Website nics.com. North America: E. Peakview Ave. Centennial, CO 80111
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1 COCHLEAR IMPLANT BRAND COMPANY INFORMATION COCHLEAR (NUCLEUS) Current Model: Nucleus N5 CI512 (Released September 2009) ADVANCED BIONICS Current Model HiResolution 90k Bionic Ear (Released July 2003) MED- EL Current Model MAESTRO System - includes PULSARci100 (Released August 2005) and SONATAti100 (Released June 2007) implants Website nics.com Location of Headquarters Year Started in Business Main Headquarters: 14 Mars Road PO Box 629 Lane Cove NSW 2066 AUSTRALIA North America: E. Peakview Ave. Centennial, CO European Region (including Saudia Arabia and the Middle East) Cochlear AG Peter Merian- Weg Basel Switzerland See icas.com/support/405.asp for complete list Main Headquarters: Advanced Bionics, LLC San Fernando Road Sylmar, CA USA Europe: 76 rue de Battenheim Rixheim, France Asia Pacific: Suite 4203, 42/F, Tower One Lippo Centre, 89 Queensway Hong Kong Latin America: Mann Biomedical Park Rye Canyon Loop Valencia, CA 91355, USA See nics.com/about_us/locati ons/index.cfm?langid=1 for complete list Main Headquarters: Fürstenweg 77a A Innsbruck Austria USA: 2511 Old Cornwallis Rd. Suite 100 Durham, North Carolina See s/show2/index/id/294/tit el/med- EL+Offices+Worldwide for complete list PERFORMANCE Number of Electrodes 22 intracochlear electrodes +2 grounding grounding 24 contacts + 2 grounding Internal Implant Materials Titanium and silicone Titanium and silicone PULSAR: Ceramic and silicone SONATA: Titanium and
2 silicone Processing Strategies Hi- Ace (Freedom and N5) Ace (N24 and Freedom) HiRes Fidelity 120 sound processing ClearVoice (Not yet FDA approved in the US.) FSP (Fine Structure Processing) and HDCIS (High Definition Continuous Interleaved Sampling. FSP is not indicated for use in prelingual children. Stimulation type(s) and Rate Sequential stimulation 32,000 hertz HiRes- P w/ Fidelity 120 (paired), HiRes- S w/fidelity 120 (sequential) Sequential stimulation at a maximum rate of 50,704 pps. HiRes- P (paired), HiRes- S (sequential) CIS and MPS modes - Up to 83,000 Stimulation Pulses Per Second - Up to 120 Bands of Spectral Information Possible Number of Pitch Percepts Average aggregate # discriminable pitches across the entire array: ,36 When intensity was roved to eliminate loudness cues: 127 discriminable pitches across the entire array. 3 Based on the assumption that the number of pitch percepts on these three electrode pairs was representative of the entire array, the total potential number of pitch percepts for these individual subjects was estimated to range from 8 Scientific studies have demonstrated that FineHearing enables hearing implant recipients to detect small differences in pitch for example, between two neighboring piano notes. Fine Structure Processing allows better pitch
3 Speech Perception Scores 87%, Nucleus 5, CNC words at 60dBA 4 to 466, with an average of perception, especially in the low frequencies %, Harmony, CNC words at 60dBA 4 69%, AB Words at 70 db SPL 27 (Freedom Sound Processors Previous Generation) 96%, CUNY Sentences at 70 db SPL 27 (Freedom Sound Processors Previous Generation) 59%, AB Words at 70 db SPL 27 87%, CUNY Sentences at 70 db SPL 27 71%, AB Words at 70 db SPL 27 98%, CUNY Sentences at 70 db SPL 27 Hearing in Noise Music Appreciation Set it and Go program intelligently adjusts to fit listening environment in conjunction with Nucleus 5 SmartSound 2 technology. Noise designed for improved hearing in significant background noise Focus designed for more focused conversations in noise Music program designed to enhance music experience HiResolution is designed to preserve the broad spectrum of sounds to improve listening abilities in difficult situations. Automatic gain control HiResolution is designed to preserve the broad spectrum of sounds to enhance music appreciation. FineHearing provides benefits to users for hearing in noise. Automatic Sound Management adjusts the processor based on the listening environment of the user. This means that listeners do not typically have to make manual adjustments to their processor throughout the day. 15 FineHearing provides users with specific cues for the fine timing details of sounds, which are especially important for the enjoyment of music. 92% of MED- EL users report that music is pleasant to listen to, and 84% report listening to music every week if not every day. 17 Microphone Two microphones for better quality sound and direction - A front and rear microphone, both omni directional to capture sound from a both in front and in back of the user. Designed to capture sound from all around. T- mic available placing microphone at entrance to ear. T- mic provides added convenience when using telephones and consumer electronic products, improved hearing in noise, and enhanced directional hearing. 33 MED- EL s processors feature an omni- directional microphone, which captures sound from all directions.
