New Study Shows Impressive Results with Abutment-Free Sophono System

Implantable hearing device improves children’s hearing, speech-in-noise.

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Boulder, Colo. (PRWEB) February 07, 2013

Children with the abutment-free, implantable bone conduction hearing device from Sophono, Inc., experienced significant improvement in hearing – without skin complications – according to a new study.

Sophono, Inc., is a Colorado-based medical device manufacturer. The Sophono Alpha 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 System 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.

The article summarizing the study findings, with preliminary results on how Sophono’s closed-skin bone-anchored implant worked in children with ear atresia, appears in the February issue of Otology & Neurotology. The study, conducted in Hôpital d’Enfants Armand-Trousseau (Paris Childrens’ Hospital) in 2012, evaluated the results of children between 6 and 9 years old. All had high-grade ear atresia, defined as the absence an external ear canal and resulting in the child’s inability to hear in the affected ear. A review of patient benefit at six months of use with the Sophono system showed that the children experienced the following.

1.    Hearing levels improved from severe conductive loss to nearly normal hearing.

2.    A high level of overall satisfaction – among both children and their parents

3.    No pain or skin complications

4.    Statistical and clinical improvement in speech-in-noise, an indication of how well the children could understand speech in a noisy environment

Study authors were: Françoise Denoyelle, M.D., Ph.D.; Nicolas Leboulanger, M.D., Ph.D.; Cyrille Coudert; Olivia Mazzaschi, M.D.; Natalie Loundon, M.D.; Eric Vicaut; Natacha Tessier; and Eréa-Noël Garabedian, M.D.

“The results that the article presents confirm the hearing performance Sophono continually sees with those using the Sophono Alpha System – in terms of hearing ability, speech understanding and high levels of satisfaction,” says Jim Kasic, president and CEO of Sophono. “Children, in particular, benefit from Sophono’s abutment-free technology.”

Sophono, Inc. (http://www.sophono.com)
Sophono, Inc., is a medical device manufacturer specializing in implantable, bone conduction hearing devices. 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 device 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.

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