For Professionals BONEBRIDGE SYSTEM. Including BCI 601, SAMBA Audio Processor, BCI Lifts and BCI Sizer Kit

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1 For Professionals BONEBRIDGE SYSTEM Including BCI 601, SAMBA Audio Processor, BCI Lifts and BCI Sizer Kit

2 Selection Criteria for BONEBRIDGE BONEBRIDGE augments hearing by providing acoustic information to the inner ear via bone conduction. This is achieved by actuating a vibratory transducer, which is implanted in the mastoid bone. Conductive or Mixed Hearing Loss Frequency (Hz) BC 5 years old or above Hearing Level (db HL) Conductive or mixed hearing loss as indicated by audiometric testing with bone conduction thresholds within the shaded area (as shown in diagram) Anatomy that allows for appropriate placement of the BONEBRIDGE implant as determined by CT scan Absence of retro-cochlear and central auditory disorders Conductive and mixed hearing loss Single-sided Sensorineural Deafness Frequency (Hz) Hearing Level (db HL) Contralat. Ear Single-sided sensorineural deafness 5 years old or above Single-sided sensorineural deafness (air conduction in the contralateral ear should be equal to or better than 20dB HL as shown in diagram) Anatomy that allows for appropriate placement of the BONEBRIDGE implant as determined by CT scan Absence of retro-cochlear and central auditory disorders 2

3 Output Curves Output Curves for SAMBA BB Max. Output (OFL90) Max. Gain 3

SAMBA Audio Processor Design Meets Technology 30 mm 10 mm 35 mm Intelligent Hearing System Intelligent Sound Adapter Adaptive directional microphones Speech Tracking Wireless Connectivity*

Programs Up to 5 individual programs Remote Control Easy adjustment of the volume and change between the programs of SAMBA Optimized Fitting Procedure Fitting via battery pill or wireless

logistics Basic package of 9 covers shipped with SAMBA; users can individually adapt colour and design SYMFIT 7.

4 SAMBA Audio Processor Design Meets Technology 30 mm 10 mm 35 mm Intelligent Hearing System Intelligent Sound Adapter Adaptive directional microphones Speech Tracking Wireless Connectivity* Wireless connectivity options via bluetooth or telecoil to external devices such as mobile phones, FM-systems, ALDs etc. This function is possible by using the Siemens minitek TM. Programs Up to 5 individual programs Remote Control Easy adjustment of the volume and change between the programs of SAMBA Optimized Fitting Procedure Fitting via battery pill or wireless fitting Vibrogram for BONEBRIDGE and VIBRANT SOUNDBRIDGE Data-logging providing information about the usage of SAMBA Simplified Logistics Fewer audio processor variants which optimizes logistics Basic package of 9 covers shipped with SAMBA; users can individually adapt colour and design SYMFIT 7.0 Optimized workflow due to standardized fitting procedure for the BONEBRIDGE and SOUNDBRIDGE systems. With the new SYMFIT 7.0 software fitting can be carried out either wirelessly or via the battery pill. Additionally, Vibrograms can be created for the BONEBRIDGE as well as for the SOUNDBRIDGE systems. 4

BCI 601 The First Active Bone Conduction Hearing Implant Magnet Coil Anchor holes BC-FMT 28.6 mm Demodulator Transition Demodulator Transition 4.5 mm 23.8 mm 8.7 mm 69 mm 15.

processing provides excellent audiological outcomes Intact Skin Device The implant including the transducer is safely embedded under the skin The risk of skin infection is very low and no continuous

5 BCI 601 The First Active Bone Conduction Hearing Implant Magnet Coil Anchor holes BC-FMT 28.6 mm Demodulator Transition Demodulator Transition 4.5 mm 23.8 mm 8.7 mm 69 mm 15.8 mm World s First Active Bone Conduction Implant System Transcutaneous technology now available for bone conduction stimulation Direct drive bone conduction together with state-of-the-art signal processing provides excellent audiological outcomes Intact Skin Device The implant including the transducer is safely embedded under the skin The risk of skin infection is very low and no continuous skin care is needed Cosmetically appealing solution First Active Hearing Implant Where no Surgical Access to the Middle Ear is Necessary BONEBRIDGE is Available for Adults and Children Aged 5 Years or Above MR Conditional up to 1.5 Tesla 5

BCI Lifts and BCI Sizer Kit BCI Lifts As the anatomy can differ considerably between patients the use of BCI Lifts may be required when implanting BONEBRIDGE.

3mm 4mm Advantages Greater surgical flexibility Solution for anatomical variations Can help avoid uncovering sigmoid sinus / dura Less drilling depth required 1mm 2mm BCI Sizer Kit The BCI Sizer Kit

6 BCI Lifts and BCI Sizer Kit BCI Lifts As the anatomy can differ considerably between patients the use of BCI Lifts may be required when implanting BONEBRIDGE. For patients who present a smaller skull or present more variable anatomy, the BCI Lifts can help avoid uncovering the dura or sigmoid sinus, as less drilling depth is required. 3mm 4mm Advantages Greater surgical flexibility Solution for anatomical variations Can help avoid uncovering sigmoid sinus / dura Less drilling depth required 1mm 2mm BCI Sizer Kit The BCI Sizer Kit is shipped in its own sterile packaging and can therefore be opened and used to assess the position of BONEBRIDGE and whether BCI Lifts are required, before the BCI Implant Kit is opened in the surgical field. Advantages Simple assembly Packaged separately to implant Assists with surgical decisions Depth-Gauge-Handle Depth-Gauge Flat-Transducer-Sizer Coil-Sizer 6

