Clinical trials: sponsored by 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
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
High Frequency Sensorineural Hearing Loss
Hybrid L24 New Enrollment Post Approval Study
This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.
- Trial name
- HNE (NCT02379819)
- Testing
- Nucleus Hybrid L24 Implant
- Where
- 19 sites in United States
- Volunteers
- 52 people
- Sponsor
- Cochlear
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
Conductive Hearing Loss, Mixed Hearing Loss
Osia CPT Code Study
To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.
- Trial name
- NCT04320407
- Testing
- Osia 2 System
- Where
- 4 sites in United States
- Volunteers
- 20 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
Single Sided Deafness
Implantation of the Cochlear® Nucleus® System in Adults With Single-Sided Deafness
The objective of this feasibility study is to obtain preliminary safety and efficacy data associated with cochlear implantation in individuals with severe to profound sensorineural hearing loss contralateral to an ear with…
- Trial name
- NCT01670006
- Testing
- Cochlear Nucleus Cochlear Implant System
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cochlear
Hearing Loss
Home Test of New Sound Processor
The purpose of this clinical investigation is to test a new Sound Processor (SP) to compare hearing performance of the new Sound Processor with unaided hearing and Baha 5 SP in adult subjects and to investigate which device (new…
- Trial name
- NCT04559282
- Testing
- New Sound Processor
- Where
- Sweden
- Volunteers
- 16 people
- Sponsor
- Cochlear
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
Deafness; Sensoneural Single Sided, Conductive Hearing Loss
Clinical Performance of a New Implant System for Bone Conduction Hearing
To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.
- Conditions
- Deafness; Sensoneural Single Sided, Conductive Hearing Loss, Mixed Hearing Loss
- Trial name
- NCT03086135
- Testing
- Osia System
- Where
- 5 sites in United States, Australia and 3 more
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Cochlear
Deafness; Sensoneural Single Sided, Conductive Hearing Loss
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
The aim of this clinical investigation is to investigate the subject´s overall preference, hearing performance and self-reported assessments with the Investigational device and its precursor Sound Processor (Comparator) after 6…
- Conditions
- Deafness; Sensoneural Single Sided, Conductive Hearing Loss, Mixed Hearing Loss
- Trial name
- NCT03848910
- Testing
- Investigational device - Sound Processor
- Where
- Australia
- Volunteers
- 11 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Low-Frequency Residual Hearing
Hearing 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 CI624 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.
- Trial name
- NCT04741048
- Testing
- CI624 Slim 20 Electrode
- Where
- United States
- Sponsor
- Cochlear