Clinical trials: Sensorineural Hearing Loss, Profound
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
Cochlear Hearing Loss
Safety and Performance of HiRes Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss
This is a prospective study designed to evaluate the safety and performance of the HiRes Ultra Cl HiFocus MS Electrode and HiRes Ultra 3D Cl HiFocus MS Electrode (Ultra X) under normal conditions of use as it is approved for this…
- Trial name
- NCT04610112
- Testing
- Cochlear implantation
- Where
- 3 sites in Germany
- Volunteers
- 30 people
- Sponsor
- Advanced Bionics AG
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, 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
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
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
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
Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Designing a Trial of Bilateral Cochlear Implantation in Adults
In the UK, cochlear implantation is the standard treatment for adults with 'severe-to-profound' deafness. This level of deafness means that without a cochlear implant they have difficulty understanding what people are saying even…
- Trial name
- FOUNDATION (NCT03287700)
- Testing
- No intervention
- Where
- United Kingdom
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Nottingham University Hospitals NHS Trust
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
Hearing Loss, Sensorineural
Evaluation of the Efficacy and Safety of the Sullivan Cochlear Implant.
The study will be conducted as a prospective, single center, repeat measure, single-arm, open label clinical study
- Trial name
- NCT07018882
- Testing
- Sullivan
- Volunteers
- 25 people
- Sponsor
- Todoc
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, 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
Sensorineural Hearing Loss, Bilateral, AUNB1
Natural History in Children up to 16 Years With Mild to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes
The purpose of this study is to follow the natural history of non-syndromic hearing loss caused by mutations in two genes (GJB2 or OTOF) in children up to 16 years of age.
- Conditions
- Sensorineural Hearing Loss, Bilateral, AUNB1, DFNB1A, Congenital Deafness
- Trial name
- Otoconex (NCT05402813)
- Testing
- Pure Tone Audiometry Assessment, Quality of Life Questionnaires
- Where
- France
- Volunteers
- 180 people
- Sponsor
- Sensorion
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
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
Neurofibromatosis Type 2, Severe Profound Sensorineural Hearing Loss
Compassionate Use Arm - ABI541 ABI for 10 NF2 Patients
The Nucleus 24 Auditory Brainstem Implant (ABI) is the only FDA approved device for restoration of meaningful hearing in Neurofibromatosis Type 2 (NF2) patients.
- Trial name
- NCT02589912
- Testing
- Nucleus Profile ABI541 Auditory Brainstem Implant
- Where
- United States
- Sponsor
- Massachusetts Eye and Ear Infirmary
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
Sensorineural Hearing Loss, Bilateral, Cochlear Implants
Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults.
This clinical investigation aims to collect data on the use of the Mi2000 system, a totally implantable cochlear implant system, for the first time in human subjects.
- Trial name
- TICI (NCT04571333)
- Testing
- Mi2000 Totally Implantable Cochlear Implant
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 6 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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