CI Comparison Chart: Main System Features

Transcription

1 Reliability MRI Triformance CI Comparison Chart: Main System Features System MAESTRO CI System Cochlear Nucleus System 7 Cochlear Nucleus System 6 Cochlear Nucleus Freedom System HiRes / Naida System Neuro CI System Venus CI System Why this Matters Number of structure preservation electrodes 4 (FLEX Series) 4 (FLEX Series) 2 (Straight, Hybrid L) 2 (Straight, Hybrid L) 2 (Straight, Hybrid L) 1 (Mid Scala) 1 (Neuro Zti EVO ) 0 Structure Preservation of the delicate structures of the cochlea optimises the benefit of a cochlear implant, both w and in the future. Soft, flexible electrodes designed for lateral wall ment are proven to preserve the delicate neural structures and ensure a hearing future. Complete Cochlear Coverage (Maximum angular insetion depth) FineHearing with Fine Structure coding strategy (720 ) -p HD- (High Definition ) (720 ) -p HD- (High Definition ) (579 ) (579 ) (579 ) (500 ) (500 ) (400, *449 on a study) Complete Cochlear Coverage provides the full spectrum of sound for a more natural hearing experience. Complete coverage of the cochlea can only be achieved through a long electrode array that stimulates the cochlea from the base to the apical region. FineHearing is the only sound-coding techlogy that provides access to the full spectrum of sound, including bass tones, for a richer and more natural listening experience. MRI compatibility Magnet removal possible / necessary at 3.0 T 0.2T / 1.0T / 1.5T /3T depending to the approval status in 0.2T / 1.0T / 1.5T depending to the approval status in removal depending to the approval status in removal depending to the approval status in removal depending to the approval status in 0.3T and 1.5T without magnet removal removal depending to the approval status in different areas / / / / / / / / 1.5 T MRI is one of the most important diagstic imaging tools for healthcare professionals. Magnetic Resonance Imaging (MRI) scans use powerful magnets to create detailed images of the inside of a person s body. MRI safety is especially important for cochlear implant recipients, because every cochlear implant has an internal magnet that can be affected by an MRI scan. MRI Request Form prior to MRI necessary unkwn unkwn Tight head bandage required unkwn Reliability reporting implant acc. To ISO :2000 plus extended csr acc. To ISO :2000 plus extended csr "Cumulative Survival Rate" for Implants" "Cumulative Survival Rate" for Implants" "Cumulative Survival Rate" for Implants" acc. To ISO :2000 Cumulative Survival Percentage (CSP) & Cumulative Failure Percentage (CFP) Product reliability is an important factor in the patient's and clinic's choice. Therefore, completeness and transparency in reporting of reliability data is very important. Reliability reporting externals average Monthly Service Rate average Monthly Service Rate Quarterly Average Service Rate Monthly Service Rate (MSR) Product reliability is an important factor in the patient's and clinic's choice. Therefore, completeness and transparency in reporting of reliability data is very important.

2 Wearing Options External Connectivity 3pin Euro Audio Connection for s included on FM cover Future ready 2.4 GHz link 3pin Euro Audio Connection for s included on FM cover Mfi - Made for iphone 2.4GHz wireless ready with software upgrade and wireless accessories plug-in accessory port (+Euro Accessory Adaptor) only with CP920 integrated telecoil Custom Connection (4 pin), built in MicroLink, quick sync; stream media; enable for bimodule systems (HA+ CI) Roger 17 for PowerCel 170 battery working with Roger Pen or Roger Clip-On Mic or Roger inspiro bluetooth (to Com Pilot/ Tvlink/My pilot) / Universal Euro 3-pin connection (FM, auxiliary inputs)/ Using built-in with 3rd party system FM systems can be connected The market for assistive listening devices is growing rapidly, serving also hearing aid patients. Especially for children in school connectivity to FM-systems is important. Moisture Resistance EAS fully integrated IP54, IP68 with WaterWear SONNET EAS IP68 with WaterWear IP68 with Aqua+ and LR44alkaline or nickel metal hybride disposable batteries IP57 with rechargable, IP44 with zinc air batteries IP57 with rechargable, IP44 with zinc air batteries IP57 IP68 with Neptune Coating (tropicalization) Single Unit Processor RONDO RONDO Kanso Kanso Kanso Water option Rechargeable options Baby/children's wearing options (Off the ear) Baby/children's wearing options (Less on the ear) WaterWear for BTE and RONDO (May 2016) (in development 2016) use safety pin and huggy rings RONDO (AP itself) MBP (May 2016) WaterWear for BTE and RONDO Aqua+ Aqua+ Aqua+ Aqua Case, Neptune BabyBTE/ActiveWear RONDO (AP itself) Clip for Clothes Clip for Clothes Clip for Clothes Childrens Battery Pack, MBP LiteWear LiteWear LiteWear Neptune/ Swimmable BP, Clip for clothes Powerpack adaptor/ AAA Powerpack/ bilateral power adaptor (IP44) Bodyworn Single unit pull benefits such as easier maintenance (cable free), weight on the Ear. SUP also can support patients who want to discreet AP with their longer hair. SUP is especially useful for receipients who are wearing glasses This option allows recipients diversify their life style by enjoying water activities where additional protection is needed. Rechargeable batteries can easily and conveniently be recharged with a simple battery charger. This alternative options would be helpful for patients who want to save time and cost via using rechargable battery option.

