Clinical trials: Profound Hearing Impairment
Acoustic Neuroma, Labyrinthitis Ossificans
Maintaining Cochlear Patency After VIIIth Nerve Surgery
Tumors arising from the VIIIth Nerve (vestibulo-cochlear nerve) typically present with progressive unilateral hearing loss and tinnitus.
- Conditions
- Acoustic Neuroma, Labyrinthitis Ossificans, Profound Hearing Impairment
- Trial name
- NCT03261726
- Testing
- MedEl Test Electrode Placer
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Henry Ford Health System
Hearing Loss, Unilateral, Hearing Loss, Profound
Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants
The purpose of this study is to understand the speech perception in noise and in quiet and localization benefits in a laboratory setting in listeners that receive a cochlear implant in an ear with severe to profound hearing loss…
- Trial name
- NCT03929809
- Testing
- Cochlear Implant
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Iowa
Profound Hearing Loss, Cochlear Implants
The Value Electrical Stapedial Reflex Thresholds (eSRTs) Cochlear Implant Mapping
One of the most significant challenges in cochlear implant programming, particularly for very young children and those with an associated pathologies, is the measurement of subjective comfort levels (= C-Subjective).
- Trial name
- eSRT (NCT06051006)
- Testing
- ESR and ECAP measurements, Device setting, Speech audiometry
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Unilateral Severe to Profound Hearing Loss OR Bilateral Severe to Profound Hearing Loss
Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss
The goal of the study was to evaluate the safety, tolerability, and the potential ability of CGF166 delivered through IL-infusion to improve hearing.
- Trial name
- NCT02132130
- Testing
- CGF166
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Hearing Loss, High-Frequency
Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents
The purpose of this study is to determine if adults and children with residual low-pitch hearing in the severe hearing loss range can develop improved speech perception by combining their residual acoustic hearing with electrical…
- Trial name
- NCT01975571
- Testing
- Cochlear® Nucleus™ Hybrid L24, Cochlear® Nucleus™ Hybrid S12
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Bruce J Gantz
Hearing Loss, Sensorineural, Severe, Hearing Loss, Sensorineural, Bilateral
Hear Again, Work Again
Project synopsis: This prospective cohort study investigates impact of (1) hearing loss and (2) cochlear implantation on cost and health state on one hand, and employment, productivity and social wellbeing on the other hand in a…
- Conditions
- Hearing Loss, Sensorineural, Severe, Hearing Loss, Sensorineural, Bilateral, Hearing Loss, Unilateral, Hearing Loss, Sensorineural, Profound
- Trial name
- NCT05196022
- Testing
- Cochlear implant
- Where
- Belgium
- Volunteers
- 200 people
- Sponsor
- University Hospital, Antwerp
Deafness
Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients
This study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. For this reason, the evolution of these neurophysiological measures, expressing the encoding of pure…
- Trial name
- NEUROSYLLABIC (NCT02323256)
- Testing
- Auditory steady-state response ASSR, Speech-ABR, Acoustic Change Complex ACC
- Where
- France
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
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, 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
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
Severe to Profound Prelingual Hearing Loss
Language Development in Children With Cochlear Implants and Speech-language Therapy Interventions
Cochlear implantation is currently offered to children with severe to profound prelingual hearing loss for whom hearing aids alone are insufficient to provide access to oral language (HAS, 2009).
- Trial name
- ICORTHO (NCT07447427)
- Testing
- Speech-language therapy (observed standard care)
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Severe to Profound Sensorineural Hearing Loss
Correlations Between Subjective and Objective Responses to Cochlear Implant Stimulation
Cochlear implants have been used for several decades, with major technological advances. However, adjustment can be difficult for patients who have to get used to a new sound that is electrical rather than acoustic.
- Trial name
- CRSOSIC (NCT07371299)
- Testing
- Objective electrophysiological measures (eCAP, eABR, eSRT)
- Volunteers
- 60 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Profound Hearing Impairment, Nutrition, Healthy
The Effectiveness of a Tailored Nutritional Education Program on Profound Hearing Impairment Adults
Literature suggests that profound hearing-impaired people have poor access to health care directly related to communication difficulties. A lack of knowledge regarding health and healthy dietary patterns has been documented.
- Trial name
- NCT06530979
- Testing
- Tailored nutritional education program utilizing Saudi-sign language supplied by Saudi-sign language interpreter
- Where
- Saudi Arabia
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- King Saud 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
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 to Profound Hearing Loss
Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants.
This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized.
- Trial name
- BELPS (NCT07777562)
- Testing
- Cochlear implantation
- Where
- Switzerland
- Volunteers
- 700 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Cochlear Hearing Loss
Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss
This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM SlimJ Electrode and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Ultra X) under normal conditions of use as it is…
- Trial name
- NCT04929470
- Testing
- cochlear implantation
- Where
- 3 sites in Germany
- Volunteers
- 37 people
- Sponsor
- Advanced Bionics AG