Download Cochlear Implant Brand Comparison

COCHLEAR IMPLANT BRAND COCHLEAR (NUCLEUS) Current Model: Nucleus N5 CI512 (Released September 2009) ADVANCED BIONICS Current Model HiResolution 90k Bionic Ear July 2003 MED-­‐EL Current Model Maestro (Pulsar and Sonata) (Released ??) COMPANY INFORMATION Website http://www.cochlear.com http://www.advancedbio
nics.com Location of Main Headquarters: Main Headquarters: Headquarters 14 Mars Road Advanced Bionics, LLC PO Box 629 12740 San Fernando Road Lane Cove NSW 2066 Sylmar, CA 91342 USA AUSTRALIA Europe: North America: 76 rue de Battenheim 13059 E. Peakview Ave. 68170 Rixheim, France Centennial, CO 80111 Asia Pacific: European Region Suite 4203, 42/F, Tower (including Saudia Arabia One and the Middle East) Lippo Centre, 89 Cochlear AG Queensway Peter Merian-­‐Weg 4 Hong Kong 4052 Basel Switzerland Latin America: Mann Biomedical Park See 25129 Rye Canyon Loop http://www.cochlearamer Valencia, CA 91355, USA icas.com/Support/405.asp for complete list See http://www.advancedbio
nics.com/About_Us/Locati
ons/index.cfm?langid=1 for complete list Year Started 1984 1993 in Business PERFORMANCE Number of CI512 22 intracochlear Electrodes electrodes +2 grounding Internal Implant Titanium and silicone Materials http://www.medel.com/ Main Headquarters: Fürstenweg 77a A-­‐6020 Innsbruck Austria North America: 2511 Old Cornwallis Rd. Suite 100 Durham, North Carolina 27713 See http://www.medel.com/e
nglish/90_Company/20_c
ontact_medel_office.php for complete list 1989 16 + 2 grounding 24 Titanium and silicone Pulsar: ceramic housing Sonata: titanium and silicone Processing Hi-­‐Ace (Freedom and N5) Strategies Ace (N24 and Freedom) SmartSound Technology Stimulation type(s) and Rate HiRes Fidelity 120™ sound processing ClearVoice (Not yet FDA approved.) Fine Structure Processing (FSP) (The FSP strategy is approved for use by cochlear implant users with at least six months experience with the Continuous Interleaved Sampling (CIS+) or HD-­‐CIS programming options, and who have the cognitive ability to express a choice in coding strategy preference. The safety and effectiveness of FSP have not yet been established in pre-­‐
lingually deaf children and it is not indicated for use in that population.27 HiRes-­‐P w/ Fidelity 120 (paired), HiRes-­‐S w/Fidelity 120 (sequential) Sequential and parallel stimulation Maximum pulse rate: 50,704 pulses per second Pulse width per phase: 2.08 -­‐ 425.0 μs/ph Time resolution (nominal values): 1.67 μs Overall amplitude range: 0 -­‐ 1200 cu* (typical value) HiRes-­‐P (paired), HiRes-­‐S (sequential) CIS and MPS modes Number of Average Pitch Percepts aggregate # discriminable pitches across the entire array: 16135 When intensity was roved to eliminate loudness cues: 127 discriminable pitches across the entire array.3 -­‐ Up to 83,000 Stimulation Pulses Per Second -­‐ Up to 120 Bands of Spectral Information 121 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 perception, especially in the low frequencies.18 Speech Perception 77%, Nucleus 5, CNC Scores words at 60dBA at initial fit, adults and children 59% (with Freedom) after 6 months4 (Adults -­‐ CNC words at 70 dBA) Hearing in Noise 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 Music program designed Appreciation to enhance music experience 44% after 6 months4 (Adults -­‐ CNC words at 70 dBA) HINT sentences in noise test, signal to noise ratio +8db, presentation level 60 db: 68% at 12 weeks15 46% after 6 months4 (Adults -­‐ CNC words at 70 dBA) HiResolution is designed to preserve the broad spectrum of sounds to improve listening abilities in difficult situations. Automatic gain control FineHearing provides benefits to users for hearing in noise. HiResolution is designed to preserve the broad spectrum of sounds to enhance music appreciation. Microphone Two microphones for T-­‐mic available placing better quality sound and microphone at entrance direction. Designed to to ear. T-­‐mic provides capture sound from all added convenience when around. using telephones and consumer electronic products, improved hearing in noise, and enhanced directional hearing. 33 Telemetry AutoNRT Neural Response Imaging Enables the surgeon to (NRI) position the electrode A feature enabled closer to the hearing through the HiRes 90K nerve for a more focused electronics platform that and accurate stimulation -­‐ measures the electrically and apply less pressure to evoked compound action the cochlea. potential (ECAP) of the hearing nerves. NRI is designed to optimize the implant fitting process and assist in programming FineHearing to provide users the fine details of sounds especially important for the enjoyment of music. Impedance and Field Telemetry (IFT) Status Telemetry Auditory Nerve Response Telemetry (ART™) young children. Electrode Contour Advance Arrays Electrode with self curling Available array Split electrode array for ossified cochleas Input Dynamic Range5 Up to 45 db (According to an audiologist, the higher IDR is set, the more background noise comes in.) RELIABILITY Reliability – Cumulative failures (Company Reported) Reliability (Independent Objective Study8) Reference from 2007: Relevant Reliability Information HiFocus Electrode features 16 platinum-­‐
