Questionable Actions and Claims
All the manufacturers are dedicated to the well-being of their customers and have brought truly revolutionary improvements to those with hearing loss that we all have much to be thankful for; however, the competitive environment among them is strong and the fine line between aggressive marketing and being misleading is often overstepped. Given the complexity of the technology, it is relatively easy for any of the manufacturers to exaggerate claims about their own device or even to spread negative rumors regarding their competitor's devices. In addition, there are various rumors and false information perpetuated by individuals either attempting to discredit one type of implant or all cochlear implants.
I have classified the actions and claims with a severity of low, medium, or high. Low severity indicates something that, in my opinion, is merely of questionable value and may be a matter of interpreation, while high severity indicates something that I feel may be an unethically deliberate attempt to knowingly mislead unsuspecting candidates. If you are concerned about the marketing efforts of any of the companies, I encourage you to contact the manufacturer directly to let them know your feelings, to share your thoughts with others you meet, and/or to take your complaints directly to the FDA.
I. Questionable Marketing Practices by Advanced Bionics (manufactures Clarion)
| Severity | Marketing Practices | Facts |
| Medium | Failed to release Platinum BTE in timely manner | Advanced Bionics marketed and projected that it would have a BTE available as far back as 1997, years before it was actually able to deliver on that promise. Despite the considerable inconvenience that this delay placed on many Clarion users who were eagerly anticipating its release, this action does not appear to have been deliberate and the company has publicly apologized numerous times for the delay. They state that given the goal and engineering complexity of creating a BTE that matched the full capabilities of a body-worn processor, the development of the first-generation Platinum BTE took longer than anticipated. The Platinum BTE was finally released mid-2001. Since then, company has released a second-generation CII BTE, which was released on schedule. |
| Low | Received warning letter from FDA for including content about high resolution in its marketing materials | The CII Bionic Ear enjoys a split approval status with the FDA, whereby the device itself is fully FDA approved for implantation but certain capabilities (high resolution) are still in clinical trials. As such, the company is permitted to market the CII Bionic Ear device but must is not permitted to mention all aspects of the device's high resolution capabilities. Advanced Bionics received a warning letter from the FDA in regards to the fact that it was making mention of its high resolution capabilities in its marketing materials before the FDA had approved it. The warning letter did not charge Advanced Bionics with making any deceptive statements; however, FDA regulations frown against any publicity of the device's capabilities that are still in clinical trials. Further details about high resolution will therefore have to wait until the FDA approves its use. |
II. Questionable Marketing Practices by Cochlear (manufactures Nucleus)
| Severity | Marketing Practices | Facts |
| High | Claim: Other implants may not be reliable | Cochlear continues to exploit one particular study to suggest that not all the implants may be equally reliable. In fact, the authors of this study themselves concluded that they are all reliable, but Cochlear chooses to make different insinuations. A comparable study exists to argue that the Nucleus is quite unreliable, but this study has never been exploited by its competitors in the same manner, because the fact is that all of the implants have remarkable records of safety and reliability. The failure rates cited in these studies pertain to implant models that are no longer produced. The current models available from all three manufacturers are extremely reliable, with less than 1% annual failure rate. Anyone with any concerns about the reliability of any of the implants needs only to take a careful look at the FDA database to see that the number of adverse events with all of these implants is extremely low and equivalent across all implants. Cochlear's message appears to be an attempt to deliberately frighten candidates into selecting their implant using outdated and misleading information. |
| High | Claim: More channels or electrodes are better | Cochlear markets the fact that it has more electrodes than other implants to give candidates the impression that this may somehow deliver greater performance. However, to date, there is no evidence that having more than 8 channels or electrodes is providing any concrete benefit to recipients. For instance, the fact that the Nucleus, with 22 channels, never outperformed the Clarion even when it only had 8 channels, is strong testimony against the marketing claim that more channels provides better performance. Furthermore, the claim contradicts other claims that the company itself has made when promoting its ESPrit 3G BTE, which can only use 20 of the implant's 22 electrodes. In fact, the vast majority of Nucleus users only use a maxima of 8-12 channels as it is, which means that to claim that 22 channels are in effect is not an accurate depiction of how the device works. Click here for more information on what a channel is and how it works. |
| High | Provides training and compensation to select recipients who actively promote the Nucleus product online without revealing their true incentives for doing so. | Cochlear has a program called the "Nucleus Advocate Program" in which they provide extensive training, all expenses paid and $3,000/year to select individuals who go online and promote the Nucleus among peers without uniformly disclosing the financial incentives they have for doing so. At one point, it was even standard practice to deliberately hide this association from those they counseled. Public pressure has forced some of the paid advocates to admit to participating in the program, but many continue to hide their affiliation. Statements by some of these advocates have often been factually incorrect or exaggerated, raising troubling issues regarding the responsibility Cochlear has over the kind of training it provides them. It damages the veracity of information sources on newsgroups as a whole and the inherent trust among a tight knit community of peers and confidants. Other manufacturers have volunteers online which speak about their experiences with their implant, but to date only Cochlear has provided financial incentives for this explicit marketing purpose. |
