Clinical trials: sponsored by Cochlear
Hearing Impairment
A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients
This feasibility study is designed to explore several facets of hearing performance that may show improvements for alternative modes of stimulation compared to Monopolar (MP) stimulation within a group of adult cochlear-implant…
- Trial name
- FOCUS (NCT05003674)
- Testing
- Focused stimulation strategy, ACE stimulation strategy
- Where
- 4 sites in Australia
- Volunteers
- 19 people
- Sponsor
- 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
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
Chronic Otitis Media
Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery
The objective of this multicentre study is to evaluate the standard of care of participants diagnosed with Chronic Otitis Media that have already gone through a first middle ear surgery but still have at least a moderate hearing…
- Trial name
- NCT04864912
- Testing
- Questionnaires and survey
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 69 people
- Sponsor
- Cochlear
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
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
Intracochlear Potentials: Volta Study
Collection of normative voltage tomography data during and/or immediately after electrode insertion into the cochlea using Surgical Assistant (SA16) research software and postoperatively at activation, three and twelve months…
- Trial name
- CLTD5663 (NCT02852330)
- Testing
- SA16 research software, CS19 (1.6.2)
- Where
- 2 sites in Australia
- Volunteers
- 20 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
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
Hearing Loss, Sensorineural, Severe, Hearing Loss, Sensorineural, Bilateral
Hear Again, Work Again
Project synopsis: This prospective cohort study investigates impact of (1) hearing loss and (2) cochlear implantation on cost and health state on one hand, and employment, productivity and social wellbeing on the other hand in a…
- Conditions
- Hearing Loss, Sensorineural, Severe, Hearing Loss, Sensorineural, Bilateral, Hearing Loss, Unilateral, Hearing Loss, Sensorineural, Profound
- Trial name
- NCT05196022
- Testing
- Cochlear implant
- Where
- Belgium
- Volunteers
- 200 people
- Sponsor
- University Hospital, Antwerp
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
Hearing Loss
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751.
- Trial name
- NCT04754477
- Testing
- Active Osseointegrated Steady-State Implant System (OSI)
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 20 people
- Sponsor
- Cochlear
Hearing Loss
Telemonitoring in Cochlear Implant Patient Care
Following a sufficient delay after the cochlear implantation and initial implant activation, the patient will return to the hospital for follow-up visits for equipment maintenance and auditory performance evaluation only once per…
- Trial name
- EMPSICOT (NCT05566353)
- Testing
- Remote Check
- Where
- France
- Volunteers
- 78 people
- Sponsor
- University Hospital, Montpellier
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, 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
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
Acceptance of the CP950 Sound Processor
Acceptance of CP950 sound processor with experienced CP810/CP910/CP920 BTE sound processor users.
- Trial name
- NCT03613909
- Testing
- CP950 OTE Sound processor
- Volunteers
- 23 people
- Sponsor
- Cochlear
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
Deafness, Bilateral, Deafness Neurosensory
Auditory Diagnostics and Error-based Treatment
The main objective of this study is to assess the effectiveness of an integrated program of fitting and training interventions aimed at reducing unexpected variability and addressing the specific error patterns of each recipient.
- Conditions
- Deafness, Bilateral, Deafness Neurosensory, Deafness Permanent
- Trial name
- AuDiET (NCT05307952)
- Testing
- Tone Audiometry, Spectrotemporal Assessment, Phoneme and Speech Perception
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Radboud University Medical Center
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