Hiring a cochlear implant surgeon for yourself or your child is just as important as selecting the right implant manufacturer, as the quality of the outcome is at stake. Unlike fitting hearing aids where the Best Practices are well documented and easily available to the consumer, the same cannot be said for CI surgery, as these practices are mostly scattered throughout hundreds of journal articles behind paywalls.
Video fluoroscopy courtesy of Med-El 10 Click to view full YouTube videoWe at The Hearing Blog are addressing this issue, with our information having been vetted by several industry insiders for accuracy, with this article taking over six months to research, edit, and vet. However, when you cut to the proverbial chase, it comes down to the “touch” in the surgeon’s fingertips as s/he threads the inch-long flexible electrode resembling a wet noodle into the pea-sized hearing organ without making hash of the delicate structures inside, let alone folding over or kinking the electrode array. Almost everything else, such as bedside manner, number of papers published, or standing in the community, is no more than mere window dressing.
Update (6/23/2015): The 9th & 10th paragraphs on operating room electrical testing and radiographic imaging were edited to clarify terminology. Also, please see Brief Addenda to Selecting a Cochlear Implant Surgeon for additional discussion.
With CI’s, there is no 30 Day Return privilege, so choosing wisely at every step of the process is vitally important for the best outcome. Unfortunately, especially here in the United States, there are factors that conspire against making an informed choice, not the least of which is the CI manufacturers quietly keeping reams of information on each of the approximately 700 or so US CI surgeons’ outcomes. The problem is that the manufacturer’s patient reps and support personnel maintain omerta, lest they offend the delicate feelings of the audiologists or bruise the fragile egos of the surgeons, both of whom guide the brand selection. Unfortunately, the CI manufacturers’ patient reps — as nice as they are to get you to select their brand — will give you zero guidance on selecting a surgeon, let alone a CI program, as you are .NOT. the customer: The CI center is their customer, and the manufacturers will do nothing to offend their customers.A This even extends to when there is a problem during MAPping: The patient reps & tech support audiologists are not allowed to touch the MAPping computer, lest s/he offends the audiologist’s delicate ego, instead looking over her shoulder “suggesting” changes.
There is some effort to gather “tribal knowledge” amongst the various facilities by the Association for the Advancement of Medical Instrumentation (AAMI) into a sort of “standards” or “best practices” document.1 However, it’s still in draft form, it’s complex; and one of the experts who reviewed this document just made us aware of this as the draft was published only days ago.
Here are pertinent questions for which you need to get answers from the surgeons and audiologists, preferably in writing on the consent forms, and other things to watch out for:
First, just exactly who is threading the electrode into your or your loved ones’ cochleas, anyway? While it’s vitally important to train the next generation of CI surgeons, in fact at many programs in teaching hospitals it’s the resident, not the surgeon you believed you hired performing this delicate task. It’s one thing to have a resident performing the “grunt work” of grinding out the pocket for the implant package and cutting the mastoid opening without nicking any nerves; however drilling the cochleostomy and threading the electrode is what separates the top surgeons from the rest, especially when residual hearing preservation is required for hybrid (EAS) procedures (and more on this later). Our attitude on this is “go train your residents on someone elses’ ears.” Make sure you get this in writing on the consent form, as often in the fine print you really provide consent for the resident to perform the surgery’s actual delicate tasks, with the surgeon you think you hired “supervising;”
Second, as we alluded to above, you want to assure your surgeon will be using hearing preservation techniques to get the best performance, even if there is no residual hearing remaining, in order to keep the electrode in the scala tympani (bottom of the three chambers) to get the best outcome 2, 3 and to minimize the chance of triggering or exacerbating tinnitus. 12 [Worth noting is that on May 28th Advanced Bionics received the CE marque by TÜV for their Naída CI Q90 EAS combination hearing aid/CI speech processor, which unlike the Med-El and Cochlear systems uses a full length electrode insertion. We’ll have much more on this in an upcoming article, as we already know one person participating in the FDA clinical trials.]
