Clinical trials: Hearing Implants
Hearing Loss
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided…
- Trial name
- NCT04041700
- Testing
- Osia 2 system
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 29 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural
Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults
The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor
- Trial name
- SME (NCT03007472)
- Testing
- CI532, Nucleus 7
- Where
- 10 sites in United States
- Volunteers
- 96 people
- Sponsor
- Cochlear
Hearing Loss
Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System
To evaluate the performance of the Nucleus 5 Cochlear Implant System.
- Trial name
- NCT01072409
- Testing
- Nucleus 5 Cochlear implant, Cochlear implantation
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Cochlear
Heart Failure, Arrhythmias, Cardiac
Heart Failure and Sudden Cardiac Death Japan Registry
The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart…
- Conditions
- Heart Failure, Arrhythmias, Cardiac, Sudden Cardiac Death
- Trial name
- HINODE (NCT03185832)
- Testing
- CRT-D, ICD, PM / CRT-P
- Where
- 34 sites in Japan
- Volunteers
- 354 people
- Sponsor
- Boston Scientific Corporation
Conductive Hearing Loss
Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System
An international multicentre, open, comparative, parallel group, prospective clinical investigation with a single 5 year follow up visit.
- Trial name
- NCT02092610
- Testing
- Novel Implant BI300, Standard Implant BI300
- Where
- 4 sites in Netherlands, Sweden and 1 more
- Volunteers
- 77 people
- Sponsor
- Cochlear Bone Anchored Solutions
Hearing Loss, Sensorineural
Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients
This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.
- Trial name
- DUAL (NCT06298396)
- Testing
- Program using default MAP, Program using low-power 1 (LP1) MAP, Program using low-power 2 (LP2) MAP
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Cochlear
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
Ear Diseases, Hearing Loss, Bilateral
Lumity CI Study - Clinical Evaluation of Next Generation Cochlear Implant Sound Processor
This is a prospective within-subjects repeated-measures study that will enroll 18 bilateral adult users implanted with a HiResolution Bionic Ear System (HiRes 90KTM, HiRes 90K TM Advantage, HiResTM Ultra, HiResTM Ultra 3D and CII…
- Conditions
- Ear Diseases, Hearing Loss, Bilateral, Otorhinolaryngologic Diseases
- Trial name
- NCT06858826
- Testing
- Control cochlear implant sound processor, Next Generation Sound Processor
- Volunteers
- 20 people
- Sponsor
- Advanced Bionics
Sensorineural Hearing Loss
Fundamental Asynchronous Stimulus Timing Sound Coding Study
The Fundamental Asynchronous Stimulus Timing (FAST) is a novel cochlear implant sound coding strategy. Potential benefits include improved battery life, in addition to improved localization for bilateral patients.
- Trial name
- FAST (NCT02698787)
- Testing
- Experimental sound coding strategy (FAST), Commercially available ACE sound coding strategy
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Cochlear
Hearing Loss
Nucleus Hybrid L24 Extended Duration Post Approval Study
This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid L24 Implant System in a group of already implanted recipients.
- Trial name
- HED (NCT02379273)
- Testing
- Nucleus Hybrid L24 Implant
- Volunteers
- 35 people
- Sponsor
- Cochlear
Hearing Loss, Ear Diseases
Clinical Evaluation of a Cochlear Implant Sound Processor
This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer).
- Conditions
- Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases
- Trial name
- NCT04237207
- Testing
- Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software, 301-M062 sound processor & software
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Advanced Bionics
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
Usability of the CP950 Sound Processor
Studying usability and gaining feedback of the CP950 Sound Processor in experienced cochlear implant recipients.
- Trial name
- C950 (NCT02727842)
- Testing
- CP950 Sound Processor, Wireless programming pod
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cochlear
Hearing Loss
N6 Input Processing in Traditional CI Recipients
The purpose of this study is to evaluate the enhanced signal processing features of the Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the Nucleus 5 Sound Processor.
- Trial name
- NCT02239263
- Testing
- Nucleus 6 Sound Processor
- Where
- 4 sites in United States
- Volunteers
- 40 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
The Esteem® Hearing Implant Post Approval Study
The purpose of this study is to evaluate the long-term safety and efficacy of the Esteem® Hearing Implant in subjects suffering from moderate to severe hearing loss.
- Trial name
- NCT02666222
- Testing
- The Esteem Hearing Implant
- Where
- 5 sites in United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Envoy Medical Corporation
Hearing Loss, Sensorineural Hearing Loss
Non-significant Risk Study of a Cochlear Implant Headpiece
This study aims to evaluate a cochlear implant headpiece.
- Trial name
- NCT05488535
- Testing
- cochlear implant headpiece
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Advanced Bionics
Hearing Loss
Littlears Auditory Questionnaire: Validation Study in CI Children
The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years.
- Trial name
- LittlEars (NCT00785707)
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Med-El Corporation
Sensorineural Hearing Loss
Esteem New Subject Enrollment Post Approval Study
The New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe hearing loss.
- Trial name
- NCT02689349
- Testing
- Implantation of Esteem
- Where
- 6 sites in United States
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Envoy Medical Corporation
Hearing Loss, Sensorineural
Expanded Indications in the Adult Cochlear Implant Population
The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit…
- Trial name
- NCT03236909
- Testing
- MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System
- Where
- 5 sites in United States, Canada
- Volunteers
- 44 people
- Sponsor
- Med-El Corporation