Advanced Bionics Cochlear Implant System

Advanced Bionics, one of the world leaders in cochlear implant (CI) technology, is a U.S. based company founded in 1993. They marketed their first cochlear implant system in 1996, and the company was acquired by Sonova Holding AG, a world leader in hearing technology, in 2009. Sonova manufactures hearing aids under the Phonak and Unitron brands among others, and owns numerous retail companies such as Connect Hearing.

As the company notes, the Sonova ownership allows for collaboration between their cochlear implant and hearing aid divisions, supporting technology sharing and streamlining advancements for both companies. This is especially useful for patients who use both a cochlear implant and a hearing aid.

Understanding the basics of cochlear implants

Cochlear implants have traditionally been reserved only for people with profound hearing loss, but increasingly the technology is improving so it also helps people with severe and even moderate levels of hearing loss, if they cannot benefit from hearing aids. Let’s look a little more closely at CIs.

What is a cochlear implant?

A cochlear implant is a surgically implanted device that bypasses the normal hearing structures, specifically the outer and middle ear, and instead directly stimulates the inner ear (cochlea and hearing nerve).

Cochlear implants consist of several parts, including the internal implant which includes a head piece, receiver, and electrodes that are implanted into the cochlea. There is also an external speech processor and microphones that pick-up sound, digitally encode them, and then transmit the signals to the internal implant. The head piece connects magnetically through the skin to the internal implant.

Who can benefit from a cochlear implant?

Cochlear implants are intended for both children and adults with moderate to profound sensorineural hearing loss who are not receiving significant benefit from hearing aids. The hearing loss criteria will vary across manufacturers and by age, and even by insurance coverage. For example, the Centers for Medicare and Medicaid Services (CMS) have more conservative requirements than originally outlined by the FDA, and Medicaid coverage can vary by state.

Adults (age 18+ years) who exhibit moderate to profound sensorineural hearing loss and receive limited benefit from hearing aids may be a candidate, including those in their 80s and 90s. “Limited benefit” is often noted as a score of around 50% on word recognition tests in quiet.

The age requirement for children has been approved by the FDA starting as early as 9 months; however, it’s not uncommon for children to be implanted at an even younger age. The earliest possible safe implantation is recommended as this results in better speech, language, and overall auditory outcomes compared to waiting to implant after age 12 months. Children with severe to profound hearing losses may be considered for implantation if they are not seeing benefit from their hearing aids.

In general, if you or your child are struggling to hear with well-fit hearing aids, discuss your options with your hearing care provider (HCP). Please also keep in mind that a cochlear implant candidate will need to be cleared not only by an audiologist, but also medically for the cochlear implant. That is, the candidate’s overall health should be capable of undergoing surgery (usually outpatient) and the inner ear anatomy should be suitable for receiving an implant. Other considerations, especially with children, may also be considered including access to care and habilitation services.

Commonly used terms

When researching cochlear implants, you will likely come across a few terms, so let’s clarify those here.

Binaural: Simply meaning hearing from both ears and would indicate hearing devices on both ears (hearing aids and/or cochlear implants).

Bimodal: This means two different “modes” of hearing, such as a cochlear implant on one ear and a hearing aid on the other.

Bilateral: In regards to cochlear implants, this means having both ears implanted and wearing two processors.

Hybrid: Regarding cochlear implants, this refers to a speech processor that provides both acoustic and electrical stimulation to the same ear. That is, for CI recipients with residual low frequency hearing, the speech processor can provide both acoustic amplification in the low frequencies, and electrical stimulation via the electrode array for high-frequency information.

Advanced Bionics product milestones

AB has grown into the second-largest cochlear implant maker in the world largely due to its innovative devices. Here are some important milestones in the company’s evolution.

• 1993 - Company founded.
• 1996 - FDA approval of Clarion™ Cochlear Implant system for adults—the first multi-program speech processor.
• 2009 - Advanced Bionics is acquired by Sonova Holding AG.
• 2012 - FDA approval for cochlear implant manufacturing in Los Angeles.
• 2013 - Naida CI Q70™ sound processor introduced—first cochlear implant processor that allowed for real-time communication across ears to second processor.
• 2016 - Introduction of Naida bimodal hearing solution between Advanced Bionics and Phonak products.
• 2017 - Introduction of Naída Link CROS, the first wireless CROS system available for CI users.
• 2018 - Introduction of HiRes™ Ultra 3D cochlear implant which allowed for MRI compatibility without removal of internal magnet.
• 2020 - Introduction of Marvel CI products including Sky™ CI M, Naida CI M, and new fitting software allowing for bimodal fitting in one session.

