Quality Control of CE-Certified Phonak Hearing Aids - 2019_19
Hearing LossSensorineural Hearing LossPhonak 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).
Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population...
Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis)Sensorineural Hearing Loss1 moreTo study the initial experience with implanting and fitting a new Bone Conduction system in pediatric patient population with conductive, mixed or single-sided deafness.
"Core Stabilization Exercises in Hearing Impaired Children"
Hearing Disorders in ChildrenCore Stabilization3 moreIn this study the investigators will examine the effects of core stabilization exercises on respiratory muscle strength, respiratory functions and postural control in hearing-impaired children.
Noise-Induced Hearing Loss-Acute Exposure Treatment
Hearing LossNoise-InducedThe purpose of this study is to assess the safety and efficacy of zonisamide for the treatment of noise-induced hearing loss in adults.
FX-322 in Adults With Severe Sensorineural Hearing Loss
Hearing LossSensorineural2 moreThis is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with severe sensorineural hearing loss.
Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System...
Sensorineural Hearing LossBilateral4 moreOn June 23, 2021, the Oticon Medical Neuro Cochlear Implant System (NCIS) was granted premarket approval (PMA) in the US to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aid(s). To help assure the continued safety and effectiveness of an approved device, a post-approval study was required as a condition of approval under 21 CFR 814.82(a)(2). The purpose of this study is to provide longer-term data on the safety and effectiveness of the Neuro Cochlear Implant System under general conditions of use in the postmarket environment.
Evaluation of Software for Self-Fitting of Hearing Aids by People With Hearing Loss
Hearing LossThe purpose of the study is to evaluate the efficacy of a prototype app for the self-fitting of hearing aids.
Computer-Assisted Speech Training for Hearing Aid Users
Hearing ImpairmentComputer-assisted speech training is a speech recognition training system developed for cochlear implant users. With minimal facilities and skills, cochlear implant users can conduct this training at home. The purpose of this study was to apply this system to adolescent and young adult hearing aid users with prelingual severe to profound hearing loss.
Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System
Conductive Hearing LossAn international multicentre, open, comparative, parallel group, prospective clinical investigation with a single 5 year follow up visit.
Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss
Hearing LossThe objective of this study is to investigate benefits of binaural hearing for non-traditional cochlear implant candidates (with Asymmetric Hearing Loss). Asymmetric candidates are patients with severe to profound hearing loss in one ear and better hearing in the other ear. (One ear is deaf and the other ear has better hearing and in most cases uses a hearing aid.) The investigators hypothesize that cochlear implantation of the poorer ear provides a functional increase in word and sentence understanding in quiet or noise, perceived benefit, localization ability, and other measures of auditory performance relative to use of the better hearing ear alone.