Biomaterials in cochlear implants

The cochlear implant (CI) represents, for almost 25 years now, the gold standard in the treatment of children born deaf and for postlingually deafened adults. These devices thus constitute the greatest success story in the field of ‘neurobionic’ prostheses. Their (now routine) fitting in adults, and especially in young children and even babies, places exacting demands on these implants, particularly with regard to the biocompatibility of a CI’s surface components. Furthermore, certain parts of the implant face considerable mechanical challenges, such as the need for the electrode array to be flexible and resistant to breakage, and for the implant casing to be able to withstand external forces

Individual Optimization of the Insertion of a Preformed Cochlear Implant Electrode Array

Purpose. The aim of this study was to show that individual adjustment of the curling behaviour of a preformed cochlear implant (CI) electrode array to the patient-specific shape of the cochlea can improve the insertion process in terms of reduced risk of insertion trauma. Methods. Geometry and curling behaviour of preformed, commercially available electrode arrays were modelled. Additionally, the anatomy of each small, medium-sized, and large human cochlea was modelled to consider anatomical variations. Finally, using a custom-made simulation tool, three different insertion strategies (conventional Advanced Off-Stylet (AOS) insertion technique, an automated implementation of the AOS technique, and a manually optimized insertion process) were simulated and compared with respect to the risk of insertion-related trauma. The risk of trauma was evaluated using a newly developed “trauma risk” rating scale. Results. Using this simulation-based approach, it was shown that an individually optimized insertion procedure is advantageous compared with the AOS insertion technique. Conclusion. This finding leads to the conclusion that, in general, consideration of the specific curling behaviour of a CI electrode array is beneficial in terms of less traumatic insertion. Therefore, these results highlight an entirely novel aspect of clinical application of preformed perimodiolar electrode arrays in general

Three-dimensional histological specimen preparation for accurate imaging and spatial reconstruction of the middle and inner ear

PURPOSE:    This paper presents a highly accurate cross-sectional preparation technique. The research aim was to develop an adequate imaging modality for both soft and bony tissue structures featuring high contrast and high resolution. Therefore, the advancement of an already existing microgrinding procedure was pursued. The central objectives were to preserve spatial relations and to ensure the accurate three-dimensional reconstruction of histological sections. METHODS:    Twelve human temporal bone specimens including middle and inner ear structures were utilized. They were embedded in epoxy resin, then dissected by serial grinding and finally digitalized. The actual abrasion of each grinding slice was measured using a tactile length gauge with an accuracy of one micrometre. The cross-sectional images were aligned with the aid of artificial markers and by applying a feature-based, custom-made auto-registration algorithm. To determine the accuracy of the overall reconstruction procedure, a well-known reference object was used for comparison. To ensure the compatibility of the histological data with conventional clinical image data, the image stacks were finally converted into the DICOM standard. RESULTS:    The image fusion of data from temporal bone specimens’ and from non-destructive flat-panel-based volume computed tomography confirmed the spatial accuracy achieved by the procedure, as did the evaluation using the reference object. CONCLUSION:    This systematic and easy-to-follow preparation technique enables the three-dimensional (3D) histological reconstruction of complex soft and bony tissue structures. It facilitates the creation of detailed and spatially correct 3D anatomical models. Such models are of great benefit for image-based segmentation and planning in the field of computer-assisted surgery as well as in finite element analysis. In the context of human inner ear surgery, three-dimensional histology will improve the experimental evaluation and determination of intra-cochlear trauma after the insertion of an electrode array of a cochlear implant system

Das medizinische Grundproblem: Hörsystem und Hördefizite

Das Hören ist neben dem Sehen unser wichtigster Sinn. Von 1000 Kindern werden 1 bis 3 mit einer Schwerhörigkeit unterschiedlichen Ausmaßes geboren, dieselbe Zahl entwickelt eine Schwerhörigkeit bis zum Schuleintritt. Ab dem 70. Lebensjahr ist jeder zweite Bürger davon betroffen. Prof. Thomas Lenarz von der Medizinischen Hochschule Hannover (MHH) erläutert den Aufbau des Ohres sowie die Formen und Behandlungsmöglichkeiten von Schwerhörigkeit

A psychoacoustic "NofM"-type speech coding strategy for cochlear implants

We describe a new signal processing technique for cochlear implants using a psychoacoustic-masking model. The technique is based on the principle of a so-called "NofM" strategy. These strategies stimulate fewer channels (N) per cycle than active electrodes (NofM; N < M). In "NofM" strategies such as ACE or SPEAK, only the N channels with higher amplitudes are stimulated. The new strategy is based on the ACE strategy but uses a psychoacoustic-masking model in order to determine the essential components of any given audio signal. This new strategy was tested on device users in an acute Study, with either 4 or 8 channels stimulated per cycle. For the first condition (4 channels), the mean improvement over the ACE strategy was 17%. For the second condition (8 channels), no significant difference was found between the two strategies

