CLEAR SOUND. IMPROVED POWER. MORE FREEDOM. Alpha 2 MPO eplus Magnetic Bone-Anchored Hearing Device

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Gordon Norton
5 years ago
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1 CLEAR SOUND. IMPROVED POWER. MORE FREEDOM. Alpha 2 MPO eplus Magnetic Bone-Anchored Hearing Device

HEARING LOSS IS COMPLEX. Each patient s journey is unique. HEARING EVOLVED.

canal stenosis Chronic otitis media Chronic drainage of ears Otitis externa Chronic mastoiditis Cholesteatoma Otosclerosis Ossicular disease

Ototoxicity RESTORATIVE TECHNOLOGY FOR BETTER QUALITY OF LIFE Improved convenience and power 1 Rechargeable system provides up to 1-year

2 HEARING LOSS IS COMPLEX. Each patient s journey is unique. HEARING EVOLVED. Introducing Alpha 2 MPO eplus Magnetic Bone-Anchored Hearing Device CONDUCTIVE HEARING LOSS Congenital aural atresia and microtia Auditory canal stenosis Chronic otitis media Chronic drainage of ears Otitis externa Chronic mastoiditis Cholesteatoma Otosclerosis Ossicular disease SINGLE-SIDED DEAFNESS Sudden idiopathic deafness Meniere s disease Acoustic neuroma Surgical intervention Neurological degenerative disease Ototoxicity RESTORATIVE TECHNOLOGY FOR BETTER QUALITY OF LIFE Improved convenience and power 1 Rechargeable system provides up to 1-year battery life 2 Low risk of skin issues 3 Uses the body s natural ability to transfer sound through bone conduction 4 Lowest profile processor and implant Processor s discreet design can be hidden from view under the hair 5

HAIR REMOVAL 8 REDUCED SKIN INFECTION RISKS KEEP LIFE SIMPLE 3 THEY NEED THE BEST SCHOOL EXPERIENCE AND EQUAL LEARNING

3 CHILDREN & TEENAGERS Alpha 2 MPO eplus is the sound choice. ADULTS WITH ACTIVE LIFESTYLE FEWER SURGERIES AND MORE ENCOURAGING OUTCOMES 5,6,7 LITTLE TO NO VISIBLE ABUTMENT OR PERMANENT HAIR REMOVAL 8 REDUCED SKIN INFECTION RISKS KEEP LIFE SIMPLE 3 THEY NEED THE BEST SCHOOL EXPERIENCE AND EQUAL LEARNING CHANCES THEY DESERVE TO PLAY WITH THEIR FRIENDS WITHOUT THINKING ABOUT THEIR DIFFERENCE THEIR PARENTS ARE LOOKING FOR AN ABUTMENT-FREE SOLUTION WITH REDUCED INFECTION RISKS FOR THEIR CHILDREN

THE SOUND CHOICE Alpha 2 MPO eplus Magnetic Bone-Anchored Hearing Device The

for people with mixed, conductive hearing loss or single-sided deafness (SSD).

CONVENIENCE MORE GAIN THAN EVER SAFETY & SIMPLICITY Long-lasting battery life up

skin issues 3 Providing a significant hearing and speech recognition improvement

4 THE SOUND CHOICE Alpha 2 MPO eplus Magnetic Bone-Anchored Hearing Device The Alpha 2 MPO eplus provides significant hearing and speech recognition improvement for people with mixed, conductive hearing loss or single-sided deafness (SSD). 1,9 RECHARGEABLE BATTERY CHARGER BASE STATION RECHARGEABLE BATTERY MAGNETIC CONVENIENCE MORE GAIN THAN EVER SAFETY & SIMPLICITY Long-lasting battery life up to 1 year 2 Powered by the lowest profile processor with no abutment Low risk of skin issues 3 Providing a significant hearing and speech recognition improvement 9,10 Simple, minimally invasive surgery and the smallest MRI shadow 11 UP to 3 TESLA MRI 12,13

MEDTRONIC HEARING RESTORATION PORTFOLIO PRODUCT SPECIFICATIONS PRODUCT SPECIFICATION

Alpha 2 MPO eplus processor With our hearing restoration portfolio, we are dedicated to

Configuration Yes Abutment-Free Yes 4 PROGRAM SWITCH TWO MICROPHONES Digital Signal

COMPACT FOR LATERAL SKULL BASE SURGERY VENT TUBES FOR MYRINGOTOMY NIM 3.

isolated compartment with omni- and directional modalities Direct Audio Input Standard

Noise Reduction Yes Auto Feedback Suppression Yes Frequency Range 125-8000 Hz Processor

PISTONS FOR STAPEDECTOMY INDIGO OTOLOGY DRILL FOR MASTOIDECTOMY MEROCEL / MEROGEL FOR EAR

Type 13 zinc air battery or ZPower Rechargeable battery Zinc Air Battery Up to 250 hrs

re 1µN 121 db Output Force Level 2 at 60 db SPL re 1µN 105 db Audible Warning Tones Yes

HOW IT WORKS The Medtronic implant is placed under the skin above and behind the ear.

