Study Confirms Long-Term Effectiveness of Abutment-Free Sophono System for Aural Atresia Patients

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-- Implantable hearing device improves hearing, speech understanding without complications - -

A new follow-up study has confirmed that the advanced implantable, magnetic bone conduction hearing system from Sophono, Inc., produces the same hearing gains as traditionally used devices that work with an abutment – and with no complications.

The study, conducted by physicians in the Department of Oto-Rhino-Laryngology, Head and Neck Surgery at Prosper Hospital in Recklinghausen, Germany, evaluated clinical and audiological results of the Sophono Alpha 2™ System in patients with congenital aural atresia – a condition defined by the absence or incomplete formation of an external ear canal. The Sophono system is the only available abutment-free, implantable, bone-anchored hearing system. Fitted to the patient’s head with the use of small, implantable magnets, the system eliminates 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 study concluded that the Sophono Alpha 2 improved hearing abilities and speech understanding in both adults and children, with no complications. “We feel that the overall patients’ satisfaction, as well as clinical and audiologic outcomes, are encouraging, and have come to the conclusion that this technique is a new option for this patient group,” stated study authors Ralf Siegert, M.D., and Jan Kanderske, M.D.

“The results of this follow-up study present more independent confirmation that Sophono’s abutment-free systems perform just as well as conventional systems that work with an abutment – but with fewer complications,” says Jim Kasic, president and CEO of Sophono.

The article summarizing the study findings appears in the July issue of Otology & Neurotology (“A New Semi-Implantable Transcutaneous Bone Conduction Device: Clinical, Surgical, and Audiologic Outcomes in Patients With Congenital Ear Canal Atresia”). The study evaluated the results of patients, age 6 to 50 years old, who had been using the Sophono Alpha implant for up to four years.

Results included these findings.
1.    No complications in any way related to the implantation or the implants; all wounds healed uneventfully
2.    Major improvements in understanding, speech perception with background noise, and SSQ (speech, spatial and qualities of hearing scale).
3.    Aesthetically “quite pleasant,” with “very good wearing comfort.”
4.    Convenience for active users – Patients can easily change baseplates themselves to wear stronger ones for sports and other activities, and weaker ones for quieter situations.

“We have found high comfort and safety of this system, and conclude that it could be a valuable alternative to other conventional or percutaneous bone conducting hearing solutions,” concluded the authors.

Sophono, Inc. (
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.

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