Cochlear Americas (Englewood, Colorado) is making some noise with the introduction of its newest cochlear implant system, the Nucleus Freedom. FDA-approved earlier this month and rolled out to clinicians last week at the 10th Symposium on Cochlear Implants in Children in Dallas, the Nucleus Freedom will begin shipping to clinics April 4.

"We've already seen quite a bit of interest, and we're getting lots of questions [from patients]," Sara Harms, vice president of marketing, told Medical Device Daily. "It's great to work on a product that has such a huge impact on people's lives."

Designed to mimic functions of the human ear and fit seamlessly into a user's lifestyle, the Nucleus Freedom provides severe-to-profoundly deaf children and adults with a listening experience more similar to natural hearing and, in effect, restoring one of the five senses.

"The isolation that derives from deafness is really a life-changing thing, as is the restoration of hearing when someone has been without it," explained Chris van den Honert, Cochlear Americas vice president of research.

The company's fourth generation cochlear implant system includes various new features and industry-first technologies. The device consists of an internal component and an external speech processor. CustomSound software, used by clinicians to program the device for each recipient, rounds out the offering.

"One of key elements of the new software is that it's made the fitting procedure much, much faster and simpler," said Peter Gibson, product strategy group manager at worldwide headquarters Cochlear Ltd. (Lane Cove, Australia), which launched the world's first cochlear implant system more than 20 years ago.

The Nucleus Freedom features an entirely new speech processor, Gibson said, and is the only cochlear implant system to offer a speech processor with SmartSound digital technology. SmartSound, which is designed to provide better hearing performance in a variety of everyday listening situations, is a combination of three sound technologies.

SmartSound Beam is a two-microphone system designed to soften distracting background sounds, allowing for focused listening in crowds and noisy environments, a first of its kind in the industry.

"That's a very important feature of this system because people with hearing impairment do reasonably well in a quiet environment, it's when they get into a noisy environment that it really gets very difficult to hear," van den Honert told MDD. "What SmartSound Beam does is to allow the external speech processor to [filter out noises] on their behalf."

Another element, SmartSound ADRO, for Adaptive Dynamic Range Optimization, automatically adjusts sound levels to deliver a balance of clarity and comfort in dynamic environments.

This function can take a consistent sound level – Gibson used the example of the constant hum of an air conditioner – and "take it down" while keeping "the frequency in all of the other bands there for you."

In contrast to SmartSound Beam and SmartSound ADRO, which are designed to help the user hear more clearly in dynamic environments, is SmartSound Whisper, which enhances softer sounds.

Gibson used the examples of a library, a church or a forest as places where SmartSound Whisper would "magnify the very softest sounds" and allow recipients to understand them more clearly.

Users can select from four settings on the earpiece of their Nucleus Freedom speech processor to correspond to different environments.

The Nucleus Freedom implant features the Contour Advance electrode, a self-curling array that allows the electrodes to be placed close to the hearing nerve for targeted stimulation and increased power efficiency, while applying minimal pressure on the cochlear structures. The Contour Advance electrode array is designed to protect cochlear structures during surgery, which the company said is essential in preserving residual hearing. The implant's small size makes it ideal for toddlers and children, and enables both shorter surgery and faster recovery time.

The implant works by measuring neural response, which van den Honert compared to how an EEG (electroencephalogram) would measure brain waves.

"You can actually detect the activity of the auditory nerve. It manifests itself as an electrical event," he explained.

Gibson added: "It's a much better system for doing that detection. Especially for people like infants who can't report back whether they're hearing or how well they're hearing, you've got the ability to utilize the biological system to set up a confident program."

The Nucleus Freedom operates on commercially available batteries for up to five days, which Harms said is a "great advantage."

The Nucleus Freedom implant also is stronger, "more impact-resistant than our previous designs, which have led the industry in reliability for years," van den Honert said. "It has to be able to absorb reasonable impacts and continue to function to be a practical device."

Another new feature that enhances the durability of the device – and the convenience of the user – is its resistance to water. The Nucleus Freedom is the only cochlear implant system with a "splash-proof" speech processor, Gibson said. In contrast to other cochlear implants, the water resistance of the Nucleus Freedom means that recipients don't have to worry if they get caught in the rain, work up a sweat or experience other aspects of daily living.

"Those sorts of instances are not nearly as significant or dramatic [than with other models] and they don't need to take the processor off," Gibson said. Its water resistance "increases the reliability of the implant in the system and also increases the reliability of the speech processor substantially."

However, he qualified, the device is not waterproof, and like other cochlear implants should be removed before swimming or bathing.

Users wear the device all day, removing it before bedtime, Harms explained. The external speech processor – worn behind the ear – can be easily attached and removed, while the surgically-implanted component is designed to last a lifetime.

The Nucleus Freedom implant surgery is completed under general anesthesia and may be performed on an inpatient or outpatient basis. The implantation and subsequent programming of the device is "a team-oriented process, right from the start," Gibson said, involving an ear-nose-throat surgeon in conjunction with a cochlear implant audiologist and a speech pathologist.

The FDA approval clears the device for use in severe-to-profoundly-deaf patients as young as two years of age. Children between the ages of 12 months and two years must have a profound hearing loss.

The company has designed the speech processor as a modular system. While the current clearance is for the behind-the-ear model, a body-worn alternative is pending FDA approval.

"This gives us opportunities in the future to customize additional componentry that is designed specifically for many different applications," Gibson said.

The company also is seeking FDA approval to make the Nucleus Freedom speech processor compatible with prior devices.

Harms said the company will be conducting regional training programs for professionals in April and May, and the first patients implanted with the Nucleus Freedom in April will have their initial hook-ups by the end of May.

An ongoing clinical study at 15 centers will give the company more information and feedback on the implant's new features.

"People who have been wearing these devices in trials have reported that they are indeed more comfortable than previous devices," Gibson told MDD. "These systems are a real leap ahead."