4 Telemetry AutoNRT (Automated Neural Response Telemetry) enables your specialist to confirm the precise placement of the stimulation contacts by measuring your hearing nerve response 4. Neural Response Imaging (NRI) A feature enabled through the HiRes 90K electronics platform that measures the electrically evoked compound action potential (ECAP) of the hearing nerves. NRI is designed to optimize the implant fitting process and assist in programming young children. Impedance and Field Telemetry (IFT) provides an objective measure of implant function while Auditory Nerve Response Telemetry (ART ) measures the electrically evoked compound action potential (ECAP) generated by the auditory nerve. Electrode Arrays Available Contour Advance Electrode with self curling array Split electrode array for ossified cochleas HiFocus Electrode features 16 platinum- iridium contacts that focus stimulation on the hearing nerve fibers Standard electrode array Medium electrode array Compressed electrode array Split electrode array Flex soft electrode array (Not yet approved by the FDA.) Flex EAS electrode array (Not yet approved by the FDA.) Input Dynamic Range 5 (According to an audiologist, the higher IDR is set, the more background noise comes in.) RELIABILITY The Insertion Test Device, or ITD, facilitates testing for the presence of any cochlear obstruction. By using the ITD, surgeons can determine the need for an alternative electrode array prior to unpacking the implant. Up to 45 db Up to 80 db db Adaptive sound window moves within a 75 db IDR. 16
5 Reliability Cumulative failures (Company Reported) Freedom at 4 years out all failures: 0.64% 9 Nucleus 24 at 12 years out all failures: 2.6% 9 Nucleus 22 at 21 years out all failures: 7.4% 9 HiResolution 90K: 2.5 years out post recall: 0.8% years out. Supplier A: 1.9% 6 CII: 6 years out 3.2% Clarion after modification of ceramic casing: 8 years out 11.7% 6 Clarion: 10 years out 15.4% 6 Sonata at 2 years out: 0.33% (device issues only) % (device + medical, surgical & accident) 10 Pulsar at 4.75 years out: 0.21% (device issues only) % (device + medical, surgical & accident) 11 Reliability (Independent Objective Study 8 ) Reference from 2007: 169/8581 = 2% failure rate 123/1761 = 7% failure rate 179/1987 = 9% failure rate Relevant Reliability Information Cochlear manufactures all of its own parts and does not rely on an outside vendor. Reports on all of its devices, Nucleus 22 and beyond. Reports on hard and soft failures. AB reports on hard and soft failures. MED-EL reports on all devices, including both hard and "soft" failures, according to the relevant ISO standard and the international consensus committees recommendations. MED- EL also offers transparent information about the type of failure (device failure, surgical or medical complication, or accidentrelated failure) with that data available to be viewed by anyone on medel.com. Past Recalls with Year Recall Announced 1995: power supply inside the implanted part of the cochlear implant malfunctioned causing some devices to fail 2010: The internal implants were voluntarily recalled due to two instances where the internal device had to be explanted due to experienced malfunction. The recipients were experiencing severe pain, overly loud sounds and/or shocking sensations shortly after initial activation of their cochlear implant. 2009: Metal case surrounding internal magnet not welded
6 properly leading to decrease in magnet strength over time in some implants : As of 2006, 15% of implants failed due to elevated internal moisture, for which AB cited one of its two suppliers, supplier B, for a specific part that connects the sealed section of the implant with an electrode. 12 (Note: Failure rate for supplier A was only 1.4% 2.5 years out.) : Recall due to moisture trapped inside the titanium receiver- stimulator leading to failure 7 Processor Reliability PROCESSOR EASE OF USE Built on titanium foundation with new durable plastic. GORE- TEX microphone protection. Teflon coated titanium bayonet connectors : Recall due to positioner increasing risk of meningitis 14 Harmony BTE: Average monthly service rate = 1.5% 7 Platinum Series BWP: 0.9% 7 Auria BTE: 1.17% 6 Opus 2: Average monthly service rate = 0.54% Opus 1: 0.97% Processors (Most recent models only) Nucleus5 System CP810 Harmony BTE Platinum Series BWP Opus 2 BTE + various configurations for wearing processor Processor Photo
