Our implants are designed to reside in the human body for an indefinite amount of time, and they have to be safe without question.
Building the Gift of Sound - How Cochlear Implants are Made
Thursday, July 29, 2021
Cochlear implants are small, yet incredibly intricate and sophisticated devices. As Class III medical devices, they are also stringently regulated and scrutinized. Needless to say, manufacturing a cochlear implant is no simple process. We caught up with Ali Kashen, AB’s Vice President of Global Operations, to tell us about how his team creates each one of AB’s implants and sound processors.
What are Class III medical devices, and how does that affect how we make cochlear implants?
Class III medical device is an FDA classification reserved for devices that sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. As such, they are subject to the most rigorous regulatory scrutiny. Cochlear implants are considered Class III medical devices, and rightfully so. Our implants are designed to reside in the human body for an indefinite amount of time, and they have to be safe without question.
This designation also means that, throughout the entire manufacturing process, we are required to adhere to the absolute highest quality standard.
How are cochlear implants manufactured at AB?
I’m proud to be a part of the only American company designing and manufacturing cochlear implants. In fact, all of our devices are manufactured in-house at our headquarters in Valencia, California, just outside of Los Angeles. It is a highly complex process that involves hundreds of steps. These steps include receiving and inspecting raw material, assembly of the various parts into a finished product, testing, sterilization, packaging and delivery. Making each cochlear implant or sound processor is a very rigorous process that can take weeks.
First, we source raw materials from hundreds of suppliers from around the world. These materials include precious metals like titanium, platinum, and gold, which go into electronic circuit boards in the sound processor and implant. We also use rare earth magnets in the implant and head piece.
Once we receive these raw materials, they are closely inspected for quality. Next, our manufacturing teams assemble them into finished products completely in-house. This happens inside “clean rooms” —highly specialized facilities that are environmentally controlled and monitored to minimize product exposure to particulates and other forms of contamination. For example, all employees working inside these rooms must wear protective gowns, gloves, as well as shoe and hair coverings. A specialized air filtration system cycles and purifies the air inside the clean rooms over 30 times per hour.
Inside these environmentally controlled rooms, the vast majority of work is done by hand under microscopes. Cochlear implants are small, and the components inside are even smaller. In fact, the wires for the electrode designed to be inserted into the cochlea are only one-tenth of the width of a human hair. This incredibly delicate work is done painstakingly and meticulously by our team of highly trained and specialized production associates.
I believe many people, when they think about manufacturing, picture machines and robots putting parts together down an assembly line, which is not the case here. While we do employ robots, some of which are even designed and created in-house for product testing and validation purposes, our CIs are literally handmade, one by one.
What do you consider the biggest challenge in this manufacturing process?
AB is privileged to have a highly talented, experienced, and dedicated team of manufacturing experts, many of whom have been working at AB for decades. We are also fortunate to have the support of our parent company, Sonova, which helps ensure that we have the resources and agility to create the best products.
The biggest challenge we’re currently facing is the squeeze in the supply chain, a situation that almost all industries are experiencing. We see everywhere in the news today that it’s harder to get everything, from lumber to microchips. Cars and smartphone deliveries are delayed, and just about every other piece of consumer electronics is impacted. With this global shortage of raw materials, we are also being challenged to deliver products to our customers on time.
The demand for our new Marvel CI products has been extraordinary. It’s obvious that what these devices offer really resonates with the needs and wishes of people who depend on CI technology every day. Marvel is comprised of electronic components and batteries, both of which are seeing unprecedented shortages globally. This has hindered our ability to build up adequate inventories to meet the very high demand.
It’s obvious that what these devices offer really resonates with the needs and wishes of people who depend on CI technology every day.
To address this issue, we are providing an alternative battery type, free of charge, to the individual, if the preferred battery isn’t available within a reasonable amount of time. Their preferred batteries will be sent as soon as the supply recovers. Over the longer term, we’re working with our suppliers to assist in procuring difficult-to-find components, and ensuring adequate supply going forward. We’re doing everything possible to continue delivering this life-changing technology to people around the world.
As a healthcare manufacturing leader, what drives and motivates you?
I feel honored and humbled to be a part of such a mission-driven company. Knowing that the individuals with our cochlear implants rely on us to help them hear again, or for the first time—it is a great honor, but also a profound responsibility that I do not take lightly. It requires tremendous attention to detail and focused leadership. But my job is to make sure everything comes together so that the finished cochlear implant is something I’m willing to have implanted into my own child or grandparent.
During the first few days on the job, I had the wonderful opportunity to visit a few clinics and meet people with AB CIs in person. One person I met was a gentleman in his 80s coming into the audiologist’s office for a follow-up appointment after having had his sound processor activated a few weeks prior. When his audiologist asked how he was doing, he replied, “I feel like I’m 20 again!” That moment affirmed my decision to join AB. And ever since then, it brings meaning to the work I do every day.
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