3 CI Comparison Chart: Implants Nucleus Profile CI532 Nucleus Profile CI500 Series Nucleus Freedom CI24RE Series HiRes 90K Advantage HiRes Ultra Neuro Zti Nurotron Venus Date of Launch (2014) DIMENSIONS - PHYSICAL CHARACTERISTICS Housing Material Titanium Titanium Titanium Titanium Titanium Titanium Titanium Titanium Titanium (housing) Zirconia (housing cover) Titanium Weight [g] Overall implant length [mm] app Stimulator housing [mm x mm x mm] 25.4 x 17.3 x x 17.3 x x 17.3 x x 24.0 x x22.0x x19.3x x 20.0 x x 25.0 x 4.5 diameter 30.5 / thickness 4.0 (centre) to 4.5 (edge) Implant Volume (without electrode) 3.7cm³ 3.7cm³ 4.2cm³ 3.9cm³ 3.9cm³ n/a n/a n/a 4.15cm³ n/a Electrode Lead Location side side side center center center center center center center Explantable - reimplantable with ather device diameter 20.0 / thickness x 33 x 6.9 (titanium part) Magnet and reciever coil external to the stimulator housing Other PIN housing variant PIN housing variant n/a 3rd version of CI500 ELECTRICAL CHARACTERISTICS 2nd version of CI500 n/a n/a n/a screw fixation n/a Maximum Current Amplitude [µa@1kohm] Median value = 1250 µa range = 500 µa Median value = 1250 µa range = 500 µa Median value = 1250 µa range = 500 µa 10 μa to 1.75 ma μa to 1.75 ma n/a n/a 100 μa to 2 ma 1700 Maximum Pulse Width [µs] Median value= 203,8 µs range= 8,2 µs Median value= µs range= 8.2 µs Median value= µs range= 8.2 µs 12 μs to 400 μs per phase 400 µs per phase 12 μs to 400 μs per phase 400 µs per phase 400 µs per phase n/a n/a 8 μs to 250 μs 200 µs Max. Stimulation rate [pps] up to 50,704 up to 50,704 up to 50,704 up to 31,500 up to 31,500 up to 31,500 83, ,500 pps (Software limited: 1,040 Hz per channel) 06.Jul

4 Stimulation modes mopolar, sequential and simultaneous, biphasic - triphasic - triphasic precision pulses mopolar, sequential and simultaneous, biphasic - triphasic - triphasic precision pulses mopolar, sequential and simultaneous, biphasic - triphasic - triphasic precision pulses BP+n, MP1, MP2, MP(1+2), CG, MP(1+2), double electrode mode, ECE1- ECE2, ECE to common ICE* BP+n, MP1, MP2, MP(1+2), CG, MP(1+2), double electrode mode, ECE1- ECE2, ECE to common ICE* BP+n, MP1, MP2, MP(1+2), CG, MP(1+2), double electrode mode, ECE1- ECE2, ECE to common ICE* n/a n/a mopolar (mo-phasic Passive Discharge) biphasic symmetric, sequential and parallel Telemetry capabilities IFT: Impedance Field Telemetry ART: Auditory Nerve Response Telemetry ESRT: Electrically evoked stapedius reflex threshold EABR: Electrically evoked auditory brainstem response IFT: Impedance Field Telemetry ART: Auditory Nerve Response Telemetry ESRT: Electrically evoked stapedius reflex threshold EABR: Electrically evoked auditory brainstem response IFT: Impedance Field Telemetry ART: Auditory Nerve Response Telemetry ESRT: Electrically evoked stapedius reflex threshold EABR: Electrically evoked auditory brainstem response IFT, NRT, AutoNRT, ESRT, ABR, CEP IFT, NRT, AutoNRT, ESRT, ABR, CEP IFT, NRT, AutoNRT, ESRT, ABR, CEP IFT, ESRT, NRI 2RF signals (one for forward telemetry, other for backward telemetry) IFT, ESRT, NRI 2RF signals (one for forward telemetry, other for backward telemetry) IFT, Integrity, EABR, ESRT, ECAP IFT, ESRT, NRM FEATURES Magnet removal possible / necessary at 3.0 T / / / / / / / / / / MRI compatibility 0.2T / 1.0T / 1.5T /3T depending to the approval status in 0.2T / 1.0T / 1.5T depending to the approval status in 0.2T / 1.0T / 1.5T depending to the approval status in removal depending to the approval status in different areas removal depending to the approval status in different areas removal depending to the approval status in different areas 0.3T and removal depending to the approval status in removal depending to the approval status in different areas MRI Request Form prior to MRI necessary? unkwn Tight head bandage required unkwn Number of independent current sources , Jän 04.Jän Parallel stimulation possible unkwn 1.5 T Virtual channels (250) (250) (250) (161) (161) (161), 120 virtual channels claimed, 120 virtual channels claimed unkwn Coding strategies -p FSP HD -p FSP HD -p FSP HD (MP3000) (MP3000) (MP3000) HiRES-S HiRES-P HiRES-Fidelity 120 SAS MPS HiRES-S HiRES-P HiRES-Fidelity 120 SAS MPS CrystalisCAP CrystalisXDP MpisCAP MPISXDP / advanced peak selection (APS) / Virtual channel (Symphony) ECAP recording tool art art art NRT NRT NRT NRI NRI Neuro ECAP unkwn implant ID backwards compatible unkwn unkwn Continuous monitoring of implant function unkwn unkwn max. diving depth [m] m above and 380m below sea level 3000m above and 380m below sea level 3bar = 20m unkwn