Advanced Bionics technology

Advanced Bionics’ develops and manufactures FDA Class III medical devices, and its CI technology originated from pioneering research at the University of California, San Francisco (UCSF). AB also evolved from two successful companies that created new-generation pacemakers and microinfusion systems (tiny drug delivery pumps used in the treatment of diabetes).

Electrode Arrays

Advanced Bionics has continued to improve upon their electrode array and implant housing designs over the years. This includes improvements not only in the size and thickness of the internal devices but also in the electrode design and surgical approaches. They, along with other companies, have also improved upon their magnet design allowing for the patient to undergo MRI evaluation without the need for removal of the internal magnet.

Their HiFocus electrodes were developed to minimize cochlear structure damage during surgery, with the intent of preserving residual hearing. Multiple electrode arrays are available depending on the CI surgeon’s preference and your individual cochlea anatomy. Other CI manufacturers—including Cochlear and Med-El—also manufacture electrode arrays that are intended to minimize damage to the cochlea during the surgical insertion process.

The internal components of a CI are intended to last many years and allow for upgrades to the external components while still maintaining compatibility with the internal implant. For example, the new Advanced Bionics Naida CI M and the Sky CI M are compatible with the older CII implant which dates back to 2001. So, even if a recipient was implanted 21 years ago, they can still take advantage of the advancements made with the new Advanced Bionic processors.

The implants themselves are required to be sturdy and robust, capable of withstanding many years of use. In general, the failure rate for cochlear implants hovers around 1% across manufacturers with a slightly higher rate found with children.

There have been some exceptions for all 3 manufacturers including Advanced Bionics who, in February 2020, initiated a voluntary recall of their HiRes Ultra and Ultra 3D cochlear implant devices due to a reduction in performance in a small percentage of their recipients. For some, this meant the removal of the internal device and re-implantation with a newer CI.

Advanced Bionics warranties their internal devices for 10 years. For complete information on reliability rates for the company across multiple implants, you can reference the Advanced Bionics Spring 2022 Reliability report.

Sound Processors

Advanced Bionics has offered numerous sound processors since the company’s original Clarion processor in 1996. Advancements have occurred on many fronts, including reduced size and weight, water-proof wearing options, improved speech processing strategies, the introduction of rechargeable batteries, and wireless functionality.

They have also improved upon the head piece by making it smaller, slimmer, and lighter while still accommodating multiple magnet strengths. For example, the new Slim HP (Head Piece) is 24.5% thinner than the previous UHP (Universal Head Piece). It is also available in a waterproof option with the Slim HP AquaMic™ which is designed to be used with the M waterproof battery. A Slim HP Mic is also available and is intended for off-ear processor wearing.

The most current Advanced Bionics processors are the Naida CI M and the Sky CI M which were introduced in December 2020. The M refers to the Marvel platform that is also part of the Phonak hearing aid product portfolio.

The Naida CI M is intended for adult use while the Sky CI M is targeted specifically to pediatrics. However, some adults have chosen the Sky processor due to additional fun color choices. The technology between the 2 processors is very similar; other than additional color choices, the Sky processor adds more environmental classification settings that might be appropriate for a child.

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The Naida CI M and the Sky CI M are compatible with Phonak Naida Link™ M and Sky Link M hearing aids as part of a bimodal hearing solution. That is, the two types of hearing technology can work together to make listening less cumbersome for the wearer.

In the case of Naida CI M and Sky CI M paired with a compatible Phonak hearing aid, what this means is that audio can be streamed to both devices via Bluetooth wireless connectivity. It also means that the smartphone app can control both devices, the directional microphone modes are aligned, and any changes to the volume and/or the program mode will also occur in both devices.

