Clinical trials: Profound Hearing Loss
Bilateral Sensorineural Hearing Loss
Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population
Purpose: The purpose of this study is 1) to evaluate the safety and efficacy of currently available multichannel cochlear implant systems for newly implanted adults with an indication based on open-set sentence recognition that…
- Trial name
- NCT02075229
- Testing
- Cochlear implant
- Where
- 19 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- American Cochlear Implant Alliance
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
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
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
Neurofibromatosis Type 2, Severe Profound Sensorineural Hearing Loss
Compassionate Use Arm - ABI541 ABI for 10 NF2 Patients
The Nucleus 24 Auditory Brainstem Implant (ABI) is the only FDA approved device for restoration of meaningful hearing in Neurofibromatosis Type 2 (NF2) patients.
- Trial name
- NCT02589912
- Testing
- Nucleus Profile ABI541 Auditory Brainstem Implant
- Where
- United States
- Sponsor
- Massachusetts Eye and Ear Infirmary
Profound Bilateral Deafness Due to, Bilateral Cochlear Aplasia
A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients
Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities, are limited and, in the case of absent cochleas, non-existent.
- Conditions
- Profound Bilateral Deafness Due to, Bilateral Cochlear Aplasia, Bilateral Cochlear Nerve Deficiency, Bilateral Cochlear Ossification Secondary to Meningitis
- Trial name
- NCT02102256
- Testing
- Auditory Brainstem Implant
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Laurie Eisenberg
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, Unilateral, Hearing Loss, Profound
Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants
The purpose of this study is to understand the speech perception in noise and in quiet and localization benefits in a laboratory setting in listeners that receive a cochlear implant in an ear with severe to profound hearing loss…
- Trial name
- NCT03929809
- Testing
- Cochlear Implant
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Iowa
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
Profound Hearing Impairment, Nutrition, Healthy
The Effectiveness of a Tailored Nutritional Education Program on Profound Hearing Impairment Adults
Literature suggests that profound hearing-impaired people have poor access to health care directly related to communication difficulties. A lack of knowledge regarding health and healthy dietary patterns has been documented.
- Trial name
- NCT06530979
- Testing
- Tailored nutritional education program utilizing Saudi-sign language supplied by Saudi-sign language interpreter
- Where
- Saudi Arabia
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- King Saud University
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
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
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
Hearing Loss
Optimization of Hearing Performance in the Subject Implanted
In the past two decades, the selection criteria for cochlear implantation have been greatly relaxed so that about 60-70% of present cochlear implant (CI) candidates have significant residual hearing in their contralateral ear.
- Trial name
- OPERSA (NCT05325450)
- Testing
- Program A, Program B, Control
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Toulouse
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
Acoustic Neuroma, Labyrinthitis Ossificans
Maintaining Cochlear Patency After VIIIth Nerve Surgery
Tumors arising from the VIIIth Nerve (vestibulo-cochlear nerve) typically present with progressive unilateral hearing loss and tinnitus.
- Conditions
- Acoustic Neuroma, Labyrinthitis Ossificans, Profound Hearing Impairment
- Trial name
- NCT03261726
- Testing
- MedEl Test Electrode Placer
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Henry Ford Health System
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
Deafness
Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients
This study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. For this reason, the evolution of these neurophysiological measures, expressing the encoding of pure…
- Trial name
- NEUROSYLLABIC (NCT02323256)
- Testing
- Auditory steady-state response ASSR, Speech-ABR, Acoustic Change Complex ACC
- Where
- France
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Cochlear Hearing Loss
Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss
This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM SlimJ Electrode and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Ultra X) under normal conditions of use as it is…
- Trial name
- NCT04929470
- Testing
- cochlear implantation
- Where
- 3 sites in Germany
- Volunteers
- 37 people
- Sponsor
- Advanced Bionics AG
Sudden Hearing Loss, Extracellular Vesicles
Study on the Safety and Efficacy of Intratympanic Injection of Small Extracellular Vesicles Derived From Mesenchymal Stem Cells in Severe and Profound Sudden Sensorineural Hearing Loss
The goal of this clinical trial is to learn if small extracellular vesicles derived from mesenchymal stem cells work to treat severe and above sudden sensorineural hearing loss.
- Trial name
- NCT07404709
- Testing
- Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at low doses, Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at moderate doses, Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at high doses
- Where
- 5 sites in China
- Volunteers
- 9 people
- Sponsor
- The Affiliated Hospital of Qingdao University