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18.09.2013
Right from the start, speech comprehension is critical for your child’s language and communication development. Children with severe to profound hearing loss face many challenges to full participation in normal child life. Speech Guard E preserves the natural speech cues essential to improving speech understanding, helping your child build critical language skills. Speech Rescue “rescues” the soft consonants like ‘s’ and ‘t’, and pastes them into a lower frequency range where your child can hear them, giving your child the ability to hear more speech sounds. Inium Sense Feedback Shield SP controls hearing aid feedback, ensuring continuously high sound quality for comfortable wear during the day.
Rated with the IP58 classification, protecting it from the rough and tumble of everyday use.
Get a hearing test, receive help and advice, and buy accessories, spare parts, and cleaning tools from authorised Oticon hearing care professionals. This is a photo of scans of the front and back of the Siemens binax product launch envelope. In 1994, the Hearing Industries Association (HIA) developed guidelines for the substantiation of hearing aid performance claims. These Guidelines are designed to assist manufacturers in understanding and identifying the substantiation requirements for hearing aid claims, including performance or user-benefit claims.
To determine the appropriate substantiation for a claim, identifying the claim made is critical.
The FDA’s jurisdiction encompasses product “labeling.” This term is broadly defined to include written, printed, or graphic material on or accompanying the device. Engadget is a popular technology blog that just ran a short story about what I assume are the Binax hearing aids as a part of their CES 2015 coverage.
When conducting your due diligence, could you establish whether an open or closed ear fitting is being utilized?
UPDATED: Qualifying For Cochlear Implants: Were YOU Washed Out Due To Improper Speech Testing? Aside from audiometric threshold, perhaps the more definitive component of determining adult implant candidacy involves speech recognition testing.
Yet another consideration for the administration of speech recognition materials is the presentation level for determining candidacy.
It could potentially disqualify an individual from candidacy who could derive significant benefit from cochlear implantation. If you are in the United States and you’re in a metropolitan area with several CI programs, Find Another CI Center.
This is audiogram from a CI evaluation performed by the Western Institute for the Deaf and Hard of Hearing in Vancouver. Ms Shyng, we take your reply seriously, and we appreciate your concern about the issue of recorded vs MLV speech testing. Sensei Super Power is specially designed to help children overcome the challenges of severe to profound hearing loss. The discreet behind-the-ear (BTE) design comes in attractive colours, making Sensei Super Power hearing aids ideal for children of all ages. Sensei SP incorporates many features to ensure robust and safe hearing aids to fit their many changing needs as they grow from infancy to adolescence. ConnectLine makes it easier to stay connected and enjoy more kinds of entertainment, receiving the sound right into their Sensei hearing aids.
We had a long conversation with a very senior audiologist in Piscataway, where we were promised certain documents. 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. As part of that goal, these Guidelines outline study procedures that a manufacturer may follow to obtain scientific data to substantiate claims.


