UPDATED: Qualifying For Cochlear Implants: Were YOU Washed Out Due To Improper Speech Testing?

UPDATED: Qualifying For Cochlear Implants: Were YOU Washed Out Due To Improper Speech Testing?

 

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:

  1.  It is not representative of average conversational levels in the real world;
  2. It has the potential to artificially inflate one’s speech recognition performance, and
  3. 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.
This is audiogram from a CI evaluation performed by the Western Institute for the Deaf and Hard of Hearing in Vancouver. 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%. Also note that neither speech-in-noise nor aided soundfield testing was performed, nor were acoustic (stapedial) reflex thresholds measured.

This is audiogram from a CI evaluation performed by the Western Institute for the Deaf and Hard of Hearing in Vancouver. 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%. Also note that neither speech-in-noise nor aided soundfield testing was performed, nor were acoustic (stapedial) reflex thresholds measured.
Click to open in a new window

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

References:

  1. Wilson, Blake S; Dorman, Mike F: Cochlear implants: current designs and future possibilities Journal of Rehabil Res Dev 2008;45:695-730
  2. Gifford, René H PhD: Who is a cochlear implant candidate? Hearing Journal June 2011 – Volume 64 – Issue 6 – pp 16,18-22
  3. Roeser, Ross; Clark, Jackie: Live voice speech recognition audiometry—Stop the madness Audiology Today 2008;20:32–33
  4. 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
  5. 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
  6. 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
  7. 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.
  8. Advanced Bionics HiRes 90K Harmony System Physician’s Package Insert 9055522-001 RevA
  9. Med-El Physician’s Package Insert — See Bootnotes
  10. Cochlear Nucleus CI422 Physician’s Package Insert (mirror copy here)
  11. 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.
  12. 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.
  13. Etymotic Research, Inc. BKB-SIN Test. Speech-in-Noise Test Version 1.03, 2005.
  14. 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.
  15. Peterson GE, Lehiste I. Revised CNC lists for auditory tests. Journal of Speech & Hearing Disorders, 1962;27:62-72.
  16. Minimum Speech Test Battery (MSTB) for Adult Cochlear Implant Users (2011). Auditory Potential, LLC. MSTB instruction manual (mirror copy here)
  17. Carhart, Raymond. Selection of hearing aids. Archives of Otolaryngology. 44, 1-18 (1946)
  18. State-by-State list of audiology professional licensing Boards
  19. 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

Bootnotes:

  • 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.

~

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About the author

Dan Schwartz

Electrical Engineer, via Georgia Tech

10 Comments

  1. Grace Shyng
    December 11, 2013 at 3:02 pm

    Thank you for the opportunity to respond to your blog post. The Western Institute for the Deaf and Hard of Hearing does not provide CI candidacy assessments. In British Columbia (BC), Canada, CI candidacy assessments are conducted by the Audiology Department at St. Paul’s Hospital in Vancouver, BC. CI candidacy is based on a lengthy audiological examination that includes recorded speech testing (e.g. Az-Bio) and a detailed otolaryngological examination conducted at St. Paul’s Hospital. If a client is determined to be ineligible, it would not be based on a live speech test result. To find out more about the specific tests conducted for CI candidacy in BC, please contact St. Paul’s Hospital Audiology directly at http://www.providencehealthcare.org/cochlear-implant-clinic. Our audiogram you have posted reflects a hearing assessment conducted for the purposes of a hearing aid trial as part of an aural rehabilitation program. 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. While we cannot comment on the surgeon’s decision for this client, surgical decisions are not based on a single unaided word reception score, live or recorded.


    • Dan Schwartz
      December 11, 2013 at 5:19 pm

      Ms Shyng, we take your reply seriously, and we appreciate your concern about the issue of recorded vs MLV speech testing. We are investigating exactly what occurred, and if there are corrections to the record to be made, we shall do so with dispatch.

      Dan Schwartz
      Editor


  2. Macari
    December 12, 2013 at 8:55 am

    This is an interesting blog. I do agree that recorded voice is the most stable under any situation and should be used whenever possible. I was just wondering if you had contacted the audiologist that administered the test prior to posting it? It seems that she was quite thorough as most clinics either test MLV or recorded, not both. Also, was the audiogram administered by an audiologist that was actually determining CI candidacy? I know that in our clinic we follow guidelines and refer to the appropriate clinics that work specifically with CIs. I believe that all professions (not exclusive to audiology) should know their expertise and know when to refer further. Our focus being amplification, we look at different aspects including live speech with and without lip-reading values as they are important for daily communication. When we refer, we expect the CI clinic to administer their own tests to determine candidacy. Finally, I don’t think that the audiologists name should be posted (unless she actually approved this).


