Clinical trials: Hearing Loss, Bilateral Sensorineural
Hearing Loss, Bilateral Sensorineural, Progressive
Quality Control of CE-Certified Phonak Hearing Aids - 2016_37
A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch.
- Trial name
- NCT03108768
- Testing
- Hearing Aid (Successor of Phonak Virto V), Hearing Aid (Phonak Virto V)
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- Sonova AG
Sensorineural Hearing Loss, Bilateral
Comparison of Speech Understanding Between Tonotopy-based Fitting and Setting Based on Evolutionary Algorithms
Main objective: Compare speech recognition in noise with tonotopic setting (FS4T) and with tonotopic fitting modified by evolutionary algorithm (EAFS4T) in adult patients implanted for 6 months or more with a MED-EL cochlear…
- Trial name
- NCT06737185
- Testing
- EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting
- Where
- France
- Volunteers
- 22 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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, Bilateral or Unilateral, Hearing Loss, Sensorineural
A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss
This clinical study will test a new investigational totally implanted cochlear implant system (TICI G2). The cochlear implant has an implantable microphone under the skin to detect speech and sound from the environment allowing…
- Conditions
- Hearing Loss, Bilateral or Unilateral, Hearing Loss, Sensorineural, Hearing Loss, Cochlear
- Trial name
- ENHANCE (NCT06642935)
- Testing
- Totally implantable cochlear Implant
- Where
- Australia
- Volunteers
- 18 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Optimizing Soft Speech Recognition in Children With Hearing Loss
Overhearing is important for vocabulary learning and speech and language development in young children. However, contemporary hearing aids are generally unable to provide adequate access to low-level auditory inputs from multiple…
- Trial name
- SoftSpeech (NCT05299892)
- Testing
- Phonak Audeo P or Naida P hearing aid
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Sonova AG
Sensorineural Hearing Loss, Bilateral
Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy
Main objective: Investigate how the FineHearing strategy of the MED-EL cochlear implant can extract prosody based solely on the frequency of the voice fundamental (F0) in speech Secondary objectives: Evaluate the time evolution…
- Trial name
- NCT03694704
- Testing
- FineHearing strategy
- Where
- France
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss, Bilateral Sensorineural
A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
This clinical study examines the performance of an investigational totally implantable cochlear implant (TICI) system. The system includes an implantable microphone under the skin to detect speech and sound from the environment…
- Trial name
- ENTERPRISE (NCT07139327)
- Testing
- Cochlear Implant
- Where
- 8 sites in Australia, France
- Volunteers
- 36 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral, Bilateral Hearing Loss
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting
Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.
- Trial name
- NCT05955469
- Testing
- FS4 then TFS4 (cochlear implant), TFS4 then FS4 (cochlear implant)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Bilateral
Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis
The purpose of this study is to characterize and assess the evolution of hearing impairment of patients with adulthood-onset bilateral sensorineural hearing loss carrying mutations on GJB2 gene.
- Trial name
- SONG (NCT06354010)
- Testing
- Genotyping, Audiological assessments
- Where
- 2 sites in United States, France
- Volunteers
- 134 people
- Sponsor
- Sensorion
Sensorineural Hearing Loss, Bilateral
Otoferlin Gene-mediated Hearing Loss Natural History Study
This is a retrospective and prospective longitudinal study in participants with Otoferlin Gene-Mediated Hearing Loss.
- Trial name
- NCT05572073
- Testing
- Natural History Study
- Where
- 10 sites in United States, Australia and 5 more
- Volunteers
- 150 people
- Sponsor
- Akouos, Inc.
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
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 Loss, Sensorineural, Hearing Loss, Bilateral
Investigating Hearing Aid Frequency Response Curves 2
Internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve.
- Trial name
- NCT05828017
- Testing
- Hearing Aid - Standard Curve under Program 1, Hearing Aid - Variation #1 under Program 1, Hearing Aid - Variation #2 under Program 5 - Streaming Only
- Where
- Canada
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Sonova AG
Mixed Conductive and Sensorineural Hearing Loss, Bilateral
Middle-Ear Implant With MET V Transducer (Aka MET V System)
The purpose and objective of this study is to evaluate the safety and efficacy of the MET V System for the treatment of individuals with mixed hearing loss.
- Trial name
- NCT01529333
- Testing
- Middle Ear Implant with MET V Transducer
- Volunteers
- 130 people
- Sponsor
- Otologics LLC
Otoferlin Gene-mediated Hearing Loss
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
This multi-center, observational, post-intervention long term follow-up (LTFU) study will monitor for safety and efficacy of AAVAnc80-hOTOF in individuals with sensorineural hearing loss due to otoferlin gene mutations who have…
- Trial name
- NCT06696456
- Where
- 5 sites in United States, Spain and 1 more
- Volunteers
- 30 people
- Sponsor
- Akouos, Inc.
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
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, 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
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, 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