5 MEDICAL SURGICAL CONSIDERATIONS Housing - round edges Small incision possible Location of bed/stimulator mastoid mastoid mastoid mastoid mastoid mastoid mastoid mastoid mastoid mastoid Implant bed necessary (about 1 mm) (about 1 mm) (up to 2 mm) ramp-like implant bed (up to 2.2mm anterio-inferior) ramp-like implant bed (up to 2.2mm anterio-inferior) (2,3mm bone bed depth) (max. 3 mm) (min. 0.5mm ramplike) (2.5 mm) Electrode channel recommended unkwn Implant immobilization recommended (2 screws) unkwn Preferred fixation method tight periost pocket tight periost pocket tight periost pocket sutures sutures sutures separate lead for reference electrode, cylindrical, ball type, cylindrical, ball type, cylindrical, ball type n-resorbable sutures (1 on housing, 1 on active array) Impact resistance [joules] up to 2.5 up to 2.5 up to 2.5 6,0 Max. flap thickness [mm] unkwn unkwn unkwn Reliability reporting CSR OTHER CONSIDERATIONS # of electrode arrays available (w/o CMDs) 2:2000 plus extended csr 10 (FLEXsoft, FLEX28, FLEX24, FLEX20, FORM24, FORM19, Standard, Medium, Compressed, ABI) 2:2000 plus extended csr 10 (FLEXsoft, FLEX28, FLEX24, FLEX20, FORM24, FORM19, Standard, Medium, Compressed, ABI) 2:2000 plus extended csr 9 (FLEXsoft, FLEX28, FLEX24, FLEX20, FORM24, FORM19, Standard, Medium, Compressed) 2: (Contour Advanced, CI522 (Slim Straight) CI532 (Slim Modiolar Electrode), ABI) 2: (Contour Advanced, CI522 (Slim Straight) CI532 (Slim Modiolar Electrode), ABI) 2: (Hybrid L24, Hybrid S24, CI422 (Slim Straight), CI24RE (CA), CI24RE (ST), ABI) Ideal 5 up to 7 2: (Helix, 1J, Mid- Scala) tight implant sit in implant bed (1 on housing, 1 on active array) Exceeds the rm EN :2010 Ideal 5 up to 7 screws Housing 2.5 Zirconia cover 7.0 optimal up to 5 ensured up to 8 2:2000 unkwn 1.5 unkwn 1 (Mid-Scala) 2 (CLA, EVO) 1 (Standard) Fulfils standard EN :2010 Warranty [years] unkwn (see impact resistance)

6 CI Comparison Chart: Electrode Arrays FLEX SOFT FLEX 28 FLEX 24 FLEX 20 FORM 24 FORM 19 Standard Medium Compressed Split ABI Contour Advance Slim Straight Hybrid L24 (EAS) Full-Band Straight Double Array Slim Modiolar ABI HiFocus Helix HiFocus 1J HiFocus Mid-Scala Neuro Zti CLA Neuro Zti EVO Long Medium Short Standard Date of launch / / / before FEATURES (FLEX Series) (FLEX Series) (FLEX Series) (FLEX Series) (FORM Series) (FORM Series) (Classic Series) (Classic Series) (Classic Series) (CMD) ABI Number of contacts Number of channels x Number of independent current sources Supported implants CMD CMD Nucleus Freedom (CI412) Nucleus Profile (CI512) Nucleus Freedom (CI422) Nucleus Profile (CI522) Nucleus Freedom Nucleus CI24RE Nucleus CI24M Nucleus Profile (CI532) Nucleus Profile (ABI541) HiRes 90K Advantage HiRes 90K Advantage HiRes 90K Advantage HiRes Ultra Neuro Zti Neuro Zti Venus Venus Venus Venus Other FLEX Tip Techlogy FLEX Tip Techlogy FLEX Tip Techlogy FLEX Tip Techlogy SEAL Feature SEAL Feature PET-Mesh wing, colored marker wing, colored marker, basal stiffener wing, basal stiffener 10 stiffening rings to aid insertion Two intracochlear arrays extracochlear ball and plate electrodes silicone sheet for insertion and 3 white markers square PET mesh colored marker wing design; can withstand 15mm stretch tensor wing design; can withstand 15mm stretch tensor wing design; can withstand 15mm stretch tensor wing design; can withstand 15mm stretch tensor DIMENSIONS Diameter apical [mm] 0.5x x x x x x / (Soft tip = 0,2) 0.35x x x0.4 unkwn x 0.62 Diameter basal [mm] x x x0.5 unkwn x 0.88 Diameter extracochlear [mm] n.a unkwn unkwn unkwn 0.6 n.a unkwn unkwn unkwn 1.1 unkwn unkwn unkwn unkwn unkwn Cochleostomy size required [mm] n.a unkwn unkwn unkwn unkwn n.a 1.2 x unkwn unkwn unkwn unkwn Contact spacing [mm] app unkwn unkwn unkwn Active length [mm] / unkwn unkwn unkwn unkwn unkwn Insertion depth [mm] /10.0 n.a unkwn n.a Complete Cochlear Coverage with EAS n.a n.a Pre-shaped unkwn Shape of stimulating contact surface oval oval oval oval oval oval oval oval oval oval oval half band half band half band full band half band half band unkwn rectangular rectangular rectangular band (micromachinedmachined) band (micro- rectangular rectangular rectangular rectangular Contacts recessed in electrode carrier partially partially partially partially partially partially partially partially Contacts inserted facing toward the modiolus possible possible possible possible possible possible possible possible possible possible possible possible possible possible possible possible possible possible possible (wing design) (wing design) (wing design) (wing design) Wire shape in array wave-shaped wave-shaped wave-shaped wave-shaped wave-shaped wave-shaped wave-shaped wave-shaped wave-shaped wave-shaped straight straight straight straight straight straight straight straight straight straight straight unkwn unkwn straight straight straight straight Wire shape in lead wave-shaped wave-shaped wave-shaped wave-shaped wave-shaped wave-shaped wave-shaped wave-shaped wave-shaped wave-shaped helical helical helical helical helical helical helical helical helical helical helical helical helical helical helical helical helical Lateral wall trauma little little little little some some some some some some n.a little little little little little unkwn n.a severe some some severe little unkwn unkwn unkwn unkwn Medial wall trauma little little little little little little little little little little n.a severe little little little little unkwn n.a some little some some little unkwn unkwn unkwn unkwn MEDICAL SURGICAL CONSIDERATIONS RW insertion possible n.a Intended use/ Indication open cochleae, ossification for an depth of about 31mm used in open cochleae ( ossification) for an depth of about 28mm open cochleae, ossification; patients with partial deafness (mild to moderate hearing loss in the low frequencies, severe to profound hearing loss in the high frequencies) for an depth of about 24mm as per request of the surgeon open cochleae, ossification; patients with partial deafness (mild to moderate hearing loss in the low frequencies, severe to profound