5 MEDTRONIC HEARING RESTORATION PORTFOLIO PRODUCT SPECIFICATIONS PRODUCT SPECIFICATION Abutment-Free Bone Conduction with the Smallest Implant on the Market Feature Details Alpha 2 MPO eplus processor With our hearing restoration portfolio, we are dedicated to supporting patients during their entire journey. ALPHA 2 MPO eplus LOW PROFILE FOR CONDUCTIVE HEARING LOSS OR SINGLE SIDED DEAFNESS Placement Either side, with ergonomic grip design Headband Configuration Yes Softband Configuration Yes Abutment-Free Yes 4 PROGRAM SWITCH TWO MICROPHONES Digital Signal Processor Yes Data Logging Yes PROSTHESIS FOR OSSICULAR CHAIN RECONSTRUCTIONS FUSION COMPACT FOR LATERAL SKULL BASE SURGERY VENT TUBES FOR MYRINGOTOMY NIM 3.0 FOR ACOUSTIC NEUROMAS, MENINGIOMAS Programs/Memories 4 Microphone Two microphones in an isolated compartment with omni- and directional modalities Direct Audio Input Standard Europlug Retention Clip and Lanyard Standard VOLUME CONTROL TAMPERPROOF BATTERY DOOR Auto Noise Reduction Yes Auto Feedback Suppression Yes Frequency Range Hz Processor 16-band, 8-channel WDRC PROGRAMMING PORT DIRECT AUDIO INPUT CONNECTOR SAFETY LINE ANCHOR PISTONS FOR STAPEDECTOMY INDIGO OTOLOGY DRILL FOR MASTOIDECTOMY MEROCEL / MEROGEL FOR EAR PACKING AND DRESSING EPIDISC / EPIFILM FOR TYMPANIC MEMBRANE PERFORATIONS Power Supply Type 13 zinc air battery or ZPower Rechargeable battery Zinc Air Battery Up to 250 hrs ZPower Battery Up to a full day on one full charge Peak Output Force Level 2 at 90 db SPL re 1µN 121 db Output Force Level 2 at 60 db SPL re 1µN 105 db Audible Warning Tones Yes Colors Anthracite, Brown, Champagne, Silver Skinit Decal Gift card for one pair included HOW IT WORKS The Medtronic implant is placed under the skin above and behind the ear. After healing, the skin and hair look normal, with no abutment protruding through the skin like other bone conduction systems. The implant consists of two magnets hermetically sealed in a titanium case. The external processor houses a bone oscillator and uses a metal disc and spacer shim to magnetically couple to the internal component and deliver auditory stimulation through the closed skin.

6 PRODUCT CONFIGURATION PROCESSORS BASEPLATES & RACETRACK Alpha 2 MPO eplus, Brown, SO Alpha 2 MPO eplus, Champagne (Beige), SO Alpha 2 MPO eplus, Anthracite (Black), SO Alpha 2 MPO eplus, Silver, SO IMPLANT Alpha Implant Kit SO Sterile, MRI Conditional HEADBAND & SOFTBAND Monaural Softband, Black, S Monaural Softband, White, S Monaural Softband, Cafe, S Monaural Softband, Pale Pink, S Binaural Softband, Black, S Binaural Softband, White, S Binaural Softband, Cafe, Binaural Softband, Pale Pink, S Monaural Headband, S FITTING Sophono NOAH Fitting Software CD, S Rev G Magnetic Retention Scale Kit w/weight, S0390 Baseplate, Black, -1-Dot Strength, S Baseplate, Black, 0-Dot Strength, S Baseplate, Black, 1-Dot Strength, S Baseplate, Black, 2-Dot Strength, S Baseplate, Black, 3-Dot Strength, S Baseplate, Black, 4-Dot Strength, S Baseplate, Black, 5-Dot Strength, S Baseplate, Black, 6-Dot Strength, S Baseplate, Black, 8-Dot Strength, S Baseplate, Black, 9-Dot Strength, S Baseplate, Black, 10-Dot Strength, S Baseplate, Black, 11-Dot Strength, S Baseplate Set, Black, 1-5 Dot Strength, S Baseplate, Natural, -1-Dot Strength, S Baseplate, Natural, 0-Dot Strength, S Baseplate, Natural, 1-Dot Strength, S Baseplate, Natural, 2-Dot Strength, S Baseplate, Natural, 3-Dot Strength, S Baseplate, Natural, 4-Dot Strength, S Baseplate, Natural, 5-Dot Strength, S Baseplate, Natural, 6-Dot Strength, S Baseplate Set, Natural, 1-5 Dot Strength, S Racetrack, S0394 ACCESSORIES (OPTIONAL NON-MEDICAL DEVICES) Black Nylon Retention Cord, S Blue Nylon Retention Cord, S Green Nylon Retention Cord, S Pink Nylon Retention Cord, S Purple Nylon Retention Cord, S Red Nylon Retention Cord, S Clear Nylon Retention Cord, S Bobcat Nylon Retention Cord, S Pediatric Care Kit, S0582 Cable DAI, S0613 HI PRO Programming Cable, S Specifications, designs, prices and availability are subject to change. Refer to product instruction manual/package insert for instructions, warnings, precautions, and contraindications. Sophono and The Leader in Magnetic Bone Conduction Hearing are trademarks of Medtronic, Inc. Copyright 2017 Medtronic, Inc. All rights reserved. SO EN, UC EN

