A New Surgical Approach for Direct Acoustic Cochlear Implant: A Temporal Bone Study

The direct acoustic cochlear implant (DACI) is among the latest developments in the field of implantable acoustic prostheses. The surgical procedure requires a mastoidectomy and a posterior-inferior tympanotomy, with access to the facial recess at the level of the oval window, in a complex and lengthy surgical approach. Here, we report a new and considerably shorter surgical approach

Indication of direct acoustical cochlea stimulation in comparison to cochlear implants

AbstractThe new implantable hearing system Codacs™ was designed to close the treatment gap between active middle ear implants and cochlear implants in cases of severe-to-profound mixed hearing loss. The Codacs™ actuator is attached to conventional stapes prosthesis during the implantation and thereby provides acoustical stimulation through a stapedotomy to the cochlea. Cochlear implants (CIs) on the other hand are an established treatment option for profoundly deaf patients including mixed hearing losses that are possible candidates for the Codacs™.In this retrospective study, we compared the clinical outcome of 25 patients with the Codacs™ (≥3 month post-activation) to 54 CI patients (two years post-activation) with comparable pre-operative bone conduction (BC) thresholds that were potential candidates for both categories of devices. The word recognition score (Freiburg monosyllables test) in quiet was significantly (p < 0.05) better in the Codacs™ than in the corresponding CI patients for average pre-operative bone conduction below 60 dB HL and equal in patients with a pre-operative BC PTA between 60 and 70 dB HL. Speech in noise intelligibility (HSM sentences test at +10 dB SNR) was significantly (p < 0.001) better in Codacs™ (80% median) than in CI patients (25% median) in all tested groups.Our results indicate for patients with sufficient cochlear reserve that speech intelligibility in noise with the Codacs™ hearing implant is significantly better than with a CI. Further, results in Codacs™ were better predictable, encouraging the extension of the indication to patients with less cochlear reserve than reported here

A bone-thickness map as a guide for bone-anchored port implantation surgery in the temporal bone

The bone-anchored port (BAP) is an investigational implant, which is intended to be fixed on the temporal bone and provide vascular access. There are a number of implants taking advantage of the stability and available room in the temporal bone. These devices range from implantable hearing aids to percutaneous ports. During temporal bone surgery, injuring critical anatomical structures must be avoided. Several methods for computer-assisted temporal bone surgery are reported, which typically add an additional procedure for the patient. We propose a surgical guide in the form of a bone-thickness map displaying anatomical landmarks that can be used for planning of the surgery, and for the intra-operative decision of the implant’s location. The retro-auricular region of the temporal and parietal bone was marked on cone-beam computed tomography scans and tridimensional surfaces displaying the bone thickness were created from this space. We compared this method using a thickness map (n = 10) with conventional surgery without assistance (n = 5) in isolated human anatomical whole head specimens. The use of the thickness map reduced the rate of Dura Mater exposition from 100% to 20% and OPEN ACCESS Materials 2013, 6 5292 suppressed sigmoid sinus exposures. The study shows that a bone-thickness map can be used as a low-complexity method to improve patient’s safety during BAP surgery in the temporal bone

Design of a semi-implantable hearing device for direct acoustic cochlear stimulation

A new hearing therapy based on direct acoustic cochlear stimulation was developed for the treatment of severe to profound mixed hearing loss. The device efficacy was validated in an initial clinical trial with four patients. This semi-implantable investigational device consists of an externally worn audio processor, a percutaneous connector, and an implantable microactuator. The actuator is placed in the mastoid bone, right behind the external auditory canal. It generates vibrations that are directly coupled to the inner ear fluids and that, therefore, bypass the external and the middle ear. The system is able to provide an equivalent sound pressure level of 125 dB over the frequency range between 125 and 8000 Hz. The hermetically sealed actuator is designed to provide maximal output power by keeping its dimensions small enough to enable implantation. A network model is used to simulate the dynamic characteristics of the actuator to adjust its transfer function to the characteristics of the middle ear. The geometry of the different actuator components is optimized using finite-element modeling