Audiologic and Surgical Outcomes of a Novel, Nonpercutaneous, Bone Conducting Hearing Implant

Abstract

The surgical procedure requires no specialized equipment and can be performed as a day case. This device complements treatment for patients requiring bone conduction aids and presents as an alternative to conventional percutaneous bone-anchored implants.

Audiological Results and Quality of Life of Sophono Alpha 2 Transcutaneous Bone-Anchored Implant Users in Single-Sided Deafness

“…The use of the Alpha 1 system has already been described in conductive or mixed hearing loss in adults and children [Denoyelle et al, 2013;Escorihuela-García et al, 2014;Hol et al, 2013;Magliulo et al, 2015;Siegert and Kanderske, 2013;Sylvester et al, 2013;]. No studies have yet been published in the English literature concerning the use of Alpha 2.…”

“…The Sophono Alpha system is a bone-conductive transcutaneous implant that transmits the vibrations of the external processor thought an intact skin by means of a magnetic coupling. It was first described by Siegert [2011], and since then other papers have been published concerning the use of this device in different pathological conditions [Denoyelle et al, 2013;Escorihuela-García et al, 2014;Hol et al, 2013;Leterme et al, 2015;Magliulo et al, 2015;Siegert and Kanderske, 2013;Sylvester et al, 2013].…”

“…The major advantage of this system, compared to the percutaneous ones, is the presence of intact skin that dramatically reduces skin-related complications [Wazen et al, 2008]. The use of the Alpha 1 ® system has already been described for conductive or mixed hearing loss in adults and children [Escorihuela-García et al, 2014;Denoyelle et al, 2013;Hol et al, 2013;Magliulo et al, 2015;Siegert and Kanderske, 2013;Sylvester et al, 2013]. The first prospective clinical study comparing the Alpha 1 system to CROS hearing aids in SSD has recently been published [Leterme et al, 2015].…”

Implantable Hearing Devices

“…All current devices are semiimplantable and transmit sound to the cochlea via bone conduction, bypassing the impaired outer or middle ear (Table 1). Traditionally, these systems took advantage of direct osseointegration using a titanium bone fixture and percutaneous abutment connected to an external sound processor [2]. Several methods of transcutaneous transmission with the use of magnetic coupling between the processor and scalp have been more recently introduced (Fig.…”

“…The current transcutaneous systems are approved in the US for children older than 5 years and adults with conductive hearing loss or mixed hearing loss with bone conduction thresholds no [45 dB HL, and adults with single-sided deafness [2].…”