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New implant addresses hearing loss caused by inner-ear damage

New Esteem implant stimulates inner ear rather than turning up the volume

 

Since her teens, Lesa Merlo, of Hinsdale, had learned to compensate as her hearing declined. She used the television’s closed-captioning feature. She read lips and paid attention to body language. Often, it meant only being able to do one thing at a time, explained the mother of three young children.

 

Now, thanks to an implant called Esteem, Merlo can multitask. “I can make dinner and supervise homework at the same time,” she said. “I don’t have to stop and look directly at the children. I can hear what they’re saying behind my back.”

 

Unlike a hearing aid, which amplifies sounds, Esteem is a prosthetic inner-ear stimulator. “When I wore a hearing aid, I turned it off when I got home because all the background noise was so agitating,” said Merlo, 40. “But I keep (the Esteem) on.” A controller the size of a cellphone enables her to set her Esteem to different environments, such as “home,” “restaurant” or “school.”

 

Merlo’s doctor, ear surgeon Sam Marzo of Loyola University Medical Center in Maywood, has performed 40 Esteem implants since he was trained by its manufacturer, Envoy Medical Corp. in St. Paul, Minn., in 2010. He is the only Chicago-area surgeon authorized to implant the device, said an Envoy representative. Esteem was approved by the Food and Drug Administration in March 2010. (For surgeons outside Chicago, visit envoymedical.com.)

 

“This really fills a need for adults with moderate to severe sensorineural hearing loss,” Marzo said. The condition is caused by damage to the inner ear or to nerves from the inner ear to the brain. For patients with profound hearing loss, a cochlear implant is a better option, he said.

 

“Esteem is great for people who have used hearing aids but are not happy with them,” Marzo said. “Aids require a lot of upkeep and need frequent battery changes. And they amplify all the noise so it’s hard to filter out background noise.”

 

Implanting the Esteem is a three-hour outpatient procedure done under general anesthesia. About two months post-surgery, when internal swelling has subsided, the doctor turns on the device.

 

“It is surgery, so there is pain at first,” Merlo said. “But within a few days I was comfortable. I had an incision behind my ear, but my hair covers it. Cosmetically, you can’t see anything now.”

 

The implant is permanent. It contains a battery that must be replaced in about seven years.

 

Merlo had Esteem implanted in her left ear in September. In March, she plans to have one put in her right ear.

 

Even with one implant, Merlo called the results “surreal.” “There are little things that I probably heard when I was younger, before my hearing loss, but I don’t remember them,” she said. “Since I got the implant, they’re new to me. Branches tapping the windows, the breathing of the horses when I ride, different instruments in my favorite songs. I always loved music but now I can really hear it.”

 

The implant also allows Merlo to hear herself talking. “That helps my speech,” she said. “Now I know if I blur my THs.”

 

Merlo said her children no longer have to be her extra ears, telling her when the oven timer beeps or when the doorbell rings. “Now they tell me, ‘You never say ‘What?’ anymore,” she said.

 

“My husband and I joke that the best wife is the one who doesn’t hear,” Merlo said. “But not hearing affects everything. People used to think I was standoffish in social situations because I was quiet. I nodded a lot because I couldn’t hear them. Now I can.”

 

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New implant addresses hearing loss caused by inner-ear damage

Our Review Summary

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.

 

 

Why This Matters

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.

 

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

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.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

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).

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

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).

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

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.

Does the story commit disease-mongering?

Satisfactory

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.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

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.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story briefly mentions hearing aids, but the article does not go into detail about other alternatives to surgery.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

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?

Does the story establish the true novelty of the approach?

Satisfactory

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.”

Does the story appear to rely solely or largely on a news release?

Not Satisfactory

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.

Total Score: 2 of 10 Satisfactory

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