7 Technical Data SAMBA Audio Processor Dimensions see figure on page 4 Weight < 9 g (incl. battery) Material in Tissue Contact Eastman Tritan Copolyester MX731 Power Supply Power supply of the audio processor: One non-rechargeable 675 zinc-air button cell with a nominal 1.4-Volt supply and 600mA-Hrs of capacity Power supply of the remote control: Two AAA batteries Audio Frequency Range 250 Hz to 8 khz Signal Processing 16-band Digital Equalizer 16 independent Compression Channels Sound Smoothing Speech and Noise Management Adaptive directional microphones Intelligent Sound Adapter Classifier 5 different programs Wind Noise Reduction Controls SAMBA Remote Control Turn off the system by opening the battery case Wireless Technology (from Remote Control to Audio Processor) Type: NFMI (near field magnetic induction) Frequency: 3.26 MHz Modulation type: FM Wireless range: 1 m Microphone Features Ambient Sound Adaptive directional microphones Speech Tracking Omnidirectional microphones Basic Package of Covers (Shipped with SAMBA) Simply Black Glossy Black Chocolate Brown Mahogany Terra Brown Golden Sand Light Blond Silver Grey Tweed BCI 601 Dimensions See figure on page 5 Weight 25 g Materials Materials in contact with the body: medical grade silicone elastomer, titanium grade 5 (per ASTM F 136) C-Sizer and T-Sizer Materials in contact with the body: polypropylene (PP), (implant grade stainless steel Drill Bit Connection: standard dental coupling Diameter 1.5 mm, maximum drilling depth 3.9 mm (limited by stopper when used in conjunction with the T-Sizer as a drill guidance) Materials in contact with the body: (stainless steel) Screws Regular screws: 2 x 6 mm, golden surface finish Emergency screw: 2.4 x 6 mm, blue surface finish Materials in contact with the body: Ti6Al7Nb (per ASTM F1295) MRI Conditions MR Conditional up to 1.5 Tesla Content of Implant Kit Bone Conduction Implant (BCI 601) C-Sizer T-Sizer Cortical screws (2 regular screws, 1 emergency screw) Drill bit with stopper (requires handpiece with dental coupling) BCI Lifts and Sizer Kit BCI Lifts Materials BCI Lifts: OXPEKK-IG200 Cortical screws: Ti 6AI 7Nb (titanium alloy) Dimensions See page 6 Single-use device. Do not reuse! BCI Sizer Materials Flat-Transduer-Sizer: Tritan MX731 with 1,5 % MasterBatch 8825 Tritan laser natur; (implant grade stainless steel) Depth-Gauge: Tritan MX731 with 1,5 % MasterBatch 8825 Tritan laser natur Depth-Gauge-Handle: Tritan MX731 with 1,5 % MasterBatch 8825 Tritan laser natur Coil-Sizer: Polypropylene (PP) Purell HP 371 P natural Single-use device. Do not reuse! The BCI Sizer Kit contains the Coil-Sizer Flat-Transducer-Sizer Depth-Gauge Depth-Gauge-Handle SYMFIT 7.0 System Requirements Windows XP, Windows Vista, Windows 7, Windows 8 Required hard disk space: 300 MB free storage (2 GB free storage recommended) 512 MB RAM (1 GB recommended) Graphics Display resolution (1280 x 1024 recommended) Programming Interface: HI-PRO / NOAH- Link / CONNEXX Link CD-ROM drive CONNEXX USB interface 1.1 (2.0 recommended) Different design covers additionally available. Visit More information on * Wireless connectivity feature is available with the Siemens minitek. Sivantos is not responsible for the operation with the SAMBA or its compliance with safety and regulatory standards in operation with the SAMBA. 7

8 MED-EL GmbH Niederlassung Wien MED-EL Deutschland GmbH MED-EL Deutschland GmbH Büro Berlin MED-EL Deutschland GmbH Office Helsinki MED-EL Unità Locale Italiana VIBRANT MED-EL Hearing Technology France MED-EL BE MED-EL GmbH Sucursal España MED-EL GmbH Sucursal em Portugal MED-EL UK Ltd MED-EL UK Head Office MED-EL UK London Office MED-EL Corporation, USA MED-EL Latino America S.R.L. MED-EL Colombia S.A.S. MED-EL Mexico MED-EL Middle East FZE MED-EL India Private Ltd MED-EL Hong Kong Asia Pacific Headquarters MED-EL Philippines HQ MED-EL China Office MED-EL Thailand MED-EL Malaysia MED-EL Singapore MED-EL Indonesia MED-EL Korea MED-EL Vietnam MED-EL Japan Co., Ltd MED-EL Australasia VIBRANT MED-EL Hearing Technology GmbH Fürstenweg Innsbruck, Austria medel.com

VIBRANT SOUNDBRIDGE SYSTEM

For Professionals VIBRANT SOUNDBRIDGE SYSTEM Including the SAMBA TM audio processor, the VORP 503 and the Vibroplasty Couplers. NEW Selection Criteria for the VIBRANT SOUNDBRIDGE Conductive and mixed hearing