| High | Claim: The ESPrit 3G is the "smallest and lightest" of tall the BTEs on the market. | This statement has been made by the head of "consumer education" at Cochlear, as well as paid advocates. There is no truth to the claim. The Med-El's BTE is actually the smallest and the lightest of the BTEs. The CII BTE is smaller in volume than the ESPrit 3G, and identical in weight. |
| Medium | Claim: Advanced Bionics has only developed a "1st generation" BTE, where as Cochlear is on their "3rd generation" BTE | A "1st vs. 3rd generation" argument is being advanced by Cochlear as it attempts to make its new ESPrit 3G appear to be the most advanced on the market. Cochlear acknowledges in its own marketing materials that it's ESPrit 22/24 is really "the industry's first BTE," yet simultaneously attempts to claim that the real "1st generation" BTE was a prototype BTE which never saw widespread commercial release or that the ESPrit 22 and 24 are radically different products. In doing so, they are able to position the prototype BTE or the ESPrit 22 as "1st generation," the ESPrit 24 as a "2nd generation," and the ESPrit 3G as a "3rd generation" BTE. Meanwhile, they depict the Clarion has having only released a "1st generation" BTE when in fact, the company has released not one but two different generations of BTE: the Platinum BTE and the CII BTE. In summary, Cochlear's attempts to portray the CII BTE as "1st generation" BTE and the ESPrit 3G as a "3rd generation" BTE appears to be a deliberate distortion of the facts in order to exaggerate the differences between the two. |
| Low | Claim: Nucleus is capable of creating "virtual channels" | Cochlear Corporation has made the claim that the Nucleus 24 is also capable of delivering "virtual channels," but there are two problems with this argument. First, there is a tradeoff between the number of channels an implant can deliver and its stimulation rate per channel. For the most part, the Nucleus 24 is currently operating at its maximum capacity, so it is unclear how it would be able to deliver stimulation to additional channels at a rate that is effective. Its ESPrit 3G BTE is limited to using 20 channels, so this in itself contradicts the claim that additional virtual channels may be a possibility. Second, "virtual channels" requires the use of simultaneous stimulation capabilities which the Nucleus 24 does not have. Cochlear suggests it can replicate this process using an alternative method, but one that is not akin to true "virtual channels" as mentioned above and proven to work in experiments. For the time being, the claim that the Nucleus 24 can incorporate "virtual channels" appears to be a sales pitch designed to maintain competitiveness with the Clarion CII's capabilities. Click here for more information on what a channel is and how it works. |
III. Questionable Marketing Practices by Med-El
| Severity | Marketing Practices | Facts |
| Medium | Claim: "The long battery life offered by the TEMPO+ also means significantly lower yearly battery costs compared to other devices." | This claim is not accurate. Under some circumstances, Nucleus' ESPrit 3G can get longer battery life, and hence cheaper operating cost, than the Med-El's BTE. In addition, because the Clarion BTE's rechargeable batteries are often considered "durable equipment" by insurance companies, they are more likely to be covered by health insurance than disposable batteries and may also be cheaper. Even discounting these points, the actual operating cost difference between the latest BTEs of any implant is not very significant (all are approximately $300-500 a year), especially in comparison to the far more substantial costs of mapping appointments. The claim that one implant may be cheaper to operate than another is generally not very substantial or truthful. |
| Low | Claim: Med-El's straight electrode array design is better because it's causes less damage and delivers same performance as other electrode arrays | There is not much evidence to substantiate the claim that a straight electrode causes significantly less damage, and even if there was, the fact is that all the electrode array designs have been proven to be relatively safe and harmless. Furthermore, all the electrodes cause some trauma upon insertion, and there is no evidence of any practical benefit to the difference caused by different electrode designs. In fact, despite their marketing claims, Med-El has recognized the benefits of more advanced electrode designs and is working to develop an electrode array similar to that of the Clarion's HiFocus or the Nucleus Contour. |
IV. General Rumors/Heresay
| Severity | Claims/Rumors | Facts |
| Low | Cochlear implants "shock" the cochlea with dangerous electrical stimulations | The body's natural hearing works using electrical stimulation that is similar to the cochlear implant. In normal hearing, when the fluid in the cochlea vibrates, it bends the hair cells to where the fluid inside the hair cell comes into contact with the fluid in the cochlea. Since there is a difference in polarity between the two fluids, an electrical current is generated which then travels through the auditory nerve into the brain. A cochlear implant simply uses higher amounts of electrical current to spur the hair cell into generating that electric current that travels through the auditory nerve. Research studies thus far have shown little or no damage to result from the electrical currents of a cochlear implant. In addition, recent developments in electrode arrays have made it so that the amount of electricity used is much lower than it used to be. Finally, if the auditory nerve is not stimulated at all, it can atrophy and die, which is more damaging than anything the cochlear implant's electrical stimulation does to it. |
| Low | Cochlear implantation is brain surgery and the brain is touched during the operation. | At no point is the brain exposed or touched during the operation. The implant is placed on the outside of the skull (but under the skin). A microscopically thin electrode array does go into the inner ear, but never touches the brain itself. |
| Low | Cochlear implant recipients can't go swimming. | A cochlear implant sits under the skin and is not at all exposed to the outside. So as long as a cochlear implant user takes off the external processor and transmitting coil, there is absolutely no reason why he or she can't swim! Unfortunately, s/he won't be able to hear while swimming because s/he won't have the processor with him/herself! |