October 5th 2015 Update: Two new articles on residual hearing preservation have just been published: The Impact of Perioperative Oral Steroid Use on Low-frequency Hearing Preservation After Cochlear Implantation 11 by David Haynes MD & his crew at Vanderbilt; and Effects of CI Electrode Insertion on Tinnitus 12 by Thomas J Balkany MD in The Institute for Cochlear Implant Training blog. Although Balkany talks about how tinnitus can be generated when the basilar membrane is pierced, in fact “when CI electrodes ruptured intrascalar partitions and traversed between the scala, tinnitus had a 16% chance of being generated or becoming worse; while when electrodes did not traverse scala, tinnitus was not made worse. We’re going to have a brief article breaking out these two articles;
Third, how many implant surgeries per year of each brand does this surgeon perform? You want a surgeon who performs at least 50 implants per year, and at least 25 implants of your particular brand choice in the last year: Experience pays;
Fourth, will the surgeon be advancing the electrode array off the stylet the proper way with the tip just inside the cochleostomy or round window opening, or will he be inserting the stylet down to near the basal bend 5-6mm in? [This paragraph was edited for clarity on June 12th, 2015.] If the stylet is inserted down into the cochlea to near the basal turn to avoid array kinking, it can act like a “spear” piercing the basilar membrane and protrude into the scala tympani (the topmost of the three chambers in the cochlear duct), instantly destroying residual hearing and, more importantly, causing a poorer quality stimulation, with resultant lower word recognition scores.2, 3 Although this is not an issue with AB’s Mid-Scala and Helix arrays as their stylet can be reloaded in the operating room in the event the surgeon accidentally kinks the electrode, this is not the case with the Nucleus Contour array; and what’s more, if the Contour electrode array becomes kinked on insertion because the surgeon does not have adequate “touch” in his fingertips to feel the interference, Cochlear Americas will not honor the warranty. This goes to explaining why, in one informal survey of CI surgeons, 85% use the potentially more traumatic method of inserting the stylet too deep when placing the 22 contact Contour electrode array. [6/12/2015] To clarify, it’s the combination of the inability of the Contour array to be reloaded onto the stylet .AND. Cochlear Americas’ not honoring their warranty if the surgeon kinks the electrode which conspire to cause 85% of surgeons to improperly insert the stylet too deep risking trauma.
Fifth, it’s mandatory that the implant be booted up in the OR by the audiologist with a cleaning cycle and an impedance check performed: This takes about 10 minutes but is necessary to detect electrical problems. Also, the inter-electrode impedance test (also known as Electric Field Imaging (EFI) test; if the audiologist performs it and knows how to interpret the result matrix) will usually detect folded electrodes. For the example in the picture on the right, the impedance between electrodes 1 & 8, and 2 & 7 will be abnormally low, revealing the folded-over electrode. The problem is that OR time is booked in 15 minute increments with anesthesiologist fees the cost driver, with prices ranging as much as $1,000 per 15 minute block: The cost containment pressure is to skip this step; and when skipping boot-up is combined with delayed or even no post-op radiography, disaster can result. [Paragraph edited 6/23/2015.]
Sixth, it’s vitally important for radiologic imaging to be performed preferably in the OR before closing up. The reason for this is two-fold: First, you will not need to go through a needless second “revision” surgery if the surgeon makes an error; and second, that fibrous tissue starts growing around the electrode almost immediately, making revision surgery for a folded or kinked electrode more difficult, if not impossible after a few days — And this applies to a decade or two when the CI needs replacing, as well. At university hospitals there is tremendous pressure from the Ivory Tower to cut costs, and often this step is either postponed until the switch-on, or even skipped altogether, with the surgeon & audiologist crossing their fingers that all will turn out OK. The gold standard is to wheel a small CT scanner for the head into the OR, which is about the size of a breadbox, to verify the precise electrode placement; however an x-ray plate will suffice to spot gross problems such as a folded-over electrode. What’s more, by not using radiographic imaging the patient with the improperly placed electrode would need to be reimplanted, which involves additional trauma to the skin flap, an increased risk of infection, and also needless additional pain and lost time due to the second surgical procedure which could have been avoided. We are aware of a medical malpractice case at a major Michigan program where both the boot-up and imaging steps were skipped and the electrode was folded over between the 3rd & 4th contacts. This was not discovered until switch-on when there were major problems; but because this was four weeks after the surgery, fibrous tissue had already started to grow, making revision surgery impossible. [Paragraph revised 6/30/2015.]
