View clinical trials related to Sensorineural Hearing Loss.
Filter by:To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.
Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
The goal of this study is to measure patient performance after cochlear implantation with the Food and Drug Administration (FDA) approved Advanced Bionics HiFocus L23 device. The specific aims of the project are as follows: 1. To measure implant audiologic performance as defined by speech performance in standard cochlear implant speech test batteries. 2. To determine scalar location after insertion through either intraoperative or postoperative imaging and correlate this with audiologic outcomes. 3. To assess the rates of preservation of residual acoustic hearing and correlate those with scalar location as determined in specific aim 2 and audiologic performance as determined in specific aim 1. 4. To correlate speech outcomes with quality of life measures, as defined by validated questionnaires including the Tinnitus Handicap Index (THI), Speech and Spatial Qualities (SSQ) Questionnaire, and Nijmegen Questionnaire. 5. To evaluate intraoperative ease of insertion from the surgeon's perspective and correlate this with postoperative electrode location and audiologic performance.
To assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.
Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
This is a phase 1/2 study of FX-322 at two dose levels compared to placebo in male and female adults otherwise healthy with stable sensorineural hearing loss.
The primary objective of this study is to assess the usability of a Cochlear implant system.
Hearing is the ability to perceive sounds through the ear. If the transmission of sound is defective, the person suffers some degree of hearing loss. Cochlear Implants (CI) provide partial hearing by stimulating auditory nerve cells. The evaluation of the functionality of the CI is facilitated by several analysis tools, such as the clinical calibration software. This offers the possibility of measuring electrical impedances in the cochlea. The electrical impedance is the opposition to the current flow between two electrodes. It is composed of two main elements: resistance and reactance. The impedances in a cochlear implant are not stable over time. The value is minimal immediately after surgery, and increases progressively in the first 2 to 3 weeks after the procedure due to the immune response of the organism against a foreign body and the trauma of the array insertion. Several authors have suggested the use of topical or intravenous corticosteroids to decrease intracochlear fibrosis. The use of Dexamethasone could have a protective effect by reducing the initial inflammatory response, apoptosis, and delayed fibrosis, which could impact the impedance. There is limited evidence on the effect of intra-surgical topical corticosteroids on the impedance of the cochlear implant. The aim of this clinical trial is to evaluate the impact of topical dexamethasone on the electrical impedance of the cochlear implant, with special attention to the analysis of the capacitive component. It will be carried out through an experimental, prospective, randomized and double-blind study. Objective To determine whether the use of topical dexamethasone in a single dose applied in the tympanic cavity (middle ear) during cochlear implant surgery modifies the capacitive component of the electrical impedance of the electrodes in the cochlea before the activation of the cochlear implant. Material and methods A phase 3 clinical trial will be conducted. The design is a parallel, randomized, controlled and double-blind experimental study. Expected impact The use of local dexamethasone during cochlear implant surgery would decrease the inflammatory response, improving postoperative impedances.
The present study aims to evaluate patient satisfaction and audiological performance with their current cochlear implant speech processor, the Neuro 1, and to compare it with the satisfaction and performance obtained with the new speech processor, the Neuro 2.