EC: Med-EL Cochlear Implants
Med-EL Cochlear Implant System
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Med-EL System Components
Synchrony Cochlear Implant
Med-EL Electrodes
Sonnet Audio Processor (ear level)
Rondo Single-Unit Audio Processor
WaterWear Accessory
MRI Safety and MedEL cochlear implants
Treatment of Single-Sided Deafness & Asymmetric Hearing Loss
The Med-EL cochlear implant system is called the SYNCHRONY System and combines a number of powerful technologies. Med-EL has introduced the concept of "Triformance" in an attempt to provide patients with a natural sense of hearing given our available technology.
Triformance combines the design concepts of:
- Complete cochlear coverage - full-length, long electrodes to cover the entire length of the cochlea
- FineHearing - a sound coding strategy that delivers the deepest bass tones available
- Structure preservation - electrodes designed to be soft, gentle, and flexible to protect remaining, delicate cochlear structures
Components include:
- Synchrony Cochlear Implant ( surgically implanted electronics)
- Sonnet Audio Processor (ear level processor that magnetically links with the Synchrony CI)
- Optional Rondo Single-Unit Processor (processor that magnetically links with the Synchrony CI)
- Maestro System Software (current version 6.0) & MAX Programming Interface for programming the Synchrony CI
- Bilateral, single unit design
- Switch-less design that works with a computer interface
- Maestro will permit programming the Synchrony with 4 specific maps for different listening environments
- Data-logging for Sonnet processor that includes usage time and volume range
- Supports all currently available Med-EL CI's and audio processors
SYNCHRONY Cochlear Implant
The Synchrony CI by Med-EL is available in multiple electrode configurations.
Features include:
- Conditionally MRI safe at 1.5 and 3.0 Tesla strength without the need for magnet removal
- Rotatable, self-aligning magnet that reduces torque for increased patient comfort during MRI scans
- CI design that permits magnet removal, if necessary, to minimize MRI image distortion (requires special instruments for removal)
- Magnet is removed from the medial side of the implant making dislocation due to trauma almost impossible
- Designed with Synchrony PINs consisting of titanium fixation pins to help secure the placement of the implant to enhance stability and help prevent inadvertent implant migration.
- Smallest titanium CI available, especially nice for pediatric patients
Med-EL Electrodes
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Med-EL electrode array within cochlea. Notice unique wave shaped wire design. |
Position of electrodes within the cochlea at frequency-specific areas. Notice electrode tip located at the apex of the cochlea. |
Med-EL cochlear implant design provides a comprehensive electrode portfolio to permit customization of electrode length and shape to accommodate differences in individual cochlear anatomy:
- Two electrode designs: CLASSIC Series and FLEX Series
- Featuring atraumatic electrodes in various lengths and shapes
- FLEX series electrodes are engineered to help ensure cochlear integrity and atraumatic insertions
- Unique FLEX-Tip technology featuring:
- Single contacts at the leading end
- Full length tapered tip design
- Ultra-flexible, wave-shaped wires
- Tapered tip for increased mechanical flexibility
CLASSIC Series Electrodes
FLEX Series Electrodes
Sonnet Audio Processor (ear level processor)
The Sonnet Audio Processor minimizes the need to manually adjust setting or change programs.
Features include:
- Water-resistant, splash-proof design (IP54 standard) to help protect against rain, sweat and other moisture
- Tamper proof design
- Automatic Sound Management with Automatic Volume Control that actively and intelligently adapts to changing listening environments
- Dual loop automatic gain control to instantly dampen sudden, loud sounds without muffling softer sounds
- Integrated data-logging to provide detailed information concerning usage behavior
- Up to 60 hours of battery life without a trade-off in processor performance
- Sonnet uses 2 disposable, easy-to-replace, readily available, zinc-air batteries
- No recharging
- Fully compatible with the last 20 years of previous Med-EL cochlear implants
- Weight of 10.6 grams with batteries for all-day wearing comfort
- 2.4 GHz wireless connectivity and flexible direct-audio input options
- Sonnet is able to connect to external audio sources
- Integrated telecoil to connect to a wide variety of audio-streaming systems
- FM battery cover and 3.5mm accessory cable enables direct audio input from any electronic device with a headphone jack
- Ready for upgrades
- Multiple color options (6 base colors, 4 cable colors, 6 coil colors)
- Battery and microphone covers are available in 15 colors
Rondo Single-Unit Processor
The Med-EL Rondo sound processor is the world's first and only CI single-unit processor and does not require any hook placement around the external ear.
