Navigation Links
Sophono Alpha 2 Hearing System Receives FDA Clearance for Use With MRI
Date:4/11/2013

BOULDER, Colo., April 11, 2013 /PRNewswire/ -- Sophono, Inc.– manufacturer of abutment-free, implantable, bone conduction hearing devices – has received clearance from the U.S. Food and Drug Administration for magnetic resonance imaging (MRI).

(Photo:  http://photos.prnewswire.com/prnh/20130411/PH92743LOGO)

With the clearance, individuals in the United States who have the Sophono Alpha 2™ System can undergo MRI – in both 1.5 and 3-tesla magnetic fields – without removing the magnetic implant. In January, the Sophono Alpha earned clearance for use in an MRI field for device wearers in Europe and other countries around the world by passing tests from ASTM International, the globally recognized leader in the development and delivery of international voluntary consensus standards.

"Worldwide clearance of the Alpha 2 device for MRI gives patients and providers full assurance that the Sophono Alpha implant will not need to be removed should the patient need to undergo MRI testing at any point in the future," says Jim Kasic , president and CEO of Sophono. "The absence of contraindications for MRI with the Sophono Alpha System is a great step forward for patients, as well as the physicians, audiologists and clinicians who serve those with hearing loss."

Sophono, Inc., is a Colorado-based medical device manufacturer. The Sophono Alpha 2 System is the only abutment-free, implantable, bone-anchored hearing system on the market, treating those with conductive hearing loss, mixed hearing loss and single-sided deafness. Fitted to the patient's head with the use of small, implantable magnets, the Sophono Alpha 2 eliminates the problems associated with other bone conduction hearing systems. These include drilling a hole in the patient's skull and installing a very noticeable screw that pokes out through the skin on the side of the head.

Sophono, Inc. (www.sophono.com)

Sophono, Inc., is a medical device manufacturer specializing in abutment-free, implantable, bone conduction hearing systems. The company's products are designed for individuals suffering from severe to profound hearing loss or impairment. The Sophono Alpha 2™ System is the only abutment-free, implantable, bone-anchored hearing system available today. Treating those with conductive hearing loss, mixed hearing loss, and single-ear deafness, the FDA-cleared Alpha 2 eliminates the problematic abutment of devices by using magnets to affix external sound processors.

Sophono corporate headquarters and manufacturing operations reside in Boulder, Colo. The company maintains an office in Germany, works with more than 20 distributors, and is actively selling in more than 30 countries.

Contacts:

Elissa Lewis , Sophono, 720-407-5160, Email  
Aimee Bennett , Fagan Business Communications, 303-843-9840, Email

This press release was issued through eReleases® Press Release Distribution. For more information, visit http://www.ereleases.com.


'/>"/>
SOURCE Sophono, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Sophono Names Global Sales and Marketing Vice President
2. Sanofi and Regeneron Report Positive Proof-of-Concept Data for Dupilumab, an IL-4R alpha Antibody, in Atopic Dermatitis
3. Actinium Pharmaceuticals Sponsors Webinar on Clinical Use of Alpha Immunotherapy
4. Alpha Imaging Acquires Clinical Applications Training Company
5. Actinium Pharmaceuticals and Philogen S.p.A. Announce Collaboration for Alpha Therapy Based Antiangiogenesis Program
6. Grifols Initiates Safety Study of Inhaled Alpha1-Proteinase Inhibitor (Human) Following Orphan Drug Designation for Cystic Fibrosis
7. Roger bridges the understanding gap for students with hearing loss
8. European Hearing Aids and Audiology Devices Market
9. Sonitus Medical Announces Affirmative Update Regarding Bone Conduction Oral Appliances in American Academy of Otolaryngology-Head and Neck Surgery Policy Statement on Implantable Hearing Devices
10. Neutronic Ear Introduces Worlds First Rechargeable-Powered Hearing Device
11. Producer Austin Chapman Reaches Millions with Inspiring Story on Hearing Loss; Launches Contest in Partnership with Phonak
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)...  NDS received FDA 510(k) clearance in May 2017 for its ... specifically designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... to support the improvement of patient outcomes, procedural efficiency, and the ... ... ...
(Date:10/4/2017)... -- According to the Centers for Disease Control and Prevention (CDC), influenza ... Care is helping communities across Massachusetts , ... no-cost* flu shots through the end of the month. *Some ... ... flu shot is by the end of October, according to the Centers ...
(Date:10/2/2017)... 2, 2017 Halo Labs announces the European launch of ... the HORIZON at MIBio 2017 in Cambridge, U.K ... particulate matter in biopharmaceutical samples with unprecedented speed and sensitivity while ... technique Backgrounded Membrane Imaging. ... HORIZON subvisible particle analysis system ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... The ... to promote standards of excellence for the field of eating disorders, announces the ... – 25, 2018 in Orlando, Florida at the Omni Resort at ChampionsGate. ...
(Date:10/13/2017)... ... ... Lori R. Somekh, founder of the Law Office of Somekh & Associates ... special needs planning attorneys. “Membership in ElderCounsel helps our office remain up to date ... elder law attorneys nationwide,” said Somekh. , ElderCounsel was founded by ...
(Date:10/13/2017)... N.J. (PRWEB) , ... October 13, 2017 , ... The ... Holly Day Market. Featuring a collection of specialty vendors and unique items from across ... personalized and quality-focused health and wellness services offered by the VNA. The boutique ...
(Date:10/13/2017)... ... 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, ... and least understood books in the Holy Scriptures, Revelation. The Book of Revelation paints ... for centuries. Many have tossed it off as mere rubbish, but Yisrayl Hawkins says ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to the Mission ... lost souls in the Philippines. “The Journey: From the Mountains to the Mission Field” ... the Bible. She has taught all ages and currently teaches a class of ladies ...
Breaking Medicine News(10 mins):