It should be noted that Advanced Bionics does not offer an off-the-ear processor, while its competitors, Med-El and Cochlear, do. However, both the Sky CI M and the Naida CI M can be worn off the ear using accessories that allow for wearing the processor on the body and using a head piece with a built-in microphone (Slim HP Mic).

Sound Processing Technology

Although it’s true that a huge amount of the success of any cochlear implant relies on the electrode array and the processor, the digital sound processing technology inside the processor is where “the rubber meets the road” for programming the best sound for the user.

AutoSense OS™ 3.0 and AutoSense OS Sky 3.0

Borrowed from Phonak Marvel hearing aid technology, Advanced Bionics has introduced the AutoSense Operating System (OS) 3.0 in their newest sound processors. The operating system’s purpose is to automatically align multiple sound processing strategies across numerous listening environments. The intent is the same whether it’s a cochlear implant or a hearing aid: to minimize manual adjustments on the part of the wearer and increase hearing performance while ensuring listening comfort.

The operating system was designed with artificial intelligence trained with machine learning methods to classify a wide range of acoustic scenes. It can analyze the listening environment every 0.4 seconds to determine a match to 7 pre-defined sound classes. A total of 3 of the classes are exclusive, meaning they cannot be blended with other classified environments, and these include speech in loud noise, music, and speech in the car. The 4 other sound classifications—comfort in echo, comfort in noise, speech in noise and calm situation—can be determined on their own or blended with other classified environments.

These stand-alone classifications or combinations allow for classifying 200 possible settings. AutoSense 3.0 can also classify a streamed signal as either speech or music, again automatically aligning the processor features with the desired effect of providing the best possible listening parameters.

AutoSense OS Sky 3.0 is implemented into the pediatric Sky CI M, adding more environmental classification scenes that might be appropriate for children. For example, it can identify environments such as classrooms which are often noisy and may have substantial echo. A playground classification is also added.

What this means for the recipient is that there should be fewer manual adjustments to the processor, including program and volume changes. As an example, for a bimodal patient in very loud noise, the processor may decide to implement directionality in both the speech processor and the hearing aid while also engaging noise reduction strategies.

This is all done automatically without the recipient having to think about it. The hope is that they can keep the processor in the AutoSense 3.0 program most of the day, regardless of the listening environment, and rarely need to change listening programs or even volume.

T-Mic™

A unique feature to Advanced Bionics, the T-mic is an optional accessory that places the microphone at the opening of the ear canal and also incorporates a telephone coil (telecoil / t-coil). T-Mic is designed to take advantage of the natural sound gathering capabilities of our external ear, as well as shield the microphone from wind noise.

Generally, CI processors have two mics on the processor itself which are worn Behind-the-Ear (BTE), on the head, or on the body. Obviously, these other placements do not take advantage of the natural capabilities of the ear and can be more prone to wind noise, as well as other noise in the environment. At least one study showed a 44% increase in sentence understanding in noise compared to a competitor’s processor with a BTE microphone placement.

The T-mic placement at the entrance of the ear canal also lends itself to listening with headphones and some earbuds, as well as phones without the use of Bluetooth. When you use the phone, you can hold it up to your ear just like anybody else. The imbedded telecoil will also pick up sound from telecoil-compatible phones or from looped rooms like those found in some theaters or houses of worship.

Advanced Bionics notes that the T-Mic has been improved with the release of the new processors in that it now incorporates an additional Kevlar coating around the T-Mic wire to help improve durability. The curvature of the wires has also changed with the intent of improving ear retention. The T-Mic is available in 3 different sizes, depending on your ear and the size of your battery.

Again, the T-Mic is an optional accessory for the processors, as the Naida CI M and Sky CI M come standard with 2 microphones on the processor. Another option is to have a microphone imbedded within the head piece when off-the-ear options are required. So, multiple wearing choices are available, although a head-level processor is not available.

Microphone Modes

There are several ways the microphones on the processor can be utilized:

• Real Ear Sound (RES): The Naida CI M and Sky CI M can utilize multiple microphone modes beyond the T-Mic. The processors can use the incorporated microphones or a microphone integrated in the Slim HP (head piece). When a microphone other than the T-Mic is in use, the processor will automatically employ a feature called Real Ear Sound (RES). This feature attempts to mimic the natural directionality of the ear and will mildly attenuate sounds from behind the listener.
• UltraZoom: Is a directionality setting that attenuates noise from the side and back of the listener with the intent of improving speech understanding in noise.
• UltraZoom + SNR Boost: As the name implies, this is the UltraZoom directional setting in addition to the activation of noise reduction based upon the location of the noise.
• StereoZoom: This directional microphone setting dampens noise from the side or rear of the listener and is aligned for bilateral or bimodal recipients.

