Several people are posting stories about their hearing journeys. One website with postings that include hearing journeys of a variety of people is http://www.hearingjourney.com. Although each person’s journey is unique, mine is not that much different than those of many others and I’ve sustained fewer serious repercussions than many others who have followed the path. Nevertheless, I think of my journey also qualifying as an odyssey, so I am using that title. The word “odyssey” originates from the Homer’s epic story of Odysseus, which began after the Trojan War ended. Odysseus longed for home and his faithful wife, Penelope. The story, though, recounts his ten-year journey though hardships and his encounter with marvelous and frightful beings along the way. Sometimes Odysseus solved dire problems using his wits; sometimes he gained additional help. About 1889, the term odyssey began to be applied to mean a wondrous journey. I think of my long journey towards better hearing, begun in the 1950’s and hopefully entering a new chapter later this year, as an odyssey. Along the way, I often received help and advice from others, and occasionally I needed to use my own wits to overcome obstacles. Sometimes I wandered aimlessly, not knowing I had a better choice, but now I am convinced that I see the way home to better hearing.
This is my sixth post. Readers are invited to communicate with me. Please refer to the last paragraph for details.
I was scheduled to obtain my second cochlear implant on December 10, 2010. Just a few weeks before then, about Thanksgiving time, I received a telephone call from my surgeon. He stated that the company had voluntarily recalled the Hires 40K devices that are implanted. People associated with Advanced Bionics are passing information to the public on the Hearing Journey website, http://www.hearingjourney.com. There, I learned that the company was informed of two cases, out of 28,000 implants, where the people experienced discomfort shortly after the devices were activated, of such a degree that they had to have their devices removed and another device implanted in its place. Nine other people had also reported similar but less intense symptoms, but further testing reduced the group of people with similar symptoms to five.
Now the story is that engineers are working to identify the cause of the problem and to fix the problem. When they have done so (if not already), they will inform the FDA and the agency will review the case to determine whether the company has found and fixed the problem. The FDA has up to six months to evaluate the case. If the agency identifies issues that need further remediation, it initiates another cycle of the process.
My first reaction to the recall was dismay, but not a great deal of discouragement. I had requested December 10 because it was right after classes ended for the winter break, and that gave me maximum time for me to recover before classes resumed in late January. If the recall and FDA review pushes things back to May, then I’ll undergo surgery after the spring semester ends. I decided to spend my time in December more actively, doing things for the house, rather than planning on recuperation and mostly rest during that time.
Advanced Bionics is a quality company. I say this because its parent company, Sonova, of Switzerland, commented on the voluntary recall, saying something like the following, “The recall will affect our revenues by four percent, but that’s only money. It is much more important that we do the right thing for our clients.” The recall is worldwide, but the FDA doesn’t have jurisdiction in other countries. When Advanced Bionics has a solution that they submit to the FDA, they will also have a solution that many other countries can use with little or no delay in their regulatory review processes. By the time the FDA approves the fix for the U.S., other countries will have demonstrated it.
Several people on the Hearing Journey website have indicated their willingness to wait for FDA approval. There are likely to be some cases where people may choose another company rather than wait, such as for insurance reasons or for providing a young child with the opportunity to hear for the first time. For me, I already have one cochlear implant from Advanced Bionics and I don’t want two sets of hearing devices that are incompatible with one another. The tonality of the sound will probably differ from devices produced by two different companies, and I don’t want that issue, either. At the present time, I’m waiting and I’m prepared to wait until Advanced Bionics and the FDA both determine that the product performs acceptably.
I hope this blog is interesting to readers. I am a mentor for the Bionic Ear Association (BEA). As a mentor, I am committed to helping people who are in various stages of obtaining a cochlear implant. Please feel welcome to submit comments. As a mentor, I am one of a network of people, including hearing specialists with BEA. For anyone who may be considering getting a cochlear implant, or perhaps investigating what that involves, the BEA can answer more technical questions than I can, and moreover the BEA can act as a travel agent to ease your journey to better hearing. For anyone with a cochlear implant or two, the BEA can better help with issues involving living with a cochlear implant.