Claims may be explicit or implicit, and a manufacturer is responsible for possessing substantiation data for both types.
Essentially, any written materials distributed by the company making claims regarding the performance of a hearing aid may be considered labeling.
These communication techniques create at least two claims and thus two substantiation requirements. It distresses us to no end when people who finally decide to take the step of getting implanted are turned down because the audiologist performing the testing violated the specific FDA-mandated candidacy requirements as delineated in the Physician’s Package Insert by using their own live voice instead of recorded speech testing materials.
As many of us recognize, individuals with significant hearing loss often report that they are unable to adequately “hear” someone unless they are looking directly at them. You can even go so far as to remind them that Raymond Carhart — one of the Fathers of modern audiology — recommended using recorded speech stimuli as far back as 1946,17 so there is No Excuse for any competent clinician to use MLV.
Note the 20% and 64% scores when using recorded speech; however when the audiologist used her own live voice it artificially inflated the results to 60% and 92%. At my last test my speech recognition scores were better with live speech (female voice) than with recorded speech (male voice). Performance of subjects fit with the Advanced Bionics CII and Nucleus 3G cochlear implant devices. Quick SIN and BKB-SIN, two new speech-in-noise tests permitting SNR-50 estimates in 1 to 2 min (A). However, when we contacted Med-El, which has perhaps a 10% share of the American CI market, we received very heavy push-back from their VP of corporate communications. The Western Institute for the Deaf and Hard of Hearing does not provide CI candidacy assessments. We are investigating exactly what occurred, and if there are corrections to the record to be made, we shall do so with dispatch. 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. 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.
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. The FTC regulates claims in advertisements appearing in any media, such as magazines, television, radio, and the Internet. Thus, they are relying heavily—if not entirely—on visual cues such as lip reading and nonverbal signals for communication. The problem with this is that 70 dB SPL is not representative of average conversational speech. Finally, consider contacting your CI manufacturer Patient Coordinator; but keep in mind her hands are somewhat tied, as she does not want to offend their CI center customer.
But for me the female voice is easier to understand than male – that and the artificial environment of loud presentation and little to no background noise is what made the difference. This lady raised a legitimate point about the medico-legal jargon acting to discourage some CI candidates from continuing; and in fact it gave us pause… For all of a New York minute, as this condescension is insulting to our readers, many of whom in fact are hearing care professionals. In British Columbia (BC), Canada, CI candidacy assessments are conducted by the Audiology Department at St. Sensei SP ensures a consistent sound processing approach that will give your child the best opportunity to get the most out of their hearing. Accordingly, HIA has revised the Guidelines to reflect and incorporate these changed circumstances and technologies.
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. Promotional materials may contain multiple claims, all of which must be covered by substantiation that is appropriate for the claim made.
The company making the claim must possess data demonstrating the factual validity of what the endorser says regarding his or her experience.


In determining cochlear implant candidacy, in order to gain an understanding of an individual’s auditory-based speech recognition abilities, speech materials are presented without visual cues. Every claim requires some level of substantiation and the manufacturer must possess the requisite substantiation at the time a claim is made. Substantiation data must be maintained throughout the period in which the claims are made plus at least an additional two years.
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. Just as important as presenting speech stimuli without visual cues is the presentation of recorded materials for the assessment of speech recognition abilities. Seems the decision is made using ideal conditions (loud female live voice) rather than real life.
The nature and quantum of the substantiating data depends largely on the claim that is made. 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 guidelines also apply to oral communications by the company regarding the performance of one or more of its products.
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. Roeser and Clark evaluated monosyllabic word recognition using both recorded stimuli as well as monitored live voice (MLV) for 32 ears.3 They reported that word recognition scores for MLV and recorded stimuli were significantly different for 23 of the 32 ears (72%), with the difference between the scores being as high as 80 percentage points—with the scores obtained via MLV being higher in every case.
I thought he only option I have is to wait until the criteria changes or the technology improves… So it isn’t only me!
All this depends on your child’s ability to detect the details of speech and pass them on to the brain.
The extrapolation may be based on appropriate documented bridging studies that show the applicability of the data from one model to another. These results show that using MLV presentation of speech stimuli for determining cochlear implant candidacy will likely exclude a large proportion of individuals who may actually have met candidacy criteria using standardized recorded materials.
Sensei SP helps your child perceive speech more clearly and supports language development by giving your child access to the full spectrum of speech sounds his or her brain needs. 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. Furthermore, Cochlear Americas, Med El, and Medicare all specify the use of recorded stimuli for the implant evaluation. I know that in our clinic we follow guidelines and refer to the appropriate clinics that work specifically with CIs. Especially being able to hear the critical consonants like “s” and “t” makes speech understanding so much easier. 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. 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. This audiogram was not used in a formal CI evaluation, for which you have erroneously stated.
However, you will notice our clinician performed BOTH recorded and live speech tests to demonstrate the differences in results that can occur between live and recorded speech, just as you have stated in your blog.



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