Processing Modes

Similarly, there are several algorithms and digital strategies the processor can employ to improve listening clarity and comfort.

• Noise Block. A noise reduction feature that is available only to recipients who utilize the acoustic earhook.
• WindBlock. A noise reduction feature that helps reduce the bothersome sound of wind noise. Most algorithms of this type minimize low frequency sound where the intensity of wind noise is found.
• SoundRelax. Noise reduction that applies to impact sounds such as sudden sounds or sounds like silverware on a plate or glasses clinking. Again, the intent is to help improve overall wearing comfort.
• EchoBlock. As its name implies, this minimizes the annoyance of echoes in the listening environment. May be helpful in reverberant environments such as classrooms.

Wireless connectivity

Phonak has been a leader in hearing aid wireless technology for several years and that experience and technology are now part of the Advanced Bionics portfolio. The Naida CI M and Sky CI M offer Bluetooth compatibility with Android™ and Apple® devices and allow for hands-free calls and streaming of audio. This is made capable utilizing the Sonova Wireless One Digital (SWORD) chip and Bluetooth 4.2 certified compatibility.

SWORD supports the proprietary 2.4 GHz radio signal, while the devices also incorporate Bluetooth Low Energy (LE) and Bluetooth Classic. This allows for connection to a generous number of devices, including smart phones, laptops, tablets, etc. Importantly, it also allows for binaural listening and hands-free calling with compatible devices.

Additionally, SWORD supports connectivity to accessories such as Roger™ remote microphones and a TV connector among others (see below). Naida CI M and Sky CI M can pair to up to 11 devices, but can be connected to only one at a time. Which devices work with the Advanced Bionics processors can change frequently so please check the AB Bluetooth and Mobile App Compatibility page for up-to-date compatibility information.

Naida CI M and Sky CI M also boast Binaural Voice Stream Technology™ which allows for streaming of audio between 2 compatible hearing devices—this can be 2 speech processors, 2 hearing aids, or a hearing aid worn with a cochlear implant. It also allows for synchronizing of sound processing features, such as allowing the microphones on two devices to work together to focus on speech in front of the listener. In practical terms, it also synchronizes program and volume changes across devices.

AB Remote App

Advanced Bionics offers their AB Remote app both for Android and Apple phones. The app provides control and connectivity to the Naida CI M and Sky CI M sound processors. It is also compatible with Phonak Naida Link M and Sky Link M hearing instruments allowing you to control both your CI and your hearing aid with one remote (in case of bimodal fitting) or both CIs (in case of bilateral implantation).

AB Remote allows for the changing of your volume and program settings, and provides data such as average wearing time per day. However, it does not display the type of listening environments you were in, such as speech in noise or speech in quiet.  Knowing how much time you spend in different listening environments can be useful in meeting therapy goals set by your audiologist and implant team.

The app also displays your battery life and has a Device Check page to show you the status of your battery, microphone, and whether or not the head piece is connected to the internal implant. The Device Check can also let you know if a component of the processor is not responding. In the example below, the T-Mic is not being recognized indicating that there may be a problem (shown by the question mark and grey shading).  The Device Check feature is a great way for the recipient and/or a caregiver to check the status of the device.

Keep in mind that an optional “listening check module” is available from Advanced Bionics that allows a hearing care provider, a hearing parent, or caregiver the ability to listen to and validate the integrity of the input sources of the implant. That is, they can listen to what the processor microphones are picking up, and what an FM or streamed signal sounds like. If there is an issue, they can take steps to replace or repair the damaged components.

Within programs like the TV Connector program or a streaming program, the AB Remote gives you the ability to adjust the balance between the processor’s microphone input and the streamed signal. This way, you have control over which sound you would like to have more priority, for example, the TV or the surrounding environment (eg, via AutoSense 3.0). It’s essentially audio mixing at your fingertips.

