Clinical trials: Cochlear Hearing Loss
Cochlear Synaptopathy
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Like retinopathy, neuropathy and nephropathy, sensorineural hearing loss is a common and underserved complication of uncontrolled diabetes.
- Trial name
- RESPLAND (NCT07472907)
- Testing
- CIL001 (Paliroden)
- Volunteers
- 135 people
- Sponsor
- Cilcare SAS
Tinnitus, Hearing Loss, Cochlear Implant Users
Sound Therapy for Tinnitus Relief in Cochlear Implant Users
The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy for tinnitus relief in cochlear implant users with tinnitus.
- Trial name
- NCT03026829
- Testing
- CART sound therapy
- Where
- 2 sites in Netherlands
- Volunteers
- 32 people
- Sponsor
- Cochlear
Cochlear Implant Recipients, Hearing Loss, Cochlear
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
This study will evaluate a range of experimental sound coding strategies that may improve hearing for cochlear implant recipients.
- Trial name
- SONORA-MU (NCT06867380)
- Testing
- Investigational sound coding strategy A, Cochlear default sound coding strategy A, Investigational sound coding strategy B
- Where
- 2 sites in Australia
- Volunteers
- 120 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural Hearing Loss
Non-significant Risk Study of a Cochlear Implant Headpiece
This study aims to evaluate a cochlear implant headpiece.
- Trial name
- NCT05488535
- Testing
- cochlear implant headpiece
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Advanced Bionics
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, Bilateral Hearing Loss
Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
- Trial name
- CI-DEX-LTFU (NCT06936449)
- Testing
- CI632D, CI632
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss
This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.
- Trial name
- NCT04462198
- Testing
- PIPE-505
- Where
- 8 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Contineum Therapeutics
Hearing Loss, Sensorineural, Cochlear Implantation
Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
- Trial name
- AIMBOT (NCT06664710)
- Testing
- iotaSOFT Insertion System with AIM, iotaSOFT Insertion System with AIM Control
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- iotaMotion, Inc.
Hearing Loss, Bilateral Sensorineural
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system.
- Trial name
- ELEVATE (NCT07287124)
- Testing
- Cochlear implant
- Where
- 11 sites in United States
- Volunteers
- 56 people
- Sponsor
- Cochlear
Hearing Loss
Bilateral Cochlear Implant Benefit in Young Children
The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in…
- Trial name
- NCT00424307
- Testing
- HiResolution Bionic Ear System
- Where
- 14 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Advanced Bionics
Hearing Loss
Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System
To evaluate the performance of the Nucleus 5 Cochlear Implant System.
- Trial name
- NCT01072409
- Testing
- Nucleus 5 Cochlear implant, Cochlear implantation
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Cochlear
Hearing Loss, Bilateral Sensorineural, Hearing Loss, Sensorineural
Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)
This clinical study will test a newly developed cochlear implant known as CI622D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone.
- Conditions
- Hearing Loss, Bilateral Sensorineural, Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Cochlear
- Trial name
- DETECT (NCT06424262)
- Testing
- CI622D, CI622
- Where
- 11 sites in Australia, France and 2 more
- Volunteers
- 50 people
- Sponsor
- Cochlear
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
Sensorineural Hearing Loss, Bilateral
Speech Perception of a Tonotopy-based Fitting for Cochlear Implant Recipients for 6 Months With Conventional Setting
Main objective: Compare speech recognition in noise with tonotopic fitting (FS4T) and with conventional non-tonotopic fitting (FS4noT) in adult patients implanted for 6 months with a MED-EL cochlear implant with FS4noT strategy.
- Trial name
- NCT06723262
- Testing
- Tonotopic cochlear implant fitting FS4T
- Where
- France
- Volunteers
- 25 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss
An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
The study is a feasibility, prospective, repeated-measures, multi-country, multi-centre, study of the Mobile Research App to measure and validate speech perception endpoints in adult cochlear implant recipients.
- Trial name
- VALDE-MU (NCT06098482)
- Testing
- Mobile Research App (MRA), SOC/validated delivery of the speech perception test material
- Where
- 4 sites in United States, Australia and 1 more
- Volunteers
- 46 people
- Sponsor
- Cochlear
Sensory Hearing Loss
Evaluation of N6 Sound Processor in Group of Freedom Users
Study of freedom sound processor users that upgrade to N6 sound processor CP900 series. To test speech understanding in each device and usability of upgrade.
- Trial name
- NCT02856659
- Volunteers
- 25 people, healthy volunteers welcome
- 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
Hearing Loss, Sensorineural, Cochlear Hearing Loss
Neuro 1 vs. Neuro 2 Sound Processors
This study evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other half will be tested with Neuro 2 first and…
- Trial name
- NCT03756337
- Testing
- Neuro 1 & Neuro 2, Neuro 2 & Neuro 1
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Oticon Medical
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
Cochlear Hearing Loss
Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
This is a prospective and monocentric clinical investigation, non-interventional and non-randomized. The overall goal of this clinical study is to generate additional clinical data confirming the safety and efficacy of the remote…
- Trial name
- NCT06894303
- Testing
- Target CI v1.5 remote programming
- Where
- France
- Volunteers
- 51 people
- Sponsor
- Advanced Bionics AG