Local drug application to the inner ear offers a number of advantages over systemic delivery. Local drug therapy currently encompasses extracochlear administration (i. e., through intratympanic injection), intracochlear administration (particularly for gene and stem cell therapy), as well as various combinations with auditory neurosensory prostheses, either evaluated in preclinical or clinical studies, or off-label. To improve rehabilitation with cochlear implants (CI), one focus is the development of drug-releasing electrode carriers, e. g., for delivery of glucocorticosteroids, antiapoptotic substances, or neurotrophins to the inner ear. The performance of cochlear implants may thus be improved by protecting neuronal structures from insertion trauma, reducing fibrosis in the inner ear, and by stimulating growth of neuronal structures in the direction of the electrodes. Controlled drug release after extracochlear or intracochlear application in conjunction with a CI can also be achieved by use of a biocompatible, resorbable controlled-release drug-delivery system. Two case reports for intracochlear controlled release drug delivery in combination with cochlear implants are presented. In order to treat progressive reduction in speech discrimination and increased impedance, two cochlear implant patients successfully underwent intracochlear placement of a biocompatible, resorbable drug-delivery system for controlled release of dexamethasone. The drug levels reached in inner ear fluids after different types of local drug application strategies can be calculated using a computer model. The intracochlear drug concentrations calculated in this way were compared for different dexamethasone application strategies.
Objective: To assess the efficacy of cochlear implantation (CI) after surgical removal of sporadic intracochlear or intravestibulocochlear schwannomas. Study Design: Nonconcurrent cohort study. Setting: Monocentric study at a tertiary referral center. Patients: Patients with tumor resection and CI between 2011 and 2018 and a historic control group of CI patients matched by age, CI electrode type, and follow-up. Interventions: Partial or subtotal cochleoectomy for tumor removal and single-stage CI. Outcome Measures: Main outcome measure: word recognition score for monosyllables in quiet at 65 dB SPL. Results: Sixteen patients with tumor removal and CI (6 female, 10 male; mean age 55 ± 14 years) and 16 control patients (6 female, 10 male; mean age 55 ± 15 years) were identified. In the tumor group, surprisingly good word recognition scores were reached even after substantial structural defects in the cochlear capsule. While 12 months after cochlear implantation mean word recognition score for monosyllables in quiet was 58% (SD: 26) and 41% (SD: 26) in the control groups, it was 75% (SD: 19%) in the tumor group. Conclusions: In patients with intracochlear schwannomas, despite substantial structural damage to the cochlear capsule by partial or subtotal cochleoectomy, a tendency toward better performance with respect to word recognition with CI was observed as compared with other CI patients. The surprisingly good functional results despite substantial cochlear trauma may change clinical thinking with respect to cochlear implantation also beyond this special indication.
Aim This European multicentric study aimed to prove safety and performance of the Bonebridge BCI 602 in children and adults suffering from either conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided sensorineural deafness (SSD). Methods 33 patients (13 adults and 10 children with either CHL or MHL and 10 patients with SSD) in three study groups were included. Patients were their own controls (single-subject repeated measures), comparing the unaided or pre-operative to the 3-month post-operative outcomes. Performance was evaluated by sound field thresholds (SF), word recognition scores (WRS) and/or speech reception thresholds in quiet (SRT) and in noise (SNR). Safety was demonstrated with a device-specific surgical questionnaire, adverse event reporting and stable pure-tone measurements. Results The Bonebridge BCI 602 significantly improved SF thresholds (+ 25.5 dB CHL/MHL/SSD), speech intelligibility in WRS (+ 68.0% CHL/MHL) and SRT in quiet (− 16.5 dB C/MHL) and in noise (− 3.51 dB SNR SSD). Air conduction (AC) and bone conduction (BC) thresholds remained stable over time. All adverse events were resolved, with none unanticipated. Mean audio processor wearing times in hours [h] per day for the CHL/MHL group were ~ 13 h for adults, ~ 11 h for paediatrics and ~ 6 h for the SSD group. The average surgical length was 57 min for the CHL/MHL group and 42 min for the SSD group. The versatility of the BCI 602 (reduced drilling depth and ability to bend the transition for optimal placement) allows for treatment of normal, pre-operated and malformed anatomies. All audiological endpoints were reached. Conclusions The Bonebridge BCI 602 significantly improved hearing thresholds and speech understanding. Since implant placement follows the patient’s anatomy instead of the shape of the device and the duration of surgery is shorter than with its predecessor, implantation is easier with the BCI 602. Performance and safety were proven for adults and children as well as for the CHL/MHL and SSD indications 3 months post-operatively.
In patients with conductive hearing loss caused by middle ear disorders or atresia of the ear canal, a Bonebridge implantation can improve hearing by providing vibratory input to the temporal bone. The expected results are improved puretone thresholds and speech recognition. In the European Union, approval of the Bonebridge implantation was recently extended to children. We evaluated the functional outcome of a Bonebridge implantation for eight adults and three children. We found significant improvement in the puretone thresholds, with improvement in the air-bone gap. Speech recognition after surgery was significantly higher than in the best-aided situation before surgery. The Bonebridge significantly improved speech recognition in noisy environments and sound localization. In situations relevant to daily life, hearing deficits were nearly completely restored with the Bonebridge implantation in both adults and children.
Intralabyrinthine schwannomas (ILS) are a rare differential diagnosis of sudden hearing loss and vertigo. In an own case series of 12 patients, 6 tumors showed an intracochlear, 3 an intravestibular, 1 a transmodiolar including the cerebellopontine angle (CPA), 1a transotic including the CPA, and 1 a multilocular location. The tumors were removed surgically in 9 patients, whereas 3 patients decided for a “wait-and-test-and-scan” strategy. Of the surgical patients, 3 underwent labyrinthectomy and cochlear implant (CI) surgery in a single-stage procedure; 1 patient had extended cochleostomy with CI surgery; 3 underwent partial or subtotal cochleoectomy, with partial cochlear reconstruction and CI surgery (n = 1) or implantation of electrode dummies for possible later CI after repeated MRI follow-up (n = 2); and in 2 patients, the tumors of the internal auditory canal and cerebellopontine angle exhibiting transmodiolar or transmacular growth were removed by combined translabyrinthine–transotic resection. For the intracochlear tumors, vestibular function could mostly be preserved after surgery. In all cases with CI surgery, hearing rehabilitation was successful, although speech discrimination was limited for the case with subtotal cochleoectomy. Surgical removal of intracochlear schwannomas via partial or subtotal cochleoectomy is, in principle, possible with preservation of vestibular function. In the authors’ opinion, radiotherapy of ILS is only indicated in isolated cases. Cochlear implantation during or after tumor resection (i. e., as synchronous or staged surgeries) is an option for hearing rehabilitation in cartain cases and represents a therapeutic approach in contrast to a “wait-and-test-and-scan” strategy.
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