Seventh, and this one should almost go without saying, but given cost-cutting measures you never know, so it’s better to specify that facial nerve monitoring be used. This is just about de rigeur but it’s better to be safe than sorry, so make sure you get this in writing;
Eighth, how will the implant electronics package be fastened down to the skull? It takes the surgeon time to carefully cut the pocket in the skull without going too deep and nicking the dura mater, and to drill the holes for the tie-downs. In the aforementioned Michigan MedMal case the surgeon used a “slip and go” method to reduce the OR time even further, which allows for movement of the implant package, and more harmfully puts unnecessary stress and strain on the delicate electrode array wires where they emerge from the package, which can result in premature device failure. As we understand it, a prominent Atlanta CI surgeon with over 1,000 procedures is also now using “slip and go,” needlessly compromising the device reliability;
Ninth, and often overlooked, is post-surgical infection control. Because of very limited blood circulation in the scalp, it’s easy for a “biofilm” infection to set in, which can spread into the cochlea causing ossification; and if the infection jumps the dura mater barrier, can cause life-threatening bacterial meningitis: Be sure to discuss post-surgical infection control with your surgeon and carefully follow his or her instructions;
Tenth, what is guiding the CI brand recommendation by the audiologist and surgeon? The best ones are comfortable implanting and MAPping all three major brands, so sometimes financial “considerations” are in play, such as exclusivity deals for better device pricing; or outright kickbacks, through Cochlear Americas’ unethical and unlawful Partners’ Program;4 and as we just discovered a few days ago but not publicized in the industry press, just two months ago by Med-El by providing them [the surgeons] free meals, overseas travel opportunities and honoraria requiring little to no actual work by the physicians.5, 6 What’s more, although for an American corporation it is highly illegal under the Foreign Corrupt Practices Act7 (FCPA) to pay any kind of bribe or kickback to any party anywhere in the world (under penalty of the CEO going to prison), this is not the case elsewhere, as in both the European Union and Australia these overseas bribes are considered a legitimate business expense that can be deducted from corporate taxes (though it is unlawful for EU corporations to pay bribes to entities inside the EU itself);
Finally, as you look at the list of surgeons we like, you’ll notice that there is only one pediatric program listed: If you have a deaf infant or child, you’ll quickly find out that the audiology & CI programs at many (but not all) “Children’s Hospital of [insert city name]” or “[insert big donor name] Children’s Hospital” are generally rather lousy (especially at diagnosing & managing ANSD), despite the “halo effect” from their name and “standing in the community;” so you’ll do much better by going to a CI center that also implants adults. As best we can tell, based on numerous off-the-record conversations, the problem with pediatric hospital audiology departments centers on very poor Medicaid reimbursement due to the indigent patient load;D and since adult hearing aid sales are a profit center, the audiologists at pediatric hospitals are generally at the bottom of the pay scale… And they get what they pay for.
CI surgeons & programs we like&c.
Just because the CI surgeon is not listed here doesn’t mean he or she is not good: This is merely a brief list of surgeons who have proven track records of good outcomes, in no particular order:
- Tom RolandB, C at NYU Langone (we like “Roland’s Rules”);
- Daniel LeeC at Mass Eye & Ear in Boston;
- Eric WilkinsonB, C & Bill Slattery at House Ear Clinic in LA;
- Rob Labadie & David Haynes at Vanderbilt’s Bill Wilkerson Center in Nashville (ask for a tour, including their anechoic chamber!);
- Stanley Baker in Oklahoma City (and if you can convince Jace Wolfe across the street at Hearts for Hearing to MAP your CI, you’ll be in superb shape). Dr Baker also implants at Surgery Center of Oklahoma in OKC for a flat $8,800 plus the cost of the device;
- Dana Suskind (pediatric only) at Comer Children’s in Chicago (we also really ♥Love♥ her Thirty Million Words project she developed);
- Rick Chole and Craig BuchmanC at WUSTL in St Louis;
- Michael Novak at UI-Urbana Carle Foundation in Urbana Illinois;
- Adrien Eshraghi at Univ. of Miami;
- Colin Driscoll at the Mayo Clinic in Rochester, Minnesota;
- Alejandro Rivas at the Rivas Clinic in Columbia;
- Vittorio CollettiC in Milan;
- Perhaps the best of them all is John Niparko at USC-Keck in LA. UPDATE: Dr Niparko suddenly died on April 26th, 2016. He was our “go-to guy” for many years when he implanted at Johns Hopkins, fixing mistakes other, lesser otologic surgeons caused. Three years ago he decamped for LA to take over the neurotology program at USC-Keck; and although he temporarily stopped implanting, he resumed in June of last year. In addition, he singlehandedly saved many neurotology and audiology research programs when House Research Institute (across the street from House Ear Clinic) imploded a couple years ago. Besides being a tremendously nice guy as well as a talented surgeon, he was also one hell of a manager, starting and managing Hopkins’ then-world-class CI program. [You’ll notice I used the term “”then-world-class,” as since Dr Niparko departed, it has slipped markedly, especially in audiology; and we have stopped referring people to that CI program after several incidents of poor quality services.]
On The Other Hand, certain cities such as Philadelphia, Atlanta, and (especially) Las Vegas have no decent CI programs; and candidates or parents of candidates would be wise to contact one of the facilities above. In fact, in Atlanta the pediatric CI centers and their associated audiology programs are so dodgy (especially with diagnosing and managing ANSD), your humble editor has literally established a “conveyor belt” to Vanderbilt’s world-class program just four hours away.
Choosing a CI brand:
On choosing a CI brand, The Hearing Blog recommends you focus on the implant electronics package itself, as that is what will be wired into your head for the next 20 or so years; and except for the Advanced Bionics HiRes 90k which is software upgradeable, is what you’ll be stuck with. (For more on this, see Prof. Mike Marzalek P.E.‘s tutorial here.) In addition, as we previously documented, Cochlear (and now Nurotron) have too many electrode contacts (for marketing purposes?) forcing them too close together, causing undesired channel crossover and poor performance, especially with music.9 Yes, some manufacturers’ have “sexy” externals; but the processors are replaced every 3-5 years; and also once one manufacturer has an “innovation” in their externals the others soon follow along, as with over 400,000 users worldwide and one million predicted by 2020, it’s a Big, Competitive Market out there.
