Clinical trials: Hearing Impairment, Sensorineural
Sensorineural Hearing Loss, Bilateral, Cochlear Implants
Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults.
This clinical investigation aims to collect data on the use of the Mi2000 system, a totally implantable cochlear implant system, for the first time in human subjects.
- Trial name
- TICI (NCT04571333)
- Testing
- Mi2000 Totally Implantable Cochlear Implant
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 6 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss, Sensorineural
Acceptance of the CP950 Sound Processor
Acceptance of CP950 sound processor with experienced CP810/CP910/CP920 BTE sound processor users.
- Trial name
- NCT03613909
- Testing
- CP950 OTE Sound processor
- Volunteers
- 23 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral
Study of Sound and Speech Perception in New Cochlear Implanted Subjects Using or Not an Anatomy-based Fitting
Main objective: Compare the recognition of environmental sounds with an anatomy-based fitting and with a default fitting adult patients newly implanted with a MED-EL cochlear implant.
- Trial name
- NCT05230498
- Testing
- anatomy-based fitting then default fitting, default fitting then anatomy-based fitting
- Where
- France
- Volunteers
- 17 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Bilateral
Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy
Main objective: Investigate on new cochlear implanted patients whether the FineHearing strategy of the MED-EL cochlear implant gives better results on musical perception if the depth of stimulation (stimulation or not of the…
- Trial name
- NCT04591093
- Testing
- FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated
- Where
- France
- Volunteers
- 32 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
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
Hearing Loss, Sensorineural
Sound Quality Comparisons With Different Hearing Aid Couplings and Venting Systems
Participants will be comparing the sound quality of their own voice and the sound quality of streamed music using universal couplings and a custom earmold with a dynamic vent.
- Trial name
- NCT05180630
- Testing
- Audeo P90 hearing aid with custom earmolds using dynamic venting, Audeo P90 hearing aid with Open domes, Audeo P90 hearing aid with Vented domes
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Sonova AG
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Optimizing Soft Speech Recognition in Children With Hearing Loss
Overhearing is important for vocabulary learning and speech and language development in young children. However, contemporary hearing aids are generally unable to provide adequate access to low-level auditory inputs from multiple…
- Trial name
- SoftSpeech (NCT05299892)
- Testing
- Phonak Audeo P or Naida P hearing aid
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Sonova AG
Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children/Infants, Adolescents and Adults With Hearing Loss Due to Otoferlin Mutations
Regeneron is conducting a study of an investigational new drug called DB-OTO. DB-OTO is a gene therapy that is being developed to treat pediatric and adult participants who have severe-to profound and profound hearing loss due to…
- Trial name
- CHORD (NCT05788536)
- Testing
- DB-OTO
- Where
- 17 sites in United States, Germany and 3 more
- Volunteers
- 36 people
- Sponsor
- Regeneron Pharmaceuticals
Seneorineural Deafness, Sudden Sensorineural Hearing Loss
A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
The goal of this 2 step-up, exploratory study is to test safey, tolerability and PK/PD profiles in healthy volunteers and safety, tolerability and efficacy in sudden sensorineural hearing loss patients as an early salvage…
- Trial name
- NCT06249919
- Testing
- NS101
- Where
- 15 sites in South Korea
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Neuracle Science Co., LTD.
Sensorineural Hearing Loss, Bilateral
Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss
Part A of this trial evaluated the safety and tolerability of a single surgical administration procedure in one or both ear(s) with one of two dose levels of AAVAnc80-hOTOF (LY888891) and evaluated the Akouos Delivery Device…
- Trial name
- NCT05821959
- Testing
- AAVAnc80-hOTOF via Akouos Delivery Device, AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 48 people
- Sponsor
- Eli Lilly and Company
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Investigating Hearing Aid Frequency Response Curves
Internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve.
- Trial name
- NCT05521308
- Testing
- Hearing Aid - Standard Curve, Hearing Aid - Variation #1, Hearing Aid - Variation #2
- Where
- Canada
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Sonova AG
Hearing Loss
Home Test of New Sound Processor
The purpose of this clinical investigation is to test a new Sound Processor (SP) to compare hearing performance of the new Sound Processor with unaided hearing and Baha 5 SP in adult subjects and to investigate which device (new…
- Trial name
- NCT04559282
- Testing
- New Sound Processor
- Where
- Sweden
- Volunteers
- 16 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral
An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.
- Trial name
- NCT03904420
- Testing
- Clinical Education and Treatment Model, Traditional Model
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Cochlear
Noise Exposure, Noise-induced Hearing Loss
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for preservation of sensory structures in the cochlea after noise exposure. The main aims of the study are: 1.
- Conditions
- Noise Exposure, Noise-induced Hearing Loss, Noise; Adverse Effect, Mild Therapeutic Hypothermia
- Trial name
- NCT06729632
- Testing
- Cold pack-delivered mild therapeutic hypothermia
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Restorear Devices LLC
Hearing Loss, Sensorineural, Hearing Loss
Speech Intelligibility in Quiet and Noise for New vs. Legacy Hearing Aids
This clinical investigation is designed to compare audiological performance (i.e., measurements of sound quality and speech understanding) between Starkey's new receiver-in-canal device and a commercially available legacy…
- Trial name
- NCT05101083
- Testing
- New Receiver-in-Canal Device, Legacy Receiver-in-Canal Device
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Starkey Laboratories, Inc
Hearing Loss, Sensorineural
Evaluation of the Efficacy and Safety of the Sullivan Cochlear Implant.
The study will be conducted as a prospective, single center, repeat measure, single-arm, open label clinical study
- Trial name
- NCT07018882
- Testing
- Sullivan
- Volunteers
- 25 people
- Sponsor
- Todoc
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, Sensorineural, Cochlear Implantation
Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
- Trial name
- AIMBOT (NCT06664710)
- Testing
- iotaSOFT Insertion System with AIM, iotaSOFT Insertion System with AIM Control
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- iotaMotion, Inc.
Deafness, Hearing Loss
Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique
To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection, overgrowth, pain and numbness at the site of…
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
- Trial name
- NCT01796236
- Testing
- Minimally invasive surgery and BA400, Traditional surgery and BA300
- Where
- 7 sites in France, Netherlands and 2 more
- Volunteers
- 106 people
- Sponsor
- Cochlear Bone Anchored Solutions