Clinical trials: Profound Deafness
Bilateral Sensorineural Hearing Loss
Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population
Purpose: The purpose of this study is 1) to evaluate the safety and efficacy of currently available multichannel cochlear implant systems for newly implanted adults with an indication based on open-set sentence recognition that…
- Trial name
- NCT02075229
- Testing
- Cochlear implant
- Where
- 19 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- American Cochlear Implant Alliance
Hearing Loss, Bilateral Sensorineural, Hearing Loss, Sensorineural
Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)
This clinical study will test a newly developed cochlear implant known as CI622D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone.
- Conditions
- Hearing Loss, Bilateral Sensorineural, Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Cochlear
- Trial name
- DETECT (NCT06424262)
- Testing
- CI622D, CI622
- Where
- 11 sites in Australia, France and 2 more
- Volunteers
- 50 people
- Sponsor
- Cochlear
Congenital Profound Hearing Loss
Evaluation of a Cohort of Congenital Deep Deafness Patients and/or With Auditory Neuropathy, Looking for DFNB9
Evaluation of a cohort of deaf children looking for autosomal recessive deafness-9 (DFNB9). Clinical and audiologic evaluation of patients with known auditive neuropathy / auditory dys-synchrony (ANAD) or recently diagnosed…
- Trial name
- AUDIOFERLINE (NCT04202185)
- Testing
- Data collection, Genetic analysis
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Severe to Profound Hearing Loss, in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.
- Trial name
- NCT01616576
- Testing
- Control first, then Experimental, Experimental first, then Control
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Advanced Bionics
Frequency Compression, Severe-profound Hearing Impairment
Use of Frequency Compression in Severe-profound Hearing Loss Adults
The purpose of this study is to investigate the functional benefits of frequency compression vs no frequency compression or fitted to hearing loss in severe-profound hearing impaired adults with high frequency hearing losses.
- Trial name
- FC (NCT04623112)
- Testing
- Hearing aid feature: Frequency Compression
- Volunteers
- 27 people
- Sponsor
- University College, London
Severe, Profound Deafness
Balance in Children With Cochlear Implants
The purpose is to test the balance of children with unilateral,bilateral cochlear implants and patients having unilateral implants before,bilateral implants after surgery,using the Bruininks-Oseretsky Test 2nd ed.
- Trial name
- NCT00642343
- Testing
- Evaluation of motor proficiency skills., Evaluation of motor proficiency, Evaluation of motor proficiency.
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- University of Oklahoma
Profound Hearing Impairment
Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation.
Our main objective is to study how the extent of reorganization of the central auditory system is related to the binaural integration in cochlear implanted subjects with asymmetric hearing loss.
- Trial name
- UniTEP (NCT03117413)
- Testing
- Positron emission tomography scan
- Where
- 2 sites in France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Hospital, Toulouse
Severe to Profound Sensorineural Hearing Loss, Undergoing Cochlear Implant Surgery
Radiological Classification of the Facial Nerve
Cortical mastoidectomy and posterior tympanotomy is a classic approach for cochlear implant. Intimate knowledge of the relevant surgical anatomy of the temporal bone and facial recess is important to safely perform the posterior…
- Trial name
- NCT02925208
- Testing
- cochlear implant surgery
- Where
- Saudi Arabia
- Volunteers
- 140 people
- Sponsor
- Imam Abdulrahman Bin Faisal University
Hearing Loss
Retrospective CI532 Hearing Performance
The aim of this retrospective study is to collect and assess hearing performance data that have been measured by five clinics in Germany as part of their clinical routine in recipients implanted with a commercial CI532.
- Trial name
- NCT03039283
- Testing
- Nucleus CI532 cochlear implant
- Where
- 5 sites in Germany
- Volunteers
- 162 people
- Sponsor
- Cochlear
Profound Congenital Deafness, Cochlear Implantation
Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
The language environment that influences the child's language development has been studied using different subjective tools, mainly audio and/or video recording and manual transcriptions.
- Trial name
- ACLEIC (NCT05917496)
- Testing
- LENA tool: Language ENvironment Analysis, Return of the analysis of the data of LENA
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Deafness
Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS
The principal aim of this study is to evaluate the cortical developement of perceptual skills and executive functions over time, in children with cochlear implants aged 10-24 months and 3-7 years compared with normally hearing…
- Trial name
- HearCog (NCT04495660)
- Testing
- Near InfraRed Spectroscopy (fNIRS), Passive perceptual stimulation, Task A not B
- Where
- France
- Volunteers
- 80 people
- Sponsor
- University Hospital, Toulouse
Hearing Impairment
Computer-Assisted Speech Training for Hearing Aid Users
Computer-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.
- Trial name
- NCT02092337
- Testing
- computer-assisted speech training
- Where
- Taiwan
- Volunteers
- 12 people
- Sponsor
- National Taiwan University Hospital
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Societal Merit of Intervention on Hearing Loss Evaluation
The primary objective of this study is to determine the (long term) effect of intervention with a CI in adult participants with progressive postlingual moderate/severe-to-profound sensorineural hearing loss on societal related…
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Adult-Onset, Hearing Loss, Bilateral Sensorineural, Progressive
- Trial name
- SMILE (NCT05525221)
- Where
- 5 sites in Netherlands
- Volunteers
- 156 people
- Sponsor
- Radboud University Medical Center
Sudden Hearing Loss
Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss
Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss
- Trial name
- NCT07814677
- Testing
- intracochlear injection of triamcinolone acetonide through the round window membrane, intratympanic dexamethasone injection through the tympanic membrane
- Where
- China
- Volunteers
- 56 people
- Sponsor
- Eye & ENT Hospital of Fudan University
Unilateral Moderate to Profound Hearing Loss, Asymmetric Hearing Loss
Cochlear Implantation in Cases of Single-Sided Deafness
The primary goal of this project is to determine whether subjects with Single-Sided Deafness (SSD) experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an…
- Conditions
- Unilateral Moderate to Profound Hearing Loss, Asymmetric Hearing Loss, Single-Sided Deafness (SSD)
- Trial name
- CI in SSD (NCT02203305)
- Testing
- Cochlear Implant, Control Group
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- University of North Carolina, Chapel Hill
Severe-to-profound Hearing Loss
Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing
The goal of this investigation is to generate the needed PMCF data for the HiFocus Mid-Scala electrode. As a point of interest the investigators would like to evaluate the benefit to patients with low-frequency residual hearing…
- Trial name
- NCT01824563
- Testing
- Observational study
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Advanced Bionics AG
Profound Deafness
Optimization of Cochlear Implant Fitting in Patients With Functional Contralateral Hearing Using an Evolutionary Algorithm.
360 million people worldwide suffer from disabling hearing loss. The prevalence of hearing impairment, all stages combined, in the French population is 7% (4 million people), of which 9% have severe impairment and 3% have…
- Trial name
- Algo Fréq (NCT04888143)
- Testing
- questionnaires, Evolutionary algorithm
- Where
- France
- Volunteers
- 18 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Severe to Profound Mixed Hearing Loss
Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs
The purpose of this study is to evaluate the effect of the sound processor upgrade from the C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor for the Codacs™ system on the speech…
- Trial name
- NCT02156167
- Testing
- CP810 and Codacs™ system test
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss
Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study
The objective of this multisite study is to evaluate the performance of the Nucleus Freedom cochlear implant system in a large population of sequentially implanted pediatric subjects.
- Trial name
- NCT00589511
- Volunteers
- 69 people
- Sponsor
- Cochlear
Cochlear Implant, Severe-Profound Hearing Loss
Bimodal, CROS and Severe Profound Hearing Loss Study
The study will involve the comparison of three groups with severe-profound hearing loss. Patients with a Cochlear Implant only, patients with a cochlear implant and Hearing Aid, and finally patients with two hearing aids.
- Conditions
- Cochlear Implant, Severe-Profound Hearing Loss, Hearing Loss, Bilateral, Hearing Loss, Cochlear
- Trial name
- NCT04222296
- Testing
- Fitting strategy of cohlear implant of hearing aid
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust