Clinical trials: Cochlear Implants
Hearing Loss
Multi-center Study to Examine Changes to the Environment Surrounding the Electrodes in the Cochlea and to Capture the Most Challenging Listening Environments Experienced by Persons With a Cochlear Implant
This early feasibility study aims to collect pilot data on impedance measurements in real-world environments and to collect real-world and difficult listening situations and the factors impacting this, reflecting situations the…
- Trial name
- DICE (NCT06173687)
- Testing
- The impedance measurement task using the Mobile Research App (MRA)
- Where
- 4 sites in Australia, Belgium and 1 more
- Volunteers
- 51 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
Severe to Profound Hearing Loss, in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.
- Trial name
- NCT01616576
- Testing
- Control first, then Experimental, Experimental first, then Control
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Advanced Bionics
Hearing Loss
Evaluation of the Benefits for Overall Health Following Cochlear Implant Treatment in the Elderly Population
The purpose of this study is to show that cochlear implant treatment improves the overall health related quality of life and general well-being in elderly individuals.
- Trial name
- NCT03072862
- Testing
- Commercial Nucleus Cochlear Implant Systems
- Where
- 8 sites in France, Israel and 2 more
- Volunteers
- 100 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Hearing Loss in Older Adults Study
This is a prospective, 1:1 randomized controlled trial of immediate versus delayed cochlear implantation (CI) on hearing handicap, communicative function, loneliness, mental wellbeing, and cognitive functioning.
- Trial name
- NCT03382769
- Testing
- Cochlear implantation
- Where
- 8 sites in United States
- Volunteers
- 1 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural
Expanded Indications in the Adult Cochlear Implant Population
The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit…
- Trial name
- NCT03236909
- Testing
- MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System
- Where
- 5 sites in United States, Canada
- Volunteers
- 44 people
- Sponsor
- Med-El Corporation
Sensorineural Hearing Loss, Bilateral Hearing Loss
Cochlear Implant With Dexamethasone Eluting Electrode Array
An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
- Trial name
- NCT04750642
- Testing
- CI632D, CI632
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 42 people
- Sponsor
- Cochlear
Hearing Loss
Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients
This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use…
- Trial name
- NCT05270876
- Testing
- Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique
- Where
- 5 sites in Australia, Belgium
- Volunteers
- 20 people
- Sponsor
- Cochlear
Hearing Loss, Partial Deafness
Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness
The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with…
- Conditions
- Hearing Loss, Partial Deafness, Hearing Disorders, Ear Diseases
- Trial name
- NCT02189798
- Testing
- HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode, EAS sound processor
- Where
- 11 sites in United States
- Volunteers
- 67 people
- Sponsor
- Advanced Bionics
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, Sensorineural
Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults
The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor
- Trial name
- SME (NCT03007472)
- Testing
- CI532, Nucleus 7
- Where
- 10 sites in United States
- Volunteers
- 96 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral, Cochlear Implant
Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
- Trial name
- NCT03304106
- Testing
- Commercially available cochlear implant and AI system
- Where
- 9 sites in United States
- Volunteers
- 102 people
- Sponsor
- Cochlear
Hearing Impairment, Sensorineural
CP1150 Sound Processor Speech Perception Compared With the Next Generation of Signal Processing Technology
This clinical study aims to investigate speech performance in quiet with an OTE Sound Processor with modified firmware compared with the commercially available CP1150.
- Trial name
- NCT05286385
- Testing
- CP1150 Sound Processor, CP1150 NF, CP1150 + FF
- Where
- Australia
- Volunteers
- 10 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, Sensorineural
Design Improvements With SONNET 3
Measuring user-reported satisfaction with the latest behind-the-ear (BTE) audio processor model.
- Trial name
- NCT06597747
- Testing
- Audio processor
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Med-El Corporation
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
Adult Cochlear Implant Recipients
CP1110 Sound Processor Feasibility
The clinical study aims to investigate the speech performance with the CP1110 Sound Processor, compared with the CP1000 Sound Processor, and inclusion of a noise reduction feature in the Automatic Scene Classifier..
- Trial name
- NCT04898673
- Testing
- CP1110, CP1000
- Where
- Australia
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral
Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults
The aim of this study is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition score in adults using currently a Nucleus cochlear implant.
- Trial name
- PROGRESS (NCT05265260)
- Where
- France
- Volunteers
- 32 people
- 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