Clinical trials: Cochlear Hearing Loss
Hearing Loss, Cochlear
Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlear Implant User.
The aim of the study is to evaluate the interaural time difference (ITD) benefit in patients with bilateral cochlear implants and to assess speech performance in noisy conditions compared to normal hearing listeners.
- Trial name
- APPIC (NCT04357704)
- Testing
- S0N0, S0N500, S-500N500
- Volunteers
- healthy volunteers welcome
- Sponsor
- Oticon Medical
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.
Cochlear Hearing Loss
MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE
The goal of this interventional study is to describe how people with cochlear implants perceive the perceive speech in noise and their sound environment on adults who are native French speakers with typical hearing or with…
- Trial name
- MIRACLE (NCT06420921)
- Testing
- Speech in noise comprehension test, Objective tests of perception of ambient sound cues in noise, Subjective tests of perception of ambient sound cues in noise
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
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.
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
Cochlear Hearing Loss
Investigation of the Automatic Technology on the Naída M Hearing Devices
In this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of the device under investigation on sound perception.
- Trial name
- NCT04610216
- Testing
- Naida CI M hearing device
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- Advanced Bionics AG
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
A Monocentric Study Evaluating Pupillometry as an Objective Measurement for CI Fittings
This trial is a monocentric, prospective and controlled study of the pupil response to detect hearing threshold and comfortable loudness of normal-hearing (NH) and CI-subjects.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Cochlear Hearing Loss, Hearing Loss, Cochlear
- Trial name
- PupillOM (NCT05586555)
- Testing
- Pupillometry (Eve-tracking measurements)
- Where
- France
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Oticon Medical
Cochlear Hearing Loss
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices.
- Trial name
- NCT06301581
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Advanced Bionics AG
Cochlear Hearing Loss, Cochlear Trauma
Using Electrocochleography During Cochlear Implantation of the Neuro Zti.
The main objective of this study is to evaluate the correspondence between eCochG and residual hearing by adding two modifications.
- Trial name
- PIC-22_eCoN (NCT04651660)
- Testing
- Neuro Cochlear Implant System
- Sponsor
- Oticon Medical
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
PROM, Cochlear Hearing Loss
A Study Evaluating the French Version of the CIQoL-35 Quality of Life Questionnaire in Adult Cochlear Implant Use.
The Cochlear Implant - Quality of Life (CIQoL) PROM is a quality-of-life assessment questionnaire for adults with cochlear implants.
- Conditions
- PROM, Cochlear Hearing Loss, Hearing Loss, Quality of Life
- Trial name
- CIQoL (NCT05709431)
- Testing
- Questionnaire CIQoL-35
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Oticon Medical
Cochlear Hearing Loss
Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios
In this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of Naída Link M90 hearing aid and Naída CI M90 sound processor on sound perception.
- Trial name
- NCT04815343
- Testing
- Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Advanced Bionics AG
Hearing Loss, Sensorineural, Hearing Loss, Cochlear
The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
The purpose of the study is to assess the efficacy and the safety profile of the Neuro Cochlear Implant System (CIS) in adults with severe-to-profound hearing loss.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Cochlear, Deafness
- Trial name
- NCT02941627
- Testing
- Neuro Zti, Neuro One
- Where
- 6 sites in Canada, Denmark
- Volunteers
- 53 people
- Sponsor
- Oticon Medical
Hearing Loss, Cochlear, Neurinoma of the Acoustic Nerve
Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma
The aim of this study is to assess the auditory nerve functionality with an intraoperative approach following a surgical removal of acoustic neuroma in patients with severe to profound sensorineural hearing disabilities.
- Trial name
- NeuriStim (NCT02948790)
- Testing
- Neuristim, Cochlear implant
- Where
- 4 sites in France
- Volunteers
- 17 people
- Sponsor
- Oticon Medical
Hearing Loss, Sensorineural, Cochlear Hearing Loss
Neuro 1 vs. Neuro 2 Sound Processors
This study evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other half will be tested with Neuro 2 first and…
- Trial name
- NCT03756337
- Testing
- Neuro 1 & Neuro 2, Neuro 2 & Neuro 1
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Oticon Medical
Hearing Loss, Cochlear
Effects of Pulses on Loudness
The aim of this study is to investigate the effect of varying additional factors on loudness summation in Neuro Zti Cochlear Implant users.
- Trial name
- EfPuL (NCT04010721)
- Testing
- Experiment 1, Experiment 2:, Experiment 3
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Oticon Medical
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
Tinnitus, Hearing Loss, Cochlear Implant Users
Sound Therapy for Tinnitus Relief in Cochlear Implant Users
The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy for tinnitus relief in cochlear implant users with tinnitus.
- Trial name
- NCT03026829
- Testing
- CART sound therapy
- Where
- 2 sites in Netherlands
- Volunteers
- 32 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Cochlear Hearing Loss
Listening Effort in Cochlear Implant Users
Listening with a cochlear implant remains difficult and most listeners will report high levels of listening effort.The present study is a "pilot" aiming to evaluate listening effort for cochlear implant users.
- Trial name
- NCT03212924
- Testing
- Pupillometry, Evaluation of speech comprehension in quiet, Evaluation of speech comprehension in noise
- Where
- France
- Volunteers
- 16 people
- Sponsor
- Oticon Medical