Clinical trials: Cochlear Implantation
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
Clinical Investigation of the Nucleus® CI532 Cochlear Implant
The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant and to demonstrate the atraumatic nature of the electrode design.
- Trial name
- NCT02392403
- Testing
- Nucleus CI532 cochlear implant
- Where
- 8 sites in Australia, France and 2 more
- Volunteers
- 45 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural
Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear
Speech understanding in noise remains the greatest challenge for people using cochlear implants, particularly when the speech of interest comes from the side of the head opposite to the implant.
- Trial name
- NCT03867396
- Testing
- CROS, Hearing Aid, Cochlear Implant Alone
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Colorado, Denver
Sensorineural Hearing Loss
Fundamental Asynchronous Stimulus Timing Sound Coding Study
The Fundamental Asynchronous Stimulus Timing (FAST) is a novel cochlear implant sound coding strategy. Potential benefits include improved battery life, in addition to improved localization for bilateral patients.
- Trial name
- FAST (NCT02698787)
- Testing
- Experimental sound coding strategy (FAST), Commercially available ACE sound coding strategy
- Where
- United States
- Volunteers
- 11 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 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
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
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
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
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, 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
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
Sensorineural Hearing Loss
Implantation of the Cochlear™ Nucleus® Hybrid S Round Window (S-RW) in Adults
Evaluate the Cochlear™ Nucleus® S-Round Window (S-RW) implant in newly implanted adults with broader requirements to be considered an eligible candidate.
- Trial name
- NCT02638883
- Testing
- Hybrid SRW cochlear implant
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Cochlear
Hearing Loss, Unilateral
Single-Sided Deafness in the Medicare Population
The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.
- Trial name
- NCT05250414
- Testing
- MED-EL Cochlear Implant System
- Where
- 3 sites in United States, Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Med-El Corporation
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
Tympanomastoid Surgery, Cochlear Implant
Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery
The investigators goal is to determine the efficacy and duration of analgesia with the addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of the great auricular nerve in children undergoing…
- Conditions
- Tympanomastoid Surgery, Cochlear Implant, Mastoidectomy, Cholesteatoma
- Trial name
- NCT01638052
- Testing
- 0.25% Bupivacaine + Clonidine
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
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
Total Unilateral Deafness, Unilateral Partial Deafness
Cochlear Implantation for Treatment of Single-sided Deafness
This is a research study to determine whether a cochlear implantation (CI) device can improve hearing in people who are deaf in one ear (known as single-sided deafness).
- Trial name
- NCT02532972
- Testing
- Med-el MAESTRO Cochlear Implant with Flex 28 electrode array
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Dr. Daniel Lee