Clinical trials: Sensorineural Hearing
Sensorineural Hearing Loss, Bilateral
Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis
The purpose of this study is to characterize and assess the evolution of hearing impairment of patients with adulthood-onset bilateral sensorineural hearing loss carrying mutations on GJB2 gene.
- Trial name
- SONG (NCT06354010)
- Testing
- Genotyping, Audiological assessments
- Where
- 2 sites in United States, France
- Volunteers
- 134 people
- Sponsor
- Sensorion
Sensorineural Hearing Loss, Tinnitus
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
The purpose of this study is to investigate the degree of benefit to tinnitus symptoms by using a Totally Implantable cochlear implant (TICI) in a group of patients who have moderate-to-severe tinnitus pre-operatively.
- Trial name
- EXCITE (NCT07893860)
- Testing
- Cochlear implant
- Where
- Spain
- Volunteers
- 14 people
- Sponsor
- Cochlear
Cochlear Implant Recipients, Hearing Loss, Cochlear
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
This study will evaluate a range of experimental sound coding strategies that may improve hearing for cochlear implant recipients.
- Trial name
- SONORA-MU (NCT06867380)
- Testing
- Investigational sound coding strategy A, Cochlear default sound coding strategy A, Investigational sound coding strategy B
- Where
- 2 sites in Australia
- Volunteers
- 120 people
- Sponsor
- Cochlear
Hearing Loss, Unilateral, Hearing Loss, Sensorineural
Single-Sided Deafness and Asymmetric Hearing Loss
The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.
- Trial name
- NCT04506853
- Testing
- MED-EL Cochlear Implant System
- Where
- 5 sites in United States, Canada
- Volunteers
- 65 people
- Sponsor
- Med-El Corporation
Meniere's Disease, Meniere Disease
Expanded Access Protocol for SPI-1005
The purpose of this protocol is to facilitate expanded access ("compassionate use") of SPI-1005 to Meniere's disease (MD) or sudden sensorineural hearing loss (SSNHL) patients who cannot gain access through ongoing clinical…
- Conditions
- Meniere's Disease, Meniere Disease, Meniere´s Disease, Meniere's Disease Aggravated
- Trial name
- NCT07873281
- Testing
- Ebselen
- Sponsor
- Sound Pharmaceuticals, Incorporated
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
Hearing Loss, Sensorineural, Cochlear Implantation
Comparison of Performance Using MED-EL Automatic Sound Management
This study will evaluate the speech perception ability of adult cochlear implant users in background noise using various MED-EL Automatic Sound Management (ASM) features.
- Trial name
- NCT07500311
- Testing
- Automatic Sound Management Fixed Directionality, Automatic Sound Management Adaptive, Omnidirectional Settings
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Med-El Corporation
Sensorineural Hearing Loss, Presbyacusis
First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant
Rinri Therapeutics is conducting a clinical trial of a new cell therapy called Rincell-1. Rincell-1 is being developed to treat adults with neural hearing loss, either age related hearing loss or auditory neuropathy, who also…
- Conditions
- Sensorineural Hearing Loss, Presbyacusis, Auditory Neuropathy
- Trial name
- NCT07032038
- Testing
- Otic neural progenitors, cochlear implantation
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Rinri Therapeutics
Hearing Loss, Bilateral Sensorineural
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system.
