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Local Firm Creates Device, Gives Patients Chance to Hear

Advanced Bionics, only American manufacturer of whole cochlear implants, shares process with patient

Posted: October 24, 2013 2:16 p.m.
Updated: October 24, 2013 2:16 p.m.

Musician and cochlear implant recipient Lisa Jordan plays her flute for the technicians inside Electrode Assembly Clean Room at Advanced Bionics headquarters in Valencia.

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About one year ago, musician Lisa Jordan was deaf. Three weeks ago, she gracefully lifted her flute to her lips and let her fingers fly.

In a hallway at Advanced Bionics in Valencia, the single American manufacturer of a complete cochlear implant, Jordan executed each note with the same precision and skill it took to assemble her hearing.

A Maryland resident, Jordan had flown to Santa Clarita to meet the makers of her state-of-the-art hearing device, and standing with her back to a manufacturing lab, she began a concerto by Mozart.

Jordan wasn’t born deaf, but the college-educated musician rapidly lost her hearing within a three-year span. Because of her cochlear implant, she now enjoys nearly the same level of hearing she did before her loss.

Advanced Bionics has been headquartered in Santa Clarita since 1999 and is now in a large facility near where Newhall Ranch Road turns into Highway 126.

The company has been manufacturing cochlear implants in Santa Clarita since 2011, and it’s one of three firms in the world that manufacture the complete implant, said Cheryl Garma, spokesperson for Advanced Bionics.

 

From start to hearing

The building’s manufacturing and assembly floor is built in a loop with large glass panes, offering a look into daily operations at the company.

Jordan stood in the hallway, her back facing a wall of windows that looked into the Electrode Assembly Clean Room, a portion of the manufacturing laboratory.

Cochlear implants are the only medical technology able to functionally restore one of the five senses, according to the company’s website. Unlike hearing aids, which amplify sound, cochlear implants are electronic devices that bypass the damaged part of an inner ear so a person can best hear.

The device has two major parts: the external sound processor and microphone, which captures sound and converts it to digital information; and the internal implant, which converts digital into electrical information that can be understood by the brain.

Advanced Bionics purchases the raw materials but assembles the device entirely on site.

From one end of the hallway to the other, the windows reveal each person building a tiny piece of the implant, starting with the internal pieces and moving toward the external pieces.

“Sometimes people ask, ‘Where are the robots,” Garma said. “There are no robots.”

Outside, a green and red flashing light guards the entrance of the Clean Room lab, monitoring the airflow and letting employees know when they can enter. Inside, the floors are grounded to keep electricity from affecting the device, Garma said.

To enter, employees suit up from head to toe in a white jumpsuit, gloves and protective foot- and headwear.

“They’re suited from boot to glove,” Garma said.

Moving along to the external manufacturing, visitors can see employees with a different look — casual, comfortable clothes — as they work in the Externals Manufacturing without the same sterilization controls.

Each piece of the implant is assembled by hand, with painstaking care. Two shifts of about 150 people each work meticulously assembling each piece of the device, Garma said.

Together, the two shifts produce about 800 implants a month to be shipped out to recipients, said Jim Robinson, vice president of operations for Advanced Bionics.

After the device is assembled, it is sent out for sterilization before it returns to Advanced Bionics for final quality-control testing, Garma said.

Once the device is finished, it is shipped out to one of almost 60 countries around the world that are approved for sale, Robinson said. About 25 to 30 percent of the implants find a home in the U.S.

Also at Advanced Bionics in Santa Clarita, employees teach surgeons how to implant the device in a surgical lab, covering the process from manufacturing to implantation.

 

Focus on patient feedback

In the hallway, Jordan continued playing the flute with her back to the Clean Room windows, her front to Advanced Bionic’s wall of patents.

The whole Advanced Bionics team is able to contribute to this wall, all working together and providing feedback to improve the product. Audiologists, manufacturers and even recipients can contribute ideas that lead to a patent — with their names on it, said Lauren Nadler, a production development audiologist.

Patents cover the wall, all naming an improvement or advancement on the device, making the product nearly as personalized as its wearer.

Part of the success of the device depends on Advanced Bionics’ focus on patient feedback. Visits like Jordan’s are not uncommon through the Connect to Patient program, and audiologists on site spend a couple hundred days a year working with patients to adjust implanted devices, Nadler said.

“Meeting patients is a huge part of the culture at Advanced Bionics,” Nadler said.

Everyone works constantly to improve the performance of the device. Employees are always trying to advance the nature of the product with smaller sizes, more features and patient feedback, Nadler said.

“You go in there, and you’re nervous because you have all these high hopes and all these expectations,” Jordan said. “But I’ve been very happily surprised.”

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