Clinical trials: SNHL
Hearing Loss, Bilateral Sensorineural
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system.
- Trial name
- ELEVATE (NCT07287124)
- Testing
- Cochlear implant
- Where
- 11 sites in United States
- Volunteers
- 56 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Cochlear Hearing Loss
Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors
The present study aims to evaluate patient satisfaction and audiological performance with their current cochlear implant speech processor, the Neuro 1, and to compare it with the satisfaction and performance obtained with the new…
- Trial name
- NCT03288753
- Testing
- Satisfaction questionnaire, Speech intelligibility in quiet, Speech intelligibility in noise
- Where
- 9 sites in France
- Volunteers
- 98 people
- Sponsor
- Oticon Medical
Hearing Loss
Littlears Auditory Questionnaire: Validation Study in CI Children
The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years.
- Trial name
- LittlEars (NCT00785707)
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Med-El Corporation
Sensorineural Hearing Loss, Bilateral
Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure
The objectives of this study are to explore the efficacy and safety of a robotic procedure for a minimally invasive cochlear implantation.
- Trial name
- NCT04777565
- Testing
- Robotic surgery
- Where
- France
- Volunteers
- 10 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Conductive Hearing Loss, Sensorineural Hearing Loss
Middle Ear Optical Coherence Tomography Imaging and Vibrometry in Patients With Hearing Loss
This study involves imaging ears with hearing loss with a new system that allows the user to see the middle ear bones and measure their movement in response to sound.
- Trial name
- NCT07732920
- Testing
- OCT - clear
- Where
- 2 sites in Canada
- Volunteers
- 500 people
- Sponsor
- Audioptics Medical Incorporated
Sensorineural Hearing Loss
OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
The purpose of this study is to evaluate the safety, tolerability, and exploratory efficacy of OTO-413 administered as an intratympanic injection for the treatment of speech-in-noise hearing impairment.
- Trial name
- NCT04129775
- Testing
- OTO-413
- Where
- 8 sites in United States
- Volunteers
- 110 people
- Sponsor
- Otonomy, Inc.
Single Sided Sensorineural Deafness, Mixed Hearing Loss, Unilateral
Evaluation of Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System
The aim of this clinical investigation is to evaluate objective and subjective hearing performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System, compared to the unaided hearing performance.
- Trial name
- NCT02722330
- Testing
- Baha 5 SuperPower on Baha Attract System
- Where
- 4 sites in Belgium, Denmark and 2 more
- Volunteers
- 23 people
- Sponsor
- Cochlear Bone Anchored Solutions
Sensorineural Hearing Loss, Bilateral
Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss
Part A of this trial evaluated the safety and tolerability of a single surgical administration procedure in one or both ear(s) with one of two dose levels of AAVAnc80-hOTOF (LY888891) and evaluated the Akouos Delivery Device…
- Trial name
- NCT05821959
- Testing
- AAVAnc80-hOTOF via Akouos Delivery Device, AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 48 people
- Sponsor
- Eli Lilly and Company
Sensorineural Hearing Loss, Bilateral
Study of Music and Speech Perception in New Cochlear Implanted Subjects Using or Not a Tonotopy Based Fitting
Main objective: Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the perception speech in noise.
- Trial name
- NCT04922619
- Testing
- tonotopy based fitting then default fitting, default fitting then tonotopy based fitting
- Where
- France
- Volunteers
- 26 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Meniere's Disease, Meniere Disease
Expanded Access Protocol for SPI-1005
The purpose of this protocol is to facilitate expanded access ("compassionate use") of SPI-1005 to Meniere's disease (MD) or sudden sensorineural hearing loss (SSNHL) patients who cannot gain access through ongoing clinical…
- Conditions
- Meniere's Disease, Meniere Disease, Meniere´s Disease, Meniere's Disease Aggravated
- Trial name
- NCT07873281
- Testing
- Ebselen
- Sponsor
- Sound Pharmaceuticals, Incorporated
Sensorineural Hearing Loss, Cochlear Hearing Loss
Listening Effort in Cochlear Implant Users
Listening with a cochlear implant remains difficult and most listeners will report high levels of listening effort.The present study is a "pilot" aiming to evaluate listening effort for cochlear implant users.
- Trial name
- NCT03212924
- Testing
- Pupillometry, Evaluation of speech comprehension in quiet, Evaluation of speech comprehension in noise
- Where
- France
- Volunteers
- 16 people
- Sponsor
- Oticon Medical
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.
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
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, Idiopathic Sudden Sensorineural
Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).
- Trial name
- ASSENT (NCT02809118)
- Testing
- AM-111 0.4 mg/ml, AM-111 0.8 mg/ml
- Where
- 51 sites in United States, Canada and 1 more
- Volunteers
- 56 people
- Sponsor
- Auris Medical, Inc.
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, Sensorineural
Investigating Electrical Categorical Loudness Scaling Using a Mobile Research App in Experienced Adult Cochlear Implant Participants
This clinical study will evaluate a feature of the investigational Nexus Research System used for programming cochlear implants.
- Trial name
- ELSA (NCT07077070)
- Testing
- Standard Electrical Categorical Loudness Scaling task (Standard-ELS), Fast Electrical Categorical Loudness Scaling task (Fast-ELS)
- Where
- 3 sites in United States, Belgium
- Volunteers
- 20 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting With or Without Synchronization
Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without…
- Trial name
- NCT05898659
- Testing
- ABFnoS then ABFS (Cochlear implant), ABFS then ABFnoS (Cochlear implant)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss
A Trial of LY3056480 in Patients With SNLH
A phase 2 trial with LY3056480 in patients with stable SNHL
- Trial name
- VESTA (NCT05061758)
- Testing
- LY3056480
- Where
- 3 sites in United States
- Sponsor
- Audion Therapeutics BV
Sensorineural Hearing Loss, Bilateral, Cochlear Implant
Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
- Trial name
- NCT03304106
- Testing
- Commercially available cochlear implant and AI system
- Where
- 9 sites in United States
- Volunteers
- 102 people
- Sponsor
- Cochlear