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:2/22/2017)... LONDON , Feb. 22, 2017 ... protrudes through the abdominal wall due to weak ... types, namely inguinal hernia, incisional hernia, femoral hernia, ... hernia). The hernia surgeries are performed ... material with the help fixation devices. Among the ...
(Date:2/22/2017)... 2017 Summary Provides understanding and ... entered into by the worlds leading healthcare companies. ... The Global Spinal Cord Partnering Terms and Agreements since ... and agreements entered into by the world,s leading healthcare ... - Top deals by value - Deals listed ...
(Date:2/22/2017)... YORK , Feb. 22, 2017 Summary ... neurone disease partnering deals and agreements entered into by ... report: http://www.reportlinker.com/p03605682-summary/view-report.html Description The Global Motor ... provides understanding and access to partnering deals and agreements ... - Trends in partnering deals - Top ...
Breaking Medicine Technology:
(Date:2/22/2017)... ... February 22, 2017 , ... The Waismann Method® is providing a ... have recently fallen victim to America’s opioid epidemic. Now, opiate dependent individuals can be ... are free from the shame, stigma, and harmful labeling believed to prevent ...
(Date:2/22/2017)... ... February 22, 2017 , ... The National Academy of ... with the April 2017 testing period. NACCM, a nonprofit organization, has provided the ... (CMC) exam is periodically re-calibrated to ensure that newly certified professionals are prepared ...
(Date:2/22/2017)... ... February 22, 2017 , ... Giving ... fewer trips the emergency room, fewer hospital admissions, and better blood pressure and ... Care® (AJMC®) finds. The study can be found here . , The ...
(Date:2/22/2017)... (PRWEB) , ... February 22, 2017 , ... ... adults with chronic conditions reported skipping doses or not filling a prescription because ... or under-insured, rates of cost-related problems getting medications were 30-60%*. At ...
(Date:2/22/2017)... ... , ... Doctors on Liens is continuing its steady expansion of medical specialties ... at North Valley Eye Medical Group in Mission Hills . Eye injuries and ... injury cases. These injuries have a major impact on the quality of life ...
Breaking Medicine News(10 mins):