iridium contacts that focus stimulation on the hearing nerve fibers Up to 80 db15 Standard electrode array Medium electrode array Compressed electrode array Split electrode array Flexsoft electrode array FlexEAS electrode array 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. 55 db Adaptive sound window moves within a 75 db IDR.16 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%7 3.75 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%6 169/8581 = 2% failure rate 123/1761 = 7% failure rate Sonata at 2 years out: 0.33% (device issues only)10 2.27% (device + medical, surgical & accident)10 Pulsar at 4.75 years out: 0.21% (device issues only)11 6.11% (device + medical, surgical & accident)11 179/1987 = 9% failure rate Cochlear manufactures all AB reports on hard and of its own parts and does “soft” failures. not rely on an outside vendor. Reports on all of its devices, Nucleus 22 and beyond. Reports on hard and “soft” failures. Past Recalls with 1995: power supply inside Year Recall the implanted part of the Announced 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 properly leading to decrease in magnet strength over time in some implants.32 2006: 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.)7 2004: Recall due to moisture trapped inside the titanium receiver-­‐
stimulator leading to failure7 2002: Recall due to positioner increasing risk of meningitis14 2004: Warning letter from FDA temporarily halting import of Med-­‐El implants into U.S. due to “significant violations” in manufacturing process17 Processor Reliability Built on titanium foundation with new durable plastic. GORE-­‐
TEX microphone protection. Teflon® coated titanium bayonet connectors29 PROCESSOR EASE OF USE Processors Nucleus5 System (Most recent models CP810 only) 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% Harmony BTE Platinum Series BWP Opus 2 BTE + various configurations for wearing processor Processor Photo Processor Remote Yes (Bidirectional Control Communication between Processor and Wireless remote assistant) No Yes (Unidirectional Remote to processor only) Number of Programs 4 Processor Can Hold Battery Type(s) CP810: Standard Rechargeable Compact Rechargeable 2 HP 675 Disposable Battery Life -­‐ Standard rechargeable: up to 31 hours -­‐ Compact rechargeable: up to 18 hours -­‐ Disposable zinc air batteries: Up to 60 hours30 Harmony and Platinum Series: 3 9 Rechargeable PowerCelTM Rechargeable 3 675 disposable or AA rechargeable or disposable Rechargeable: average = 10-­‐12 hours Disposable batteries: 3-­‐5 days27 PowerCel Slim: average = 14 hours PowerCel Plus: average = 24 hours28 Low Battery Indicator -­‐ Flashing Light on Processor (Can be deactivated) -­‐ Private tone in Processor -­‐ Audible tone from Wireless remote assistant -­‐ Visual display on Remote wireless assistant Baby/Child LiteWear option Processor Options Snugfit (3 sizes) These can be chosen for any age and lifestyle (see http://www.cochlearamer
icas.com/nucleus5/access
ories_popup.html for photos) How Magnet Strength is Different strength Adjusted magnets can be screwed in or out to further tighten or loosen. 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. FM Connection -­‐ Any FM system with Euro plug connection -­‐ Any FM accessible through T-­‐coil Water Resistance IP44 (Protected against water spray from any direction) IP57** with Rechargeable battery Harmony: light flashes orange Platinum Series: light flashes and processor beeps 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. Harmony: Off the ear power option reducing portion worn on ear Platinum Series body worn processor with microphone on headpiece Baby BTE Children’s battery pack Remote battery pack (see http://www.medel.at/eng
lish/30_Products/01_MAE
STRO/opus2/02_wearing_
options.php for photos) You order a magnet and the order has to come from your audiologist as the audiologist will add or remove magnetic disks from the headset.23 Audiologist can add or remove magnetic disks from the headset. 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 products33 FM Battery Pack Cover for wireless access9 Telephone Use AutoPhone™ technology in conjunction with built-­‐
in telecoil. Recipients can automatically connect to a variety of signal sources with no manual switching. COMPANY COMMITTMENT Advertised as “water tolerant” but not to formal IP standards. Built-­‐in Telecoil Customer http://www.cochlearamer
Support icas.com/Support/33.asp (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 http://www.cochlearamer
icas.com/support/2427.as
p -­‐ Telephone With Confidence (Accessible through www.cochlearcommunity.
