A new study published in the February edition of Otology & Neurotology (Vol 34, No 2:275-281) shows that children with the abutment-free, implantable bone conduction hearing device from Sophono Inc, Boulder, Colo, experienced significant improvement in hearing without skin complications, according to a news release from the company.
The Sophono Alpha System™ is said to be 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 system reportedly eliminates the problems associated with other bone conduction hearing systems, including the need to drill a hole in the patient’s skull and the visible screw that protrudes through the skin.
The article summarizes the study findings, with preliminary results on how Sophono’s closed-skin bone-anchored implant worked in children with ear atresia. The study, conducted in Hôpital d’Enfants Armand-Trousseau (Paris Childrens’ Hospital) in 2012, evaluated the results of children ages 6 to 9. All had high-grade ear atresia, defined as the absence of an external ear canal, resulting in the child’s inability to hear in the affected ear. A review of patient benefit at 6 months of use with the bone-anchored system showed that the children experienced:
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; and
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, MD, PhD; Nicolas Leboulanger, MD, PhD; Cyrille Coudert; Olivia Mazzaschi, MD; Natalie Loundon, MD; Eric Vicaut; Natacha Tessier; and Eréa-Noël Garabedian, MD. The abstract can be found by clicking here.
“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.”
Source: Sophono Inc
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