- Trial name
- ELEVATE (NCT07287124)
- Testing
- Cochlear implant
- Where
- 11 sites in United States
- Volunteers
- 56 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral
Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss
Part A of this trial evaluated the safety and tolerability of a single surgical administration procedure in one or both ear(s) with one of two dose levels of AAVAnc80-hOTOF (LY888891) and evaluated the Akouos Delivery Device…
- Trial name
- NCT05821959
- Testing
- AAVAnc80-hOTOF via Akouos Delivery Device, AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 48 people
- Sponsor
- Eli Lilly and Company
Hearing Loss, Bilateral Sensorineural
A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
This clinical study examines the performance of an investigational totally implantable cochlear implant (TICI) system. The system includes an implantable microphone under the skin to detect speech and sound from the environment…
- Trial name
- ENTERPRISE (NCT07139327)
- Testing
- Cochlear Implant
- Where
- 8 sites in Australia, France
- Volunteers
- 36 people
- Sponsor
- Cochlear
Bone Conduction, Hearing Loss, Conductive
Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
The goal of this interventional study is to confirm the safety and performance of the latest generation Osia System and to examine its benefits compared to the Baha Connect System in adults with mixed or conductive hearing loss…
- Conditions
- Bone Conduction, Hearing Loss, Conductive, Hearing Loss, Mixed
- Trial name
- OSIRIS (NCT07130136)
- Testing
- Cochlear™ Osia® System, Cochlear™ Baha® System
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Cochlear
GJB2-mediated Hearing Loss, GJB2 Gene Mutation
Open-label Study of SKY-GJB2 in Pediatric Subjects With GJB2-mediated Hearing Loss
Skylark Bio is conducting a study of an investigational new drug called SKY-GJB2 and its delivery device, the SKY-CAT. SKY-GJB2 is a gene therapy that is being developed to treat children who have hearing loss due to changes in…
- Conditions
- GJB2-mediated Hearing Loss, GJB2 Gene Mutation, DFNB1A
- Trial name
- SONIX (NCT07627971)
- Testing
- SKY-GJB2
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Skylark Bio Inc.
Hearing Loss, Conductive, Hearing Loss, Mixed
Expanded Indications in the Pediatric BONEBRIDGE Population
This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.
- Trial name
- NCT05615649
- Testing
- MED-EL BONEBRIDGE Bone Conduction Implant
- Where
- 6 sites in United States
- Volunteers
- 36 people
- Sponsor
- Med-El Corporation
Hearing Loss, Hearing Loss, Conductive
The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study
The Bonebridge system using the BCI 601 is marketed since 2012. Previous prospective, multi-center, non-randomized studies on the BCI 601 Bonebridge performed in adult and paediatric populations have shown a significant…
- Conditions
- Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral
- Trial name
- NCT04427033
- Testing
- Bone Conduction Implant
- Where
- 8 sites in Austria, Germany and 1 more
- Volunteers
- 52 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Low-Frequency Residual Hearing
Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing
The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI632 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.
- Trial name
- NCT04741009
- Testing
- CI632 Slim Modiolar Electrode
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Cochlear
Hearing Loss, Conductive, Hearing Loss, Mixed
Pediatric Expansion Study of the Sentio System
This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Single Sided Deafness
- Trial name
- BC119 (NCT06976086)
- Testing
- Active transcutaneous bone conduction system
- Where
- 8 sites in Netherlands, Spain and 1 more
- Volunteers
- 50 people
- Sponsor
- Oticon Medical
Cochlear Implantation, Sensorineural Hearing Loss
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
MED-EL Cochlear Implants (CI) provide auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing-impaired individuals who obtain little or no benefit from acoustic amplification in…
- Trial name
- LORIS (NCT07697911)
- Testing
- Transfer of data of SONATA 2 cochlear implant recipients
- Where
- 2 sites in Spain
- Volunteers
- 200 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
iotaSOFT Pediatric Study
Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Unilateral
- Trial name
- NCT06106373
- Testing
- iotaSOFT Insertion System
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- iotaMotion, Inc.
Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children/Infants, Adolescents and Adults With Hearing Loss Due to Otoferlin Mutations
Regeneron is conducting a study of an investigational new drug called DB-OTO. DB-OTO is a gene therapy that is being developed to treat pediatric and adult participants who have severe-to profound and profound hearing loss due to…
- Trial name
- CHORD (NCT05788536)
- Testing
- DB-OTO
- Where
- 17 sites in United States, Germany and 3 more
- Volunteers
- 36 people
- Sponsor
- Regeneron Pharmaceuticals