COCHLEAR

IMPLANT BRAND

COCHLEAR (NUCLEUS) Current Model: Nucleus N5 CI512 (Released September 2009)

ADVANCED BIONICS Current Model HiResolution 90k Bionic Ear (Released July 2003)

COMPANY INFORMATION

MED-EL Current Model MAESTRO System - includes PULSARci100 (Released August 2005) and SONATAti100 (Released June 2007) implants http://www.medel.com/ Main Headquarters: Frstenweg 77a A-6020 Innsbruck Austria USA: 2511 Old Cornwallis Rd. Suite 100 Durham, North Carolina 27713 See http://www.medel.com/u s/show2/index/id/294/tit el/MED- EL+Offices+Worldwide for complete list

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 16 + 2 grounding

1989 24 contacts + 2 grounding PULSAR: Ceramic and silicone SONATA: Titanium and

Number of 22 intracochlear Electrodes electrodes +2 grounding Internal Implant Titanium and silicone Materials

Titanium and silicone

silicone Processing Hi-Ace (Freedom and N5) Strategies 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) Sequential stimulation and Rate 32,000 hertz

HiRes-P w/ Fidelity 120 (paired), HiRes-S w/Fidelity 120 (sequential) HiRes-P (paired), HiRes-S (sequential) CIS and MPS modes

Sequential stimulation at a maximum rate of 50,704 pps.

- Up to 83,000 Stimulation Pulses Per Second - Up to 120 Bands of Spectral Information Possible Number of Average Based on the assumption Pitch Percepts aggregate # discriminable that the number of pitch pitches across the entire percepts on these three 35,36 array: 161 electrode pairs was When intensity was roved representative of the to eliminate entire array, the total loudness cues: 127 potential number of pitch discriminable pitches percepts for these across the entire array.3 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

to 466, with an average of perception, especially in 93.37 the low frequencies.18 Speech Perception 87%, Nucleus 5, CNC Scores words at 60dBA4 69%, AB Words at 70 dB SPL27 (Freedom Sound Processors Previous Generation) 96%, CUNY Sentences at 70 dB SPL27 (Freedom Sound Processors Previous Generation) 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 79%, Harmony, CNC words at 60dBA4 59%, AB Words at 70 dB SPL27 87%, CUNY Sentences at 70 dB SPL27 71%, AB Words at 70 dB SPL27 98%, CUNY Sentences at 70 dB SPL27

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.

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

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 MED-ELs processors feature an omni- directional microphone, which captures sound from all directions.

Telemetry AutoNRT (Automated Neural Response Telemetry) enables your specialist to confirm the precise placement of the stimulation contacts by measuring your hearing nerve response4.

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. HiFocus Electrode features 16 platinum- iridium contacts that focus stimulation on the hearing nerve fibers

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 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

Up to 80 db15

Standard electrode array Medium electrode array Compressed electrode array Split electrode array Flexsoft electrode array (Not yet approved by the FDA.) FlexEAS electrode array (Not yet approved by the FDA.) 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

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%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%6 123/1761 = 7% failure rate

Reliability (Independent Objective Study8) Reference from 2007: Relevant Reliability Information

169/8581 = 2% 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.

MED-EL reports on all devices, including both hard and "soft" failures, according to the relevant ISO standard and the international consensus committees recommendations. MEDEL 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 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

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) Processor Photo

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 Harmony BTE: Average monthly service rate = 1.5%7 Platinum Series BWP: 0.9%7 Auria BTE: 1.17%6 Harmony BTE Platinum Series BWP

Opus 2: Average monthly service rate = 0.54% Opus 1: 0.97%

Opus 2 BTE + various configurations for wearing processor

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 Harmony and Platinum Series: 3 Rechargeable PowerCelTM 4
Options include DaCapo rechargeable ear-level battery, 3 675 disposable batteries, or one AA rechargeable or disposable battery

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 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)

PowerCel Slim: average = 14 hours PowerCel Plus: average = 24 hours28

DaCapo average = 10-12 hours Disposable batteries: 3-5 days27

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.
BabyBTE Childrens Battery Pack Remote Battery Pack FM Extension Battery Pack for connecting assistive listening devices or FM systems at ear-level

Harmony: Off the ear power option reducing portion worn on ear Platinum Series body worn processor with microphone on headpiece

How Magnet Strength is Different strength Adjusted magnets can be screwed in or out to further tighten or loosen.

You order a magnet and the order has to come from your audiologist as the audiologist will add or

(see http://www.medel.at/eng lish/30_Products/01_MAE STRO/opus2/02_wearing_ options.php for photos) Audiologist can add or remove magnetic disks from the headset.

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

remove magnetic disks from the headset.23

iConnect provides cable- free connectivity to most commonly available FM receivers.

Water Resistance IP44 (Protected against water spray from any direction) IP57** with Rechargeable battery

Telephone Use 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. COMPANY COMMITTMENT Customer http://www.cochlearamer Support icas.com/Support/33.asp

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 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.

http://www.medel.com/us /show4/index/id/4/title/US ER-SUPPORT.

http://www.advancedbio nics.com/Support_Center /Customer_Support/index .cfm?langid=1

 (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 ($99 online for Nucleus recipients. Others need to call Cochlear to purchase.) - Telephone With Confidence - (Accessible through www.cochlearcommunity. com) (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. (https://webstore.cochlea r.com/OA_HTML/ibeCCtpI tmDspRte.jsp?section=10 194&item=646647 (Available for $19.99 online) 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. The Listening Room http://www.hearingjourn ey.com/listening_room/in dex.cfm?langid=1 (Available online to all) Bridge - to Better Communication http://www.medel.com/U S/img/download/BRIDGE_ Catalog.pdf (Multiple products available for purchase online. Costs range from Free to $910.)

-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

OPUS 2 is back compatible to all previous MED-EL implants.

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 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

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

Internal: 10 years Processor: 3 years including one free-of- charge replacement for a stolen, lost or damaged processor26 ESCO policy also available for theft and loss.

1 year service plan See http://www.advancedbio nics.com/UserFiles/File/Ex tSrvAgreement-Terms-US- Flyer.pdf

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

U.S. Yes, FDA approved for 0.2 Tesla with magnet in place Europe 1.5 Tesla with magnet in place

MRI Compatibility U.S. U.S. Yes, 1.5 tesla with internal Yes, 1.5 tesla with internal magnet removed 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

Surgical Drilling Depth: 2 mm

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
Surgical Drilling Depth: 2 mm

Association of Processor yes with Specific Implant

Intellilink Safety Feature Important for young children and bilateral recipients. The Intellilink feature locks customized programs to the recipients specific implant so that the implant cannot be activated with a different processor.

IRIS implant identification MED-ELs 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.
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).

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 2 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

 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 cant 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.

ACCESSIBILITY Location of Implant Centers in Major Geographic Areas

See http://www.cochlearamer icas.com/Support/38.asp to find a clinic near you. Number of 140,000+ Recipients Worldwide

http://www.advancedbio nics.com/clinics/index.cf m?langid=1

http://www.medel.at/eng lish/clinic-finder/Asia- test.php

1 2

BTE = Behind the Ear BWP = Body Worn Processor 3 Pitch Percepts 4 http://cochlearimplantonline.com/Research/JaceWolfe2010.pdf 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. ODonoghue, 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 Sabine Haumann Thomas Lenarz Andreas Bchner. Speech Perception with Cochlear Implants as Measured Using a Roving-Level Adaptive Test Method. ORL 2010;72:312318 16 http://www.medel.com/US/MAESTRO-Cochlear-Implant-System/Speech-Processors/Automatic-Sound-Management.php 17 MED-EL FSP Clinical Trial, 2008. Data on file at MED-EL. 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 Brough et al. (2010) Speech discrimination scores using the latest generation of speech processors 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://cochlearimplantonline.com/Research/FUN656_Pitch%20Steering_WhitePaper.pdf 36 http://cochlearimplantonline.com/Research/Dual- 37 electrode%20pitch%20discrimination%20.pdf http://cochlearimplantonline.com/Research/HiRes%20120%20White%20Paper%20(0 90706).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.

 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.