com) ($99 online for Nucleus recipients. Others need to call Cochlear to purchase.) Backward Compatibility CP810 currently backward History of Processors 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. Initial Warranty Internal: 10 years Processor: 3 years repair and one time replacement for theft or loss31 ESCO policy also available for theft and loss. Extended 1 year service plan, 3 Warranty options, plus Advance Options Processor Purchase Plan providing 5 years of protection See http://www.cochlearamer
icas.com/Support/2166.as
p for all details http://www.advancedbio
nics.com/Support_Center
/Customer_Support/index
.cfm?langid=1 The Listening Room http://www.hearingjourn
ey.com/listening_room/in
dex.cfm?langid=1 (Available online to all) http://www.medel.at/eng
lish/60_Support/index.ph
p?navid=59 -­‐Auria and Harmony backwards compatible to -­‐
CII and 90K recipients25 (Harmony processor not compatible with firefly earhook, Auria AA power pack, or the system sensor test wand24) -­‐Platinum BTE for 1st generation Clarion users but very short battery life -­‐Harmony available for C1/1.2 users, secondary to release of Soundwave 2.0 software -­‐ announced September 13, 201034 Internal: 10 years Processor: 3 years not including theft or loss ESCO policy also available for theft and loss Opus 1 and 2 backwards compatible to first generation Med El Combi 40+ 1 year service plan See http://www.advancedbio
nics.com/UserFiles/File/Ex
tSrvAgreement-­‐Terms-­‐US-­‐
Flyer.pdf Choice of plans through Med El, including plans offering theft, loss and damage. ESCO policy also available for theft and loss. Bridge -­‐ to Better Communication http://www.medel.com/U
S/img/download/BRIDGE_
Catalog.pdf (Multiple products available for purchase online. Costs range from $7 to $910.) Internal: 10 years Processor: 3 years including one free-­‐of-­‐
charge replacement for a stolen, lost or damaged processor26 Facilitation of Community Cochlear Community Connections Network, Cochlear Awareness Volunteer Network, Nucleus Forum, Semi-­‐Annual Cochlear Celebration, Cochlear Implant Education Events, Graeme Clark Scholarship SAFETY 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 high-­‐powered MRI up to 3 Tesla with magnet removed in a simple outpatient procedure. Internal Implant Thickness at receiver-­‐
Dimensions stimulator: 3.9 mm21 Association of Processor yes with Specific Implant Hearing Journey online community, Connect to a Mentor, Bionic Ear Association HearPeers U.S. U.S. Yes, 1.5 tesla with internal Yes, FDA approved for 0.2 magnet removed Tesla with magnet in place Europe 1.5 Tesla with magnet in place Width: 28 mm Length: 56 mm Coil diameter: 20 mm Surgical drilling depth: 3 mm20 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 g19 Intellilink™ Safety Feature IRIS™ implant Important for young identification children and bilateral recipients. The Intellilink MED-­‐EL’s unique implant feature locks customized identification feature, programs to the IRIS™ (Individual recipient’s specific Recognition of the implant so that the Implant System), prevents implant cannot be stimulation from activated with a different occurring if the incorrect processor. 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 Softip™ Array to Minimize A patented Softip at the Cochlear Damage end of electrode array allows for gentle insertion in order to minimize the risk of damage to the delicate cochlea structures Other Internal implant 2½ times stronger than previous generation Nucleus implant Nucleus Freedom Tamper resistant battery lock ACCESSIBILITY Location of Implant Centers in Major Geographic Areas Safety locks: All OPUS wearing options can be locked to ensure that no parts of the speech 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. See http://www.cochlearamer