Consensus Statement on Bone Conduction Devices and Active Middle Ear Implants in Conductive and Mixed Hearing Loss

Nowadays, several options are available to treat patients with conductive or mixed hearing loss. Whenever surgical intervention is not possible or contra-indicated, and amplification by a conventional hearing device (e.g., behind-the-ear device) is not feasible, then implantable hearing devices are an indispensable next option. Implantable bone-conduction devices and middle-ear implants have advantages but also limitations concerning complexity/invasiveness of the surgery, medical complications, and effectiveness. To counsel the patient, the clinician should have a good overview of the options with regard to safety and reliability as well as unequivocal technical performance data. The present consensus document is the outcome of an extensive iterative process including ENT specialists, audiologists, health-policy scientists, and representatives/technicians of the main companies in this field. This document should provide a first framework for procedures and technical characterization to enhance effective communication between these stakeholders, improving health care

Die minimal-invasive Cochlea-Implantat-Chirurgie : Der lange Weg von der Forschung in die klinische Routine

Der Einsatz eines Cochlea- Implantats bei tauben oder schwerhörigen Patienten ist bis heute nur durch eine Operation möglich, bei der eine 2 bis 3 cm tiefe Öffnung in den Schädel-knochen gefräst werden muss. Seit langer Zeit bemühen sich Wissenschaftlerinnen und Wissenschaftler Technologien zu entwickeln, um diesen Vorgang minimal-invasiv vornehmen zu können. Dr.-Ing. Thomas Rau von der Medizinischen Hochschule Hannover und Prof. Dr. Tobias Ortmaier vom Institut für Mechatronische Systeme beschreiben die gemeinsamen, interdisziplinären Forschungs-ansätze an beiden Einrichtungen

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

Identification of factors influencing insertion characteristics of cochlear implant electrode carriers

Insertion studies in artificial cochlea models (aCM) are used for the analysis of insertion characteristics of different cochlear implant electrode carrier (EC) designs by measuring insertion forces. These forces are summed forces due to the measuring position which is directly underneath the aCM. The current hypothesis is that they include dynamic friction forces during the insertion process and the forces needed to bend an initially straight EC into the curved form of the aCM. For the purposes of the present study, straight EC substitutes with a constant diameter of 0.7 mm and 20.5 mm intracochlear length were fabricated out of silicone in two versions with different stiffness by varying the number of embedded wires. The EC substitutes were inserted into three different models made of polytetrafluoroethylene (PTFE), each model showing only one constant radius. Three different insertion speeds were used (0.11 / 0.4 / 1.6 mm/s) with an automated insertion test bench. For each parameter combination (curvature, speed, stiffness) twelve insertions were conducted. Measurements included six full insertions and six paused insertions. Paused insertions include a ten second paused time interval without further insertion movement each five millimetres. Measurements showed that dynamic and static components of the measured summed forces can be identified. Dynamic force components increase with increased insertion speeds and also with increased stiffness of the EC substitutes. Both force components decrease with larger radius of the PTFE model. After the insertion, the EC substitutes showed a curved shape, which indicates a plastic deformation of the embedded wires due to the insertion into the curved models. The results can be used for further research on an analytical model to predict the insertions forces of a specific combination of selected parameters as insertion speed and type of EC, combined with given factors such as cochlear geometry

A software for online monitoring of orientation-compensated forces during CI insertion

The electrode array insertion is a critical point during CI surgery and should be performed as gently as possible to preserve residual hearing. In order to measure occurring forces, an insertion tool with an integrated force sensor and an inertial measurement unit (IM U) is being developed. The weight of the electrode holder and the sensor add an unknown offset to the measured forces, depending on the tool orientation. To address this problem, a software which calculates the orientation-induced error and computes a corrected force was developed. The software was written in C++ using the library Qt 5.12.9. For maximization of the computing frequency, the data acquisition of both sensors and the monitoring was parallelized. An algorithm was developed to calculate the error caused by the electrode holder and sensor. For this purpose both weights were determined in a calibration procedure and merged with the provided IM U data. The evaluation was done in two test series (each n=5) with different initial tool orientations. To this end a stepwise 360° rotation around the horizontal axis was performed, while recording the corrected forces. The developed software allows a computing frequency up to 100 Hz with a latency of 10 ms for the online monitoring of the processed data. The evaluation of the corrected force shows a residual error of 0.347 mN ± 0.325 mN for the first and 0.176 mN ± 1.971 mN for the second test series. With the created algorithm, the impact of the extra weight on the sensor can be almost fully equalized. The highly responsive software offers a new possibility to process insertion forces and provide feedback to surgeons. Determining the influence of the tool orientation on the corrected forces is the subject of future researches