Clinical trials: Cochlear Implants
Hearing Loss, Ear Diseases
Clinical Evaluation of a Cochlear Implant Sound Processor
This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer).
- Conditions
- Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases
- Trial name
- NCT04237207
- Testing
- Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software, 301-M062 sound processor & software
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Advanced Bionics
Hearing Loss, Sensorineural
Expanded Indications in the Adult Cochlear Implant Population
The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit…
- Trial name
- NCT03236909
- Testing
- MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System
- Where
- 5 sites in United States, Canada
- Volunteers
- 44 people
- Sponsor
- Med-El Corporation
Sensorineural Hearing Loss, Presbyacusis
First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant
Rinri Therapeutics is conducting a clinical trial of a new cell therapy called Rincell-1. Rincell-1 is being developed to treat adults with neural hearing loss, either age related hearing loss or auditory neuropathy, who also…
- Conditions
- Sensorineural Hearing Loss, Presbyacusis, Auditory Neuropathy
- Trial name
- NCT07032038
- Testing
- Otic neural progenitors, cochlear implantation
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Rinri Therapeutics
Hearing Loss, Sensorineural
Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
The purpose of this investigation is to demonstrate the safety and effectiveness of MED-EL cochlear implants in children 7 months to 5 years, 11 months of age who fall outside the current FDA-approved candidacy criteria and, yet…
- Trial name
- NCT03900897
- Testing
- MED-EL SYNCHRONY PIN Cochlear Implant, Cochlear Implant
- Where
- 8 sites in United States
- Volunteers
- 247 people
- Sponsor
- Med-El Corporation
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
Hearing Loss, Hearing Loss, Sensorineural
Front-End Processing 3.0
This study investigated the impact of Automatic Sound Management 3.0 (i.e. ambient noise reduction, transient noise reduction and an adaptive intelligence) as implemented in the SONNET2 on CI users' speech performance and their…
- Conditions
- Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Bilateral
- Trial name
- FEP3 (NCT03861442)
- Testing
- Audio processor SONNET, SONNET 2: Configuration 1, SONNET 2: Configuration 2
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss, Cochlear Trauma
SPI-1005 in Adults Receiving Cochlear Implant
The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.
- Trial name
- NCT06340633
- Testing
- Ebselen
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
Hearing Loss, Cochlear
Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlear Implant User.
The aim of the study is to evaluate the interaural time difference (ITD) benefit in patients with bilateral cochlear implants and to assess speech performance in noisy conditions compared to normal hearing listeners.
- Trial name
- APPIC (NCT04357704)
- Testing
- S0N0, S0N500, S-500N500
- Volunteers
- healthy volunteers welcome
- Sponsor
- Oticon Medical
Hearing Loss, Binaural, Cochlear Implantation
Mi2000 TICI - Post-market Implantation Study
This Post-Market Clinical Follow-up (PMCF) investigation aims to further collect evidence on safety and performance of the Mi2000 TICI.
- Trial name
- TUPIS (NCT07897318)
- Testing
- Cochlear Implantation
- Volunteers
- 22 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Tinnitus
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
The purpose of this study is to investigate the degree of benefit to tinnitus symptoms by using a Totally Implantable cochlear implant (TICI) in a group of patients who have moderate-to-severe tinnitus pre-operatively.
- Trial name
- EXCITE (NCT07893860)
- Testing
- Cochlear implant
- Where
- Spain
- Volunteers
- 14 people
- Sponsor
- Cochlear
PROM, Cochlear Hearing Loss
A Study Evaluating the French Version of the CIQoL-35 Quality of Life Questionnaire in Adult Cochlear Implant Use.
The Cochlear Implant - Quality of Life (CIQoL) PROM is a quality-of-life assessment questionnaire for adults with cochlear implants.
- Conditions
- PROM, Cochlear Hearing Loss, Hearing Loss, Quality of Life
- Trial name
- CIQoL (NCT05709431)
- Testing
- Questionnaire CIQoL-35
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Oticon Medical
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
Cochlear Hearing Loss
MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE
The goal of this interventional study is to describe how people with cochlear implants perceive the perceive speech in noise and their sound environment on adults who are native French speakers with typical hearing or with…
- Trial name
- MIRACLE (NCT06420921)
- Testing
- Speech in noise comprehension test, Objective tests of perception of ambient sound cues in noise, Subjective tests of perception of ambient sound cues in noise
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Hearing Loss
Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array
This clinical study will test a new type of cochlear implant known as CI632D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone.
- Trial name
- DEE-REX (NCT06598059)
- Testing
- Cochlear implant, Dexamethasone
- Where
- 11 sites in United States
- Volunteers
- 56 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
DFNB9, Cochlear Implantation
Safety, Tolerability, Efficacy of EA0010 in OTOF Patients With CI
This study will evaluate the safety, tolerability, and efficacy of EA0010 injection in patients with OTOF-related hearing loss who have already undergone cochlear implantation.
- Trial name
- NCT07752888
- Testing
- EA0010 Injection
- Where
- China
- Volunteers
- 1 people
- Sponsor
- Shanghai EmayGene Technology Co., Ltd
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
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
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
Cochlear Implantation
Voice Guard Processing Evaluation in a Cohort of Subjects Implanted With the Neuro Cochlear Implant System
The study aims to compare two different cochlear implant sound processing strategies. All the participants will start off with a sound processing strategy called the XDP (extended performance).
- Trial name
- NCT03256097
- Testing
- XDP sound processing strategy - Period 0, XDP sound processing strategy - Period 1, VG sound processing strategy - Period 1
- Where
- 2 sites in United Kingdom
- Volunteers
- 21 people
- Sponsor
- Oticon Medical