Clinical trials: Profound Hearing Loss
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
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
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
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
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
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
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
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
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
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
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
Profound Bilateral Deafness Due to, Bilateral Cochlear Aplasia
A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients
Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities, are limited and, in the case of absent cochleas, non-existent.
- Conditions
- Profound Bilateral Deafness Due to, Bilateral Cochlear Aplasia, Bilateral Cochlear Nerve Deficiency, Bilateral Cochlear Ossification Secondary to Meningitis
- Trial name
- NCT02102256
- Testing
- Auditory Brainstem Implant
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Laurie Eisenberg