Clinical trials: Deafness; Perception, Bilateral, open to volunteers
Sensorineural Hearing Loss, Bilateral
Comparison of Speech Understanding Between Tonotopy-based Fitting and Setting Based on Evolutionary Algorithms
Main objective: Compare speech recognition in noise with tonotopic setting (FS4T) and with tonotopic fitting modified by evolutionary algorithm (EAFS4T) in adult patients implanted for 6 months or more with a MED-EL cochlear…
- Trial name
- NCT06737185
- Testing
- EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting
- Where
- France
- Volunteers
- 22 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Bilateral, Bilateral Hearing Loss
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting
Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.
- Trial name
- NCT05955469
- Testing
- FS4 then TFS4 (cochlear implant), TFS4 then FS4 (cochlear implant)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Bilateral
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting With or Without Synchronization
Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without…
- Trial name
- NCT05898659
- Testing
- ABFnoS then ABFS (Cochlear implant), ABFS then ABFnoS (Cochlear implant)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
Sensorineural Hearing Loss, Bilateral
Otoferlin Gene-mediated Hearing Loss Natural History Study
This is a retrospective and prospective longitudinal study in participants with Otoferlin Gene-Mediated Hearing Loss.
- Trial name
- NCT05572073
- Testing
- Natural History Study
- Where
- 10 sites in United States, Australia and 5 more
- Volunteers
- 150 people
- Sponsor
- Akouos, Inc.
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
Bilateral Sensorineural Hearing Loss, Cochlear Implant
Binaural Cue Sensitivity in Children and Adults With Combined Electric and Acoustic Stimulation
There is a rapidly growing population of adult and pediatric cochlear implant (CI) recipients with acoustic hearing preservation in the implanted ear(s) allowing for combined Electric and binaural Acoustic Stimulation (EAS).
- Conditions
- Bilateral Sensorineural Hearing Loss, Cochlear Implant, Hearing Preservation, Electric and Acoustic Simulation
- Trial name
- NCT07356128
- Testing
- binaural processing over time, binaural processing over time for children and adults with normal hearing
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Hearts for Hearing
Sensorineural Hearing Loss, Bilateral Hearing Loss
Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
- Trial name
- CI-DEX-LTFU (NCT06936449)
- Testing
- CI632D, CI632
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral
Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy
Main objective: Investigate on new cochlear implanted patients whether the FineHearing strategy of the MED-EL cochlear implant gives better results on musical perception if the depth of stimulation (stimulation or not of the…
- Trial name
- NCT04591093
- Testing
- FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated
- Where
- France
- Volunteers
- 32 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Bilateral Sensorineural Hearing Loss
Noise Reduction With Hearing Aids
The purpose of this study is to use an optimized version of the SEDA algorithm (SEDA-HA) for hearing aids to evaluate the benefit for listeners with varying degrees of hearing loss in realistic environments and evaluate its…
- Trial name
- NCT07700043
- Testing
- Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm, Hearing aid (HA) prototype with SEDA-HA algorithm
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- NYU Langone Health
Cochlear Implants, Bilateral Sensorineural Hearing Loss
Assessing the Effect of Computer-based Auditory Training on Adult Cochlear Implant Speech and Quality-of-life Outcomes
The purpose of this study is to compare the effectiveness of a free computer-based auditory training program, Sound Success (Advanced Bionics, Valencia, CA), with the current standard of care of patient-directed auditory training…
- Trial name
- NCT06607146
- Testing
- Sound Success, Standard of Care
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Mayo Clinic
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
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
Otoferlin Gene-mediated Hearing Loss
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
This multi-center, observational, post-intervention long term follow-up (LTFU) study will monitor for safety and efficacy of AAVAnc80-hOTOF in individuals with sensorineural hearing loss due to otoferlin gene mutations who have…
- Trial name
- NCT06696456
- Where
- 5 sites in United States, Spain and 1 more
- Volunteers
- 30 people
- Sponsor
- Eli Lilly and Company
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
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
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
Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe
Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users
On June 23, 2021, the Oticon Medical Neuro Cochlear Implant System (NCIS) was granted premarket approval (PMA) in the US to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who…
- Conditions
- Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe, Sensorineural Hearing Loss, Profound
- Trial name
- PACIFIC (NCT05154188)
- Testing
- Neuro Cochlear Implant system
- Volunteers
- 60 people
- Sponsor
- Oticon Medical