Features include:
- Control unit, battery pack, and coil integrated into an all-in-one, compact, single unit that is worn "off-the-ear"
- NO cables, NO switches
- Rondo disappears under longer hair enabling discreet wearing
- Especially comfortable for individuals who regularly wear eye glasses or sun glasses
- Up to 75 hours of use with a set of three 675 high-power, zinc-air batteries (readily available)
- Rechargeable 675 batteries may be used providing flexible power options
- Fully compatible with the last 20 years of previous Med-EL cochlear implants
- Available in 4 colors
- An inexpensive, reusable, waterproof WaterWear accessory is available for the Rondo
- Sleek fitted cover for the Rondo
- Designed for optimal microphone performance
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Rondo Single-Unit Sound Processor |
Rondo Controls |
Rondo Dimensions |
WaterWear Fully Waterproof Accessory for Sonnet, Opus2 & Rondo Sound Processors
- Fully waterproof , sleek, skin-tight cover for Sonnet and Opus2 sound processors
- Designed for optimal microphone performance in or near water
- Each WaterWear pack includes 3 covers (for 3 uses each) and 9 adhesive strips (for one use each)
- Each cover may be used up to 3 times & for up to 10 hours during each use
- Withstand water depths of up to 4 meters (13 feet for 2 hours)
- Function effectively in chlorinated pools, fresh water & saltwater environments
- Protection from common cosmetics & soap and is dustproof
- Has highest IP rating for water protection
- Used with rechargeable, alkaline or silver oxide batteries (not to be used with zinc air batteries)
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WaterWear skin-tight cover for Sonnet, Opus2 and Rondo |
MRI Safety and MedEL Cochlear Implants (the following information is courtesy of MedEL)
"Whether it’s a slip on an icy sidewalk or a routine diagnostic scan, it’s safe to say we’ll all need an MRI someday. In fact, in the Unites States alone, more than 100,000 MRI scans are performed daily.
For cochlear implant recipients, MRI safety is especially important, because every cochlear implant has an internal magnet. However, not every implant magnet is created equal.
Both Advanced Bionics™ and Cochlear™ implants use a basic axial magnet held in a soft silastic pocket. The powerful static magnet of the MRI scanner will create a concentrated torque force on the implant magnet as it attempts to align to the static magnetic field.
This thin silastic pocket cannot effectively resist the powerful magnetic torque of an MRI scanner, so a rigid splint and tight head bandage are required for any 1.5 Tesla scan with these implants. Even with these precautions, complications such as pain, discomfort, or magnet dislocation are still common. The magnet must also be surgically removed for every 3.0 Tesla MRI scan—including knee scans and other routine procedures. And even after magnet removal, a significant image artifact can persist.
In contrast, the SYNCHRONY Cochlear Implant has a rotatable, self-aligning magnet that nearly eliminates magnetic torque. SYNCHRONY enables comfortable 1.5 and 3.0 Tesla MRIs without any need for a head bandage or surgical magnet removal. This includes head and neck imaging—contralateral brain structures are generally not affected by an image artifact with SYNCHRONY.
In rare cases (<1%), clear imaging is needed of the area of the brain directly surrounding the implant. That’s why the SYNCHRONY magnet can be optionally removed to minimize image artifact. The magnet is held in a secure titanium housing that can be quickly and easily removed with a precise process."
A straightforward procedure for removing a SYNCHRONY magnet enables complete control. "This allows the magnet to be removed and replaced without damaging the implant."
MedEL engineers have developed magnet removal and magnet reinsertion instruments for precise magnet removal and replacement. There is some risk of developing infection or complications if magnet removal and replacement are performed.
"After magnet removal, there’s minimal artifact, which enables useful diagnostic imaging with good image quality of brain structures ipsilateral to the implant."
MedEL Synchrony & Synchrony 2 Cochlear Implants Approved by the FDA for Treatment of Single-Sided Deafness & Asymmetric Hearing Loss
On July 22, 2019, MedEL announced that the U.S. FDA has approved the MedEL Synchrony & Synchrony 2 cochlear implants for treating single-sided deafness and asymmetric hearing loss in both adults and children. FDA approval was based on a research study performed at the University of North Carolina-Chapel Hill.
It is estimated that 4.9 million American adults have single-sided deafness. Cochlear implants should help these patients:
- Hear better in noisy environments
- Improve social and communication interactions
- Enhance work performance in adults
- Help with speech and language development in children
- Improve sound localization and spatial hearing abilities
Indications:
- Age 5 yrs or older
- Single-sided deafness with profound sensorineural hearing loss in one ear & normal or mild sensorineural hearing loss in the opposite ear
- Asymmetric sensorineural hearing loss with profound sensorineural hearing loss in one ear & mild to moderately severe hearing loss in the opposite ear, with a difference of at least 15 dB in pure tone average between ears
- Limited benefit from unilateral hearing aid amplification with 5% correct or less on consonant-nucleus-consonant (CNC) testing in quiet in the ear to be implanted alone
- For children, insufficient functional access to sound in the ear to be implanted as determined by aided speech perception test scores of 5% or less on developmentally appropriate monosyllabic word lists when tested in the ear to be implanted alone
- Functional auditory nerve
- Prior use of optimally fitted hearing aid, if appropriate
- At least one month of experience wearing a hearing aid, CROS hearing aid system, or other relevant device and not show any subjective benefit
- Limited or no benefit from acoustic amplification
- Ability to undergo general anesthesia
- Have a patent cochlea
- Adequate motivation and realistic expectations concerning the possibility for hearing improvement
To read a summary article about the topic, please click here.
To learn more about Med-EL, visit their website at www.medel.com.
If you have questions about cochlear implantation at The Ear Center of Greensboro, P.A., please contact our Audiology Department at 336-273-9932 during normal business hours.
Last revised July 24, 2019