Hearing Loss in Older Adults Study
Hearing LossSensorineural2 moreThis is a prospective, 1:1 randomized controlled trial of immediate versus delayed cochlear implantation (CI) on hearing handicap, communicative function, loneliness, mental wellbeing, and cognitive functioning. Participants are randomized 1:1 to an immediate cochlear implant intervention group versus a hearing aid control intervention.
Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial
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.
The EarLens Contact Hearing Device (CHD) Spectrum Study
Hearing LossSensorineuralThe EarLens System is an assistive hearing device that is intended to provide amplification for the treatment of patients with sensorineural hearing impairment. The purpose of the proposed study (Extended Investigation under the Continued Access Policy) is to continue to allow access to the investigational medical device with the collection of device utility and clinic process-flow data while the marketing application is under review at the FDA.
Esteem New Subject Enrollment Post Approval Study
Sensorineural Hearing LossThe New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe hearing loss.
OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
Sensorineural Hearing LossThe purpose of this study is to evaluate the safety, tolerability, and exploratory efficacy of OTO-413 administered as an intratympanic injection for the treatment of speech-in-noise hearing impairment.
FX-322 in Sensorineural Hearing Loss
Sensorineural Hearing LossThis 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.
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.
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.
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.