We at The Hearing Blog have recently received several troubling reports of severe-to-profoundly deaf people who are clearly candidates for cochlear implants being denied in the qualification process, on the basis of improper speech perception testing protocol being used when the audiologist performing the test used monitored live voice (MLV) instead of recorded speech: Due to inconsistent results, live voice speech testing is Not Acceptable for CI candidacy evaluations; and because of this as we will clearly document in this article, violates FDA labeling requirements.
Update 1: It seems this practice extends north of the border: When we published this article & posted the link on our Facebook page, it elicited a comment from another victim in Vancouver of live speech testing (see below).
Cochlear implants (CI’s) have been shown to literally transform the lives of recipients in a way such that they have been clearly shown they are the most successful and effective implantable prosthesis both in terms of restoring function to recipients and improving their lifestyle; and the one-third of a million people who have received CI’s outnumber the recipients of other types of neural prostheses by orders of magnitude.1 FDA-approved label indications for CI’s refer to the explicit criteria for which the manufacturer intends to market their product; and each device is shipped with the manufacturer-specific “Physician’s Package Insert,” 8, 9, 10 which specifies the FDA-approved label indications for implantation. 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.
Fortunately, Vanderbilt CI program director René H Gifford, PhD spelled this out in June 2011 in The Hearing Journal in Who is a cochlear implant candidate?,2 from which we are excerpting the following:
Aside from audiometric threshold, perhaps the more definitive component of determining adult implant candidacy involves speech recognition testing. 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. Thus, they are relying heavily—if not entirely—on visual cues such as lip reading and nonverbal signals for communication. 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. Just as important as presenting speech stimuli without visual cues is the presentation of recorded materials for the assessment of speech recognition abilities. 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. 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. Furthermore, Cochlear Americas, Med El, and Medicare all specify the use of recorded stimuli for the implant evaluation.
However, it’s not just the improper use of live voice speech testing that is problematic: If the presentation level is artificially inflated, it too will overstate actual speech perception, again improperly disqualifying candidates. Dr Gifford goes on to address this problem as well:
Yet another consideration for the administration of speech recognition materials is the presentation level for determining candidacy. Historically, stimuli were presented at 70 dB SPL in the sound field. The problem with this is that 70 dB SPL is not representative of average conversational speech. Pearsons et al. reported that average conversational speech levels were 60 dB SPL.4 A number of studies have examined the effect of presentation level on speech recognition outcomes for individuals with cochlear implants and those who may be cochlear implant candidates.5, 6, 7 They found that post-implant speech recognition was essentially identical for 60 and 70 dB SPL, but that pre-implant performance was significantly poorer for 60 dB SPL as compared to 70 dB SPL. Consequently, using 70 dB SPL as the presentation level for determining implant candidacy puts the patient at a disadvantage because:
- It is not representative of average conversational levels in the real world;
- It has the potential to artificially inflate one’s speech recognition performance, and
- It could potentially disqualify an individual from candidacy who could derive significant benefit from cochlear implantation.
[In addition], the implant companies have recently come together to determine a recommended test battery [Minimum Speech Test Battery (2011) – Ed.] for both pre- and post-implant assessment of performance which includes AzBio sentences,11, 12 BKB-SIN sentences in noise,13, 14 and CNC monosyllabic words.15
What to do if you believe you were improperly denied CI’s because FDA-mandated speech perception testing standards were violated:
- If you are in the United States and you’re in a metropolitan area with several CI programs, Find Another CI Center. Also, if you have a CI Mentor, discuss this with him or her. 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. Here are the links to the Advanced Bionics, Med-El and Cochlear clinic finders;
- If you are in a “one CI center town” first put your ZIP code the clinic finders above to see if there is indeed another of the ≈250 CI programs within an acceptable distance, especially if you can get to an excellent program in a major city; or alternately check the travel discount websites19 for airfares into New York, Baltimore, Nashville, Tampa, OKC, LA, San Francisco, or (under 18 only) Chicago, where you can find top-notch CI surgeons & their programs. Also, contact your CI manufacturer Patient Coordinator;
- If you are not anywhere near another CI center and you don’t want to travel, request a meeting with the CI surgeon and the audiologist, bring along a printed copy of the Physician’s Package Insert, and ask them to justify their action in their violating the FDA-mandated protocol by going “off label” with their qualification testing – Remember, these people already improperly turned you down, so you need to stand up and be your own advocate. 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. None. Period.
