On April 11, 2013, Sophono Bone Anchored Hearing Devices received clearance from the U.S. Food and Drug Administration for their patients with the Alpha 1 or 2 bone conduction hearing system to be able to have a magnetic resonance imaging (MRI) test.
With the clearance, individuals in the United States who have the Sophono Alpha Bone Anchored Hearing System™ can undergo MRI – in both 1.5 and 3-tesla magnetic fields – without removing the magnetic implant. In January, the Sophono Alpha Bone Anchored Hearing device 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 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.”
The Abutment-Free Alpha™ Bone Conduction Hearing System
There are two Bone Conduction Hearing Systems available from Sophono. First is the Alpha (S)™ which functions without an implant, is an external sound processor used with a softband or a headband for those not ready to commit to surgery or for patients under 5 years old. Second is the Alpha 2™ System that uses an implantable device with a sound processor system. Your audiologist or doctor can help you choose the right components for you.
The Alpha 2 Sound Processor System
The Alpha 2 sound processor is offered in four colors: Champagne, Brown, Anthracite and Silver. They feature eight channels, 16 frequency bands and four programmable memories (for easy change of program when surroundings change), The Alpha 2 sound processor provides superb digital capabilities comparable to other bone anchored hearing aids.
Alpha 2 Features
Magnetically coupled bone anchored hearing device. The Alpha 2 has no external abutment for improved comfort and no daily maintenance of a wound site.
The Alpha 2 is available in four colors to match basic hair colors: Champagne, Anthracite, Silver and Brown.
Dual-Microphone Technology. Improves hearing in environments where background noise is an issue. Automatically detects and reduces amplification of unwanted noise from behind while preserving frontal amplification of people or sound for clearer conversations and communication.
Integral DAI connection for link to FM systems, personal music players, cellphones and other similar systems.
Tamper-proof locking battery door.
Simple, single stage surgery. The implant surgery is simple and can be performed on an outpatient basis. Fitting for the Alpha 2 can take place four weeks after surgery.
Completely programmable, digital hearing system including:
• 8 Channels
• 16 Frequency Bands
• 4 Programs
• Customizable program switching and low battery warning tones
• Automatic noise reduction and feedback suppression
You can also customize your Alpha Processor with the colorful SkinitTM decals. These decals are made of strong, durable vinyl, are easy to apply and remove and there are thousands of designs available. To learn more, go to www.skinit.com/sophono.
Otomag GmbH, the small German company created to manufacture the original Alpha 1 System, was acquired and integrated into Sophono, Inc. in September 2010. Based in Boulder, Colorado, Sophono, Inc. is a medical device firm dedicated to improving the hearing and the quality of life of those it serves.
For more information, talk with your Audiologist or hearing professional today. You can also reach a Sophono representative who will be glad to answer any questions you may have at this toll-free number: 1-877-604-9441.