Intratympanic gentamicin treatment for Ménière's disease: A randomized, double-blind, placebo-controlled trial on dose efficacy - results of a prematurely ended study

Background: Gentamicin is used as a therapeutic agent for Ménière's disease because of its vestibulotoxicity causing chemo-ablation of the vestibular sensory epithelia. Its use has increased in recent years. However, there is still no consensus about the dose regimen of gentamicin in the treatment of Ménière's disease. In this study two different dose regimen treatment protocols are compared in a placebo controlled study design. The primary objective is to quantify the treatment effect on dizziness, the secondary objective is hearing evaluation.Methods: We performed a randomized, double-blind, placebo-controlled study in adults with unilateral Ménière's disease according to the AAO-HNS guidelines resistant to conservative medication. Three groups received four injections, administered weekly (four intratympanic injections with 40 mg/mL gentamicin solution, two injections gentamicin solution and two injections of placebo in random order, or four injections with placebo). Outcome measures were the score on the Dizziness Handicap Inventory and pure tone audiometry (PTA). Intended follow-up was 2 years.Results: During follow-up one patient exceeded the accepted amount of hearing loss. Further, enrollment was very slow (until 12 months between two patients) and new insights showed an apparent benefit of intratympanic gentamicin treatment (ITG). Therefore we performed an unscheduled interim analysis which showed that PTA threshold shifts reached the stopping criteria in two more patients. Because of this, this study was ended. Of the three patients with the significant PTA threshold shift two were enrolled in the gentamicin group.Conclusion: No conclusions can be drawn concerning doses regimens. Now that new publications have shown that ITG treatment can be an effective and safe treatment, a placebo-controlled randomized controlled trial may not pass the ethical committee because of these recent reports in literature. Still, a dose regimen study (without placebo) on ITG treatment needs to be performed.Trial registration: This trial was registered in The University Medical Center Utrecht/ Gelre hospital Apeldoorn. Protocol ID: 07/343, EudraCT number 2006-005913-37

Oorzaak en gevolg

In de komende drie kwartier ga ik met u enkele onderwerpen bespreken die gaan over het gehoor, gehoorverlies en de revalidatie van ernstige slechthorendheid. Ik zal mijn visie geven op waar wij in de toekomst het onderzoek betreffende het gehoor op zullen richten. Kortom, ik ga het hebben over oorzaak en gevolg. Tevens wil ik met u bespreken hoe de afdeling Keel-, Neus- en Oorheelkunde van het UMC Utrecht telemedicine gebruikt om de oorchirurgie aan (toekomstige) collega’s uit te leggen en hoe deze multimediatechnieken het onderwijs zullen gaan veranderen. Voor mij is dit een onderwerp dat door mijn recente aanstelling door de Raad van Bestuur van het UMC Utrecht als manager onderzoek en onderwijs van de Divisie Heelkundige Specialismen (DHS) nog actueler is geworden

First experience with a new stapes clip piston in stapedotomy

Objective: Hearing results after 23 implantations of a newly designed titanium-clip stapes piston prosthesis (the aWengen Clip Piston prosthesis) in patients with otosclerosis were evaluated. This new type of stapes piston was designed to avoid the crimping onto the incus in stapedotomy. This one clip fits all designs and enables solid fixation by clicking the prosthesis onto the long process of the incus without crimping. Study Design: A retrospective pilot study was carried out by microcomputer of the preoperative and postoperative audiological results of patients in whom the titanium-clip stapes piston prosthesis was implanted. Setting: Ear, nose and throat department of Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. Patients: 23 Patients underwent a stapedotomy for hearing improvement suffering from otosclerosis. implantations of a newly designed titanium-clip stapes piston prosthesis (the aWengen Clip Piston prosthesis) in patients with otosclerosis were evaluated. Intervention(s): The stapedotomy was performed with the aWengen Clip Piston prosthesis. Main Outcome Measure(s): Pre and postoperative audiograms were used to evaluate the hearing gain improvement with the new stapes piston. Especially we looked at the airbone gap Closure and the sensorineural hearing after the surgical procedure and compared these with the ones before surgery. Results: The hearing results showed a closure of the pure-tone average air-bone gap to within 10 dB in 56.6% of cases (10 of 23 implantations) and to within 20 dB in 100% (23 of 23 implantations). A residual air-bone gap of greater than 20 dB was seen in the present pilot study. Postoperative overclosure of bone-conduction thresholds was discovered only for the frequency of 2 kHz. Sensorineural hearing loss greater than 10% did not occur, and there was no decline in the speech discrimination. Conclusions: The use of a newly designed titanium-clip stapes piston prosthesis with a diameter of 0.4 mm gives good results in cases of stapedotomy for otosclerosis. The titanium-clip design is a new development in the evolution of stapes piston prostheses. Surgical introduction, placement, and fixation are not always easy, depending on the anatomy of the middle ear and the thickness of the fixation area on the long process of the incu

Development and realization of an artificial patient with hearing impairment

The paper proposes a narrowband stochastic system model for auditory signal processing. The parameters are ipsilateral, contralateral and interaural hearing losses, false positive and false negative responses, and patient response time. The auditory model is then used to realize a patient simulator (artificial patient), comprising out of two microphones, a skull simulator, sound cards and a noiseless personal computer. A locally stored database contains the simulated and the recorded patient data. First field trials in an audiometric test room at the University Medical Center, Utrecht, The Netherlands, indicate that the artificial patient resembles the behavior of a real patient within a band of 10 dB-HL over the entire audiometric frequency range

Monitoring practitioner’s skills in pure-tone audiometry

So far, there exists no standard, to evaluate a practitioner’s skills in pure-tone audiometry. To narrow the gap, this article presents an artificial patient (AP) emulating various types of hearing impairment. In contrast to other solutions, the AP autonomously listens to real pure-tones in soft real-time, while taking into account elements from psycho-acoustics. The emulated patient profiles are reproducible. New profiles can be easily added. The AP is able to recover from error. In this contribution, the authors develop software requirements specifications and derive a modular system architecture. To analyze the performance, the article proposes a stochastic extension to existing synchronous data flow graphs, taking into account the unbounded nature of the tasks’ worst case response time. Maximization and summation over the graph reveals the joint distribution of the response time with first and second central moments corresponding to, respectively, the expected response time and the jitter of the task. The theoretical results have finally been validated by measurements on the target