Clinical trials: Hearing Implants
Vestibulopathy, Moderate to Severe Hearing Loss
A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration
The main aim of this study is to understand if an experimental vestibular implant system can improve balance performance. The system consists of a vestibular implant combined with a cochlear implant sound processor and…
- Conditions
- Vestibulopathy, Moderate to Severe Hearing Loss, Normal Hearing, Balance Deficits
- Trial name
- BionicVEST2 (NCT06805175)
- Testing
- vestibular implant
- Where
- 3 sites in Belgium, Spain
- Volunteers
- 18 people
- Sponsor
- Cochlear
Cochlear Implant
Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery.
- Trial name
- NCT02966379
- Testing
- cochlear implantation
- Where
- 8 sites in France
- Volunteers
- 17 people
- Sponsor
- Oticon Medical
Hearing Loss, Hearing Loss, Sensorineural
Front-End Processing 3.0
This study investigated the impact of Automatic Sound Management 3.0 (i.e. ambient noise reduction, transient noise reduction and an adaptive intelligence) as implemented in the SONNET2 on CI users' speech performance and their…
- Conditions
- Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Bilateral
- Trial name
- FEP3 (NCT03861442)
- Testing
- Audio processor SONNET, SONNET 2: Configuration 1, SONNET 2: Configuration 2
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
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
Multi-center Study to Examine Changes to the Environment Surrounding the Electrodes in the Cochlea and to Capture the Most Challenging Listening Environments Experienced by Persons With a Cochlear Implant
This early feasibility study aims to collect pilot data on impedance measurements in real-world environments and to collect real-world and difficult listening situations and the factors impacting this, reflecting situations the…
- Trial name
- DICE (NCT06173687)
- Testing
- The impedance measurement task using the Mobile Research App (MRA)
- Where
- 4 sites in Australia, Belgium and 1 more
- Volunteers
- 51 people
- Sponsor
- Cochlear
Bone Conduction, Hearing Loss, Conductive
Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
The goal of this interventional study is to confirm the safety and performance of the latest generation Osia System and to examine its benefits compared to the Baha Connect System in adults with mixed or conductive hearing loss…
- Conditions
- Bone Conduction, Hearing Loss, Conductive, Hearing Loss, Mixed
- Trial name
- OSIRIS (NCT07130136)
- Testing
- Cochlear™ Osia® System, Cochlear™ Baha® System
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Cochlear
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, 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
Hearing Loss, Bilateral or Unilateral, Hearing Loss, Sensorineural
A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss
This clinical study will test a new investigational totally implanted cochlear implant system (TICI G2). The cochlear implant has an implantable microphone under the skin to detect speech and sound from the environment allowing…
- Conditions
- Hearing Loss, Bilateral or Unilateral, Hearing Loss, Sensorineural, Hearing Loss, Cochlear
- Trial name
- ENHANCE (NCT06642935)
- Testing
- Totally implantable cochlear Implant
- Where
- Australia
- Volunteers
- 18 people
- Sponsor
- Cochlear
Deafness, Hearing Loss
Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)
The rationale behind this post-market clinical follow-up investigation is to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that are candidates for…
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive
- Trial name
- NCT02022085
- Testing
- Baha Attract System
- Where
- 6 sites in United States, Netherlands and 2 more
- Volunteers
- 54 people
- Sponsor
- Cochlear Bone Anchored Solutions
Hearing Loss
Evaluation of New Feedback Canceller for Carina™ Implant
The purpose of this study is to evaluate audio quality benefit for the patient implanted with a Cochlear or Otologics Carina implant with the new firmware (feedback canceller algorithm) whatever the patient environment is and to…
- Trial name
- NCT02309541
- Testing
- feedback canceller algorithm (Firmware)
- Where
- 3 sites in France
- Volunteers
- 12 people
- Sponsor
- Cochlear
Pulsatile Tinnitus, Venous Sinus Stenosis
BosSTENT ImpLant to trEat debilitatiNg Pulse-synchronous Tinnitus
This study is evaluating the safety and clinical performance of the BosSTENT, a new stent designed specifically for treating pulse-synchronous tinnitus due to venous sinus stenosis.
- Trial name
- B-SILENT (NCT07070089)
- Testing
- BosSTENT implantation
- Where
- 6 sites in Canada, France
- Volunteers
- 90 people
- Sponsor
- Sonorous NV, Inc
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
Hearing Loss
Hearing Outcomes With the Nucleus® 8 Sound Processor and Nucleus® 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients
The main purpose of this study is to understand how well a noise reduction feature called ForwardFocus works when used with two different sound processors: the Nucleus® 8 Sound Processor and the Nucleus® 7 Sound Processor, in…
- Trial name
- SALUTE (NCT07582198)
- Testing
- Nucleus 7 Sound Processor, Nucleus 8 Sound Processor
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Cochlear
Hearing Loss, Hearing Implants
A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults
The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems.
- Trial name
- ORBIT-MU (NCT07338864)
- Testing
- Cochlear Nucleus Nexa Cochlear implant (CI1032), Cochlear Nucleus Nexa Cochlear implant (CI1022), Cochlear Nucleus Nexa Cochlear implant (CI1012)
- Where
- Germany
- Volunteers
- 66 people
- Sponsor
- Cochlear
Severe to Profound Hearing Loss, in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.
- Trial name
- NCT01616576
- Testing
- Control first, then Experimental, Experimental first, then Control
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Advanced Bionics
Hearing Loss
Evaluation of the Benefits for Overall Health Following Cochlear Implant Treatment in the Elderly Population
The purpose of this study is to show that cochlear implant treatment improves the overall health related quality of life and general well-being in elderly individuals.
- Trial name
- NCT03072862
- Testing
- Commercial Nucleus Cochlear Implant Systems
- Where
- 8 sites in France, Israel and 2 more
- Volunteers
- 100 people
- Sponsor
- Cochlear
Deafness, Hearing Loss
Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant
The overall aim of the study is to investigate the Ponto wide implant considering; initial implant stability, stability over time, skin reaction and long term success when loaded at 3 weeks post surgery.
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive, Hearing Disorders
- Trial name
- NCT01738490
- Testing
- Bone anchored hearing implant
- Where
- Netherlands
- Volunteers
- 59 people
- Sponsor
- Oticon Medical
Deafness; Sensoneural Single Sided, Conductive Hearing Loss
Clinical Performance of a New Implant System for Bone Conduction Hearing
To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.
- Conditions
- Deafness; Sensoneural Single Sided, Conductive Hearing Loss, Mixed Hearing Loss
- Trial name
- NCT03086135
- Testing
- Osia System
- Where
- 5 sites in United States, Australia and 3 more
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Cochlear