hearing loss in the high frequencies) for an depth of about 20mm as per request of the surgeon open cochlea ( ossification) or in cochlea with malformation for an depth of about 24 mm and/or wen CSF leakage is expected cochlea with malformation, ossification for an depth ob about 19 mm and/or when CSF leakage is expected open cochleae, ossification for an depth of about 31 mm open cochleae, ossification, with mild malformations for an electrode insertion depth of about 24mm as per request of the surgeon moderate obliteration, ossification or malformation for an depth of about 15mm as per request of the surgeon used in cochleae with severe ossification where two cochleostomies have to be drilled as per request of the surgeon for adult acoustic neuroma patients- NF2 rmal anatomy & patent cochleae may be used in MONDINI malformations patent cochleae, partial / completely ossified cochleae, revision cases of ST array with a narrow tunnel developed, common cavity, may be used in MONDINI malformations mild to moderate hearing loss in the low frequencies, severe to profound hearing loss in the high frequencies Use in patients with various types of abrmal cochlea For patients with severly ossified cochlea where intracochlear is still possible but a full insertion is t expected. bilateral or unilateral sensorineural hearing loss of moderately severe to profound for adult acoustic neuroma patients- NF2 unkwn unkwn Atraumatic, Designed to avoid trauma to the osseous spiral lamina and the basilar membrane4insertio n, soft surgery approaches, for typical and difficult insertions, push rings at base minimize the risk of infection and/or CSF leakage for HP, push rings at base minimize the risk of infection and/or CSF leakage. Severely hard of hearing or profoundly deaf to discover sound./ lateral-wall ment in the cochlea Severely hard of hearing or profoundly deaf to discover sound./ lateral-wall ment in the cochlea Severely hard of hearing or profoundly deaf to discover sound./ lateral-wall ment in the cochlea Severely hard of hearing or profoundly deaf to discover sound./ lateral-wall ment in the cochlea

7 CI Comparison Chart: Audio Processors SONNET (Me1310) SONNET EAS (Me1320) RONDO (Me1100) OPUS 2XS OPUS 2 Kanso Sound Processor (CP950) Nucleus 6 (CP900) Nucleus 5 (CP810) Nucleus Hybrid (EAS) Freedom SP Naída CI Q30 Naida CI Q70 Naída CI Q90 Neptune Neuro One Sound Processor Saphyr Neo (Neurelec) Zebra (EAS) same housing as Saphyr (Neurelec) VENUS NSP-60B Speech Processor Date of Launch PHYSICAL DIMENSIONS Weight with batteries [g] (incl 3zinc-air batteries & standard magnet) 9.4 (incl. 2 zinc-air batteries) 10.1 (incl. DaCapo System) 12.4 (incl. 3 zinc-air batteries) 13.8 (M1 magnet, 2 batteries) 11.6 (M1 magnet) 8.3 ( batteries) Width/Thickness [mm] 5.9 to to to to CP910 w\ Zinc air w\ compact module 10.5 CP920 w\ Zinc air w\ compact module CP CP (incl. 2 zinc air batteries) 10.9 (incl. Li-Ion rechargable) 9 BTE: 9 MiniBTE: 7.6 Bodyworn: 25 BTE: 14.5 MiniBTE: 14.5 Bodyworn: 17 unkwn 6 only 8 off-the-ear power adapter 11 with 110 mah 13 with 170 mah 13 with 230 mah 13 with 2 zinc air batt unkwn 32 incl. AAA 12 LR03 battery 11.4 with 2 batteries 7.7g without battery 11g with 2 Zinc Air batteries 11.3 BTE 7.8 (without batteries) Bodyworn 20.2 (without batteries) 9 all variants x50x Length [mm] Diameter [mm] x x35.1 CP CP compact rechargeable battery module 19 standard rechargeable battery module 28 standard battery module 28 processing unit: 23 compact rechargable battery module: 19 standard battery module: 28 BTE: 37 Mini BTE: 31 Bodyworn: 78 short PowerCel 26 only 40 off-the ear power adapter 49 with 110 mah 55 with 170 mah 59 with 230 mah 53 with zinc air batteries short PowerCel (BTE) Coil Diameter [mm] unkwn unkwn unkwn unkwn unkwn unkwn unkwn 32 Coil Height [mm] unkwn unkwn unkwn unkwn unkwn unkwn unkwn unkwn Coil Weight [g] g (without coil magnet) 4.8 unkwn unkwn unkwn unkwn unkwn unkwn unkwn unkwn Exchangeable magnet, magnet strengths, 9 magnet strengths with DL-Coil, 9 magnet strengths with DL-Coil, 4 magnet strengths, 4 magnet strengths with D Coil, 4 magnet strengths with D Coil 1/2 to 6, 6 diff.types Yes Yes Yes Yes, 9 magnet strengths Yes, 6 magnet strengths Yes unkwn FEATURES Sound Coding Strategies -p HD- (High Definition ) Frequency range (Hertz) 70 to 8500 Input Dynamic Range [db] Automatic Sound Management 75 db with Adaptive Sound Window of 55 db -p HD- (High Definition ) (acoustic) up to 8500 (electric) 75 db with Adaptive Sound Window of 55 db ASM 2.0 ASM Microphone - Microphone Directionality Directionality - Wind Noise - Wind Noise Reduction Reduction - Automatic Volume - Automatic Volume Control (dual-loop Control (dual-loop AGC) AGC) -p HD- (High Definition ) -p HD- (High Definition ) -p HD- (High Definition ) unkwn (MP3000) (MP3000) 70 to to to to to to db with Adaptive Sound Window of 55 db ASM (dual-loop AGC) 75 db with Adaptive Sound Window of 55 db ASM (dual-loop AGC) 75 db with Adaptive Sound Window of 55 db ASM (dual-loop AGC) (MP3000) (acoustic) up to 8000 (electric) ClearVoice HiRes Optima-S*, HiRes Optima-P* Strategies, HiRes-S with Fidelity 120 *, HiRes-P with Fidelity 120*, HiRes-S, HiRes-P,, MPS ClearVoice HiRes Optima-S*, HiRes Optima-P* Strategies, HiRes-S with Fidelity 120 *, HiRes-P with Fidelity 120*, HiRes-S, HiRes-P,, MPS ClearVoice