Clinical trials: Inner Ear Hearing Loss
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
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
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population
This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation.
- Trial name
- ACE (NCT06293482)
- Testing
- Cochlear™ Nucleus® System
- Where
- 9 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral
Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults
The aim of this study is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition score in adults using currently a Nucleus cochlear implant.
- Trial name
- PROGRESS (NCT05265260)
- Where
- France
- Volunteers
- 32 people
- Sponsor
- Cochlear
Meniere's Disease
SPI-1005 for the Treatment of Patients With Meniere's Disease
This study will evaluate the safety, efficacy, and Pharmacokinetics (PK) of two dose levels of SPI-1005 administered for 28 days compared to placebo in patients with Meniere's disease.
- Trial name
- NCT03325790
- Testing
- 200mg SPI-1005 BID, 400mg SPI-1005 BID
- Where
- 13 sites in United States
- Volunteers
- 149 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
Sensory Hearing Loss
Evaluation of N6 Sound Processor in Group of Freedom Users
Study of freedom sound processor users that upgrade to N6 sound processor CP900 series. To test speech understanding in each device and usability of upgrade.
- Trial name
- NCT02856659
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Cochlear
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
Meniere's Disease
OTO-104 for the Treatment of Meniere's Disease
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
- Trial name
- NCT01412177
- Testing
- OTO-104
- Where
- 2 sites in United States
- Volunteers
- 154 people
- Sponsor
- Otonomy, 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
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
Meniere Disease, Ménière
SPI-1005 for the Treatment of Meniere's Disease
The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult subjects with definite Meniere's disease with active symptoms within three…
- Trial name
- STOPMD-3 (NCT04677972)
- Testing
- Ebselen
- Where
- 12 sites in United States
- Volunteers
- 220 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
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