Medical Device Daily

Smaller is better when it comes to implanted medical devices. Cochlear (Centennial, Colorado) has just reported FDA approval of its smallest, most water resistant sound processor, the Nucleus 5 System for adults and children with severe-to-profound hearing loss.

The new cochlear implant builds on the company's previous devices which are able to restore hearing in deaf children and offers adults and children a cleaner sound in noisy environments as well as new options for phone use.

"I just saw a surgery of one of the first done in the U.S. since we launched late last week," Christine Menapace, VP of Clinical, Training & Education for Cochlear, told Medical Device Daily. "Most of the time, with cochlear implants, you can see a bump behind the ear. This design was made to naturally fit into an individual's surgical space into the cochlea. It was implanted into a 22-month-old child and you can't see the implant under the skin. Being a little bit smaller made a big difference."

The Nucleus 5 System is the fifth generation implant and an eighth generation sound processer that the company has produced since it first launched a Nucleus system which was FDA approved in 1998.

"It's 30% thinner than any other cochlear implant on the market and 40% thinner than our previous generation of implants," said Teresa Adkins, VP of marketing.

Although 36 million American adults report some degree of hearing loss, only one out of five people who could benefit from a hearing aid actually wears one, according to the National Institute on Deafness and Other Communication Disorders (NIDCD; Baltimore, Maryland). Most people with hearing loss prefer a device that's not visible, but cochlear implants are reserved for people with profound hearing loss or total deafness.

While the newer version is smaller, it retains the 22 electrode arrays and "A very unique curved electrode array that allows for more focused listening," Adkins said.

Menapace said the company has focused a great deal of energy developing new input processing strategies to clean up and modify the signal for clearer sound.

"The outcomes we're seeing with this population in very difficult test environments, like at a noisy a cocktail party, are that they are doing better than any group I've ever seen."

Cochlear is currently designing large-scale studies to provide data that will back up its claims.

The new version cochlear implant, Nucleus 5, includes SmartSound 2 technology with a new Set It and Go program for everyday listening and AutoPhone.

Adkins explained that the AutoPhone technology addition automatically recognizes a phones system in a car so that the person need not push any buttons. "There's plenty of room on ear to wear a Bluetooth and that's boosted by the system," she said.

Set It and Go program is provided if a person doesn't want to make adjustments in volume or sensitivity as their environment changes. But that option is there when needed for use, with a remote device that looks like a small iPod.

"It's useful for parents to monitor their child's hearing to make sure the system is working well," Menapace said. "You can see that it's working appropriately, especially in a young baby. You want to be assured that they're hearing you."

Remote assistance is another feature that allows for adjustments from home. In the past, if any modifications were needed to the system, a cochlear implant wearer would have to visit an audiologist. Many changes can now be made at home via the remote feature.

One of the issues many people have with cochlear implants is poor pitch, which affects how a person listens to music and for people who speak tonal languages such as Cantonese and Mandarin because they contain tones that equate meaning. But Menapace said that Nucleus 5's 22 electrodes access 161 intermediate pitches, allowing for more precise hearing.

"Hearing scientists all over the world are trying to determine how to make more electrodes fit in a very small space," she said. "The cochlea is the size of a pea. Adding more electrodes means having the technology to allow us to do that. Scientists are working on thin film technology which will take away the bulk presented by use of silicone and titanium. We're all hoping and waiting for that to advance."

She added that Cochlear is currently working to advance that technology to allow for more electrodes and even better hearing results.

Other companies in the cochlear implant space include:

• Advanced Bionics (Sylmar, California), which received FDA approval to market the Clarion Multi-Strategy Cochlear Implant in 1997.

• Med-El (Research Triangle Park, North Carolina), which makes the FDA-approved Combi 40+ Cochlear Implant System.

• Symphonix Devices (San Jose, California), which makes the Vibrant Soundbridge, FDA approved in 2000. At the time, the agency called it the first implantable hearing device approved in the U.S. to treat moderate to severe sensorineural hearing loss the result of hair cells, or nerves in the inner ear, being damaged. This type of hearing loss affects the vast majority of people with hearing loss.

Lynn Yoffee, 770-361-4789;