No discussion of costs, or of outcomes data (benefits or harms). Only one positive patient anecdote with no explanation of whether her result was representative of what’s been seen in any other patients. There was no independent perspective provided.
The story illustrates the difficulty in reporting on a new device and new implant procedure that has not become a mainstream practice. Much scientific data may not yet have been published. If this were the case, the story could have explicitly stated so and alerted the reader on the lack of data currently available.
No discussion of costs. Cost of any new device is important as is insurance coverage. Neither are addressed in the story, an oversight we find difficult to understand. According to the manufacturers website the cost of the surgery and the device in $33,000. Insurance does not cover the device at the moment. The battery, said to need replacing every 7 years, costs approximately $6,000 and may need to be performed as early as every 3 years depending on usage per day and other factors. Again, these costs are not covered by insurance.
The benefits detailed in the story are only anecdotal – from a single patient and one implant surgeon. No quantitative data or scientific evidence are given to support the patient’s claims. Is her experience typical? Out of the 40 patients who received Esteem implants in the Chicago area, did all of them have similar outcomes? And what about nationwide? How was hearing improvement for all of these patients measured? We are not told of the clinical trial that was used to obtain FDA approval (easily available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/EarNoseandThroatDevicesPanel/ucm146740.htm).
The story provides no information about potential harms of the surgery (requiring general anesthesia) or of the device once implanted. The study reported ongoing adverse events related to the device and the surgery including dizziness, taste disturbances, facial weakness/paralysis, ear pain, tinnitus (ringing in the ear) and middle ear effusions (build up of fluid).
Only two sources are cited in this story – a patient who underwent the procedure and her surgeon who was trained by the device’s manufacturer. Furthermore, all of the evidence for the implant’s effectiveness is strictly anecdotal. There is no mention of any quantitative data to support their claims.
The article does not provide much information on the conditions leading to damage to the inner ear, or to nerves from the inner ear to the brain. More background and context on these disorders would have been welcome in this case.
The article appropriately points out that the surgeon was trained by the device’s manufacturer, Envoy Medical Corp. An independent source would have greatly helped to put the implant’s effectiveness into perspective.
The story briefly mentions hearing aids, but the article does not go into detail about other alternatives to surgery.
Although the story mentions that the Esteem implant is FDA approved, it is not clear why Dr. Marzo is the only surgeon in the entire Chicagoland area authorized to implant the device. Is this typical of other cities? Why is the procedure not more widespread?
According to the FDA, “Esteem is the first totally implantable hearing system used to treat moderate to severe hearing loss caused by a defective inner ear function.” The article could have made this fact clearer, but states that this implant, a prosthetic inner-ear stimulator, differs from a hearing aid, which “amplifies sounds.”
The story does not use the exact wording from a Loyola University Health System news release, but the content and language are similar. Same patient. Out of 40 patients implanted at Loyola, why did the story use the same patient as the one profiled in the news release? There was no new information or sources in the story than what appeared in the news release. For that reason, we rule this unsatisfactory.