Clinical trials: Hearing
Hearing Loss
Nucleus Hybrid L24 Extended Duration Post Approval Study
This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid L24 Implant System in a group of already implanted recipients.
- Trial name
- HED (NCT02379273)
- Testing
- Nucleus Hybrid L24 Implant
- Volunteers
- 35 people
- Sponsor
- Cochlear
Ear Diseases, Hearing Loss, Bilateral
Lumity CI Study - Clinical Evaluation of Next Generation Cochlear Implant Sound Processor
This is a prospective within-subjects repeated-measures study that will enroll 18 bilateral adult users implanted with a HiResolution Bionic Ear System (HiRes 90KTM, HiRes 90K TM Advantage, HiResTM Ultra, HiResTM Ultra 3D and CII…
- Conditions
- Ear Diseases, Hearing Loss, Bilateral, Otorhinolaryngologic Diseases
- Trial name
- NCT06858826
- Testing
- Control cochlear implant sound processor, Next Generation Sound Processor
- Volunteers
- 20 people
- Sponsor
- Advanced Bionics
Hearing Loss, Unilateral
Single-Sided Deafness in the Medicare Population
The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.
- Trial name
- NCT05250414
- Testing
- MED-EL Cochlear Implant System
- Where
- 3 sites in United States, Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Med-El Corporation
Hearing Loss
Evaluation of a New Noise Reduction Strategy in Hearing Aids
The goal of this exploratory interventional study is to evaluate a new hearing aid noise-reduction strategy in experienced hearing aid users, compared to currently available strategies.
- Trial name
- NCT06138665
- Testing
- Phonak Audeo Infinio Sphere, Hearing aid B, Hearing aid C
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Sonova AG
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
Hearing Loss
AutoFocus360 Sound Quality Preference and Claims Study
This study aims to generate clinical evidence to substantiate performance claims for the AutoFocus 360 feature in Sonova hearing aid products.
- Trial name
- AF360 (NCT07224919)
- Testing
- AutoFocus 360, Fixed directional microphone
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Jonathan Vaisberg
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
iotaSOFT Pediatric Study
Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Unilateral
- Trial name
- NCT06106373
- Testing
- iotaSOFT Insertion System
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- iotaMotion, Inc.
Hearing Impairment, Sensorineural
A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.
The purpose of this early feasibility study is to explore several facets of hearing performance of Focused Multipolar stimulation in adult cochlear implant users.
- Trial name
- SASC (NCT05641155)
- Testing
- Focused Multipolar Stimulation (FMS) strategy
- Where
- 5 sites in United States, Belgium
- Volunteers
- 18 people
- Sponsor
- Cochlear
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
Ototoxicity
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing…
- Trial name
- NCT02819856
- Testing
- SPI-1005 Ebselen 200mg Capsule x1, SPI-1005 Ebselen 200mg Capsule x2, SPI-1005 Ebselen 200mg Capsule x3
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
Hearing Loss Ototoxic
SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease
This study is intended to evaluate the ability of SENS-401 to prevent the ototoxicity induced by cisplatin in subjects with a neoplastic disease.
- Trial name
- NOTOXIS (NCT05628233)
- Testing
- SENS-401 (R-Azasetron Besylate)
- Where
- France
- Volunteers
- 48 people
- Sponsor
- Sensorion
Meniere's Disease
Study to Evaluate SPI-1005 in Adults With Meniere's Disease
This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease.
- Trial name
- NCT02603081
- Testing
- SPI-1005
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
Cochlear Hearing Loss
Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss
This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM SlimJ Electrode and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Ultra X) under normal conditions of use as it is…
- Trial name
- NCT04929470
- Testing
- cochlear implantation
- Where
- 3 sites in Germany
- Volunteers
- 37 people
- Sponsor
- Advanced Bionics AG
Temporary Auditory Threshold Shift
Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift
Exposure to loud sounds can cause hearing loss. The purpose of this research study is to evaluate potential prevention of temporary changes in hearing that may occur after listening to music through an iPod or personal music…
- Trial name
- NCT01444846
- Testing
- SPI-1005 Low dose, SPI-1005 Middle dose, SPI-1005 High dose
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Sound Pharmaceuticals, Incorporated
Hearing Loss
Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activation
This study aims to collect data in newly implanted cochlear implant-recipients to inform future development of fitting methods to optimally and efficiently program a cochlear implant.
- Trial name
- CALOS4 (NCT05709223)
- Testing
- Categorical loudness scaling based fitting using the research fitting system., Behavioural fitting using Custom Sound Suite (CSS 6.3) Software
- Where
- 4 sites in United States, Australia and 1 more
- Volunteers
- 17 people
- Sponsor
- Cochlear
Cochlear Hearing Loss
Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation
This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound…
- Trial name
- NCT06301568
- Where
- Germany
- Volunteers
- 55 people
- Sponsor
- Advanced Bionics AG
Cochlear Hearing Loss
Safety and Performance of HiRes Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss
This is a prospective study designed to evaluate the safety and performance of the HiRes Ultra Cl HiFocus MS Electrode and HiRes Ultra 3D Cl HiFocus MS Electrode (Ultra X) under normal conditions of use as it is approved for this…
- Trial name
- NCT04610112
- Testing
- Cochlear implantation
- Where
- 3 sites in Germany
- Volunteers
- 30 people
- Sponsor
- Advanced Bionics AG
Hearing Loss, Sensorineural, Sensorineural Hearing Loss, Bilateral
Benefits of Bimodal Streaming With MED-EL Cochlear Implants and Starkey Hearing Aids
This study will evaluate sound quality and user satisfaction with Bluetooth streaming using a new bimodal streaming option for individuals who use a MED-EL cochlear implant and Starkey hearing aid.
- Conditions
- Hearing Loss, Sensorineural, Sensorineural Hearing Loss, Bilateral, Cochlear Implant Recipients, Asymmetric Hearing Loss
- Trial name
- NCT07028619
- Testing
- Bimodal Streaming Configuration
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Med-El Corporation
Hearing Loss
Ponto Implantation Using a Minimally Invasive Surgical Technique
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands).
- Trial name
- NCT04606823
- Testing
- Minimally invasive surgery, Glasgow Benefit Inventory (GBI), Additional follow-up visits after surgery
- Where
- 7 sites in Denmark, Netherlands and 2 more
- Volunteers
- 52 people
- Sponsor
- Oticon Medical
Hearing Loss, Sensorineural
Design Improvements With SONNET 3
Measuring user-reported satisfaction with the latest behind-the-ear (BTE) audio processor model.
- Trial name
- NCT06597747
- Testing
- Audio processor
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Med-El Corporation