HiRes Optima-S*, HiRes Optima-P* Strategies, HiRes-S with Fidelity 120 *, HiRes-P with Fidelity 120*, HiRes-S, HiRes-P,, MPS unkwn up to 45 db up to 45 db db db db db unkwn Smart Sound IQ SmartSound iq ADRO ASC ADRO ASC HiRes-S HiRes-P HiRes-S with Fidelity 120 HiRes-P with Fidelity 120 MPS CrystalisCAP CrystalisXDP MpisCAP MpisXDP CRYSTALIS/ CrystalisXDP MPIS/ MPISXDP MPIS (spectral multi peak extraction and interleaved stimulation) APS (n-of-m) unkwn 150 to unkwn 100 to up to 8268Hz up to 8333Hz 190 to 8200Hz 100 to 8000 AutoSound Autosound Autosound OS db (60dB default) - dual loop AGC (AGCII) 92dB db SPL programmable Yes (Voice Guard, Automatic environment detection) 25 db SPL 105 db SPL unkwn (may be ) for acoustic part: halfgain-rule Number of programs n/a 4 unkwn (may be ) 75 db unkwn Volume steps (total) unkwn on and with CR210 + CR220 with CR 110 Remote Assistant with CR 110 Remote Assistan 10 clicks to top of volume range 10 clicks to buttom of volume range 10 clicks to top of volume range 10 clicks to buttom of volume range 10 clicks to top of volume range 10 clicks to buttom of volume range +/- 100 % setting selector wheel with on-off switch, wheel type on the AP, wheel type on the AP unkwn Sensitivity control (independent) (independent) (independent) (independent) (independent) unkwn with CR210 + CR220 with CR 110 Remote Assistant with CR 110 Remote Assistan Selectable in software and adjustable through AB mypilot Programmable + / - 10 db Selectable in software and adjustable through AB mypilot Selectable in software and adjustable through AB mypilot, programmable on/off- Gain adjustment +/-6dB unkwn

8 Program button on FineTuner on FineTuner on FineTuner on FineTuner on FineTuner on and with CR210+ CR220 on and with CR210 + CR220 with CR 110 Remote Assistant with CR 110 Remote Assistan button on quick sync with other side button on quick sync with other side button on quick sync with other side button on button on button on Microphone(s) dual microphone dual microphone 1 Omni-directional 1 Omni-directional 1 Omni-directional 2 Omni-directional auto or dual microphone, beamformer 2 omni-directional beamformer 1 directional and 1 omni-directional Universal Headpiece microphone, Microphones T-Mic 2 microphone, dual microphone (front and back microphone)/new mic techn for focusing on speech Universal Headpiece microphone, Microphones T-Mic 2 microphone, dual microphone (front and back microphone)/new mic techn for focusing on speech Universal Headpiece microphone, Microphones T-Mic 2 microphone, dual microphone (front and back microphone)/new mic techn for focusing on speech Universal Headpiece: 1 omni-directional headpiece microphone Aqua-Mic: 1 omnidirectional submersible IP68 microphone 2 omnidirectional 3 directionality modes (Full, Split, Omni) 2 adaptive (Auto-Tri, Auto-Dual) 2 omnidirectional unkwn 1 omni, Directionalmics Front end processing ASM 2.0: wind ise reduction and microphone directionality and automatic volume control (dual-loop) ASM 2.0: wind ise reduction and microphone directionality and automatic volume control (dual-loop) Dual-loop Automatic Gain Control Dual-loop Automatic Gain Control Dual-loop Automatic Gain Control SCAN (NR, WNR, ASC, ADRO, Whisper) AGC, Smart Sound IQ. Automatic-sensitivity control, ADRO, Digital AGC ADRO, Beam, Whisper Digital AGC ADRO, Beam, Whisper AutoSound OS -auto UltraZoom/ StereoZoom (bilateral only)/ultrazoom/wind Block/SoundRelax/Ech oblock/duophone/zoo mcontrol/quicksync AutoSound OS -auto UltraZoom/ StereoZoom (bilateral only)/ultrazoom/wind Block/SoundRelax/Ech oblock/duophone/zoo mcontrol/quicksync AutoSound OS -auto UltraZoom/ StereoZoom (bilateral only)/ultrazoom/wind Dual-loop AGC (AGC II) Block/SoundRelax/Ech oblock/duophone/zoo mcontrol/quicksync Automatic Envrionment Detection No unkwn gain control Noise Cancelling Algorithm Listening Modes Wind ise reduction Microphone directionality Wind ise reduction Microphone directionality unkwn Mic Mic Smart sound IQ (change automatically between speech, ise, wind, quiet) ADRO AutoSound ClearVoice Phonak Binaural VoiceStram Techlogy Speech in Quiet Speech in Noise Music Car Comfort in Noise Comfort in Wind Comfort in Sudden Noise Mic on coil dual mic on BTE tmic Phonak Binaural VoiceStram Techlogy AutoSound OS (including 7 environments) block obtrusive sounds, wind and echoes Phonak Binaural VoiceStram Techlogy Speech in Quiet Speech in Noise Music Car Comfort in Noise Comfort in Wind Comfort in Sudden Noise ClearVoice AquaMic UHP with T-Mic VoiceTrack, Wind Noise Reduction VoiceGuard, Free Focus Voice Track Noise Reduction unkwn unkwn unkwn Connectivity to assistive listening devices Standard hearing aid type connection (3 pin): Connection for direct link FM and Bluetooth systems Integrated telecoil Future ready 2.4GHz link Standard hearing aid type connection (3 pin): Connection for direct link FM and Bluetooth systems Integrated telecoil Future ready 2.4GHz link via integrated telecoil; connection via Mini Battery Pack for RONDO OPUS2 XS was devloped as a special wearing option - for FM etc. the user can change to the "rmal battery pack" integrated Standard hearing aid type connection (3 pin) Connection for direct link FM and Bluetooth systems integrated telecoil 2.4GHz wireless wireless (Bi-directional wireless cabilities, 2m) accessories (Mini