Clinical trials: Profound Deafness
Profound Bilateral Hearing Loss
Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion
The purpose of this study is to evaluate, via a randomised controlled design, the efficacy of the robotic insertion of cochlear implant, versus manual insertion. Robotic insertion will be performed using Robotol.
- Trial name
- ROBIICCA (NCT05696171)
- Testing
- Cochlear implant manual insertion, Cochlear implant robotized insertion
- Where
- 14 sites in France
- Volunteers
- 550 people
- Sponsor
- Nantes University Hospital
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
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
Conductive Hearing Loss, Conductive and Sensori-neural Hearing Loss in the Same Ear
Wide Diameter Bone Anchored Implant Study
To assess implant stability, implant loss, adverse skin reactions, and Quality of Life Benefit following implantation of the Ponto 4.5mm Wide Diameter implant.
- Conditions
- Conductive Hearing Loss, Conductive and Sensori-neural Hearing Loss in the Same Ear, Unilateral, Profound Sensori-neural Hearing Loss
- Trial name
- NCT01671176
- Testing
- Wide diameter bone anchored implant
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Oticon Medical
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
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
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
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
Bilateral Hearing Loss
Pilot Study of the Feasibility and Efficacy of Working Memory Training in Children With Cochlear Implants
This study is an investigation of the effect of a computer-based working memory training program on memory and language processing in at-risk children (e.g., those with working memory weaknesses) who have received cochlear…
- Trial name
- NCT00763243
- Testing
- Cogmed Working Memory Training Program
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Indiana University
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
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
OTOF Gene Mutation, DFNB9
A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations
This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.
- Conditions
- OTOF Gene Mutation, DFNB9, Congenital Deafness, Hearing Disorders
- Trial name
- AUDIOGENE (NCT06370351)
- Testing
- SENS-501 administration
- Where
- 2 sites in Australia, France
- Volunteers
- 12 people
- Sponsor
- Sensorion
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
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
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
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
Developmental Cochlear Nerve Deficiency, Acquired Cochlear Nerve Deficiency
Auditory Brainstem Implantation in Young Children
To purpose of this feasibility study is to demonstrate the safety and efficacy of the Nucleus 24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in children without the diagnosis of neurofibromatosis…
- Conditions
- Developmental Cochlear Nerve Deficiency, Acquired Cochlear Nerve Deficiency, Cochlear Aplasia, Post-meningitis Cochlear Ossification
- Trial name
- NCT01904448
- Testing
- Auditory Brainstem Implantation in Children
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of North Carolina, Chapel Hill
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
Hearing Loss
Relationship Between Auto NRT and Behavioural T & C Levels With the Nucleus Freedom Cochlear Implant
Cochlear implants require programming on an individual basis to provide appropriate levels of electrical stimulation. This program, or "map", is placed in the speech processor of the cochlear implant.
- Trial name
- NCT00331539
- Testing
- Cochlear Implant
- Where
- Israel
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Bnai Zion Medical Center