Clinical trials: completed, sponsored by Cochlear
Hearing Loss
Nucleus Hybrid L24 Extended Duration Post Approval Study
This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid L24 Implant System in a group of already implanted recipients.
- Trial name
- HED (NCT02379273)
- Testing
- Nucleus Hybrid L24 Implant
- Volunteers
- 35 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Low-Frequency Residual Hearing
Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing
The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI632 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.
- Trial name
- NCT04741009
- Testing
- CI632 Slim Modiolar Electrode
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Cochlear
Hearing Impairment, Sensorineural
A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.
The purpose of this early feasibility study is to explore several facets of hearing performance of Focused Multipolar stimulation in adult cochlear implant users.
- Trial name
- SASC (NCT05641155)
- Testing
- Focused Multipolar Stimulation (FMS) strategy
- Where
- 5 sites in United States, Belgium
- Volunteers
- 18 people
- Sponsor
- Cochlear
Hearing Loss
Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activation
This study aims to collect data in newly implanted cochlear implant-recipients to inform future development of fitting methods to optimally and efficiently program a cochlear implant.
- Trial name
- CALOS4 (NCT05709223)
- Testing
- Categorical loudness scaling based fitting using the research fitting system., Behavioural fitting using Custom Sound Suite (CSS 6.3) Software
- Where
- 4 sites in United States, Australia and 1 more
- Volunteers
- 17 people
- Sponsor
- Cochlear
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
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
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
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
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
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
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