For Professionals. SYNCHRONY EAS System. In Sync with Natural Hearing

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Laura Collins
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1 For Professionals SYNCHRONY EAS System In Sync with Natural Hearing

2 SYNCHRONY EAS System Electric Acoustic Stimulation The SYNCHRONY EAS System combines the SONNET EAS Audio Processor with the SYNCHRONY Cochlear Implant to deliver electric stimulation in the high frequencies and dedicated acoustic amplification across the low frequencies. With 6-channel acoustic amplification of up to 48 db across the low frequencies, SONNET EAS is the ideal solution for candidates with partial deafness. EAS Candidacy Electric Acoustic Stimulation is intended for candidates with partial deafness, also known as high-frequency hearing loss (HFHL). Partial deafness is a minimal or mild-to-moderate sensorineural hearing loss in the low frequencies that becomes a profound hearing loss in the high frequencies. By providing acoustic amplification in the low frequencies and electric stimulation in higher frequencies, the SYNCHRONY EAS System can provide effective stimulation to the whole cochlea. EAS enables recipients to experience restored hearing in the high frequencies while benefiting from their residual natural hearing. Intensity (db) Frequency (Hz) Air Conduction Threshold Candidates for EAS have minimal or mild-to-moderate low-frequency hearing loss sloping to profound hearing loss in the high frequencies. Candidacy may vary, please consult your local MED-EL representative.

Conditionally MRI safe at 0.2, 1.0, 1.5, and even 3.

3 SYNCHRONY Cochlear Implant 3.0 Tesla MRI Without Magnet Removal * Combining the highest cochlear implant MRI safety with proven performance and the most comprehensive portfolio of atraumatic electrodes available. Conditionally MRI safe at 0.2, 1.0, 1.5, and even 3.0 T without the need for magnet removal Rotatable, self-aligning magnet greatly reduces torque for increased patient comfort during MRI scans If necessary, the magnet can be removed to minimise image distortion on MRI head scans The magnet can only be removed from the bottom side of the implant, making dislocation of the magnet due to trauma almost impossible SYNCHRONY PIN implant features titanium fixation pins to secure the placement of the implant FLEX Series Electrodes Preserving Residual Hearing For EAS candidates, it is especially vital to protect the delicate structures of the cochlea to ensure that residual hearing is preserved. Specifically engineered to ensure cochlear integrity, FLEX Series electrodes are the most atraumatic electrode arrays available. Unique FLEX-Tip Technology features single contacts at the leading end, ultra-flexible wave-shaped wires, and a tapered tip for increased mechanical flexibility. Recent studies demonstrate that flexible MED-EL electrode arrays, when combined with proper surgical techniques, enable significant preservation of residual natural hearing. 1,2,3,4,5,6,7,8 Individuals with Hearing Preservation (%) n=18 n=6 n=20 n=5 n=22 n=14 n=19 n=32 Adunka Carvalho Erixon Mahmoud 2014 Rajan 2012 Santa M Tamir 2012 Usami 2014

For more natural hearing in any listening environment SONNET EAS Audio Processor Delivering exceptional hearing in any listening environment for a more natural hearing experience, SONNET

Adaptable EAS/CI audio processor 6-channel acoustic amplification with gain of up to 48 db and an MPO of 118 db SPL Water-resistant and tamper-proof Automatic Sound Management 2.

4 For more natural hearing in any listening environment SONNET EAS Audio Processor Delivering exceptional hearing in any listening environment for a more natural hearing experience, SONNET EAS minimises the need to manually adjust settings or change programs. Adaptable EAS/CI audio processor 6-channel acoustic amplification with gain of up to 48 db and an MPO of 118 db SPL Water-resistant and tamper-proof Automatic Sound Management 2.0 actively adapts to changing listening environments Dual microphones provide Wind Noise Reduction and Microphone Directionality Up to 60 hours of battery life without a trade-off in processor performance Fully compatible with all multi-channel MED-EL implants Integrated link-check coil function with LED indicator

Expanded 6-channel EAS fitting allows more specific maps to be created, and both the acoustic and electrical component can be programmed simultaneously.

5 MAESTRO System Software 6.0 Fittings Made Quick & Easy The MAESTRO System Software 6.0 with the MAX Programming Interface enables quick and easy programming of the SYNCHRONY EAS System. Expanded 6-channel EAS fitting allows more specific maps to be created, and both the acoustic and electrical component can be programmed simultaneously. SONNET Audio Processor can be programmed with 4 specific maps to ensure optimal hearing performance in any listening environment. Programmable Microphone Directionality and Wind Noise Reduction. Features Datalogging, including usage time and volume range of each selectable program. Supports all currently available MED-EL multi-channel cochlear implants and audio processors.

Technical Data SYNCHRONY EAS System Stimulation Features Sequential non-overlapping stimulation on 12 electrode channels Simultaneous (parallel) stimulation on 2 12 electrode channels 24 independent

67 μs Current range (nominal value): 0 1200 µa per pulse phase Pulse Shapes Biphasic, symmetric triphasic and triphasic precision pulses Comprehensive Diagnostic Toolkit Status Telemetry Impedance

9 mm 165 45.7 mm 4.5 mm 56.7 mm ø 1.0 mm 25.4 mm 1.4 mm 9.3 mm SYNCHRONY Implant (Mi1200) Electrode Arrays SONNET EAS Audio Processor (Me1320) MAESTRO System Software 6.

