Clinical trials: Deafness; Perception
Hearing Loss, Cochlear, Cochlear Implantation
Post-Market Clinical Investigation of the IotaSOFT Insertion System
The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject
- Conditions
- Hearing Loss, Cochlear, Cochlear Implantation, Hearing Loss, Sensorineural
- Trial name
- ACE (NCT06664697)
- Testing
- Cochlear Implantation with Robotic-Assisted Insertion System
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- iotaMotion, Inc.
Sudden Sensorineural Hearing Loss
Phase I Clinical Study of HY01 in Patients
Phase I clinical study on the safety, tolerance, efficacy and pharmacokinetics of repeated intratympanic HY01 in patients with sudden sensorineural hearing loss.
- Trial name
- NCT04961099
- Testing
- HY01
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Heyu (Suzhou) Pharmaceutical Technology Co., Ltd
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
Hearing Loss, Sensorineural
Hearing Aid Signal Processing Comparative Study
Participants will be fit with each of two hearing instruments in an ABA cross-over design. The study will consist of a total of three approximately 10-day home trials with the devices.
- Trial name
- NCT04839289
- Testing
- Receiver-in-canal hearing instrument; Manufacturer A, Receiver-in-canal hearing instrument; Manufacturer B
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Sonova AG
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.
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, 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
Deafness Neurosensory
Real-time Artificial Intelligence-based Speech Enhancement Methods for Hearing Aid Improvement
Individuals with Auditory Neuropathy Spectrum Disorders (ANSD) represent 1-10% of adults with hearing loss. These individuals have little or no benefit from current hearing aids because ANSD is a continuum of hearing impairments…
- Trial name
- REFINED (NCT05985473)
- Testing
- audiological measurements, Objective and subjective audiological measurements, Evaluation of the denoising methods REFINED
- Where
- France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Hearing Loss
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751.
- Trial name
- NCT04754477
- Testing
- Active Osseointegrated Steady-State Implant System (OSI)
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 20 people
- Sponsor
- Cochlear
Mild to Severe Sensorineural Hearing Loss
Esteem Totally Implantable Hearing System
To evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from mild to severe hearing loss.
- Trial name
- NCT01092910
- Testing
- Esteem Totally Implantable Hearing System
- Where
- 5 sites in United States
- Volunteers
- 57 people
- Sponsor
- Envoy Medical Corporation
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
Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis), Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side
Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population
To study the initial experience with implanting and fitting a new Bone Conduction system in pediatric patient population with conductive, mixed or single-sided deafness.
- Trial name
- OSIA Pediatric (NCT03509974)
- Testing
- Osseointegrated Steady State Implant
- Where
- Canada
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Cochlear
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, 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
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
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
Speech Perception
Improving Perception of Speech in Noise in Children With Communication Disorders
Smarty Ears has developed a prototype of an innovative therapeutic training system to improve speech perception in noise by training children on interrupted noise (which has silent intervals that allow for fragments of the target…
- Trial name
- L2F (NCT04473729)
- Testing
- Audiovisual speech training in noise for children
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Smarty Ears