Clinical trials: Hearing Implants
Severe to Profound Hearing Loss
Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants.
This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized.
- Trial name
- BELPS (NCT07777562)
- Testing
- Cochlear implantation
- Where
- Switzerland
- Volunteers
- 700 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss
Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array
This clinical study will test a new type of cochlear implant known as CI632D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone.
- Trial name
- DEE-REX (NCT06598059)
- Testing
- Cochlear implant, Dexamethasone
- Where
- 11 sites in United States
- Volunteers
- 56 people
- Sponsor
- Cochlear
Cochlear Hearing Loss
Safety and Performance of HiRes Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss
This is a prospective study designed to evaluate the safety and performance of the HiRes Ultra Cl HiFocus MS Electrode and HiRes Ultra 3D Cl HiFocus MS Electrode (Ultra X) under normal conditions of use as it is approved for this…
- Trial name
- NCT04610112
- Testing
- Cochlear implantation
- Where
- 3 sites in Germany
- Volunteers
- 30 people
- Sponsor
- Advanced Bionics AG
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, Binaural, Hearing Loss, Monaural
Evaluation of Different Phone Solutions in CI and Hearing Aid Users and Bimodal Recipients
Communication on telephone is challenging for people with hearing loss. For hearing aid users, for instance, the inventions for improving speech intelligibility on the phone range from an integrated tele coil and individual…
- Trial name
- PhoneCIHA (NCT03036410)
- Testing
- standard telephone setting, DECT, EasyCall
- Where
- Switzerland
- Volunteers
- 25 people
- Sponsor
- Advanced Bionics AG
Hearing Impairment, Sensorineural
A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.
The purpose of this early feasibility study is to explore several facets of hearing performance of Focused Multipolar stimulation in adult cochlear implant users.
- Trial name
- SASC (NCT05641155)
- Testing
- Focused Multipolar Stimulation (FMS) strategy
- Where
- 5 sites in United States, Belgium
- Volunteers
- 18 people
- Sponsor
- Cochlear
Cochlear Implant Recipients, Hearing Loss, Cochlear
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
This study will evaluate a range of experimental sound coding strategies that may improve hearing for cochlear implant recipients.
- Trial name
- SONORA-MU (NCT06867380)
- Testing
- Investigational sound coding strategy A, Cochlear default sound coding strategy A, Investigational sound coding strategy B
- Where
- 2 sites in Australia
- Volunteers
- 120 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural
Design Improvements With SONNET 3
Measuring user-reported satisfaction with the latest behind-the-ear (BTE) audio processor model.
- Trial name
- NCT06597747
- Testing
- Audio processor
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Med-El Corporation
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
Severe to Profound Mixed Hearing Loss
Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs
The purpose of this study is to evaluate the effect of the sound processor upgrade from the C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor for the Codacs™ system on the speech…
- Trial name
- NCT02156167
- Testing
- CP810 and Codacs™ system test
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Cochlear
Hearing Loss
Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear
The purpose of this study is to collect patient related benefit data following treatment for permanent hearing loss with a hearing implant from the company Cochlear over a period of 2 years post treatment.
- Trial name
- IROS (NCT02004353)
- Testing
- Cochlear® Hearing Implants
- Where
- 77 sites in Argentina, Austria and 14 more
- Volunteers
- 1,518 people
- Sponsor
- Cochlear
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
Conductive Hearing Loss, Mixed Hearing Loss
Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation
A bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness.
- Conditions
- Conductive Hearing Loss, Mixed Hearing Loss, Single Sided Deafness
- Trial name
- NCT02064478
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Oticon Medical
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
Mixed Conductive and Sensorineural Hearing Loss, Bilateral
Middle-Ear Implant With MET V Transducer (Aka MET V System)
The purpose and objective of this study is to evaluate the safety and efficacy of the MET V System for the treatment of individuals with mixed hearing loss.
- Trial name
- NCT01529333
- Testing
- Middle Ear Implant with MET V Transducer
- Volunteers
- 130 people
- Sponsor
- Otologics LLC
Hearing Loss
Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the…
- Trial name
- NCT04310202
- Testing
- Abbreviated Profile of Hearing Aid Benefit (APHAB), Glasgow Benefit Inventory (GBI), Additional follow-up visits after surgery
- Where
- 6 sites in Denmark, Spain and 1 more
- Volunteers
- 50 people
- Sponsor
- Oticon Medical
Hearing Loss
Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy
The Sponsor values the progression of hearing healthcare practice and acknowledges a need for re-evaluation of indications for determining adult cochlear implant candidacy.
- Trial name
- NCT01337076
- Testing
- cochlear implant
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Cochlear
Hearing Loss
Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation
The aim of the study is to assess the real-world effectiveness of managing participants within the first year post-activation (between 3 and 12 months) using Cochlear's Remote Care (Remote Check and Remote Assist), as compared…
- Trial name
- INSPIRE (NCT05552118)
- Testing
- Cochlear™ Remote care, Standard of care, Compatible Implant Series and Compatible Sound Processors
- Where
- 11 sites in Australia, Belgium and 3 more
- Volunteers
- 148 people
- Sponsor
- Cochlear
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
Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis), Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side
Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population
To study the initial experience with implanting and fitting a new Bone Conduction system in pediatric patient population with conductive, mixed or single-sided deafness.
- Trial name
- OSIA Pediatric (NCT03509974)
- Testing
- Osseointegrated Steady State Implant
- Where
- Canada
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Cochlear