Clinical trials: Severe, Profound Deafness, open to volunteers
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
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 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
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
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
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 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
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
Mild Cognitive Impairment in Middle-aged Adults
Deafness and Cognition in Middle-aged Adults
A mild cognitive impairment was observed in 50% of cochlear implant candidates aged 65 years and over, compared to 5-19% in general population. No studies analysed cognition in patients younger than 65 years.
- Trial name
- SURDICOG (NCT05149742)
- Testing
- Cognitive and audiometry evaluation
- Where
- France
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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