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
Cmv Congenital, CMV
Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants
The overall goal of this study is to determine the clinical benefit and safety of antiviral therapy for asymptomatic congenital cytomegalovirus (cCMV) infected hearing-impaired infants.
- Conditions
- Cmv Congenital, CMV, Congenital Cmv, SNHL
- Trial name
- ValEAR (NCT03107871)
- Testing
- Valganciclovir, Simple Syrup
- Where
- 30 sites in United States
- Volunteers
- 10 people
- Sponsor
- Albert Park
Hearing Loss, Bilateral
Early Communication Intervention for Toddlers With Hearing Loss
Improving spoken language outcomes for children with hearing loss has important public health implications. This is a randomized clinical trial of 96 children with hearing loss that examines the effects of a parent-implemented…
- Trial name
- NCT03803943
- Testing
- Parent-Implemented Communication Intervention (PICT), No Intervention - Business-as-usual control
- Where
- United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Northwestern University
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 Loss, Sensorineural
Self-efficacy-based Auditory Rehabilitation With Over-the-Counter Hearing Aids
This goal of this study is to learn if a new audiology treatment process called the self-efficacy-based auditory rehabilitation (SEBAR) can improve confidence and success with over-the-counter (OTC) hearing aids.
- Trial name
- NCT06560918
- Testing
- hearing aids
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- University of Arkansas
Deafness, Hearing Loss
Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers
Children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems.
- Conditions
- Deafness, Hearing Loss, Parenting, Child Behavior
- Trial name
- CHAMPS-DHH (NCT03916146)
- Testing
- Parent Training Intervention
- Where
- United States
- Volunteers
- 295 people
- Sponsor
- Christina Studts
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
Sensorineural Hearing Loss
Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss
To determine if autologous human umbilical cord blood infusion in children with acquired hearing loss is safe, feasible, improves inner ear function, audition and language development.
- Trial name
- NCT02038972
- Testing
- Autologous Stem Cells
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- James Baumgartner, MD
Hearing Loss, Sensorineural
Evaluation of an Open-source Speech-processing Platform
Determining acceptability and usability of a wearable open-source speech processing platform (Master Hearing Aid) developed for hearing-aid research
- Trial name
- EOSP (NCT03686046)
- Testing
- Exploratory use
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- San Diego State University
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
Hearing Loss, Aging
ACHIEVE Hearing Intervention Follow-Up Study
The ACHIEVE Hearing Intervention Follow-Up study is a randomized trial of a telehealth versus conventional clinic-based hearing healthcare (HHC) delivery model among older adults who are existing hearing aid users to determine if…
- Trial name
- ACHIEVE-HIFU (NCT05070429)
- Testing
- Clinic-based audiological rehabilitative service delivery, Telehealth audiological rehabilitative service delivery
- Where
- 4 sites in United States
- Volunteers
- 339 people
- Sponsor
- Johns Hopkins University