Clinical trials: Hearing Loss
Hearing Loss
Bilateral Cochlear Implant Benefit in Young Children
The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in…
- Trial name
- NCT00424307
- Testing
- HiResolution Bionic Ear System
- Where
- 14 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Advanced Bionics
Sensorineural Hearing Loss, Bilateral
Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy
Main objective: Investigate how the FineHearing strategy of the MED-EL cochlear implant can extract prosody based solely on the frequency of the voice fundamental (F0) in speech Secondary objectives: Evaluate the time evolution…
- Trial name
- NCT03694704
- Testing
- FineHearing strategy
- Where
- France
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
Hearing Loss
A Clinical Investigation of the Benefit: BTE Hearing Aids Versus ITE Hearing Aids
The current study will evaluate a new in-the-ear (ITE) hearing aid hardware. The goal is to evaluate the audiological performance, usability, feature function, and to identify unexpected or unwanted behaviour from the devices.
- Trial name
- NCT04168229
- Testing
- Mermaid 9 ITE, Mermaid 9 BTE
- Where
- Switzerland
- Volunteers
- 17 people
- Sponsor
- Bernafon AG
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
Sensorineural Hearing Loss
Implantation of the Cochlear™ Nucleus® Hybrid S Round Window (S-RW) in Adults
Evaluate the Cochlear™ Nucleus® S-Round Window (S-RW) implant in newly implanted adults with broader requirements to be considered an eligible candidate.
- Trial name
- NCT02638883
- Testing
- Hybrid SRW cochlear implant
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Cochlear
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
Primary Photoreceptor Disease, Retinitis Pigmentosa (RP)
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Study OpCT-001-101 is a Phase 1/2a first-in-human, multisite, 2-part interventional study to evaluate the safety, tolerability, and the effect on clinical outcomes of OpCT-001 in approximately 54 adults with primary photoreceptor…
- Conditions
- Primary Photoreceptor Disease, Retinitis Pigmentosa (RP), Usher Syndrome, Inherited Retinal Disease (IRD)
- Trial name
- CLARICO (NCT06789445)
- Testing
- OpCT-001
- Where
- 5 sites in United States
- Volunteers
- 54 people
- Sponsor
- BlueRock Therapeutics
Hearing Loss
Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss
The purpose of the study is to determine whether AM-111 is effective in the treatment of acute inner ear hearing loss (acute sensorineural hearing loss, ASNHL).
- Trial name
- NCT00802425
- Testing
- AM-111
- Where
- Germany
- Volunteers
- 210 people
- Sponsor
- Auris Medical AG
Hearing Impairment
A Study Examining Acceptability of Auditory Implant Fitting Software Technologies
Auditory implant fitting software is used by hearing healthcare professionals to adjust and optimize hearing implant systems for people with hearing loss.
- Trial name
- SUNRISE-MU (NCT07763873)
- Testing
- Investigational Software
- Where
- 2 sites in United States, Australia
- Volunteers
- 200 people
- Sponsor
- Cochlear
Age-Related Hearing Loss
Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss
This study aims to demonstrate that the investigational drug AUT00063 is effective and safe in the treatment of age-related hearing loss.
- Trial name
- CLARITY-1 (NCT02345031)
- Testing
- AUT00063
- Where
- 13 sites in United States
- Volunteers
- 78 people
- Sponsor
- Autifony Therapeutics Limited
Hearing Loss
The RW-Precision-Coupler Clinical Investigation
The RW-Precision-Coupler Clinical Investigation is prospective, non-randomized, open label, single subjects repeated measures, longitudinal monocentric trial.
- Trial name
- NCT04890145
- Testing
- RW-Precision-Coupler
- Where
- Germany
- Volunteers
- 5 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Bilateral, Bilateral Hearing Loss
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting
Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.
- Trial name
- NCT05955469
- Testing
- FS4 then TFS4 (cochlear implant), TFS4 then FS4 (cochlear implant)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss
MyPhonak App Junior Pediatric Usability and Benefit Investigation
Participants age 8-17 with bilateral hearing loss will be fit with Phonak BTE (Behind-The-Ear) hearing aids and given access to the myPhonak Junior hearing app.
- Trial name
- NCT05055453
- Testing
- MyPhonak Junior App, Phonak Sky hearing aid
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sonova AG
Hearing Loss
Evaluation of the Presence of SENS-401 in the Perilymph
The aim of this study is to detect the presence of SENS-401 in the perilymph of participants undergoing cochlear implant surgery after 7 days of oral administration of SENS-401.
- Trial name
- NCT05258773
- Testing
- SENS-401 (R-Azasetron Besylate)
- Where
- 7 sites in Australia, France
- Volunteers
- 28 people
- Sponsor
- Sensorion
Hearing Impaired (Partially), Hearing Impairment, Conductive
Clinical Survey of Oticon Medical Ponto BHX Implant
Investigation of stability of the BHX implant in adult patients indicated and counselled for a bone anchored hearing aid system. Patients are followed according to clinical practice for a total of 12 months in the study.
- Conditions
- Hearing Impaired (Partially), Hearing Impairment, Conductive, Deafness Unilateral
- Trial name
- NCT03289845
- Testing
- BHX implant (Bone anchored hearing system)
- Where
- 2 sites in Denmark
- Volunteers
- 36 people
- Sponsor
- Oticon Medical
Hearing Loss, Hearing Impairment
Evaluating Possible Improvement in Speech and Hearing Tests After 28 Days of Dosing of the Study Drug AUT00063 Compared to Placebo (QuicKfire)
The objective of this pilot study is to explore whether repeat doses of AUT00063 can provide an indication of improvement in performance of tests across a battery of speech and hearing assessments in cochlear implant users.
- Trial name
- NCT02832128
- Testing
- AUT00063
- Where
- 4 sites in United Kingdom
- Volunteers
- 15 people
- Sponsor
- Autifony Therapeutics Limited
Hearing Loss, Ear Diseases
Clinical Evaluation of a Cochlear Implant Sound Processor
This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer).
- Conditions
- Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases
- Trial name
- NCT04237207
- Testing
- Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software, 301-M062 sound processor & software
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Advanced Bionics
Conductive Hearing Loss, Mixed Hearing Loss
Clinical Survey of Oticon Medical Healing Cap
This study investigates the use of a new healing cap which, through altered design and choice of material, has been improved when it comes to minimizing the risk of it falling off as well as increasing patient comfort.
- Conditions
- Conductive Hearing Loss, Mixed Hearing Loss, Unilateral Partial Deafness
- Trial name
- NCT02274129
- Testing
- Healing cap II
- Where
- 2 sites in Denmark
- Volunteers
- 32 people
- Sponsor
- Oticon Medical
Hearing Loss
Collection and Characterization of Objective Measures to Explore the Specificity of Algorithms
The aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms.
- Trial name
- NCT03294681
- Testing
- Objective measures with CSEP
- Where
- 6 sites in Australia, Germany and 1 more
- Volunteers
- 153 people
- Sponsor
- Cochlear