Clinical trials: Deafness; Perception
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.
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
Sensorineural Hearing Loss
FX-322 in Sensorineural Hearing Loss
This is a phase 1/2 study of FX-322 at two dose levels compared to placebo in male and female adults otherwise healthy with stable sensorineural hearing loss.
- Trial name
- NCT03616223
- Testing
- FX-322
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Frequency Therapeutics
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
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
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.
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
Hearing Loss, Sensorineural, Noise Induced Hearing Loss
FX-322 in Adults With Acquired Sensorineural Hearing Loss
This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter study to evaluate the efficacy of FX-322, administered by intratympanic injection, in adults with acquired sensorineural…
- Conditions
- Hearing Loss, Sensorineural, Noise Induced Hearing Loss, Sudden Hearing Loss
- Trial name
- NCT05086276
- Testing
- FX-322
- Where
- 26 sites in United States
- Volunteers
- 142 people
- Sponsor
- Frequency Therapeutics
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, Sensorineural, Sensorineural Hearing Loss
Dexamethasone-Eluting Cochlear Implant Electrode
A newly developed MED-EL Cochlear Implant incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array.
- Trial name
- CIDEX (NCT04450290)
- Testing
- CIDEXEL implant
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
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
Sensorineural Hearing Loss
Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals
The purpose of this clinical study is to determine the effectiveness of low level laser light therapy when applied around the head and ears in improving unaided word recognition in ears with sensorineural hearing loss.
- Trial name
- NCT00787189
- Testing
- The Hearing Laser
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Erchonia Corporation
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
Sensorineural Hearing Loss
Esteem New Subject Enrollment Post Approval Study
The New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe hearing loss.
- Trial name
- NCT02689349
- Testing
- Implantation of Esteem
- Where
- 6 sites in United States
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Envoy Medical Corporation
Hearing Loss
An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
The study is a feasibility, prospective, repeated-measures, multi-country, multi-centre, study of the Mobile Research App to measure and validate speech perception endpoints in adult cochlear implant recipients.
- Trial name
- VALDE-MU (NCT06098482)
- Testing
- Mobile Research App (MRA), SOC/validated delivery of the speech perception test material
- Where
- 4 sites in United States, Australia and 1 more
- Volunteers
- 46 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
An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.
- Trial name
- NCT03904420
- Testing
- Clinical Education and Treatment Model, Traditional Model
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Cochlear
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