Clinical trials: Cochlear Hearing Loss, open to volunteers
Sensorineural Hearing Loss
Immunity After Cochlear Implantation and Perilymph Molecular Profiles in Sensorineural Hearing Loss
Many patients receiving cochlear implant (CI) have some residual hearing prior to implantation surgery. However, approximately one third of them will lose it in next 6 months after cochlear implantation.
- Trial name
- PERILOTO (NCT05670158)
- Testing
- Blood sampling, Perilymph sampling
- Where
- France
- Volunteers
- 80 people
- Sponsor
- University Hospital, Montpellier
Congenital Hearing Loss, Sensorineural Hearing Loss
Alpha-Tectorin, Interleukin-10 and Thiol-Disulfide Homeostasis in Children With Congenital Hearing Loss
Congenital hearing loss is one of the most common sensory disorders of childhood, and the structural, immunologic and oxidative mechanisms involved in its development are incompletely understood.
- Trial name
- NCT07860580
- Testing
- Blood sample collection
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Harran University
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
Deafness
Novel Coding Strategies for Children With Cochlear Implants
The purpose of this study is to understand performance with a cochlear implant. The long-term goals of this research are to improve sound perception with cochlear implants and to better understand the functioning of the auditory…
- Trial name
- NCT05203302
- Testing
- Single-Electrode Pulse Train, Modulation Detection Threshold (MDT) and Gap Detection Tasks, Sound coding strategy.
- Where
- United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Hearing Loss in Children With Unilateral or Bilateral Cochlear Implants
Feasibility and Reliability of Integrating Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement in a Pediatric Cochlear Implant Programming Center
In children aged 0 to 7 years, behavioral evaluation during cochlear implant programming is often difficult or unreliable. Objective, reproducible, and rapid markers are therefore essential.
- Trial name
- eSRT2 (NCT07417956)
- Testing
- Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement
- Where
- France
- Volunteers
- 48 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
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
Cochlear Implants, Cochlear Implantation
Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are: 1.
- Conditions
- Cochlear Implants, Cochlear Implantation, Hearing Loss
- Trial name
- NCT06375278
- Testing
- Intra-Ear Canal Cooling Catheter
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Restorear Devices LLC
Hearing Loss, Sensorineural, Cochlear Implantation
Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
- Trial name
- AIMBOT (NCT06664710)
- Testing
- iotaSOFT Insertion System with AIM, iotaSOFT Insertion System with AIM Control
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- iotaMotion, Inc.
Hearing Loss, Cochlear
Microtable® Method for Cochlear Implantation Investigational Device Exemption (IDE)
The Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation consists of a patient-customized microstereotactic frame which targets the cochlea.
- Trial name
- NCT03101917
- Testing
- The Microtable® Stereotactic System
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Medical University of South Carolina
Bilateral Sensorineural Hearing Loss, Speech and Language Development Delay Due to Hearing Loss
Neural Prediction to Enhance Language
The language outcome of children receiving cochlear implantation to address bilateral sensorineural hearing loss is more variable than that of typical hearing children.
- Conditions
- Bilateral Sensorineural Hearing Loss, Speech and Language Development Delay Due to Hearing Loss, Social Communication
- Trial name
- NCT05962359
- Testing
- Parent-Implemented Communication Treatment
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Unilateral Hearing Loss, Asymmetric Hearing Loss
Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
Today, unilateral hearing loss must be assessed and managed just as bilateral hearing loss is. It is recommended to consider the auditory difficulties caused by the loss of stereophonic hearing and to offer auditory…
- Trial name
- AsymIC-Ped (NCT06930170)
- Testing
- Cochlear implantation, CROS or BiCROS device fitting, French simplified matrix test (FraSimat)
- Where
- France
- Volunteers
- 36 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Sensorineural Hearing Loss, Bilateral Hearing Loss
Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants
This research study is evaluating two different methods of cochlear implant (CI) insertion - robotic-assisted insertion and manual insertion - to better understand how they affect hearing outcomes.
- Conditions
- Sensorineural Hearing Loss, Bilateral Hearing Loss, Cochlear Implantation, Hearing Disorders
- Trial name
- NCT07081542
- Testing
- IotaSoft Robotic Insertion System, Manual Cochlear Implant Insertion
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- AdventHealth
Single Sided Deafness, Unilateral Deafness
Cochlear Implants in Young Children With SSD
The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness.
- Conditions
- Single Sided Deafness, Unilateral Deafness, Hearing Loss, Unilateral, Hearing Loss
- Trial name
- Little SSD (NCT05775367)
- Testing
- Cochlear Implant
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Hearing Loss
Opto-electrical Cochlear Implants
Neural stimulation with photons has been proposed for a next generation of cochlear implants (CIs). The potential benefit of photonic over electrical stimulation is its spatially selective activation of small populations of…
- Trial name
- oCI (NCT05110183)
- Testing
- electrical stimulation, optical stimulation, combined optical and electrical stimulation
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Northwestern University
Sensorineural Hearing Loss, Bilateral
Speech Perception of a Tonotopy-based Fitting for Cochlear Implant Recipients for 6 Months With Conventional Setting
Main objective: Compare speech recognition in noise with tonotopic fitting (FS4T) and with conventional non-tonotopic fitting (FS4noT) in adult patients implanted for 6 months with a MED-EL cochlear implant with FS4noT strategy.
- Trial name
- NCT06723262
- Testing
- Tonotopic cochlear implant fitting FS4T
- Where
- France
- Volunteers
- 25 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss, Cochlear
Evaluating a Deep Neural Noise-Reduction Algorithm for Hearing Aids
This study is designed to understand how different hearing-aid noise-reduction technologies affect a listener's ability to hear speech in noisy environments.
- Trial name
- NCT07287774
- Testing
- Hearing Aid Noise Reduction - Off, Hearing Aid Noise Reduction - Low, Hearing Aid Noise Reduction - High
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Purdue University
Deafness; Perception, Bilateral
Musical Training in Cochlear Implant Users
With this protocol we want to investigate the degree to which the use of Meludia training (the online self-paced music training application) can improve music perception, music enjoyment, and speech understanding in pediatric and…
- Trial name
- NCT06540677
- Testing
- Musical training
- Volunteers
- 80 people
- Sponsor
- Hospital Universitario La Paz