icas.com/Support/38.asp to find a clinic near you. http://www.advancedbio
nics.com/clinics/index.cf
m?langid=1 http://www.medel.at/eng
lish/clinic-­‐finder/Asia-­‐
test.php 1
Number of 120,000+ Recipients Worldwide BTE = Behind the Ear BWP = Body Worn Processor 3
Pitch Percepts 4
http://www.cochlearamericas.com/nucleus5/best_hearing.html 5
IDR Range of sound heard from softest to loudest. Normal hearing dynamic range = 120 db. 6
http://www.advancedbionics.com/UserFiles/File/ReliabilityRev4.pdf 7
http://www.advancedbionics.com/UserFiles/File/2-­‐091799_Cons-­‐Reliabilty%20Report%2008-­‐rv1.pdf 8
http://www.barnplantorna.se/UserFiles/file/cochlear/Device%20failures%20in%20EUropean%20CI%20centre%20Cochlear.pdf, A Multicenter Study of Device Failure in European Cochlear Implant Centers, Battmer, Rolf-­‐Dieter, Gerald M. O’Donoghue, Thomas Lenarz, Ear & Hearing, 2007 9
http://professionals.cochlearamericas.com/sites/default/files/resources/N33357F_ISS1_JUNE08_Reliablility_Report_AQM.pdf 10
http://www.medel.com/english/img/animations/SONATA_CSR.swf 11
http://www.medel.at/english/img/animations/PULSAR_CSR.swf 12
http://www.advancedbionics.com/printables/reliabilityreport2006.pdf 13
Norkus, Ashley Nicole, The History of Cochlear Implants, Bloomsburg University, June 2007. 14
http://mdiconsultants.com/section_ni/fda_recalls/recallarchive11.htm 15
http://www.advancedbionics.com/CMS/Files/AB_Performance.pdf 16
http://www.medel.com/US/MAESTRO-­‐Cochlear-­‐Implant-­‐System/Speech-­‐Processors/Automatic-­‐Sound-­‐Management.php 17
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2004/ucm146926.htm 18
http://www.medel.com/US/img/download/20869_FineHearing.pdf 19
http://www.medel.com/US/img/download/20748%28Sonata_Datasheet%29US.pdf 20
http://www.advancedbionics.com/For_Professionals/Technical_Product_Details/HiRes_90K_Implant.cfm?langid=1 21
http://nucleus5.cochlear.com/uk/thinner-­‐stronger-­‐cochlear-­‐implant-­‐built-­‐life-­‐0 22
http://www.advancedbionics.com/UserFiles/File/HiRes90K_Harmony_System_Package-­‐Insert_9055522-­‐001_Rev-­‐C.pdf 23
Advanced Bionics customer service rep 24
http://www.advancedbionics.com/printables/compatibilitychart.pdf 25
http://www.advancedbionics.com/products/product_Upgrades/index.cfm?langid=1 26
http://www.medel.com/US/img/download/maestro3.0_faq.pdf 27
http://www.medel.at/english/80_News/Press_Releases/press_releases/31_04_2008.php 28
http://www.advancedbionics.com/Products/Harmony_HiResolution_Bionic_Ear_System/Power_Options.cfm?langid=1 29
http://nucleus5.cochlear.com/uk/processor-­‐built-­‐last-­‐active-­‐lifetime 30
http://nucleus5.cochlear.com/uk/safe-­‐powerful-­‐battery-­‐choices 31 http://products.cochlearamericas.com/support/cochlear-­‐implants/warranty-­‐information and http://www.cochlear.com/au/warranty 32
http://cochlearimplantonline.com/site/wp-­‐content/uploads/2011/01/2267-­‐09_Download_en.pdf 33
http://www.advancedbionics.com/Products/Harmony_HiResolution_Bionic_Ear_System/Connectivity_Options.cfm?langid=1 34
http://www.advancedbionics.com/CMS/upgradec1.aspx 35
http://professionals.cochlearamericas.com/cochlear-­‐products/nucleus-­‐cochlear-­‐implants/software-­‐and-­‐programming/custom-­‐
sound/pitch-­‐steering-­‐seq 2