Clinical trials: sponsored by Cochlear
Deafness
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
This is a basic investigational research study conducted with hearing impaired adults and children who use cochlear implant or auditory brainstem implant (ABI) devices.
- Trial name
- NCT05810220
- Testing
- Electrode-Neural Interface
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- NYU Langone Health
Hearing Loss, Unilateral, Deafness, Unilateral
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for…
- Trial name
- PAS-SSD (NCT05318417)
- Testing
- The Cochlear™ Nucleus® Cochlear Implant (CI) System
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Cochlear
Hearing Impaired Children, Hearing Impairment, Conductive
Single-stage Surgery Using the BI300 Implant
Over the last few decades, the classical two-stage surgical procedure for inserting bone-anchored hearing implants (BAHIs) has been modified in adults into a single-stage procedure.
- Trial name
- NCT04038216
- Testing
- Single-stage surgery, Two-stage surgery
- Where
- Netherlands
- Volunteers
- 70 people
- Sponsor
- Radboud University Medical Center
Hearing Loss
Sound Processing Innovations in Adult and Paediatric Cochlear Implant Recipients.
This is a feasibility, prospective with sequential enrolment, multicenter, clinical investigation in adults and paediatrics with a CE approved Nucleus cochlear implant. Subjects older than 5 years will be included.
- Trial name
- NCT05476328
- Testing
- SPACE, OPAL-SPACE, ACE
- Where
- 5 sites in Australia, Belgium
- Volunteers
- 8 people
- Sponsor
- Cochlear
Mixed Hearing Loss, Single-Sided Deafness
Osia 2 Pediatric Expansion Study
The CochlearTM Osia®2 System was cleared by the Food and Drug Administration November 15, 2019 (K191921) for individuals aged 12 years and older who present with conductive or mixed hearing loss (up to 55 dB HL) or…
- Conditions
- Mixed Hearing Loss, Single-Sided Deafness, Conductive Hearing Loss
- Trial name
- NCT05000931
- Testing
- Osia 2 System
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cochlear
Deafness Unilateral
Cochlear Implantation for Young Single-sided Deaf Children
Children with profound sensorineural unilateral hearing loss (UHL) lag behind in spoken language, cognition, spatial hearing, and academic performance compared to normal hearing (NH) children.
- Trial name
- CICADE (NCT04738968)
- Testing
- Cochlear implant
- Where
- 4 sites in Belgium
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Cochlear Implants
Remote Care: The Future of Cochlear Implants
The purpose of this study is to see if remote programming visits for cochlear implants are possible.
- Trial name
- NCT04721327
- Testing
- remote CI programming
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Miami
Hearing Loss, Conductive
Remote Microphone (RM) - A Comparative Study
The purpose of this investigation is to evaluate objective outcomes in pediatric bone conduction hearing device (often termed "BAHA") users with and without remote microphone (RM) technology.
- Trial name
- NCT04147611
- Testing
- BAHA, Wireless Audio Streaming Accessory, Digital Adaptive RM System
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- University of Miami
Hearing Loss
Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear
The purpose of this study is to collect patient related benefit data following treatment for permanent hearing loss with a hearing implant from the company Cochlear over a period of 2 years post treatment.
- Trial name
- IROS (NCT02004353)
- Testing
- Cochlear® Hearing Implants
- Where
- 77 sites in Argentina, Austria and 14 more
- Volunteers
- 1,518 people
- Sponsor
- Cochlear
Hearing Loss
FLI Normative Study
Single center, cross sectional observational research design to collect normative data on the acquisition of listening skills in normally-hearing children aged 0-6 years of age.
- Trial name
- FLI-P (NCT03410017)
- Testing
- Functional Listening Index
- Where
- Australia
- Volunteers
- 536 people
- Sponsor
- Cochlear
Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis), Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side
Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population
To study the initial experience with implanting and fitting a new Bone Conduction system in pediatric patient population with conductive, mixed or single-sided deafness.
- Trial name
- OSIA Pediatric (NCT03509974)
- Testing
- Osseointegrated Steady State Implant
- Where
- Canada
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Cochlear
Hearing Loss
N6 Input Processing in Traditional CI Recipients
The purpose of this study is to evaluate the enhanced signal processing features of the Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the Nucleus 5 Sound Processor.
- Trial name
- NCT02239263
- Testing
- Nucleus 6 Sound Processor
- Where
- 4 sites in United States
- Volunteers
- 40 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
Telemedicine
Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants
The purpose of this study is to demonstrate the safety and efficacy of Nucleus cochlear implant programming via telecommunication.
- Trial name
- TEL (NCT02644343)
- Testing
- Custom Sound
- Where
- 4 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Cochlear
Hearing Loss
Evaluation of Nucleus 6 Sound Coding Algorithms
The purpose of the study was to evaluate the features of the Nucleus 6 Sound Processor (CP900 series) on existing Nucleus recipients who currently use the previous generation sound processor, the Cochlear Nucleus CP810 (also…
- Trial name
- NCT01854879
- Testing
- Nucleus 6 sound processor
- Volunteers
- 97 people, healthy volunteers welcome
- 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 Loss
Retrospective CI532 Hearing Performance
The aim of this retrospective study is to collect and assess hearing performance data that have been measured by five clinics in Germany as part of their clinical routine in recipients implanted with a commercial CI532.
- Trial name
- NCT03039283
- Testing
- Nucleus CI532 cochlear implant
- Where
- 5 sites in Germany
- Volunteers
- 162 people
- Sponsor
- Cochlear
Hearing Loss, Conductive, Hearing Loss, Mixed
Evaluation of the Baha SoundArc in Pediatric Patients
The purpose of this study is to gather clinical performance data on the Baha SoundArc
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral
- Trial name
- NCT03333577
- Testing
- SoundArc
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- Cochlear
Hearing Loss
Usability of the CP950 Sound Processor
Studying usability and gaining feedback of the CP950 Sound Processor in experienced cochlear implant recipients.
- Trial name
- C950 (NCT02727842)
- Testing
- CP950 Sound Processor, Wireless programming pod
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral
CI532 - Early Experience Study
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.
- Trial name
- NCT02755935
- Testing
- Cochlear Nucleus CI532
- Where
- 6 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cochlear