Clinical trials: Hearing Loss
Hearing Loss, Binaural, Cochlear Implantation
Mi2000 TICI - Post-market Implantation Study
This Post-Market Clinical Follow-up (PMCF) investigation aims to further collect evidence on safety and performance of the Mi2000 TICI.
- Trial name
- TUPIS (NCT07897318)
- Testing
- Cochlear Implantation
- Volunteers
- 22 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
Cochlear Synaptopathy
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Like retinopathy, neuropathy and nephropathy, sensorineural hearing loss is a common and underserved complication of uncontrolled diabetes.
- Trial name
- RESPLAND (NCT07472907)
- Testing
- CIL001 (Paliroden)
- Volunteers
- 135 people
- Sponsor
- Cilcare SAS
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
An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
The study is a feasibility, prospective, repeated-measures, multi-country, multi-centre, study of the Mobile Research App to measure and validate speech perception endpoints in adult cochlear implant recipients.
- Trial name
- VALDE-MU (NCT06098482)
- Testing
- Mobile Research App (MRA), SOC/validated delivery of the speech perception test material
- Where
- 4 sites in United States, Australia and 1 more
- Volunteers
- 46 people
- Sponsor
- Cochlear
Hearing Loss, Hearing Implants
A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults
The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems.
- Trial name
- ORBIT-MU (NCT07338864)
- Testing
- Cochlear Nucleus Nexa Cochlear implant (CI1032), Cochlear Nucleus Nexa Cochlear implant (CI1022), Cochlear Nucleus Nexa Cochlear implant (CI1012)
- Where
- Germany
- Volunteers
- 66 people
- Sponsor
- Cochlear
Hearing Loss
Nucleus Hybrid L24 Extended Duration Post Approval Study
This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid L24 Implant System in a group of already implanted recipients.
- Trial name
- HED (NCT02379273)
- Testing
- Nucleus Hybrid L24 Implant
- Volunteers
- 35 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
Hearing Loss
Hearing Outcomes With the Nucleus® 8 Sound Processor and Nucleus® 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients
The main purpose of this study is to understand how well a noise reduction feature called ForwardFocus works when used with two different sound processors: the Nucleus® 8 Sound Processor and the Nucleus® 7 Sound Processor, in…
- Trial name
- SALUTE (NCT07582198)
- Testing
- Nucleus 7 Sound Processor, Nucleus 8 Sound Processor
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Cochlear
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
Ear Diseases, Hearing Loss, Bilateral
Lumity CI Study - Clinical Evaluation of Next Generation Cochlear Implant Sound Processor
This is a prospective within-subjects repeated-measures study that will enroll 18 bilateral adult users implanted with a HiResolution Bionic Ear System (HiRes 90KTM, HiRes 90K TM Advantage, HiResTM Ultra, HiResTM Ultra 3D and CII…
- Conditions
- Ear Diseases, Hearing Loss, Bilateral, Otorhinolaryngologic Diseases
- Trial name
- NCT06858826
- Testing
- Control cochlear implant sound processor, Next Generation Sound Processor
- Volunteers
- 20 people
- Sponsor
- Advanced Bionics
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
Hearing Loss, Unilateral, Deafness, Unilateral
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for…
- Trial name
- PAS-SSD (NCT05318417)
- Testing
- The Cochlear™ Nucleus® Cochlear Implant (CI) System
- Where
- 6 sites in United States
- Volunteers
- 60 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
Tinnitus, Bilateral, Cochlear Synaptopathy
A Study Testing Safety and Efficacy of Transtympanic Paliroden for the Treatment of Cochlear Synaptopathy in Participants With Chronic, Constant Tinnitus
The goal of this clinical trial is to investigate if paliroden (CIL001) is safe and can help treat cochlear synaptopathy in adult participants 18-75 years of age with normal hearing thresholds and normal cognition who exhibit…
- Trial name
- REACT (NCT07826507)
- Testing
- paliroden (CIL001)
- Volunteers
- 60 people
- Sponsor
- Cilcare SAS
Tinnitus, Subjective, Tinnitus, Bilateral
Tinnitus Patient Preferences Survey
The goal of this survey is to assess several aspects related to patient preferences regarding interventions for alleviating tinnitus through invasive electrical brain stimulation (neuromodulation).
- Conditions
- Tinnitus, Subjective, Tinnitus, Bilateral, Tinnitus, Noise Induced, Tinnitus, Hearing Loss, Cochlear Implant Users
- Trial name
- NCT06782308
- Testing
- Survey using a questionnaire.
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Nicolas Gninenko