7 References 1. Based on internal data for the Alpha 2 MPO to the Alpha 2 MPO eplus. 2. ZPower technical data on file. 3. Internal data on file. 4. Sophono Scientific White Paper: Transcutaneous Energy Transfer by Bone Conductors through the Skin 29 September Siegert, R., M.D., and Kanderske, J., A New Semi-Implantable Transcutaneous Bone Conduction Device: Clinical, Surgical, and Audiologic Outcomes in Patients with Congenital Ear Canal Atresia, Otol Neurotol Jul;34(5): Doi: /MAO.0b013e e5. 6. Friedland DR; Runge CL; Kerschner JA. Surgical implantation of the Sophono transcutaneous bone conduction system. Op Tech in Otolaryngology 2014, 25: Comparison of Two Different Sound Processors with a Transcutaneous Bone Conduction Hearing System in Single Sided Deafness Patients presented by Andrew de Jong M.D. at 29th Politzer Society Meeting, Antalya, Turkey, November 16, Baker S, Centric A, Chennupati SK. Innovation in abutment-free bone-anchored hearing devices in children: Updated results and experience. Int J Pediatr Otorhinolaryngol Oct;79(10): Amos NE, Humes LE. Contribution of high frequencies to speech recognition in quiet and noise in listeners with varying degrees. 10. Roden, D MD, MPH; Gallant, S MD; Friedmann, D MD; Kohan, D MD. Comparing Hearing Outcomes in Osseointegrated Implantable Auditory Devices, Presented at Combined Otolaryngology Spring Meetings (COSM) 2016 Chicago, IL. 11. Comparing published transcutaneous device specifications of image artifacts. 12. Internal Test Report: Evaluation of Magnetic Field Interactions, Heating and Artifacts for the Alpha 1 (M) Magnetic Implant. Frank G. Shellock. August 10, Azadarmaki R, Tubbs R, Chen DA, Shellock FG. MRI information of commonly used otologic implants: Review and update. Otolaryngology Head and Neck Surgery 2014, Vol. 150(4) Rx only. Refer to product instruction manual/package insert for instructions, warnings, precautions, and contraindications. For further information, please call Medtronic ENT at or consult Medtronic s website at Medtronic ENT 6743 Southpoint Drive N Jacksonville, FL USA Toll free: (800) Telephone: (904) Fax: (800) International Telephone Numbers Europe HQ Switzerland Latin America HQ Adriatic Region Argentina Australia Baltic Region Belgium Brazil Canada Chile China Colombia Czech Republic France Germany Greece Hong Kong Hungary India Israel Italy Japan Korea Lebanon Luxembourg Malaysia Mexico Netherlands Poland Russian Fed Singapore South Africa Spain Taiwan Thailand UK Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. UC EN

HELPING YOU HEAR. BRINGING YOU NEW SOUNDS. With Alpha 2 MPO eplus

HELPING YOU HEAR. BRINGING YOU NEW SOUNDS. With Alpha 2 MPO eplus OUR MISSION ALLEVIATE PAIN. RESTORE HEALTH. EXTEND LIFE. AMERICAS EUROPE, MIDDLE EAST, AFRICA EMEA GREATER CHINA ASIA PACIFIC 9,000+ SCIENTISTS