Microphone, Phone Clip, TV Streamer) integrated telecoil 2.4GHz wireless wireless accessories (Mini Microphone, Phone Clip, TV Streamer) integrated telecoil plug-in accessory port (+Euro Accessory Adaptor) only with CP920 Custom Connection (4 pin), integrated telecoil Custom connection (4 pin) Phonak EasyCall Phonak DECT Phone Roger System Phonak ComPilot Phonak TVLink II Phonak RemoteMic Euro socket? Phonak EasyCall Phonak DECT Phone Roger System Phonak ComPilot Phonak TVLink II Phonak RemoteMic Euro socket Phonak EasyCall Phonak DECT Phone Roger System Phonak ComPilot Phonak TVLink II Phonak RemoteMic Euro socket? Euro Port Connector, Auxiliary Input (3 pin), (Neptune Connect) Build-in, Direct auxillary connection wireless capabilities Build-in, Universal Auxiliary socket, Teleloop Silhouette (mobile phone, MP3s player, Inductive transmission), wireless capabilities Standard hearing aid type connector (3 pin) Aux-plug with Bodyworn wearing option plug for s Integrated telecoil, automatically detects input signal and switches on, automatically detects input signal and switches on automatically Indicators 1 muliticolor (audible for user) 1 muliticolor (audible for user) 2 s (audible for user) (audible for user) (audible for user) (tri-colour indication) LCD 3 color options (Blue, Green, Red) 3 color options (Blue, Green, Red) 3 color options (Blue, Green, Red) (Green, Red) Remote control FineTuner FineTuner FineTuner FineTuner FineTuner CR210 Remote Control CR210 Remote Control CR230 Remote CR 110 Remote Assistant CR230 Remote Assistant Assistant (AB mypilot) (AB mypilot) (AB mypilot) Unkwn Cables DL-Coil 3 diff.lengths (6.5, 9, 28cm) and 4 colors DL-Coil 3 diff.lengths (6.5, 9, 28cm) and 4 colors [only for mini battery pack 2 diff.lengths (27, 100cm) in 4 diff.colours] D Coil: 3 diff.lengths (7.5, 12, 28cm) D Coil: 3 diff.lengths (7.5, 12, 28cm) 4 lengths in different colours (6, 8, 11, 28cm) 4 lengths in different colours (6, 8, 11, 28cm) 4 lengths in different colours (6, 8, 11, 28cm) 5 different lengths: 9, 11, 14, 24, 30 cm and 4 colours/ Connect with Aquacase: AquaMic cable lengths: 15, 30, 46, 61, 81, 107 cm 5 different lengths: 9, 11, 14, 24, 30 cm and 4 colours/ Connect with Aquacase: AquaMic cable lengths: 15, 30, 46, 61, 81, 107 cm 5 different lengths: 9, 11, 14, 24, 30 cm and 4 colours/ Connect with Aquacase: AquaMic cable lengths: 15, 30, 46, 61, 81, 107 cm AquaMic cable lengths: 15, 30, 46, 61, 81, 107 cm 2 lengths (6, 10 cm) 4 colours 3 lenghts 6, 10, 25 cm 3 colors unkwn unkwn Remote control for bilateral users FineTuner FineTuner FineTuner FineTuner FineTuner CR210 Remote Control CR210 Remote Control CR 110 Remote Assistant

9 controls on externals - SONNET with remote control (FineTuner) - on/off on - SONNET EAS with remote control (FineTuner) - on/off on - RONDO with remote control (FineTuner) - on/off on - OPUS 2 with remote control (FineTuner) - on/off on - OPUS 2 with remote control (FineTuner) - on/off on one button on device: on/off switch programs to activate audio sources control on BTE as well as on remote control (programmable) (Remote Assistent - CR230 advanced longer version, CR210 simple shorter version) controls on BTE as well as CR110 Remote Assistant controls on BTE Controls on BTE for volume control, different programs controls on BTE for volume control, different programs Controls on BTE for volume control, different programs controls on Programm push button, setting selector wheel with on/off, Battery door lock Volume Control, program selector Volume Control, program selector Program button, 2 more controllers Colours Control Unit + FM Battery Pack Cover: 6 Microphone Cover + Battery Pack Cover: 15 customized stickers available online (Skinit & DesignSkins) Control Unit + FM Battery Pack Cover: 6 Microphone Cover + Battery Pack Cover: 15 customized stickers available online (Skinit & DesignSkins) 4 customized stickers available online (Skinit & DesignSkins) 13 colours customized skins (stickers) available online 13 colours customized skins (stickers) available online unkwn 4 standard colours and 12 covers for s and coils in different designs Skinit customized stickers 5 basic colours, covers with different motifs 4 (BTE Processor) 3 (Acoustic Component) 3 (Bodyworn Processor) 3 standard colours for 12 colors for AP and 16 AP/ 9 colours for UHP color caps for UHP 9 colours for AP/ 9 colours for UHP 5 for AquaMic 15 for UHP 7 Processor 4 Antenna 4 magnet 4 Antenna Cable 7 Colours for AP, 3 for Antenna, 3 for Antenna cable, 3 for magnets unkwn unkwn Accessories WaterWear for BTE, Glossy microphone covers, Audio skins (stickers), Huggy, Activity Hook, Mellie Clip WaterWear for electric only, Glossy microphone covers, Audio skins (stickers), Huggy, Activity Hook, Mellie Clip WaterWear for RONDO, Silicone protective cover, attachment clip for fixation to hair/clothes, Sports headband Audio skins (stickers) Audio Processor Skins (stickers) Huggy, Activity Hook, Mellie Clip WaterWear for BTE Audio Processor Skins (stickers) Huggy, Activity Hook, Mellie Clip Safety line, Headband, SoftWear pad, Aqua+ for Kanso Accessory (?) covers for s and coils against sweat, different earhooks snugfit Aqua Accessory, Snugfit, Processor Covers, LiteWear, Mic Locks, Audio Cables, Remote Assistant Leather Case, Microphone Protector Applicator, Tamper Resistant Locking Tool EasyCall accessory, Phonak DECT Phone, Roger 17 receiver& Clip-On Mic& Pen, ComPilot, TVLink II, RemoteMic, AquaMic headpiece, AquaCase, CI Clips/Standard Earhooks/AquaCase Clip/Armband/AquaCa se Lanyard/ CI Listening Check EasyCall accessory, Phonak DECT Phone, Roger 17 receiver& Clip-On Mic& Pen, ComPilot, TVLink II, RemoteMic, AquaMic headpiece, AquaCase, CI Clips/Standard Earhooks/AquaCase Clip/Armband/AquaCa se Lanyard/ CI Listening Check EasyCall accessory, Phonak DECT Phone, Roger 17 receiver& Clip-On Mic& Pen, ComPilot, TVLink II, RemoteMic, AquaMic headpiece, AquaCase, CI Clips/Standard Earhooks/AquaCase Clip/Armband/AquaCa se Lanyard/ CI Listening Check Clip, Pouch, Armband, Lanyard, Headband, Harness, Neptune Swim Cap, Carrying Case Audio and phone connection (Monaural and binaural), HearIt Media system for Wireless connection (Phonic Ear), Holding buckle, Tester Audio and phone connection (Monaural and binaural), HearIt Media system for Wireless connection (Phonic Ear),, Holding buckle, Tester unkwn Body worn battery pack Wearing options BTE Huggy+Safety pin=bodyworn, Activity Hook MBP Adapter BTE Single-Unit Processor MBP for RONDO Activity Clip Sports headband BTE BabyBTE / ActiveWear - Children's Battery Pack - Remote Battery Pack - activity hook MBP adapter one-unit standard BTE, hybrid-capability easily, Snugfit & LiteWear - Standard Earhook - LiteWear Configuration - Standard BTE (for disposable and rechargeable batteries) - Mini BTE - Bodyworn Clip for bodyworn AAA PowerPak + Adapter BTE BTE clip for bodyworn Bicros version Clip for bodyworn AAA PowerPak + Adapter BTE Universal head piece (UHP) and bodyworn Standard BTE, Remote Battery pack with 2 length cables (40, 70 cm) Standard BTE, Remote Battery pack with 2 length cables (40, 70 cm) Standard BTE only with acustical amplifier through acoustic receiver d in an individual ear mould - Standard BTE - Bodyworn batterie Power supply options Battery life time Implant types supported 2x Zinc-air batteries up to 60 hours / MED-EL CONCERT PULSAR COMBI 40+ COMBI 40 2x Zinc-air batteries up to 60 hours / MED-EL CONCERT PULSAR COMBI 40+ COMBI 40 3 x Zinc-air batteries: up to 5days / MED-EL CONCERT PULSAR COMBI 40+ COMBI 40 2x Zinc-air batteries up to 60 hours / MED-EL CONCERT PULSAR COMBI 40+ COMBI 40 - DaCapo rechargeable battery system: 16 hours - 3 x Zinc-air batteries: up to 90 hours / MED-EL CONCERT PULSAR COMBI 40+ COMBI 40 2 x Zinc-air batteries majority of users >16h (depending on settings) battery life varies according to programs and thickness of skin covering standard rechargeable:up to 31 hours zinc air batteries: up to 60 hours compact rechargeable: 18h CI24 RE CI500 (Profile) compact rechargable: up to 18 hours standard rechargable: up to 31 hours standard zinc air: up to 60 hours (battery life depending on the sound coding strategy used!) CI24RE CI500 (Profile) - BTE: PR44 (675) ZincAir or SR44 silver oxide or LR44 or Lithium Ion rechargeable - MiniBTE: PR44 (675) Zinc Air or SR44 silver oxide or LR44 - Bodyworn: AAA size, LR03 Alkaline or HR03NiMh CI24RE CI500 (Profile) PowerCel 110 Mini/ PowerCel 170 Mini/ PowerCel 170/ PowerCel 110/ PwerCel 230/ (110: up to 17 hours 170: up to 27 hours 230: up to 36 hours) Tamperproof Zn-Air Pack (i.e 2 675P Zn-Air batteries/up to 56 hours) AAA PowerPak (connect with a Power adaptor)/power pack AAA-183 hours * Bilateral Power Adapter HiRes 90 K advantage HiRes 90K CII Bionic Ear PowerCel 110 Mini/ PowerCel 170 Mini/ PowerCel 170/ PowerCel 110/ PwerCel 230/ (110: up to 17 hours 170: up to 27 hours 230: up to 36 hours) Tamperproof Zn-Air Pack (i.e 2 675P Zn-Air batteries/up to 56 hours) AAA PowerPak (connect with a Power adaptor)/power pack AAA-183 hours * Bilateral Power Adapter HiRes 90 K advantage HiRes 90K CII Bionic Ear PowerCel 110 Mini/ PowerCel 170 Mini/ PowerCel 170/ PowerCel 110/ PwerCel 230/ (110: up to 17 hours 170: up to 27 hours 230: up to 36 hours) Tamperproof Zn-Air Pack (i.e 2 675P Zn-Air batteries/up to 56 hours) AAA PowerPak (connect with a Power adaptor)/power pack AAA-183 hours * Bilateral Power Adapter HiRes 90 K advantage HiRes 90K CII Bionic Ear Lithium AAA/LR03: hours Alkaline AAA/LR03: hours Ni- MH/AAA/LR03 (rechargable): hours HiRes 90 K advantage HiRes 90K CII Bionic Ear 2 P675 Zinc Air batteries, battery life depending on settings,, Remote battery pack (AA battery/ Rechargeable) 4-7 days (40, 70cm cable) 2 P675 Zinc Air batteries (4 days), Rechargeable batteries, Remote battery pack (40, 70cm cable) Saphyr SP with 2 zincair batteries: up to 60 hours Saphyr CX: up to 30 hours Standard BTE with 3 zinc-air cells up to 36 hours: Bodyworn with 2 AAA cells: Neuro Zti Digisonic SP Digisonic SP CS-10A Water Resistance IP54 IP68 with WaterWear for BTE IP54 IP68 with WaterWear for BTE (only CI stimulation) IP68 with WaterWear for RONDO Coatings of circuit boards to prevent contact of humidity with electronic components Coatings of circuit boards to prevent contact of humidity with electronic components Coatings of circuit boards to prevent contact of humidity with electronic components IP54 IP68 with Aqua+ for Kanso IP57 with rechargeable IP44 with zinc air IP68 with AQUA+ IP57 with rechargeable IP44 with zinc air IP68 with AQUA+ IP44 with Acoustic Component receiver outlet closed IP57 IP68 with AquaCase IP57 IP68 with AquaCase IP57 IP68 with AquaCase IP68 coating (tropicalization) IP 44 RELIABILITY