7 Processor Remote Control Yes (Bidirectional Communication between Processor and Wireless remote assistant) No Yes (Unidirectional Remote to processor only) Number of Programs Processor Can Hold 4 Harmony and Platinum Series: 3 4 Battery Type(s) Battery Life CP810: Standard Rechargeable Compact Rechargeable 2 HP 675 Disposable - Standard rechargeable: up to 31 hours - Compact rechargeable: up to 18 hours - Disposable zinc air batteries: Up to 60 hours 30 Rechargeable PowerCel TM PowerCel Slim: average = 14 hours PowerCel Plus: average = 24 hours 28 Options include DaCapo rechargeable ear-level battery, disposable batteries, or one AA rechargeable or disposable battery DaCapo average = hours Disposable batteries: 3-5 days 27 Low Battery Indicator Baby/Child Processor Options How Magnet Strength is Adjusted - Flashing Light on Processor (Can be deactivated) - Private tone in Processor - Audible tone from Wireless remote assistant - Visual display on Remote wireless assistant LiteWear option Snugfit (3 sizes) These can be chosen for any age and lifestyle (see icas.com/nucleus5/access ories_popup.html for photos) Different strength magnets can be screwed in or out to further tighten or loosen. Harmony: light flashes orange Platinum Series: light flashes and processor beeps Harmony: Off the ear power option reducing portion worn on ear Platinum Series body worn processor with microphone on headpiece You order a magnet and the order has to come from your audiologist as the audiologist will add or Status Light- The Status Light is a small LED integrated in the OPUS speech processors. It flashes different patterns for different errors or low battery. BabyBTE Children s Battery Pack Remote Battery Pack FM Extension Battery Pack for connecting assistive listening devices or FM systems at ear-level (see lish/30_products/01_mae STRO/opus2/02_wearing_ options.php for photos) Audiologist can add or remove magnetic disks from the headset.
8 COMPANY COMMITTMENT FM Connection Water Resistance Telephone Use Magnet strength can be easily adjusted by the parent or CI user without an audiologist appointment. This is convenient especially for girls whose hair thickness changes depending upon whether they wear their hair down or up in a ponytail. - Any FM system with Euro plug connection - Any FM accessible through T- coil IP44 (Protected against water spray from any direction) IP57** with Rechargeable battery AutoPhone technology in conjunction with built- in telecoil. Recipients can automatically connect to a variety of signal sources with no manual switching. Built- in telecoil is available on any listening program. remove magnetic disks from the headset. 23 iconnect provides cable- free connectivity to most commonly available FM receivers. Two- fold advanced water protection: a Xylex plastic case that resists water penetration, and a special coating. Advertised as splash and sweat proof but not to formal IP standards. Built- in Telecoil; T- Mic provides added convenience when using telephones and consumer electronic products 33 FM Battery Pack for easy plug and play wireless access at ear level. Allows connection to any batteryoperated assistive listening device or accessory (such as an mp3 player or Bluetooth receiver) using the standard Euro connection. FM/ALD input is available on any program without the need for special settings. A stereo cable connection is also available for bilaterally implanted users to have a stereo listening experience from an mp3 player or similar. Advertised as water tolerant but not to formal IP standards. Built- in Telecoil is available on any listening program. Customer Support icas.com/support/33.asp nics.com/support_center /Customer_Support/index.cfm?langid=1 /show4/index/id/4/title/us ER-SUPPORT.
