Clinical Survey of Oticon Medical Ponto BHX Implant
Hearing Impaired (Partially)Hearing Impairment2 moreInvestigation of stability of the BHX implant in adult patients indicated and counselled for a bone anchored hearing aid system. Patients are followed according to clinical practice for a total of 12 months in the study. Stability of the implant is evaluated by implant stability quotient.
Audiological Benefit With Non-implantable Bone Conduction Hearing Systems
Hearing LossConductiveRecently, a new non-invasive bone conduction hearing aid was introduced. The system is connected directly to the skin with an adhesive adapter to transmit the sound to the inner ear through bone vibrations. The objective of this study is to evaluate and compare the audiological benefit of the new bone conduction hearing aid and compare it to an existing bone conduction hearing aid in normal hearing adults with bilateral simulated conductive hearing loss. An evaluation of the improvement on speech understanding in noise and sound localization allows to estimate the system performance and enables to derive recommendations for clinical usage of the novel hearing system. It is hypothesized that in the bilateral condition similar speech understanding in noise and sound localization performance can be achieved with the new system compared to existing bone conduction hearing aids that are pressed against the skull using a soft band.
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
Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System
Hearing LossTo evaluate the performance of the Nucleus 5 Cochlear Implant System.
Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and...
Hearing LossA methodical evaluation of novel measurement and fitting methods for individualizing CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. The aim of the study is to investigate and asses strength and weaknesses of these novel measurement and fitting methods in terms of optimizing hearing performance and experience and/or usability of the hearing aids and accessories. Both laboratory measurements as well as evaluations in real life environments will be carried out. This will be a controlled and randomised active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Stäfa.
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).
A Clinical Investigation of the Benefit: BTE Hearing Aids Versus ITE Hearing Aids
Hearing LossThe current study will evaluate a new in-the-ear (ITE) hearing aid hardware. The goal is to evaluate the audiological performance, usability, feature function, and to identify unexpected or unwanted behaviour from the devices. The study plans to compare the behind-the-ear (BTE) hardware style with the ITE devices regarding the benefit received from different microphone locations.
Safety and Efficacy of STR001-IT and STR001-ER in Patients With SSHL
Acute Hearing Lossa multicenter, double-blind, placebo-controlled study in patients with Sudden Sensorineural Hearing Loss (SSHL). Patients will be treated with STR001 thermogel (STR001-IT) / STR001 tablets (STR001-ER) and corresponding Placebo on top of standard of care.