10 Regular reporting of audio reliability (to be released soon) (to be released soon) Reliability documentation Internet Internet Internet Internet Internet dical.com/cochlearimplants/safe-andproven/reliability/relia bility.aspx dical.com/cochlearimplants/safe-andproven/reliability/relia bility.aspx Reporting intervals (months) unkwn unkwn Parameter reported average Monthly Service Rate average Monthly Service Rate average Monthly Service Rate average Monthly Service Rate average Monthly Service Rate t yet Monthly Service Rate SERVICE Global Warranty [years] unkwn unkwn unkwn unkwn

11 CI Comparison Chart: Remote Controls FineTuner Remote Assistent CR210 "simple control" Remote Assistent CR230 "advanced control" Remote Assistant CR110 AB my Pilot Com Pilot Neurelec Nurotron FEATURES User Interface direct access to all features, one button per function different languages are available mainly menu driven, direct access only to limited number of more important features visual confirmation colour display Adjust / Connects to AP wirelessly to other audio devices. Display/Status Lights / Indicators / Warnings 3 lights (2 amber, 1 red) for indications and warnings (visible if paired with, display shows low battery of RA, displayed on a larger display as CR210, troubleshooting with (check of connectivity to, sw-update of remote control, indicator light for battery status of remote control) (battery status of each and of the remote control is visible) display Monitoring of status FineTuner command is confirmed by the (blinking of indicatior light) different languages are available ( status - e.g. cable to coil is ok, battery status, audio input level) ( status check) + to increase - to decrease Volume Control / Microphone Sensitivity Control "up/down loudspeaker symbol" for volume or sensitivity together or separately (via direct control, with display of actual volume) unilaterally and bilaterally/ sensitivity is also changeable unilaterally, bilaterally and bimodally Lock / Unlock Keypad (direct control, 1 single button) (manual or automatically after 20 sec) (press the Connect and Home button simultaneously) on / off Change Programs 3 separate buttons to select between mic, telecoil, both 4 programs can be selected, often used during initial phase special button for activating the telecoil but also automatically up/down arrows telecoil button manual or automatically, telecoil mix with microphone also available between 2 or 4 programs (direct control, 1 single button) (change between 'Focus', 'Music', 'Noise' and 'Everyday') telecoil - integrated in the neckloop - in 2 lenghts available - unilaterally, bilaterally and bimodally; the "M"button to switch the programm Control for Bilateral patients Yes Yes Coil Sensor Speaker No Reset Button - the "Home" button returns to the startup Connectivity to IT environment USB for charging, also on a computer and port for future develpements USB cable socket (for charging battery) Mini USB (for charging) Mini USB (for charging) Connectivity to audio environment audiocable (also in a mix mode usable) with 3,5 mm euro plug streams automatically music, calls, FM via bluetooth or with 3.5mm euro plug Moisture Protection IP 44 IP 57 Accessories DIMENSIONS Overall Dimensions [mm x mm x mm] Pouch Skins (stickers) protective case Pouch with belt clip Short neckloop (51 cm) Phonak TVLink S basestation Audio cable, 1.5 m / 5 ft USB cable, 3 m / 10 ft. 88.5x54.0x6.3 66x36x10,5 110x46,1x x 45 x ~10 88 x 51 x 15 mm 71,8 x 49,2 x 14,2 mm Weight [g] ~ SERVICE Global Warranty [years] unkwn unkwn

12 CI Comparison Chart: Clinical Systems MAESTRO System Software 6.0 CustomSound In addition to CutomSound (for evoked potentials) CustomSound EP SoundWave 2.3 DigiMap 4.0 Nurotron TASKS Telemetry Measurement IFT Telemetry Impediance Implant Check Impedance Measurement IFT Impedance measurement Auditory Nerve Measurement ART Auto NRT Auto NRT NRI Neuro ECAP Stapedius Response ESRT - ESRT ESRT ESRT ESRT Brainstem EABR - EABR EABR EABR unkwn Audiogram Task unkwn unkwn Cortically Evoked Potentials CEP unkwn unkwn Sound Coding Strategies Modes -p FSP HD- Training Mode Intra-Operative Mode Live Mode Talk Mode Training Mode Intra-Operative Mode Live Mode Talk Mode unkwn HiRes 120-S HiRes 120-P HiRes-S HiRes-P MPS Training Mode Intra-Operative Mode Live Mode Talk Mode CrystalisCAP CrystalisXDP MpisCAP MPISXDP EAS unkwn unkwn, APS virtual channel (Symphony) unkwn Remote Programming unkwn Unkwn TOOLS coupling check unkwn Media Manager unkwn Visual Reinforcement Tool VRA unkwn unkwn unkwn unkwn FITTING TASK Bilateral unkwn shaping tools unkwn hearing mentor unkwn unkwn reports unkwn frequency bands Yes FRONT END PROCESSING Directionality unkwn natural directionality mode with T-mic unkwn adaptive directionality mode unkwn automatic directionality mode unkwn unkwn wind ise reduction unkwn ise reduction datalogging unkwn unkwn Automatic changing of front end features unkwn Scene Classifier unkwn EAS unkwn REQUIRED HARDWARE Interface MAX Programming Pod Programming Pod Clinical Programming Interface (CPI-3) DigiMap USB Adaptor (Chinese Interface) Audio streaming unkwn unkwn Bilateral unkwn Power USB port USB port USB port USB port USB port unkwn SOFTWARE Online Software Registration/Portal