9 (Re)habilitation Software/Programs All of these products/programs are available, either for free or for purchase, by any CI user. The auditory rehabilitation exercises in these programs apply to anyone seeking aural rehabilitation, regardless of the brand of implant use. - Sound and Way Beyond DVD icas.com/support/2427.as p ($99 online for Nucleus recipients. Others need to call Cochlear to purchase.) - Telephone With Confidence - (Accessible through com) The Listening Room ey.com/listening_room/in dex.cfm?langid=1 (Available online to all) Bridge - to Better Communication S/img/download/BRIDGE_ Catalog.pdf (Multiple products available for purchase online. Costs range from Free to $910.) (Free) Hope Notes - a program uniquely developed for cochlear implant and hearing aid users designed to help improve music perception and appreciation using original songs, traditional Folk, Blues & Country styles and some familiar tunes played in unexpected ways. ( r.com/oa_html/ibecctpi tmdsprte.jsp?section=10 194&item= (Available for $19.99 online) Backward Compatibility History of Processors CP810 currently backward compatible to Freedom Implant. It will be made backward compatible to N24, and N22 implants. All the other processors, which includes Freedom, 3G, and Esprit, are fully backward compatible to N24 and N22 Implant. - Auria and Harmony backwards compatible to - CII and 90K recipients 25 (Harmony processor not compatible with firefly earhook, Auria AA power pack, or the system sensor test wand 24 ) - Platinum BTE for 1 st generation Clarion users but very short battery life - Harmony available for OPUS 2 is back compatible to all previous MED-EL implants.
10 C1/1.2 users, secondary to release of Soundwave 2.0 software - announced September 13, Initial Warranty Extended Warranty Options Internal: 10 years Processor: 3 years repair and one time replacement for theft or loss 31 ESCO policy also available for theft and loss. 1 year service plan, 3 options, plus Advance Processor Purchase Plan providing 5 years of protection See icas.com/support/2166.as p for all details Internal: 10 years Processor: 3 years not including theft or loss ESCO policy also available for theft and loss 1 year service plan See nics.com/userfiles/file/ex tsrvagreement- Terms- US- Flyer.pdf Internal: 10 years Processor: 3 years including one free- of- charge replacement for a stolen, lost or damaged processor 26 ESCO policy also available for theft and loss. Facilitation of Community Connections SAFETY Cochlear Community Network, Cochlear Awareness Volunteer Network, Nucleus Forum, Semi- Annual Cochlear Celebration, Cochlear Implant Education Events, Graeme Clark Scholarship Hearing Journey online community, Connect to a Mentor, Bionic Ear Association Hear Peers MED-EL Patient Support Team MED-EL Community Cochlear Implant Expo Events MRI Compatibility U.S. Yes, 1.5 tesla with internal magnet removed Europe: medium strength MRI up to 1.5 Tesla with magnet in place U.S. Yes, 1.5 tesla with internal magnet removed U.S. Yes, FDA approved for 0.2 Tesla with magnet in place Europe 1.5 Tesla with magnet in place high- powered MRI up to 3 Tesla with magnet removed in a simple outpatient procedure.
