the claim made is critical. Claims may be explicit or implicit, and a manufacturer is responsible for possessing substantiation data for both types. Moreover, the manufacturer is charged with responsibility for all claims made. Promotional materials may contain multiple claims, all of which must be covered by substantiation that is appropriate for the claim made. Substantiation data must be maintained throughout the period in which the claims are made plus at least an additional two years. Substantiation data from one model may be used to support claims for another model, provided that there is an adequate scientific or technical basis to extrapolate between products. The extrapolation may be based on appropriate documented bridging studies that show the applicability of the data from one model to another. Substantiation data for some claims may also be based on scientifically valid data derived from an evaluation of the performance of components comprising a model. Companies should also consider whether the claims they make are still substantiated in light of new information. Claims that may have been adequately substantiated at the time of initial dissemination may need to be revised in light of new information about consumer usage, the performance of competitive products, or for other reasons.
The FDA’s jurisdiction encompasses product “labeling.” This term is broadly defined to include written, printed, or graphic material on or accompanying the device. Essentially, any written materials distributed by the company making claims regarding the performance of a hearing aid may be considered labeling. The FTC regulates claims in advertisements appearing in any media, such as magazines, television, radio, and the Internet. Both the FDA and the FTC will regulate claims made by manufacturers on websites. These substantiation guidelines apply to any medium used by companies to convey their product’s performance, regardless of whether the communications are deemed labeling or advertising. The guidelines also apply to oral communications by the company regarding the performance of one or more of its products.
Endorsements or testimonials are mechanisms for promoting hearing aids. These communication techniques create at least two claims and thus two substantiation requirements. First, the endorser’s statements must be true. The company making the claim must possess data demonstrating the factual validity of what the endorser says regarding his or her experience. Second, the endorsement also carries a typicality claim. Unless the advertiser can adequately substantiate that the endorser’s experience is representative of the results that will be achieved in actual use, the advertiser should clearly and conspicuously disclose the expected performance in the depicted circumstances. In addition, the advertiser should possess adequate substantiation for the representation. Guides Concerning the Use of Endorsements and Testimonials in Advertising, 16 C.F.R. Part 255.2(b). In other words, not only does the manufacturer need to demonstrate the truthfulness of the endorsement or testimonial for that individual, but the manufacturer must also be able to substantiate that the consumer’s experience is typical, or disclose what the generally expected results will be.
3. A Look Inside binax™ from Siemens, via AudiologyOnline.com