Clinical trials: Hearing Implants
Sensorineural Hearing Loss
Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System
The purpose of this study is to evaluate the safety and efficacy associated with the provision of acoustic and electric sound processing to individuals who demonstrate significant residual low-frequency hearing and profound…
- Trial name
- NCT00678899
- Testing
- Nucleus Hybrid L24
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Cochlear
Hearing Loss
CHANGE Feasibility Study
The purpose of the feasibility study is to examine audiological outcomes (audiometry and speech perception) and safety (adverse events and adverse device effects) with the Nucleus CI532 cochlear implant in group of adult subjects…
- Trial name
- CLTD5626 (NCT02671032)
- Testing
- Nucleus CI532 cochlear implant
- Where
- 2 sites in Australia
- Volunteers
- 12 people
- Sponsor
- Cochlear
Sensori-Neural Deafness, Sensorineural Hearing Loss
Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant
The goal of this clinical trial is to learn if the Acclaim CI works to treat severe to profound sensorineural hearing loss in adults. It was also learn about the safety of the Acclaim CI implant.
- Conditions
- Sensori-Neural Deafness, Sensorineural Hearing Loss, Sensorineural Hearing Loss (Disorder), Sensorineural Hearing Loss, Bilateral
- Trial name
- NCT06699797
- Testing
- Acclaim Cochlear Implant
- Where
- 7 sites in United States
- Volunteers
- 56 people
- Sponsor
- Envoy Medical Corporation
Hearing Loss, Conductive, Hearing Loss, Mixed
BONEBRIDGE Bone Conduction Implant in Adults
Approximately thirty subjects with mixed or conductive hearing loss, meeting FDA-cleared candidacy criteria for the BONEBRIDGE, will be implanted and followed for three (3) months post-activation to assess safety and…
- Trial name
- NCT03859648
- Testing
- BONEBRIDGE
- Where
- 3 sites in United States, Canada
- Volunteers
- 9 people
- Sponsor
- Med-El Corporation
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
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, Sensorineural Hearing Loss
Dexamethasone-Eluting Cochlear Implant Electrode
A newly developed MED-EL Cochlear Implant incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array.
- Trial name
- CIDEX (NCT04450290)
- Testing
- CIDEXEL implant
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
Hearing Loss, Partial Deafness
Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness
The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with…
- Conditions
- Hearing Loss, Partial Deafness, Hearing Disorders, Ear Diseases
- Trial name
- NCT02189798
- Testing
- HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode, EAS sound processor
- Where
- 11 sites in United States
- Volunteers
- 67 people
- Sponsor
- Advanced Bionics
Sensorineural Hearing Loss, Bilateral
Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy
Main objective: Show the superiority of Fine Structure (FS4) strategy compared to Continuous Interleaved Sampling (HDCIS) strategy on the qualitative preference for the listening of musical pieces.
- Trial name
- NCT03993899
- Testing
- FineHearing strategy or HDCIS strategy
- Where
- France
- Volunteers
- 19 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Vestibulopathy, Moderate to Severe Hearing Loss
A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration
The main aim of this study is to understand if an experimental vestibular implant system can improve balance performance. The system consists of a vestibular implant combined with a cochlear implant sound processor and…
- Conditions
- Vestibulopathy, Moderate to Severe Hearing Loss, Normal Hearing, Balance Deficits
- Trial name
- BionicVEST2 (NCT06805175)
- Testing
- vestibular implant
- Where
- 3 sites in Belgium, Spain
- Volunteers
- 18 people
- Sponsor
- Cochlear
Ear Diseases, Hearing Loss, Bilateral
Lumity CI Study - Clinical Evaluation of Next Generation Cochlear Implant Sound Processor
This is a prospective within-subjects repeated-measures study that will enroll 18 bilateral adult users implanted with a HiResolution Bionic Ear System (HiRes 90KTM, HiRes 90K TM Advantage, HiResTM Ultra, HiResTM Ultra 3D and CII…
- Conditions
- Ear Diseases, Hearing Loss, Bilateral, Otorhinolaryngologic Diseases
- Trial name
- NCT06858826
- Testing
- Control cochlear implant sound processor, Next Generation Sound Processor
- Volunteers
- 20 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
Sensorineural Hearing Loss
Esteem New Subject Enrollment Post Approval Study
The New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe hearing loss.
- Trial name
- NCT02689349
- Testing
- Implantation of Esteem
- Where
- 6 sites in United States
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Envoy Medical Corporation
Sensorineural Hearing Loss, Bilateral
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Fitting With or Without Fine Structure Coding
Brief Summary: Main objective: Comparison of a tonotopy based fitting strategy (TFS) with fine structure coding to a tonotopy based fitting strategy without fine structure coding (TnoFS) for speech perception in noise.
- Trial name
- NCT05754918
- Testing
- TnoFs then TFS (Cochlear implant), TFS then TnoFS (Cochlear implant)
- Where
- France
- Volunteers
- 21 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss
A Study Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients
A feasibility, prospective, multi-centre, repeated measures investigation evaluating the application of hearing aid technologies to signal processing for adult cochlear implant recipients
- Trial name
- HATSI-MB (NCT05866770)
- Testing
- U8, N8 sound processor
- Where
- 3 sites in Australia
- Volunteers
- 150 people
- Sponsor
- Cochlear
Single Sided Deafness
Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance ("SoundBite")
The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.
- Trial name
- NCT01933386
- Testing
- SoundBite
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Sonitus Medical Inc
Bone Conduction, Hearing Loss, Conductive
Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
The goal of this interventional study is to confirm the safety and performance of the latest generation Osia System and to examine its benefits compared to the Baha Connect System in adults with mixed or conductive hearing loss…
- Conditions
- Bone Conduction, Hearing Loss, Conductive, Hearing Loss, Mixed
- Trial name
- OSIRIS (NCT07130136)
- Testing
- Cochlear™ Osia® System, Cochlear™ Baha® System
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- 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