Clinical trials: Cochlear Implantation, open to volunteers
Cochlear Implants
Middle East MED-EL Observatory Study
In the field of cochlear implant research, there are only few data on long-term observational studies available to gain knowledge on clinical effectiveness.
- Trial name
- MEMOS (NCT03882229)
- Testing
- MED-EL CI systems
- Where
- 3 sites in Egypt, Saudi Arabia
- Volunteers
- 100 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Cochlear Implant, Sensorineural Hearing Loss
The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users
The present study evaluates the effect of anatomy-based fitting on speech perception in noise and music perception in newly implanted single-sided deaf (SSD) CI recipients.
- Conditions
- Cochlear Implant, Sensorineural Hearing Loss, Single Sided Deafness
- Trial name
- NCT07703800
- Testing
- Anatomy-based fitting, Default fitting
- Where
- Belgium
- Volunteers
- 20 people
- Sponsor
- University Hospital, Antwerp
Deafness
Novel Coding Strategies for Children With Cochlear Implants
The purpose of this study is to understand performance with a cochlear implant. The long-term goals of this research are to improve sound perception with cochlear implants and to better understand the functioning of the auditory…
- Trial name
- NCT05203302
- Testing
- Single-Electrode Pulse Train, Modulation Detection Threshold (MDT) and Gap Detection Tasks, Sound coding strategy.
- Where
- United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Hearing Loss in Children With Unilateral or Bilateral Cochlear Implants
Feasibility and Reliability of Integrating Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement in a Pediatric Cochlear Implant Programming Center
In children aged 0 to 7 years, behavioral evaluation during cochlear implant programming is often difficult or unreliable. Objective, reproducible, and rapid markers are therefore essential.
- Trial name
- eSRT2 (NCT07417956)
- Testing
- Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement
- Where
- France
- Volunteers
- 48 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Hearing Loss, Sensorineural, Hearing Loss
BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants
The goal of the BEARS clinical trial is to determine whether using the directional listening training delivered via the BEARS training package for 3-months alongside usual care compared to only receiving usual care improves…
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Deafness, Hearing Impaired Children and Adolescents
- Trial name
- BEARS (NCT05808543)
- Testing
- Both EARS training package (BEARS), Usual Care
- Where
- 13 sites in United Kingdom
- Volunteers
- 272 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Cochlear Implants, Hearing Loss, Sensorineural
Clinical Trial to Compare Two Surgical Approaches to the Cochlea
This is a prospective multicenter multinational randomized control trial. The duration of the study for the individual patient will be approximately 1 year (pre-operative assessments, 1 week, 3 months and 12 months follow-up…
- Trial name
- BULLS-I (NCT06453343)
- Testing
- Surgical approach: cochleostomy or extended round window
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- Radboud University Medical Center
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
Bilateral Sensorineural Hearing Loss
Noise Reduction With Hearing Aids
The purpose of this study is to use an optimized version of the SEDA algorithm (SEDA-HA) for hearing aids to evaluate the benefit for listeners with varying degrees of hearing loss in realistic environments and evaluate its…
- Trial name
- NCT07700043
- Testing
- Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm, Hearing aid (HA) prototype with SEDA-HA algorithm
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- NYU Langone Health
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
Cochlear Implant, Sensorineural Hearing Loss
Anatomy-Based Fitting in Bimodal Cochlear Implant Users
The purpose of the study is to investigate the effect of an anatomy-based frequency distribution in comparison to a default frequency distribution in bimodal CI patients, i.e.
- Conditions
- Cochlear Implant, Sensorineural Hearing Loss, Hearing Aid
- Trial name
- NCT07691853
- Testing
- Anatomy-based fitting, Default fitting
- Where
- 2 sites in Belgium
- Volunteers
- 25 people
- Sponsor
- Universitair Ziekenhuis Brussel
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
Sensorineural Hearing Loss, Bilateral Hearing Loss
Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants
This research study is evaluating two different methods of cochlear implant (CI) insertion - robotic-assisted insertion and manual insertion - to better understand how they affect hearing outcomes.
- Conditions
- Sensorineural Hearing Loss, Bilateral Hearing Loss, Cochlear Implantation, Hearing Disorders
- Trial name
- NCT07081542
- Testing
- IotaSoft Robotic Insertion System, Manual Cochlear Implant Insertion
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- AdventHealth
Sensorineural Hearing Loss, Bilateral
Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy
Main objective: Investigate on new cochlear implanted patients whether the FineHearing strategy of the MED-EL cochlear implant gives better results on musical perception if the depth of stimulation (stimulation or not of the…
- Trial name
- NCT04591093
- Testing
- FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated
- Where
- France
- Volunteers
- 32 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Impairment
Evaluating a Noise Reduction Algorithm With Cochlear Implant Users
In this study, a noise reduction algorithm will be implemented in various listening situations to evaluate its effectiveness in improving speech understanding for cochlear implant users ages 12 and older.
- Trial name
- NCT05805384
- Testing
- SEDA
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- NYU Langone Health
Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children/Infants, Adolescents and Adults With Hearing Loss Due to Otoferlin Mutations
Regeneron is conducting a study of an investigational new drug called DB-OTO. DB-OTO is a gene therapy that is being developed to treat pediatric and adult participants who have severe-to profound and profound hearing loss due to…
- Trial name
- CHORD (NCT05788536)
- Testing
- DB-OTO
- Where
- 17 sites in United States, Germany and 3 more
- Volunteers
- 36 people
- Sponsor
- Regeneron Pharmaceuticals
Sensorineural Hearing Loss
Cochlear Implanted Listening Effort and Hearing Attention
Cochlear implant users perceive mainly sound amplitude modulation cues. Processing of these amplitude modulations can be subject to interferences, so that the perception of a modulation in a target sound can be impaired by a…
- Trial name
- EffICAtt (NCT04733950)
- Testing
- Forced choice psychoacoustic task for the evaluation of modulation detection performance and selective auditory attention. (for both arm), Measurement of the pupil diameter for the evaluation of listening effort during speech perception
- Where
- France
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Hearing Loss
New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.
The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners.
- Trial name
- PRESENCE-MU (NCT06100393)
- Testing
- Investigational Pre-Processing Algorithm (Sub A), Cochlear Limited standard-of-care pre-processing algorithms, Investigational Pre-Processing Algorithm (Sub B)
- Where
- 2 sites in Australia
- Volunteers
- 150 people
- Sponsor
- Cochlear
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, 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.
Congenital Hearing Loss, Sensorineural Hearing Loss
Alpha-Tectorin, Interleukin-10 and Thiol-Disulfide Homeostasis in Children With Congenital Hearing Loss
Congenital hearing loss is one of the most common sensory disorders of childhood, and the structural, immunologic and oxidative mechanisms involved in its development are incompletely understood.
- Trial name
- NCT07860580
- Testing
- Blood sample collection
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Harran University