6 Technical Data SYNCHRONY EAS System Stimulation Features Sequential non-overlapping stimulation on 12 electrode channels Simultaneous (parallel) stimulation on 2 12 electrode channels 24 independent current sources Stimulation rates of up to 50,704 pulses per second Range of pulse phase duration: μs/phase Time resolution (nominal values): 1.67 μs Current range (nominal value): µa per pulse phase Pulse Shapes Biphasic, symmetric triphasic and triphasic precision pulses Comprehensive Diagnostic Toolkit Status Telemetry Impedance and Field Telemetry (IFT) Auditory Nerve Response Telemetry (ART ) Electrically Evoked Auditory Brainstem Response (EABR) Electrically Evoked Stapedius Reflex Threshold (ESRT) 3.3 mm 37.4 mm 5.9 mm mm 4.5 mm 56.7 mm ø 1.0 mm 25.4 mm 1.4 mm 9.3 mm SYNCHRONY Implant (Mi1200) Electrode Arrays SONNET EAS Audio Processor (Me1320) MAESTRO System Software 6.0 Housing Design Impact resistance > 2.5 Joule Unique fixation pins for additional stability Recommended flattening depth for the stimulator: 0.9 mm Stimulator: 17.3 mm x 25.4 mm x 4.5 mm (typical) Coil: 29.0 mm diameter x 3.3 mm thick (typical) Weight: 7.6 g Safety Features Output capacitors for each channel Unique Implant ID (IRIS) MRI Conditions* MR Conditional at 0.2, 1.0, 1.5 and 3.0 Tesla No magnet removal required even at 3.0 Tesla Removable Magnet Magnet removable for minimised image distortion Rotatable magnet within hermetic titanium housing Self-aligning to external magnetic field Conical shape for secure placement FLEX Series FLEX SOFT 26.4 mm stimulation range Diameter at basal end: 1.3 mm 0.5 x 0.4 mm FLEX mm stimulation range Diameter at basal end: 0.8 mm 0.5 x 0.4 mm FLEX mm stimulation range Diameter at basal end: 0.8 mm 0.5 x 0.3 mm FLEX mm stimulation range Diameter at basal end: 0.8 mm 0.5 x 0.3 mm Product Features Acoustic stimulation up to 2 khz 48 db acoustic gain 118 db SPL maximum power output (MPO) Fully digital hearing aid signal processing 6-channel acoustic fitting Splash-proof design with IP54 rating Dual microphones Datalogging Automatic Sound Management 2.0 (ASM 2.0) Microphone Directionality Wind Noise Reduction Automatic Volume Control with Dual-Loop AGC Tamper-proof design with integrated child safety features Link-check coil function with LED indicator Battery Life Up to 60 hours of use with a set of 2 zinc-air batteries Connectivity Wireless-ready for 2.4 GHz applications Integrated telecoil Direct connection with FM battery cover (standardised Euro-Audio 3-pin connection) System Requirements PC or laptop/notebook with supported Microsoft Windows operating system** Dual-core processor of 1.6 GHz or higher 2 GB RAM 2 GB free disk space Display with a minimum resolution of ( recommended) High-power USB port 2.0 or higher Connection to printer for hardcopy reports CD ROM drive for software installation * It has been demonstrated that no known hazards exist in specified MRI environments under conditions as described in the SYNCHRONY Cochlear Implant product labeling. ** Supported Microsoft Windows operating systems: Microsoft Windows XP, Service Pack 3 or higher, Microsoft Windows Vista, Service Pack 2 or higher, Microsoft Windows 7, Service Pack 1 or higher, Microsoft Windows 8 or higher 1 Adunka, O.F., Dillon, M.T., Adunka, M.C., King, E.R., Pillsbury, H.C., & Buchman, C.A. (2014). Cochleostomy versus Round Window insertions: Influence on functional outcomes in Electric-Acoustic Stimulation of the auditory system. Otol Neurotol., 35, de Carvalho, G.M., Guimaraes, A.C., Duarte, S.M., Muranaka, E.B., Soki, M.N., Martins, Castilo, A.M. () Hearing preservation after cochlear implantation: UNICAMP outcomes. Int J Otolaryngol. Article ID Erixon, E., Kobler, S., Rask-Andersen, H. (2012) Cochlear implantation and hearing preservation: Results in 21 consecutively operated patients using the round window approach. Acta Otolaryngol., 132(9), Mahmoud, A.F., Massa, S.T., Doublerly, S.L., Montes, M.L., & Ruckenstein, M.J. (2014) Safety, efficacy, and hearing preservation using an integrated electro-acoustic stimulation hearing system. Otol Neurotol., 35(8), Rajan, G.P., Kuthubutheen, J., Hedne, N., & Krishnaswamy, J. (2012) The role of preoperative, intratympanic glucocorticoids for hearing preservation in cochlear implantation: A prospective clinical study. Laryngoscope, 122(1), Santa Maria, P.L., Domville-Lewis, C., Sucher, C.M., Chester-Browne, R., & Atlas, M.D. (). Hearing preservation surgery for cochlear implantation hearing and quality of life after 2 years. Otol Neurotol., 34(3), Tamir, S., Ferrary, E., Borel, S., Sterkers, O., & Bozorg, G.,A. (2012). Hearing preservation after cochlear implantation using deeply inserted FLEX atraumatic electrode arrays. Audiol. Neurootol., 17(5), Usami, S., Moteki, H., Tsukada, K., Miyagawa, M., Nishio, S., Takumi, Y., Tono, T. (2014) Hearing preservation and clinical outcome of 32 consecutive electric acoustic stimulation (EAS) surgeries. Acta Otolaryngol., 134(7), r3.1 MED-EL Medical Electronics Fürstenweg 77a 6020 Innsbruck, Austria office@medel.com medel.com

For Professionals. SYNCHRONY System. In Sync with Natural Hearing

For Professionals. SYNCHRONY System. In Sync with Natural Hearing For Professionals SYNCHRONY System In Sync with Natural Hearing For more natural hearing in any listening environment SONNET Audio Processor RONDO Single-Unit Processor Designed for exceptional hearing