Clinical trials: Severe to Profound Hearing Loss
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
Severe to Profound Hearing Loss, in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.
- Trial name
- NCT01616576
- Testing
- Control first, then Experimental, Experimental first, then Control
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Advanced Bionics
Frequency Compression, Severe-profound Hearing Impairment
Use of Frequency Compression in Severe-profound Hearing Loss Adults
The purpose of this study is to investigate the functional benefits of frequency compression vs no frequency compression or fitted to hearing loss in severe-profound hearing impaired adults with high frequency hearing losses.
- Trial name
- FC (NCT04623112)
- Testing
- Hearing aid feature: Frequency Compression
- Volunteers
- 27 people
- Sponsor
- University College, London
Severe to Profound Sensorineural Hearing Loss, Undergoing Cochlear Implant Surgery
Radiological Classification of the Facial Nerve
Cortical mastoidectomy and posterior tympanotomy is a classic approach for cochlear implant. Intimate knowledge of the relevant surgical anatomy of the temporal bone and facial recess is important to safely perform the posterior…
- Trial name
- NCT02925208
- Testing
- cochlear implant surgery
- Where
- Saudi Arabia
- Volunteers
- 140 people
- Sponsor
- Imam Abdulrahman Bin Faisal University
Hearing Impairment
Computer-Assisted Speech Training for Hearing Aid Users
Computer-assisted speech training is a speech recognition training system developed for cochlear implant users. With minimal facilities and skills, cochlear implant users can conduct this training at home.
- Trial name
- NCT02092337
- Testing
- computer-assisted speech training
- Where
- Taiwan
- Volunteers
- 12 people
- Sponsor
- National Taiwan University Hospital
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Societal Merit of Intervention on Hearing Loss Evaluation
The primary objective of this study is to determine the (long term) effect of intervention with a CI in adult participants with progressive postlingual moderate/severe-to-profound sensorineural hearing loss on societal related…
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Adult-Onset, Hearing Loss, Bilateral Sensorineural, Progressive
- Trial name
- SMILE (NCT05525221)
- Where
- 5 sites in Netherlands
- Volunteers
- 156 people
- Sponsor
- Radboud University Medical Center
Severe-to-profound Hearing Loss
Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing
The goal of this investigation is to generate the needed PMCF data for the HiFocus Mid-Scala electrode. As a point of interest the investigators would like to evaluate the benefit to patients with low-frequency residual hearing…
- Trial name
- NCT01824563
- Testing
- Observational study
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Advanced Bionics AG
Severe to Profound Mixed Hearing Loss
Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs
The purpose of this study is to evaluate the effect of the sound processor upgrade from the C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor for the Codacs™ system on the speech…
- Trial name
- NCT02156167
- Testing
- CP810 and Codacs™ system test
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss
Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study
The objective of this multisite study is to evaluate the performance of the Nucleus Freedom cochlear implant system in a large population of sequentially implanted pediatric subjects.
- Trial name
- NCT00589511
- Volunteers
- 69 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural, Severe, Hearing Loss, Sensorineural, Profound
Association Between Severe-to-profound Hearing Loss and the Balance Function of the Inner Ear
Severe-to-profound hearing loss can have a major impact on patients´ lives leading to social isolation and decreased quality of life. Most commonly the hearing loss is caused by damage to the inner ear or cochlear nerve.
- Conditions
- Hearing Loss, Sensorineural, Severe, Hearing Loss, Sensorineural, Profound, Vestibular Disorder
- Trial name
- NCT05500521
- Testing
- Caloric irrigation, vHIT, VEMP
- Where
- Sweden
- Volunteers
- 98 people
- Sponsor
- Värmland County Council, Sweden
Hearing Loss, Sensorineural
Evaluation of the Efficacy and Safety of the Sullivan Cochlear Implant.
The study will be conducted as a prospective, single center, repeat measure, single-arm, open label clinical study
- Trial name
- NCT07018882
- Testing
- Sullivan
- Volunteers
- 25 people
- Sponsor
- Todoc
Hearing Loss
Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)
The purpose of this study is to evaluate if the new and simplified fitting method with Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the Clinical Care Innovation) provides Cochlear Implants…
- Trial name
- NCT02228148
- Testing
- NFS, CSS
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 48 people
- Sponsor
- Cochlear
Mild Cognitive Impairment in Middle-aged Adults
Deafness and Cognition in Middle-aged Adults
A mild cognitive impairment was observed in 50% of cochlear implant candidates aged 65 years and over, compared to 5-19% in general population. No studies analysed cognition in patients younger than 65 years.
- Trial name
- SURDICOG (NCT05149742)
- Testing
- Cognitive and audiometry evaluation
- Where
- France
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Hearing Loss, Sudden
Establishment of a Trans-round Window Inner Ear Continuous Drug Delivery System for the Treatment of Severe-to-profound Sudden Sensorineural Hearing Loss
The investigators enrolled patients with total sudden deafness who had failed treatment with systemic combined intra-dural hormone injections.
- Trial name
- NCT05455398
- Testing
- Surgical treatment of round window niche enlargement via round window for inner ear drug delivery, Drum chamber drug injection
- Where
- China
- Volunteers
- 218 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe
Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users
On June 23, 2021, the Oticon Medical Neuro Cochlear Implant System (NCIS) was granted premarket approval (PMA) in the US to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who…
- Conditions
- Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe, Sensorineural Hearing Loss, Profound
- Trial name
- PACIFIC (NCT05154188)
- Testing
- Neuro Cochlear Implant system
- Volunteers
- 60 people
- Sponsor
- Oticon Medical
Hearing Loss
Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to their baseline performance with hearing aids.
- Trial name
- NCT00205881
- Testing
- HiRes 90K Bionic Ear System
- Where
- 9 sites in United States
- Volunteers
- 32 people
- Sponsor
- Advanced Bionics
Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Designing a Trial of Bilateral Cochlear Implantation in Adults
In the UK, cochlear implantation is the standard treatment for adults with 'severe-to-profound' deafness. This level of deafness means that without a cochlear implant they have difficulty understanding what people are saying even…
- Trial name
- FOUNDATION (NCT03287700)
- Testing
- No intervention
- Where
- United Kingdom
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Nottingham University Hospitals NHS Trust
OTOF Gene Mutation, DFNB9
A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations
This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.
- Conditions
- OTOF Gene Mutation, DFNB9, Congenital Deafness, Hearing Disorders
- Trial name
- AUDIOGENE (NCT06370351)
- Testing
- SENS-501 administration
- Where
- 2 sites in Australia, France
- Volunteers
- 12 people
- Sponsor
- Sensorion
Unilateral Severe to Profound Hearing Loss OR Bilateral Severe to Profound Hearing Loss
Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss
The goal of the study was to evaluate the safety, tolerability, and the potential ability of CGF166 delivered through IL-infusion to improve hearing.
- Trial name
- NCT02132130
- Testing
- CGF166
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Hearing Loss, High-Frequency
Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents
The purpose of this study is to determine if adults and children with residual low-pitch hearing in the severe hearing loss range can develop improved speech perception by combining their residual acoustic hearing with electrical…
- Trial name
- NCT01975571
- Testing
- Cochlear® Nucleus™ Hybrid L24, Cochlear® Nucleus™ Hybrid S12
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Bruce J Gantz