This AB Remote app, like many hearing aid apps and CI implant company apps, has a less-than-spectacular ratings. It’s average rating (across Android and Apple users) is approximately 3.3, with the primary complaints centering on connectivity issues and the processors not remaining at the previously set volume level.

A feature found with other CI manufacturers (both Cochlear and Med-El) but lacking in the AB Remote app is the ability to “Find My Processor.” This feature will indicate on a map the last location the processor was paired to the app. For anyone who’s ever lost their hearing aids and/or glasses this is can be a very handy feature.

Finally, the AB Remote does not allow for any remote care functionality via the app. This feature is available in the Cochlear Ltd. app when activated by the clinician, and can be beneficial for simple adjustments without the need for an in-office appointment.

Battery Options

Multiple battery options are available for the Naida CI M and Sky CI M and which are chosen will depend on your cochlear implant programming (mapping) and lifestyle requirements among other variables. Three rechargeable battery sizes are available including small, medium, and large.

Curved battery options are also available to match the contour of the ear, as well as a standard (non-curved) medium battery. A medium zinc air pack is another option and may be chosen for those who want a non-rechargeable battery. This is helpful during power outages or when you are in areas without consistent access to power.

As you might expect, the larger batteries will provide longer battery life for many recipients. However, this will depend on your implant programming. You can expect approximately 9 hours of use with the small battery and 16 hours or more of use with the medium, large, and zinc air packs. A charging station is standard and will charge up to 3 batteries at a time.

Accessories

There are at least 4 accessories that Advanced Bionics CI users find helpful:

Roger Microphones

Phonak’s Roger Microphones offer the ability to further improve speech understanding in noise by placing the microphone at the source. This means the signal (speech) you want to hear is amplified more than surrounding background noise. Depending on your listening needs, several different microphone styles are available from a pen mic to table mic to educational microphones for use in the classroom.

The RogerDirect integrated receiver is needed to stream sound from the Roger mics directly to the Naida CI M, Sky CI M, or Phonak Link M hearing aids without the need for an additional external receiver. This is beneficial not only in terms of cosmetics but also for ease of use.

TV Connector

The TV connector is compatible with most TVs and is intended to be a plug-and-play solution for better TV listening.  It allows for the TV output to be streamed directly to your CI and/or Phonak Link M hearing aid. This means that noise in the room is kept to a minimum while the TV signal takes priority. It also means you can control the volume of the TV for your preferences without changing the overall TV volume and you can mix the signals via the AB Remote.

Phonak RemoteControl

For those who cannot or do not wish to utilize a smartphone application, a simple and streamline remote control is available. The RemoteControl will allow the user to change program and volume with the touch of a button. 

Hearing Tracker Audiologist Matthew Allsop, who runs a private practice near London, gives his top-5 favorite Phonak accessories which are also applicable to Advanced Bionic CIs that use the Marvel platform, including Naida Link M and Sky Link M. Closed captions are available on this video. If you are using a mobile phone, please enable captions clicking on the gear icon.

Phonak PartnerMic™

This is a simple and easy to use remote microphone intended to be worn on the lapel. It’s useful in noisy situations such as restaurants. The microphone is worn on the lapel of the person you are speaking with, and their voice is transmitted directly to your Naida CI M and/or Phonak Link M hearing aids.

Pros

Cons

Summary

AB is an industry leader in developing reliable, high quality, and sophisticated cochlear implants and is one of three manufacturers available to recipients in the U.S. Keep in mind that there are many factors to consider when choosing any hearing device, but especially a cochlear implant. For example, you should consider your lifestyle and wearing preferences, as well as any physical limitations.

We highly recommend that you reach out to each manufacturer to compare information and ask to be connected with a current CI recipient who is similar to you and your experiences. We also encourage you to ask questions of your audiologist and surgeon so you understand the key differences between each device, as well as realistic expectations given your hearing history. 

There are also numerous support groups on social media and online information sites such as Cochlear Implant HELP that can assist you in your information searches. 

Cochlear implants have improved significantly since their early days and offer hope to many people who aren’t getting the appropriate benefit from hearing aids. If you’re wondering if a CI might be right for you, ask the question of your HCP and seek appropriate referrals if needed.