Clinical trials: Cochlear
Adult Cochlear Implant Recipients
Acceptance and Performance of CP1110 Sound Processor With Experienced Adult Cochlear Implant Recipients.
The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound…
- Trial name
- PINNA (NCT05080283)
- Testing
- CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), Nucleus 7 Sound Processor (model: CP1000) system, CP1110 Sound Processor System with ForwardFocus Off (SCAN 2)
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cochlear
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, 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, Unilateral
Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss
This feasibility study evaluates whether children with unilateral, moderate to profound sensorineural hearing loss experience an improvement in speech perception, hearing in noise, localization, and quality of life with a…
- Trial name
- CIPUHL (NCT02963974)
- Testing
- Cochlear implant
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Cochlear Hearing Loss
Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss
This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM SlimJ Electrode and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Ultra X) under normal conditions of use as it is…
- Trial name
- NCT04929470
- Testing
- cochlear implantation
- Where
- 3 sites in Germany
- Volunteers
- 37 people
- Sponsor
- Advanced Bionics AG
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Iowa/Nucleus 10/10 mm and Nucleus Freedom Feasibility Study
The purpose of this study is to evaluate whether the Iowa/Nucleus 10/10 mm in one ear, in conjunction with a Nucleus Freedom implant in the other ear can provide useful binaural hearing in pediatric subjects who have bilateral…
- Trial name
- NCT00594061
- Testing
- Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Bruce J Gantz
Hearing Loss
Implantation With the Nucleus CI532 Cochlear Implant in Adults
The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant. The Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea…
- Trial name
- NCT02677220
- Testing
- CI532 cochlear implant
- Where
- United States
- Volunteers
- 1 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
High Frequency Sensorineural Hearing Impairment, Hearing Disorders in Children
Outcomes in Children With Pre-operative Residual Hearing
Purpose: Routine clinical care and pilot study data has shown evidence of postoperative hearing preservation in pediatric cochlear implant (CI) recipients.
- Trial name
- NCT03379870
- Testing
- Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting, Electric Acoustic Speech Processor: Full-electric stimulation fitting
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
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
Hearing Impairment
Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients
Acceptance and performance of the CP1170 sound processor in experienced adult cochlear implant recipients compared with the CP1150 sound processor and their current sound processor.
- Trial name
- POLAR (NCT05619575)
- Testing
- CP1170 Sound Processor, CP1150 Sound Processor
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural, Sensorineural Hearing Loss, Bilateral
Benefits of Bimodal Streaming With MED-EL Cochlear Implants and Starkey Hearing Aids
This study will evaluate sound quality and user satisfaction with Bluetooth streaming using a new bimodal streaming option for individuals who use a MED-EL cochlear implant and Starkey hearing aid.
- Conditions
- Hearing Loss, Sensorineural, Sensorineural Hearing Loss, Bilateral, Cochlear Implant Recipients, Asymmetric Hearing Loss
- Trial name
- NCT07028619
- Testing
- Bimodal Streaming Configuration
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Med-El Corporation
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
Hearing Loss
Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults
Clinical study to evaluate the safety and efficacy of the Cochlear™ Nucleus® CI422 cochlear implant for new cochlear implant adult recipients with broader requirements to be considered an eligible candidate.
- Trial name
- NCT01867008
- Testing
- Nucleus CI422 Cochlear Implant with N6 Sound Processor
- Where
- 2 sites in United States
- Volunteers
- 55 people
- Sponsor
- Cochlear
Cochlear Implant
Place-based Mapping in EAS Listeners
Purpose: Investigate monaural and binaural hearing in electric-acoustic stimulation (EAS) users with place-based versus default maps.
- Trial name
- NCT04722042
- Testing
- place-based mapping, default mapping
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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.
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
Cochlear Implant
The iotaSOFT Insertion System Safety Study
Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.
- Trial name
- NCT04577118
- Testing
- iotaSOFT Insertion System
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- iotaMotion, Inc.
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