Clinical trials: Sensory Hearing Loss
Hearing Loss, Sensorineural
Efficacy and Safety of AC102 Compared to Steroids in Adults With Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)
The purpose of this Phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of AC102 administered as single intratympanic injection compared to oral steroid treatment in patients with Idiopathic Sudden…
- Trial name
- NCT05776459
- Testing
- AC102 gel, Prednisolone
- Where
- 39 sites in Austria, Czechia and 4 more
- Volunteers
- 223 people
- Sponsor
- AudioCure Pharma GmbH
Hearing Loss, Sensorineural
Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients
This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.
- Trial name
- DUAL (NCT06298396)
- Testing
- Program using default MAP, Program using low-power 1 (LP1) MAP, Program using low-power 2 (LP2) MAP
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Cochlear
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
The Effect of Sound Stimulation on Hearing Ability
In the late 1990s, researchers discovered that acoustic stimuli slow progressive sensorineural hearing loss and exposure to a moderately augmented acoustic environment can delay the loss of auditory function.
- Trial name
- NCT01434446
- Testing
- Sound stimulation
- Where
- South Korea
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Earlogic Korea, Inc.
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
Hearing Loss, Sensorineural
First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss
This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss.
- Trial name
- NCT05664100
- Testing
- FX-345
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Frequency Therapeutics
Sudden Sensorineural Hearing Loss (SSNHL), Tinnitus
'Inner Ear Support' Oral Capsule in Patients With Sudden Sensorineural Hearing Loss
Sudden sensorineural hearing loss (SSNHL) is a medical condition where people experience rapid hearing loss, usually in one ear, over a short period of time (typically within 72 hours).
- Trial name
- NCT06997406
- Testing
- Inner ear support
- Where
- Taiwan
- Volunteers
- 80 people
- Sponsor
- Far East Bio-Tec Co., Ltd
Sensorineural Hearing Loss, Tinnitus
Regenerative Medicine and Stem Cell-Based Interventions for Inner Ear Trauma, Tinnitus, and Sensorineural Hearing Loss
The HEAR-RESTORE study is an exploratory clinical research program designed to evaluate new diagnostic and regenerative approaches for individuals experiencing inner ear injury, tinnitus, and temporary or permanent hearing loss.
- Conditions
- Sensorineural Hearing Loss, Tinnitus, Acoustic Trauma, Inner Ear Injury
- Trial name
- HEAR-RESTORE (NCT07472023)
- Testing
- Audiologic Monitoring, Investigational Regenerative Pharmacologic Therapy, Stem Cell Regenerative Therapy
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Truway Health, Inc.
Sensorineural Hearing Loss, Low-Frequency Residual Hearing
Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing
The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI632 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.
- Trial name
- NCT04741009
- Testing
- CI632 Slim Modiolar Electrode
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Cochlear
Presbycusis, Hearing Loss, Sensorineural
FX-322 in Adults With Age-Related Sensorineural Hearing Loss
This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with age-related sensorineural hearing loss.
- Conditions
- Presbycusis, Hearing Loss, Sensorineural, Noise Induced Hearing Loss, Sudden Hearing Loss
- Trial name
- NCT04601909
- Testing
- FX-322
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Frequency Therapeutics
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
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
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
Congenital Hearing Loss Secondary to Biallelic Mutations in the Otoferlin Gene (OTOF), Biallelic Mutations in the Gap Junction Beta 2 (GJB2) Gene
A Natural History Study in Pediatric Participants With Hearing Loss Due to OTOF, GJB2, or GJB2/GJB6 Mutations
This is an observational study to examine the characteristics of gene-related hearing loss in pediatric participants with biallelic otoferlin (OTOF) Mutations, Gap Junction Beta 2 (GJB2) Mutations, or Digenic GJB2/Gap Junction…
- Conditions
- Congenital Hearing Loss Secondary to Biallelic Mutations in the Otoferlin Gene (OTOF), Biallelic Mutations in the Gap Junction Beta 2 (GJB2) Gene, Digenic Mutations in GJB2/Gap Junction Beta 6 (GJB6) Genes
- Trial name
- ENSEMBLE (NCT06019481)
- Where
- 2 sites in United States
- Sponsor
- Regeneron Pharmaceuticals
Sensorineural Hearing Loss
Fundamental Asynchronous Stimulus Timing Sound Coding Study
The Fundamental Asynchronous Stimulus Timing (FAST) is a novel cochlear implant sound coding strategy. Potential benefits include improved battery life, in addition to improved localization for bilateral patients.
- Trial name
- FAST (NCT02698787)
- Testing
- Experimental sound coding strategy (FAST), Commercially available ACE sound coding strategy
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Cochlear
Cochlear Hearing Loss
Investigation of the Automatic Technology on the Naída M Hearing Devices
In this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of the device under investigation on sound perception.
- Trial name
- NCT04610216
- Testing
- Naida CI M hearing device
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- Advanced Bionics AG
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
- Eli Lilly and Company
Sensorineural Hearing Loss, Bilateral Hearing Loss
Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
- Trial name
- CI-DEX-LTFU (NCT06936449)
- Testing
- CI632D, CI632
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural Hearing Loss
Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC
This study is a single-center, randomized, placebo-controlled, double-blind, single ascending dose escalation study to determine the safety, tolerability, and PK profile of oral administration of HPN-07 in single doses to…
- Conditions
- Hearing Loss, Sensorineural Hearing Loss, Noise-Induced Hearing Loss
- Trial name
- NCT02259595
- Testing
- HPN-07, NAC
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Otologic Pharmaceutics, Inc.
Cochlear Hearing Loss, Cochlear Trauma
Using Electrocochleography During Cochlear Implantation of the Neuro Zti.
The main objective of this study is to evaluate the correspondence between eCochG and residual hearing by adding two modifications.
- Trial name
- PIC-22_eCoN (NCT04651660)
- Testing
- Neuro Cochlear Implant System
- Sponsor
- Oticon Medical