Clinical trials: Deafness, Bilateral
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population
This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation.
- Trial name
- ACE (NCT06293482)
- Testing
- Cochlear™ Nucleus® System
- Where
- 9 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cochlear
Hearing Loss, Bilateral
A Study of Objective Fitting for Focused Multipolar Stimulation
The purpose of this exploratory study is to trial various objective and behavioural fitting methods for potential use with Focused Multipolar Stimulation programming.
- Trial name
- OFIT (NCT05763342)
- Testing
- The Phoenix Research System
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral Hearing Loss
Cochlear Implant With Dexamethasone Eluting Electrode Array
An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
- Trial name
- NCT04750642
- Testing
- CI632D, CI632
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 42 people
- Sponsor
- Cochlear
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
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
Sensorineural Hearing Loss
Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study
The objective of this multisite study is to evaluate the performance of the Nucleus Freedom cochlear implant system in a large population of sequentially implanted pediatric subjects.
- Trial name
- NCT00589511
- Volunteers
- 69 people
- Sponsor
- Cochlear
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
Hearing Loss
Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant
The purpose of this study is to evaluate and document longitudinal efficacy in young children implanted bilaterally with MED-EL COMBI 40+ / PULSARCI100/SONATATI100 cochlear implant systems.
- Trial name
- NCT00784043
- Testing
- Cochlear Implant
- Where
- 9 sites in United States, Canada
- Volunteers
- 37 people
- Sponsor
- Med-El Corporation
Hearing Loss, Bilateral Sensorineural, Progressive
Quality Control of CE-Certified Phonak Hearing Aids - 2017_27
A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch.
- Trial name
- NCT03253003
- Testing
- Line extension of the Phonak Audéo B product family
- Where
- Switzerland
- Volunteers
- 19 people
- Sponsor
- Sonova AG
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
Hearing Loss, Bilateral or Unilateral, Hearing Loss, Conductive
Sentio Systematic Evaluation
The study is designed as an international, multi-center, single-armed, non-interventional/observational study including subjects who has received or are planned to receive the Sentio system as part of normal clinical practice.
- Conditions
- Hearing Loss, Bilateral or Unilateral, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Single Sided Deafness
- Trial name
- SENSE (NCT07161154)
- Testing
- Transcutaneous bone conduction hearing system
- Volunteers
- 100 people
- Sponsor
- Oticon Medical
Hearing Loss, Bilateral Sensorineural, Progressive
Quality Control of CE-Certified Phonak Hearing Aids - 2017_13
A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch.
- Trial name
- NCT03131557
- Testing
- Line extension of the Phonak Audéo B product family, Phonak Audéo B
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- Sonova AG
Sensori-Neural Deafness, Sensorineural Hearing Loss
Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant
The goal of this clinical trial is to learn if the Acclaim CI works to treat severe to profound sensorineural hearing loss in adults. It was also learn about the safety of the Acclaim CI implant.
- Conditions
- Sensori-Neural Deafness, Sensorineural Hearing Loss, Sensorineural Hearing Loss (Disorder), Sensorineural Hearing Loss, Bilateral
- Trial name
- NCT06699797
- Testing
- Acclaim Cochlear Implant
- Where
- 7 sites in United States
- Volunteers
- 56 people
- Sponsor
- Envoy Medical Corporation
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, 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
Hearing Loss, Bilateral, Hearing Loss, Unilateral
PRINCE22 System Complete Performance Study
The investigation proposes to compare a narrow reference beamformer to a novel beamformer approach, when the talker is not in front of the hearing aid user and in the presence of background noise.
- Trial name
- NCT05656313
- Testing
- Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test), Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test), Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test)
- Where
- Germany
- Volunteers
- 22 people
- Sponsor
- Sonova AG
Hearing Loss, Hearing Loss, Conductive
The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study
The Bonebridge system using the BCI 601 is marketed since 2012. Previous prospective, multi-center, non-randomized studies on the BCI 601 Bonebridge performed in adult and paediatric populations have shown a significant…
- Conditions
- Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral
- Trial name
- NCT04427033
- Testing
- Bone Conduction Implant
- Where
- 8 sites in Austria, Germany and 1 more
- Volunteers
- 52 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
An Actual Use, Open-label Study Assessing Usability of Remote Assist to Program Cochlear Implant Recipients
Clinical management of cochlear implant (CI) recipients involve programming, counselling, performance evaluation and habilitation.
- Trial name
- RAL (NCT04987021)
- Testing
- Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants
- Where
- Australia
- Volunteers
- 15 people
- Sponsor
- Cochlear
GJB2-mediated Hearing Loss, GJB2 Gene Mutation
Open-label Study of SKY-GJB2 in Pediatric Subjects With GJB2-mediated Hearing Loss
Skylark Bio is conducting a study of an investigational new drug called SKY-GJB2 and its delivery device, the SKY-CAT. SKY-GJB2 is a gene therapy that is being developed to treat children who have hearing loss due to changes in…
- Conditions
- GJB2-mediated Hearing Loss, GJB2 Gene Mutation, DFNB1A
- Trial name
- SONIX (NCT07627971)
- Testing
- SKY-GJB2
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Skylark Bio Inc.
Hearing Loss, Bilateral Sensorineural, Hearing Loss, Sensorineural
Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)
This clinical study will test a newly developed cochlear implant known as CI622D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone.
- Conditions
- Hearing Loss, Bilateral Sensorineural, Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Cochlear
- Trial name
- DETECT (NCT06424262)
- Testing
- CI622D, CI622
- Where
- 11 sites in Australia, France and 2 more
- Volunteers
- 50 people
- Sponsor
- Cochlear