Clinical trials: Cochlear Hearing Loss
Hearing Loss
Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System
To evaluate the performance of the Nucleus 5 Cochlear Implant System.
- Trial name
- NCT01072409
- Testing
- Nucleus 5 Cochlear implant, Cochlear implantation
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Cochlear
Hearing Loss, Sensorineural Hearing Loss
Non-significant Risk Study of a Cochlear Implant Headpiece
This study aims to evaluate a cochlear implant headpiece.
- Trial name
- NCT05488535
- Testing
- cochlear implant headpiece
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Advanced Bionics
Hearing Loss, Sensorineural, Hearing Loss, Cochlear
The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
The purpose of the study is to assess the efficacy and the safety profile of the Neuro Cochlear Implant System (CIS) in adults with severe-to-profound hearing loss.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Cochlear, Deafness
- Trial name
- NCT02941627
- Testing
- Neuro Zti, Neuro One
- Where
- 6 sites in Canada, Denmark
- Volunteers
- 53 people
- Sponsor
- Oticon Medical
Single Sided Sensorineural Deafness, Mixed Hearing Loss, Unilateral
Evaluation of Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System
The aim of this clinical investigation is to evaluate objective and subjective hearing performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System, compared to the unaided hearing performance.
- Trial name
- NCT02722330
- Testing
- Baha 5 SuperPower on Baha Attract System
- Where
- 4 sites in Belgium, Denmark and 2 more
- Volunteers
- 23 people
- Sponsor
- Cochlear Bone Anchored Solutions
Cochlear Hearing Loss
Safety and Performance of HiRes Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss
This is a prospective study designed to evaluate the safety and performance of the HiRes Ultra Cl HiFocus MS Electrode and HiRes Ultra 3D Cl HiFocus MS Electrode (Ultra X) under normal conditions of use as it is approved for this…
- Trial name
- NCT04610112
- Testing
- Cochlear implantation
- Where
- 3 sites in Germany
- Volunteers
- 30 people
- Sponsor
- Advanced Bionics AG
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.
Unilateral Moderate to Profound Hearing Loss, Asymmetric Hearing Loss
Cochlear Implantation in Cases of Single-Sided Deafness
The primary goal of this project is to determine whether subjects with Single-Sided Deafness (SSD) experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an…
- Conditions
- Unilateral Moderate to Profound Hearing Loss, Asymmetric Hearing Loss, Single-Sided Deafness (SSD)
- Trial name
- CI in SSD (NCT02203305)
- Testing
- Cochlear Implant, Control Group
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- University of North Carolina, Chapel Hill
Hearing Loss
Evaluation of the Presence of SENS-401 in the Perilymph
The aim of this study is to detect the presence of SENS-401 in the perilymph of participants undergoing cochlear implant surgery after 7 days of oral administration of SENS-401.
- Trial name
- NCT05258773
- Testing
- SENS-401 (R-Azasetron Besylate)
- Where
- 7 sites in Australia, France
- Volunteers
- 28 people
- Sponsor
- Sensorion
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
Littlears Auditory Questionnaire: Validation Study in CI Children
The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years.
- Trial name
- LittlEars (NCT00785707)
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Med-El Corporation
Hearing Loss, Ear Diseases
Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other…
- Conditions
- Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases
- Trial name
- NCT02811549
- Testing
- HiResolution Bionic Cochlear Implant
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Advanced Bionics
Cochlear Implant
Pediatric Image-Guided Cochlear Implant Programming
Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Recent literature has indicated that children receiving cochlear implants (CIs) often have dramatically improved speech…
- Trial name
- NCT03886168
- Testing
- Signal processing intervention of a biomedical device
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Vanderbilt University Medical Center
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
An Actual Use, Open-label Study Assessing Usability of Remote Assist to Program Cochlear Implant Recipients
Clinical management of cochlear implant (CI) recipients involve programming, counselling, performance evaluation and habilitation.
- Trial name
- RAL (NCT04987021)
- Testing
- Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants
- Where
- Australia
- Volunteers
- 15 people
- Sponsor
- Cochlear
Hearing Loss
Safety and Efficacy of the Vibrant Soundbridge (VSB) for Mixed and Conductive Hearing Losses
The purpose of this investigation is to collect feasibility data to assess the safety and efficacy of the Vibrant Soundbridge (VSB), a medical device designed to provide benefit in aided hearing thresholds, speech perception and…
- Trial name
- VSBRW (NCT00748540)
- Testing
- Vibrant Soundbridge
- Where
- 11 sites in United States
- Volunteers
- 50 people
- Sponsor
- Med-El Corporation
Hearing Loss, Ear Diseases
Clinical Evaluation of a Cochlear Implant Sound Processor
This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer).
- Conditions
- Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases
- Trial name
- NCT04237207
- Testing
- Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software, 301-M062 sound processor & software
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Advanced Bionics
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
Hearing Loss, Sensorineural
Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients
This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.
- Trial name
- DUAL (NCT06298396)
- Testing
- Program using default MAP, Program using low-power 1 (LP1) MAP, Program using low-power 2 (LP2) MAP
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Cochlear
Hearing Impairment, Sensorineural
Cochlear Response Telemetry and Hearing Preservation
The main purpose of this study is to monitor the response from the cochlea as the electrode is inserted during the operation to receive a cochlear implant.
- Trial name
- CREST (NCT03134989)
- Testing
- Cochlear implant
- Where
- Argentina
- Volunteers
- 80 people
- Sponsor
- Cochlear
Deafness, Hearing Loss
Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)
The rationale behind this post-market clinical follow-up investigation is to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that are candidates for…
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive
- Trial name
- NCT02022085
- Testing
- Baha Attract System
- Where
- 6 sites in United States, Netherlands and 2 more
- Volunteers
- 54 people
- Sponsor
- Cochlear Bone Anchored Solutions
Single Sided Deafness
Implantation of the Cochlear® Nucleus® System in Adults With Single-Sided Deafness
The objective of this feasibility study is to obtain preliminary safety and efficacy data associated with cochlear implantation in individuals with severe to profound sensorineural hearing loss contralateral to an ear with…
- Trial name
- NCT01670006
- Testing
- Cochlear Nucleus Cochlear Implant System
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cochlear