Sophono Alpha Implant System Receives Federal Drug Administration Clearance for Sterile Product Release

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Sophono, Inc. – manufacturer of abutment-free, implantable, bone conduction hearing devices – has received clearance from the U.S. Food and Drug Administration (FDA) to offer the Alpha™ Magnetic Implant System pre-sterilized and in sterile packaging for the operating room or outpatient surgery centers in hospitals and clinics.

This assurance of sterile implant products and packaging enables our surgical partners to ensure their implant patient is ready for surgery without the added time of having to sterilize product. - Peter Ruppersberg, CEO of Sophono

“With this FDA clearance, all of the Alpha System Magnetic Implant Kits can be shipped already sterilized, making it easier and more cost-effective for surgical staff to place the implant in hearing loss patients throughout the United States,” explains Peter Ruppersberg, CEO of Sophono. “This assurance of sterile implant products and packaging enables our surgical partners to ensure their implant patient is ready for surgery without the added time of having to sterilize product. For our patients waiting to undergo the single-stage implant procedure, the sterile product and packaging assures their safety by creating a robust sterile barrier system for the titanium encased magnetic implant.”

For the FDA to allow the implant kit to ship out sterile, the implant items and the secure packaging must undergo rigorous testing and validation to confirm that the sterilization process used is completely effective.

Sophono is a Boulder, Colorado-based medical device manufacturer of the Alpha System, 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 Alpha System eliminates the problems associated with other abutment-based 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. (http://www.sophono.com)
Sophono, Inc. is a medical device manufacturer specializing in abutment-free, implantable, bone conduction hearing systems. Sophono’s proven TET™ Technology enables the maximum transfer of energy from the Alpha Sound Processor through the skin to the magnetic implant, allowing for amplified bone conduction sound to improve hearing in patients with conductive, mixed hearing loss and single-ear deafness. To date, the Sophono Alpha System is the result of 10 years of clinical research, more than 7 years of human clinical experiences and has been implanted in more than 2500 patients.

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 36 countries.

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Elissa Lewis
Sophono
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