product specification sophono alpha 2 mpo processor€¦ · product specification sophono®...

2
PRODUCT SPECIFICATION SOPHONO ® ALPHA 2 MPO PROCESSOR Feature Details Alpha 2 MPO processor Placement Either side, with ergonomic grip design Headband Configuration Yes Softband Configuration Yes Abutment-Free Yes Digital Signal Processor Yes Data Logging Yes 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 Auto Noise Reduction Yes Auto Feedback Suppression Yes Frequency Range 125 - 8000 Hz Processor 16-band, 8-channel WDRC Power Supply Type 13 zinc air battery Battery Life Up to 320 hrs Peak Output Force Level 3 115 dB at 90 dB SPL re 1µN Output Force Level 3 105 dB at 60 dB SPL re 1µN Audible Warning Tones Yes Colors Anthracite, Brown, Champagne, Silver Skinit ® Decal Gift card for one pair included Abutment-Free Bone Conduction with up to 45dB of Feedback Free Gain 1 Kohan, D. Implantable Auditory Devices. Presented at the Ultimate Colorado Midwinter Meeting; Vail, CO; Feb. 3, 2015 2 Sophono internal validation testing of battery life. 3 Comparing published transcutaneous device specifications of acoustic-mechanical gain at 1.6 kHz and 60 dB SPL Abutment-free hearing with no sacrifice in performance. 1 Now with a peak output of 115 dB, the Sophono Alpha 2 MPO gives your patients uncompromised sound with four programs, eight channels, and up to 320 hours battery life. 2 Compared with other transcutaneous hearing systems: § Up to 7dB more feedback free gain compared to other transcutaneous devices. 3 § Sophono has the lowest processor profile, a sleek solution that may be hidden under the hair. The Alpha 2 MPO magnetic bone conduction system features a titanium encased magnetic implant, an external processor, and Attract ® magnetic spacers with variable strength to ensure patient comfort and secure fit. All Sophono products are specifically designed for amplification of sound force through the skin into the bone. We call this Transcutaneous Energy Transfer (TET ). Four Program Choices Two Microphones Programming Port Direct Audio Input Connector Safety Line Anchor Volume Control Symmetrical Form Factor Tamper-proof Battery Door

Upload: others

Post on 14-Jun-2020

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: PRODUCT SPECIFICATION SOPHONO ALPHA 2 MPO PROCESSOR€¦ · PRODUCT SPECIFICATION SOPHONO® MAGNETIC IMPLANT Feature Details Samarium Cobalt magnets sealed in titanium Dimensions

PRODUCT SPECIFICATIONSOPHONO®

ALPHA 2 MPO™ PROCESSOR

Feature Details Alpha 2 MPO processor Placement Either side, with ergonomic grip design HeadbandConfiguration Yes SoftbandConfiguration Yes Abutment-Free Yes DigitalSignalProcessor Yes DataLogging Yes 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 AutoNoiseReduction Yes AutoFeedbackSuppression Yes Frequency Range 125 - 8000 Hz Processor 16-band, 8-channel WDRC Power Supply Type 13 zinc air battery Battery Life Up to 320 hrs Peak Output Force Level3 115 dB at 90 dB SPL re 1µN Output Force Level3 105 dB at 60 dB SPL re 1µN AudibleWarningTones Yes Colors Anthracite, Brown, Champagne, Silver Skinit® Decal Gift card for one pair included

Abutment-Free Bone Conduction with up to 45dB of Feedback Free Gain

1 Kohan, D. Implantable Auditory Devices. Presented at the Ultimate Colorado Midwinter Meeting; Vail, CO; Feb. 3, 2015

2 Sophono internal validation testing of battery life.3 Comparing published transcutaneous device

specifications of acoustic-mechanical gain at 1.6 kHz and 60 dB SPL

Abutment-free hearing with no sacrifice in performance.1

Now with a peak output of 115 dB, the Sophono Alpha 2 MPO gives your patients uncompromised sound with four programs, eight channels, and up to 320 hours battery life.2

Compared with other transcutaneous hearing systems:

§ Up to 7dB more feedback free gain compared to other transcutaneous devices.3

§ Sophono has the lowest processor profile, a sleek solution that may be hidden under the hair.

The Alpha 2 MPO magnetic bone conduction system features a titanium encased magnetic implant, an external processor, and Attract® magnetic spacers with variable strength to ensure patient comfort and secure fit.

All Sophono products are specifically designed for amplification of sound force through the skin into the bone. We call this Transcutaneous Energy Transfer (TET™).

Four Program Choices

Two Microphones

Programming Port

Direct Audio Input Connector

Safety Line Anchor

Volume Control

Symmetrical Form Factor

Tamper-proof Battery Door

Page 2: PRODUCT SPECIFICATION SOPHONO ALPHA 2 MPO PROCESSOR€¦ · PRODUCT SPECIFICATION SOPHONO® MAGNETIC IMPLANT Feature Details Samarium Cobalt magnets sealed in titanium Dimensions

PRODUCT SPECIFICATIONSOPHONO®

MAGNETIC IMPLANT

Feature Details Samarium Cobalt magnets sealed in titanium

Dimensions 39 mm L x 16 mm W x 2.6 mm H x 10 mm D1

Weight 3.5 grams1

Abutment-Free Yes,Implanttechniqueundertheskin

LowProfile Yes,2.6mmheight1

MRI Shadow 5 cm, Smallest MRI shadow3

MRIConditional Yes,staticmagneticfieldof3Teslaorless3,4

MRI Gradient Field Yes,spatialgradientfield720Gauss/cmorless

Implant Kit Sterile double blistered package containing

implant, implant template, surgical template

Standard Mastoidectomy tools Yes,nospecialtoolsrequired

Surgical Steps Seven

Implant frame Biocompatible titanium case

Configuration Followsthecontouroftheskull

Warranty 2 years (industry standard)

Abutment-Free Bone Conduction with the Smallest Magnetic Implant2

1 Data on file2 Siegert R., M.D., Semi-implantable transcutaneous

bone conduction hearing device with fitting on the day of surgery, Presented at the 29th Politzer Society Meeting Antalya, Turkey, Nov 2013

3 Internal Test Report, Evaluations of Magnetic Field Interactions, Hearing and Artifacts for the Alpha 1 (M) Magnetic Implant, Frank G. Shellock, Ph.D, FACR, FISMRM, August 10, 2012

4 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) 512–519

5 Siegert R and Kanderske J. A new semi-implantable transcutaneous bone conduction device: clinical, surgical and Audiological outcomes in patients with congenital ear canal atresia. Otology & Neurology. 2013, 34:927-934

Sophono® and The Leader in Magnetic Bone Conduction Hearing® are registered trademarks of Medtronic, Inc. © 2016, Medtronic, Inc. S0774-00UC201603289aEN03.2016

Rx only. Refer to product instruction manual/package insert for instructions, warnings, precautions, and contraindications.For further information, please call Medtronic ENT at 800.874.5797 and/or consult Medtronic’s website at www.sophono.com

No other implant system - abutment or magnetic, offers the low profile and stability of the Sophono device.

Compared with other transcutaneous hearing systems:

§ Sophono boasts the smallest implant on the market (2.6 mm high).1

§ The implant is secure to the bone with 5 screws making it less likely to break, come loose or fall out during an impact.2

§ Our low profile implant follows the contour of the skull, ensuring a snug fit against the bone, resulting in a safer bone conduction implant.5

§ MRI compatible up to 3 Tesla and the smallest transcutaneous MRI shadow.3

Sophono Inc.5744 Central AvenueSuite 100Boulder, CO 80301

Now owned by

Only 2.6 mm high1