11 Internal Implant Dimensions Thickness at receiver- stimulator: 3.9 mm 21 Surgical Drilling Depth: 2 mm Width: 28 mm Length: 56 mm Coil diameter: 20 mm Surgical drilling depth: 3 mm 20 Sonata: Stimulator Housing Length: 17.4 mm Width: 24.8 mm Thickness: 5.9 mm Overall Implant Dimensions Length: 45.7 mm Width at coil: 29.0 mm Width at stimulator: 24.8 mm Thickness at coil: 3.7 mm Thickness at stimulator: 5.9 mm Weight: 8.6 g 19 Surgical Drilling Depth: 2 mm Association of Processor with Specific Implant yes Intellilink Safety Feature Important for young children and bilateral recipients. The Intellilink feature locks customized programs to the recipient s specific implant so that the implant cannot be activated with a different processor. IRIS implant identification MED- EL s unique implant identification feature, IRIS (Individual Recognition of the Implant System), prevents stimulation from occurring if the incorrect speech processor is worn. This is particularly important for children with bilateral implants and for school and group situations with numerous children using implants. Features of Electrode Array to Minimize Cochlear Damage Softip A patented Softip at the end of electrode array allows for gentle insertion in order to minimize the risk of damage to the delicate cochlea structures Specially designed electrode array with waveshaped wiring and recessed contacts for an atraumatic electrode insertion. These soft, flexible electrodes are designed to provide the capability for Complete Cochlear Coverage (maximal use of the entire cochlea). Other Internal implant 2½ times stronger than previous generation Nucleus implant Nucleus Freedom Safety locks: All OPUS 2 wearing options can be locked to ensure that no parts of the speech
12 Tamper resistant battery lock processor can be removed or tampered with. SoundGuard: The OPUS speech processors self- monitor all programmed data continuously to protect against inconsistencies, for example as a result of static electricity. If a problem is detected SoundGuard automatically stops stimulation and the Status Light flashes. By turning the processor off and on, all map information is restored, and no further action is required by the user. Switch-free design prevents inadvertent changes to program or volume settings. Because of the Automatic Sound Management feature, most users do not need to change settings during the day and therefore do not need to carry the FineTuner remote control with them. This feature is especially useful for small children who can t be responsible for manually adjusting their processor based on the environment. One FineTuner can control two processors, allowing bilaterally implanted patients the freedom from keeping track of extra accessories. Its battery lasts more than one year and is easily and inexpensively replaced.
13 ACCESSIBILITY Location of Implant Centers in Major Geographic Areas See icas.com/support/38.asp to find a clinic near you. nics.com/clinics/index.cf m?langid=1 lish/clinic- finder/asia- test.php Number of Recipients Worldwide 1 BTE = Behind the Ear 2 BWP = Body Worn Processor 140, Pitch Percepts IDR Range of sound heard from softest to loudest. Normal hearing dynamic range = 120 db Reliabilty%20Report%2008- rv1.pdf 8 A Multicenter Study of Device Failure in European Cochlear Implant Centers, Battmer, Rolf- Dieter, Gerald M. O Donoghue, Thomas Lenarz, Ear & Hearing, Norkus, Ashley Nicole, The History of Cochlear Implants, Bloomsburg University, June Sabine Haumann Thomas Lenarz Andreas Büchner. Speech Perception with Cochlear Implants as Measured Using a Roving- Level Adaptive Test Method. ORL 2010;72: Cochlear- Implant- System/Speech- Processors/Automatic- Sound- Management.php 17 MED- EL FSP Clinical Trial, Data on file at MED- EL stronger- cochlear- implant- built- life Insert_ _Rev- C.pdf 23 Advanced Bionics customer service rep Brough et al. (2010) Speech discrimination scores using the latest generation of speech processors built- last- active- lifetime 30 powerful- battery- choices 31 implants/warranty- information and content/uploads/2011/01/ _download_en.pdf electrode%20pitch%20discrimination%20.pdf ).pdf *DISCLAIMER This brand comparison chart is NOT affiliated with Cochlear, Med- el, and Advanced Bionics. Please use it at your own discretion, and we still recommend consulting with the CI manufacturing companies, surgeons, and audiologists to get more information.
14 2011 Cochlear Implant Online Last Updated 05/13/2011 Rachel Chaikof, Melissa Chaikof, Elizabeth Boschini Special thanks to Darla Franz, an employee from Med- El, for supplying with information on Med- El.
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