We also recommend you go on a “CI Shopping Trip” to the Hearing Loss Association of America (HLAA) &/or Association of Late-Deafened Adults (ALDA) conventions and hang out in the noisy Expo hall (Expo hall-only passes are free at the HLAA convention). The CI manufacturers will all have their lavish parties and dog-and-pony shows with their “rock star” users flown in from all over; however what you should do is talk to the hundreds of actual CI users there, but when you do, shift to “anthropologist mode” to observe how well they are actually understanding what you are saying, preferably without them speechreading (lipreading). Good speech perception in the quiet of a sound booth is one thing, but you don’t live in a sound booth, either; and since the manufacturers will all fly in their “rock star performers” to man their booths, you’ll need to seek out others to get a better perspective of performance. Yes, they will all lay in front of you their “research studies” they paid good money for, each claiming how well their devices work — But of course, they’ll not show you the ones showing their wares don’t work well. However, most of these “studies” they will show you cannot withstand engineering level scrutiny — Especially for speech-in-noise claims — and they will not release the underlying raw test data;E so at the end of the day you need to trust what you hear and see with actual, random CI recipients in the busy expo halls; and then choose your brand accordingly, as you’ll be “married” to that CI company for the next 20 or so years.
- Public review draft of AAMI/CDV-2 CI86, Cochlear implant systems – Safety, performance and reliability: Association for the Advancement of Medical Instrumentation, May 21st, 2015
- Cochlear Implant Programming: A Global Survey on the State of the Art (31 authors). The Scientific World Journal Volume 2014 (2014), Article ID 501738, 12 pages
- Role of electrode placement as a contributor to variability in cochlear implant outcomes (Charles C. Finley and Margaret W. Skinner). Otol Neurotol. 2008 Oct; 29(7): 920–928.
- United States Settles False Claims Act Allegations with Cochlear Americas for $880,000: US Department of Justice, June 9th, 2010
- Medical Device Maker Agrees to Pay $495,000 to Settle Allegations it Improperly Rewarded Military Physicians for Choosing Company Devices: US Department of Justice, US Attorney’s Office, Western District of Washington, February 13th, 2015
- Med-El Pays $495,000 to Settle Allegations it Paid Kickbacks to Military CI Surgeons: The Hearing Blog, April 24th, 2015
- Foreign Corrupt Practices Act of 1977, as amended, 15 U.S.C. §§ 78dd-1, et seq: Overview.
- Wolfe, Jace, and Schafer, Erin C. 2014. Programming Cochlear Implants 2nd Edition. San Diego: Plural Publishing. ISBN-13: 978-1-59756-552-3 ISBN-10: 1597565520. Our book review is here;
- First Person Report: Cochlear Implant Channel Crossover. The Hearing Blog, June 1, 2011;
- A Photographic Tour of the Cochlea. By Melissa Waller, The Med-El Blog, October 31, 2013.
- Impact of Perioperative Oral Steroid Use on Low-frequency Hearing Preservation After Cochlear Implantation. Sweeney, Alex D.; Carlson, Matthew L.; Zuniga, M. Geraldine; Bennett, Marc L.; Wanna, George B.; Haynes, David S.; Rivas, Alejandro. Otology & Neurotology: October 2015 – Volume 36 – Issue 9 – p 1480–1485
- Effects of CI Electrode Insertion on Tinnitus, by Thomas J Balkany MD. Institute for Cochlear Implant Training, October 1, 2015
A. We give props to Envoy Medical, maker of the troubled Esteem implanted hearing aid, for tossing out one surgeon from their program, as this individual, who is also well known in his region as a butcher CI surgeon, was taking as long as nine hours to implant the hearing aid. What’s more, this particular surgeon took almost six hours on a friend’s routine CI surgery (normal time for a good surgeon is 70-90 minutes), yet still bungled it, rendering her ear completely destroyed and unimplantable in the process;
B. These gentlemen are also trained electrical engineers, which gives them a leg up over their peers when working with CI’s, as they have been trained to have an intuitive grasp of the underlying very complex signal processing involved with these magical devices;
C. These gentlemen also implant Auditory Brainstem Implants (ABI), which truly is “brain surgery;”
D. At the March Auditory Neuropathy Spectrum Disorder Conference 2012 held at All Children’s in St Pete, the CI program coordinator told the attendees that 100% of their CI patients in the last year were Medicaid;
E. We had this same problem as well with Siemens not releasing the underlying raw data for their dodgy Binax speech-in-noise claims.
F. eBay sniper