Update 1 (continued): It seems this practice extends north of the border: When we published this article & posted the link on our Facebook page, it elicited this comment and audiogram from another victim of live speech testing, this time from Vancouver:
I have a severe to profoundly deaf loss and reverse slope. At my last test my speech recognition scores were better with live speech (female voice) than with recorded speech (male voice). 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. My CI surgeon said I don’t meet the criteria for implant. Seems the decision is made using ideal conditions (loud female live voice) rather than real life. I thought he only option I have is to wait until the criteria changes or the technology improves… So it isn’t only me!
We would be interested in hearing from the Western Institute for the Deaf and Hard of Hearing…
- Wilson, Blake S; Dorman, Mike F: Cochlear implants: current designs and future possibilities Journal of Rehabil Res Dev 2008;45:695-730
- Gifford, René H PhD: Who is a cochlear implant candidate? Hearing Journal June 2011 – Volume 64 – Issue 6 – pp 16,18-22
- Roeser, Ross; Clark, Jackie: Live voice speech recognition audiometry—Stop the madness Audiology Today 2008;20:32–33
- Pearsons, KS; Bennett, RL; Fidell S: Speech levels in various noise environments (Report No. EPA-600/1-77-025). 1977; Washington, DC: U.S. Environmental Protection Agency
- Firszt, JB; Holden, LK; Skinner, MW; et al: Recognition of speech presented at soft to loud levels by adult cochlear implant recipients of three cochlear implant systems. Ear & Hearing 2004;25(4):375–387
- Alkaf, FM; Firszt, JB: Speech recognition in quiet and noise in borderline cochlear implant candidates. Journal of the American Acadamy of Audiology 2007;18(10):872-882
- Skinner, MW; Holden, LK; Holden, TA; Demorest, ME; Fourakis, MS: Speech recognition at simulated soft, conversational, and raised-to-loud vocal efforts by adults with cochlear implants. Journal of the Acoustical Society of America 1997;101(6):3766-37828.
- Advanced Bionics HiRes 90K Harmony System Physician’s Package Insert 9055522-001 RevA
- Med-El Physician’s Package Insert — See Bootnotes
- Cochlear Nucleus CI422 Physician’s Package Insert (mirror copy here)
- Spahr AJ, Dorman MF. Performance of subjects fit with the Advanced Bionics CII and Nucleus 3G cochlear implant devices. Archives of the Otolaryngology — Head & Neck Surgery 2004;130:624–628.
- Gifford RH, Dorman MF, McKarns SA, Spahr AJ: Combined electric and contralateral acoustic hearing: word and sentence recognition with bimodal hearing. Journal of Speech, Language & Hearing Research 2007;50(4):835-843.
- Etymotic Research, Inc. BKB-SIN Test. Speech-in-Noise Test Version 1.03, 2005.
- Killion M, Niquette P, Revit L, Skinner M. Quick SIN and BKB-SIN, two new speech-in-noise tests permitting SNR-50 estimates in 1 to 2 min (A). Journal of the Acoustical Society of America 2001;109(5):2502-2512.
- Peterson GE, Lehiste I. Revised CNC lists for auditory tests. Journal of Speech & Hearing Disorders, 1962;27:62-72.
- Minimum Speech Test Battery (MSTB) for Adult Cochlear Implant Users (2011). Auditory Potential, LLC. MSTB instruction manual (mirror copy here)
- Carhart, Raymond. Selection of hearing aids. Archives of Otolaryngology. 44, 1-18 (1946)
- State-by-State list of audiology professional licensing Boards
- We recommend checking the Southwest and JetBlue websites in addition to the travel discount sites such as Expedia and Orbitz as these two airlines don’t participate in third party website bookings
- One of the candidates who was improperly turned down for CI’s is a member of our local HLAA chapter: This spring we personally referred this lovely lady to one of the better (but small) CI programs in Chicagoland; and in mid-June we received an excited e-mail from her daughter that she qualified. The next time we saw her was last month; and when we asked her how her journey was coming along, she told us that because she didn’t care too much for the surgeon’s bedside manner, she went to a large program where she was turned down because she heard too well. Upon investigation, we found that the small program used recorded speech; while the large program violated protocol by using MLV;
- Transparency is a principle we espouse: We appreciate that Cochlear Americas has their Physician’s Package Insert (PPI) on their public website; while all it took was a quick phone call to Advanced Bionics to get a copy of theirs, as it was on the Professional portion of their website. 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. 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. Her pertinaciousness continued, even as we explained to her that Med-El’s much larger competitors publicly disseminate this very similar information on their implants; and also that it is publicly available as filed with the FDA’s Medical Device Branch and is available from them upon request via FOIA (but it can take many weeks, months);
- If any of our readers would like to send us a copy of Med-El’s PPI, our e-mail address is Dan@Snip.Net.