    • Dan Schwartz
      December 12, 2013 at 9:39 am

      Please see the comment above from the head of audiology at the Western Institute for the Deaf and Hard of Hearing, and our reply, including launching an investigation into exactly what transpired.

      As for posting the audiologist’s name, the patient owns the records, not the provider. Furthermore, she is accountable for the quality of the work to which she affixed her signature, and should not fear public scrutiny~


  3. Grace Shyng
    December 17, 2013 at 12:15 pm

    In response to Macari’s comment from Dec. 12th, 2013, no, Mr. Schwartz unfortunately did not contact our clinic prior to his posting. I have since tried to contact Mr. Schwartz for further follow-up after my initial comment on Dec. 11th but I’ve not heard back from Mr. Schwartz yet. While I appreciate that the client owns the right to her records, and thus he feels justified in posting them, Mr. Schwartz should have contacted our clinic first to clarify how CI candidacy is done “north of the border”, rather than making assumptions and incorrectly captioning our audiogram as being used for a CI evaluation.


    • Dan Schwartz
      December 17, 2013 at 7:54 pm

      Ms Shang:

      We are not finished with our investigation, as we have been unable to this point to reach the patient; and to that end we conveyed this to you on 11 December 2013 as follows:

      Ms Shyng, we take your reply seriously, and we appreciate your concern about the issue of recorded vs MLV speech testing. We are investigating exactly what occurred, and if there are corrections to the record to be made, we shall do so with dispatch.

      Dan Schwartz
      Editor

      However, this audiogram is troubling on a number of fronts, as when you take the results in toto, they just do not add up, regardless of the purpose of these tests, whether for a cochlear implant evaluation or a hearing aid fitting as you claimed it was for in your comment 11 December comment above:

      First, your (signature illegible) clinician is reporting a bilateral mixed loss as evidenced by the air-bone “audiometric” gap, yet she also reports “normal middle ear pressure and compliance bilaterally.” To that end, there is no actual peak compliance or residual canal volumes indicated, nor is there a printout from your tympanometer or even a sketch of the compliance vs pressure;

      Second, there is no mention of otoscopy, which would indicate at least a gross attempt to resolve the conflict between the air-bone gap and tympanometry results;

      Third, stapedial (acoustic) reflex thresholds were not measured while the tympanometer probe tip was in each ear;

      Fourth, the speech audiometry results we highlighted clearly and without question demonstrates the premise of this article, namely that speech audiometry results using live speech are not valid. To that end, I refer you back to the peer-reviewed articles referenced in numbers 3 and 17 (repeated below):

                3. Roeser, Ross; Clark, Jackie: Live voice speech recognition audiometry—Stop the madness Audiology Today 2008;20:32–33

                17. Carhart, Raymond. Selection of hearing aids. Archives of Otolaryngology. 44, 1-18 (1946)

      Fifth, there is no indication that the patient was referred for medical (otologic) followup, despite the conductive gap and especially because of the inconsistency between the air-bone gap and tympanometry results. We do not know the precise provincial regulations for dispensing hearing aids in British Columbia, for which you claimed in your 11 December comment this testing was performed; however we can say that in the US since at least the mid-1980’s, not referring a patient with this significant a conductive gap for medical followup (or at least the patient signing a waiver) would be grounds for disciplinary action up to and including revocation of professional licencure in almost every state.

      We at The Hearing Blog recommend that instead of attacking our publication for pointing out your clinic’s deficient practices — as documented on your own report — that instead you focus on educating your staff to bring their practices up to at least basic dispensing standards~


  4. Box Hill Speech Pathology
    December 17, 2013 at 3:54 pm

    After reading all of this blog including the comments I can see you have touched some nerves. Lets hope this problem gets solved so that anyone who does decide to have this implant is treated the same.


    • Dan Schwartz
      December 17, 2013 at 8:18 pm

      @Macari and Box Hill Speech Pathology: It is not the duty of The Hearing Blog to provide succor. Our standards are the same as any other news outlet, namely to report the facts~


  5. Grace Shyng
    December 24, 2013 at 9:36 pm

    Mr. Schwartz, you continue to make incorrect clinical assumptions based on an audiogram taken out of context. I have stated my points to my satisfaction.


    • Dan Schwartz
      December 25, 2013 at 12:16 pm

      Ms Shyng:

      Even if we take you at your word on 12/11/2013 that the audiogram we cited

      …reflects a hearing assessment conducted for the purposes of a hearing aid trial as part of an aural rehabilitation program. This audiogram was not used in a formal CI evaluation

      in fact it is still very troubling as, on its’ face, it exposed a serious flaw in your procedures as we laid out on 12/17, namely that — according to your own document — your clinician violated College of Speech and Hearing Health Professionals of BC Standards of Practice by failing to make a medical referral or even have the patient sign a Waiver.

      We await you providing us documentation to the contrary.


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