Clinical Evaluation of a Cochlear Implant System
Sensorineural Hearing LossThe primary objective of this study is to assess the usability of a Cochlear implant system.
Wide Diameter Bone Anchored Implant Study
Conductive Hearing LossConductive and Sensori-neural Hearing Loss in the Same Ear2 moreTo assess implant stability, implant loss, adverse skin reactions, and Quality of Life Benefit following implantation of the Ponto 4.5mm Wide Diameter implant. Secondary: to determine the feasibility of fitting the sound processor 3 weeks after surgical implantation, and to investigate if the type of skin reactions following implantation could be related to the demographic data of subjects and the type of surgical technique used
Single-sided Deafness and Cochlear Implants
Sensorineural Hearing Loss (Disorder)As the left and right hemisphere are specialized for different auditory tasks, the proposed study aims at demonstrating different consequences of right or left-sided deafness for the affected individual. Furthermore, the question should be answered if auditory deficits and plastic changes can be partially reversed by cochlear implantation of the deaf ear. Multicenter, prospective, open, non-randomized clinical trial with 5 patients with right-sided and 5 patients with left-sided sensineural deafness. Pre-operative: Audiometry, Sound Localization Audiometry, PET, EEG/MEG Comparison of pre-operative investigations with 10 healthy subjects (age and gender matched control group) Cochlea implantation Follow-up Visits at 3, 6, 9 and 12 month post-operative: Audiometry, Sound Localization Audiometry, PET, EEG, Questionnaires Trial with medical device
Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05
Hearing LossSensorineuralPhonak 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 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).
Quality Control of CE-Certified Phonak Hearing Aids - 2017_37
Hearing LossSensorineuralPhonak 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 and functions. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
High Dose Oral Steroids in Sudden Sensorineural Hearing Loss
Sudden Sensorineural Hearing Loss (SSNHL)Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL (sudden sensorineural hearing loss).
The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation...
Sensorineural Hearing LossThe cochlear implant is a neural prosthesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation aims to atraumatically insert the electrode array of the cochlear implant into the cochlea. However, due to the location of the cochlea inside the skull, the surgeon is required to create an access from the surface of the temporal bone to the cochlea (inner ear). In conventional methods, this access is acquired by removal of portions of the mastoid bone through a mastoidectomy and posterior tympanotomy. The outcome and success of the conventional procedure varies due to mainly two factors: surgeon skill and subject anatomical variation. To overcome these variables toward a more consistent and less invasive cochlear implantation surgery, the development of robotic and image guided cochlear implantation has taken place. This study primarily aims to explore the performance of robotic cochlear implantation surgery.
Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults
Hearing LossSensorineuralThe purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor
Congenital Cytomegalovirus: Efficacy of Antiviral Treatment
Congenital Cytomegalovirus InfectionSensorineural Hearing LossThe objective of the trial is to investigate whether early treatment with oral valganciclovir of infants with both congenital cytomegalovirus infection and sensorineural hearing loss can prevent progression of hearing loss.
Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells...
Hearing LossSensorineuralThe protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods.