Clinical trials: Profound Deafness
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
Severe Sudden Sensorineural Hearing Loss
Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
Primary objective of the study is to assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period
- Trial name
- AUDIBLE-S (NCT03603314)
- Testing
- SENS-401
- Where
- 26 sites in Bulgaria, Canada and 8 more
- Volunteers
- 115 people
- Sponsor
- Sensorion
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
Hearing Loss
Optimization of Hearing Performance in the Subject Implanted
In the past two decades, the selection criteria for cochlear implantation have been greatly relaxed so that about 60-70% of present cochlear implant (CI) candidates have significant residual hearing in their contralateral ear.
- Trial name
- OPERSA (NCT05325450)
- Testing
- Program A, Program B, Control
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Toulouse
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
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
Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)
The purpose of this study is to evaluate if the new and simplified fitting method with Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the Clinical Care Innovation) provides Cochlear Implants…
- Trial name
- NCT02228148
- Testing
- NFS, CSS
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 48 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural, Severe-to-profound Hearing Loss
Hearing and Structure Preservation Via ECochG
The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.
- Trial name
- PRESERVE (NCT06268340)
- Testing
- ECochG monitored CI surgery incl. corrective action guide, Routine CI surgery without ECochG monitoring
- Where
- 7 sites in Belgium, France and 5 more
- Volunteers
- 102 people
- Sponsor
- Advanced Bionics AG
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
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
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
Severe to Profound Hearing Loss
Impact of Robotic Cochlear Implantation on Hearing Performance in Noise
The purpose of this study is to compare two methods of cochlear implantation : conventional manual insertion versus robot-assisted in order to verify whether robotic insertion provides better performance in the noisy environment.
- Trial name
- ROBOT-IC-BRUIT (NCT06248398)
- Testing
- Surgery with RobOtol®, Conventional manual surgery
- Where
- France
- Volunteers
- 140 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
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
Hearing Loss, Sudden
Establishment of a Trans-round Window Inner Ear Continuous Drug Delivery System for the Treatment of Severe-to-profound Sudden Sensorineural Hearing Loss
The investigators enrolled patients with total sudden deafness who had failed treatment with systemic combined intra-dural hormone injections.
- Trial name
- NCT05455398
- Testing
- Surgical treatment of round window niche enlargement via round window for inner ear drug delivery, Drum chamber drug injection
- Where
- China
- Volunteers
- 218 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe
Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users
On 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…
- Conditions
- Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe, Sensorineural Hearing Loss, Profound
- Trial name
- PACIFIC (NCT05154188)
- Testing
- Neuro Cochlear Implant system
- Volunteers
- 60 people
- Sponsor
- Oticon Medical
Sudden Hearing Loss, Extracellular Vesicles
Study on the Safety and Efficacy of Intratympanic Injection of Small Extracellular Vesicles Derived From Mesenchymal Stem Cells in Severe and Profound Sudden Sensorineural Hearing Loss
The goal of this clinical trial is to learn if small extracellular vesicles derived from mesenchymal stem cells work to treat severe and above sudden sensorineural hearing loss.
- Trial name
- NCT07404709
- Testing
- Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at low doses, Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at moderate doses, Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at high doses
- Where
- 5 sites in China
- Volunteers
- 9 people
- Sponsor
- The Affiliated Hospital of Qingdao University
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
Sensorineural Hearing Loss
Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System
The purpose of this study is to evaluate the safety and efficacy associated with the provision of acoustic and electric sound processing to individuals who demonstrate significant residual low-frequency hearing and profound…
- Trial name
- NCT00678899
- Testing
- Nucleus Hybrid L24
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural, Severe, Hearing Loss, Sensorineural, Profound
Association Between Severe-to-profound Hearing Loss and the Balance Function of the Inner Ear
Severe-to-profound hearing loss can have a major impact on patients´ lives leading to social isolation and decreased quality of life. Most commonly the hearing loss is caused by damage to the inner ear or cochlear nerve.
- Conditions
- Hearing Loss, Sensorineural, Severe, Hearing Loss, Sensorineural, Profound, Vestibular Disorder
- Trial name
- NCT05500521
- Testing
- Caloric irrigation, vHIT, VEMP
- Where
- Sweden
- Volunteers
- 98 people
- Sponsor
- Värmland County Council, Sweden