Clinical trials: Sound Perception
OTOF Gene Mutation, DFNB9
A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations
This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.
- Conditions
- OTOF Gene Mutation, DFNB9, Congenital Deafness, Hearing Disorders
- Trial name
- AUDIOGENE (NCT06370351)
- Testing
- SENS-501 administration
- Where
- 2 sites in Australia, France
- Volunteers
- 12 people
- Sponsor
- Sensorion
Sensorineural Hearing Loss, Bilateral, AUNB1
Natural History in Children up to 16 Years With Mild to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes
The purpose of this study is to follow the natural history of non-syndromic hearing loss caused by mutations in two genes (GJB2 or OTOF) in children up to 16 years of age.
- Conditions
- Sensorineural Hearing Loss, Bilateral, AUNB1, DFNB1A, Congenital Deafness
- Trial name
- Otoconex (NCT05402813)
- Testing
- Pure Tone Audiometry Assessment, Quality of Life Questionnaires
- Where
- France
- Volunteers
- 180 people
- Sponsor
- Sensorion
Tinnitus, Subjective, Tinnitus, Bilateral
Tinnitus Patient Preferences Survey
The goal of this survey is to assess several aspects related to patient preferences regarding interventions for alleviating tinnitus through invasive electrical brain stimulation (neuromodulation).
- Conditions
- Tinnitus, Subjective, Tinnitus, Bilateral, Tinnitus, Noise Induced, Tinnitus, Hearing Loss, Cochlear Implant Users
- Trial name
- NCT06782308
- Testing
- Survey using a questionnaire.
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Nicolas Gninenko
Hearing Loss
Evaluating Benefits of Hearing Aid Microphone Directionality Technologies
This study will evaluate the impact of hearing aid microphone directionality technologies and settings on speech understanding in noise for experienced hearing aid users.
- Trial name
- NCT04953390
- Testing
- Phonak Audeo hearing aid, Phonak hearing aid with multiple directionality settings, adjustable via a mobile app
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Sonova AG
High Frequency Sensorineural Hearing Loss
Hybrid L24 New Enrollment Post Approval Study
This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.
- Trial name
- HNE (NCT02379819)
- Testing
- Nucleus Hybrid L24 Implant
- Where
- 19 sites in United States
- Volunteers
- 52 people
- Sponsor
- Cochlear
Hearing Loss
Safety and Effectiveness of the MED-EL Electric-Acoustic System
The purpose of this investigation is to demonstrate the safety and effectiveness of the MED-EL Electric-Acoustic System (EAS), a medical device that combines the use of a cochlear implant with an external electric-acoustic…
- Trial name
- EAS (NCT00747435)
- Testing
- Electric Acoustic System
- Where
- 14 sites in United States
- Volunteers
- 73 people
- Sponsor
- Med-El Corporation
Cochlear Hearing Loss
Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation
This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound…
- Trial name
- NCT06301568
- Where
- Germany
- Volunteers
- 55 people
- Sponsor
- Advanced Bionics AG
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
Benefits of Assistive Listening Device for Speech Intelligibility
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using…
- Trial name
- NCT05072470
- Testing
- Roger microphone, Phonak Audeo hearing aid
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Sonova AG
Hearing Loss, Sensorineural
Quality Control of CE-Certified Phonak Hearing Aids - 2018_07
Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner.
- Trial name
- NCT03555084
- Testing
- Extension of Virto B-Titanium, Virto B-Titanium
- Where
- Switzerland
- Volunteers
- 16 people
- Sponsor
- Sonova AG
Hearing Loss
Venting Effects on Speech Performance
This study aims to gather behavioral data on the effect of earmold venting on speech performance in noise with a new noise reduction feature.
- Trial name
- NCT06712693
- Testing
- Phonak Audeo Infinio Hearing Aid
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Sonova AG
Conductive Hearing Loss
Comparison of a New Bone Conduction Hearing System to a Osteo-integrated Bone Conduction Hearing Aid on a Softband
Main objectives The first main objective is to evaluate the non-inferiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of average tonal gain.
- Trial name
- NCT03541967
- Testing
- ADHEAR and PONTO 3 SUPER POWER on softband hearing aids
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
Hearing Impairment
Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients
This investigation is a single-centre, prospective, single-arm, post-market, non-interventional, pilot clinical investigation designed to characterize microphone sensitivity and maximum stable gain of the Cochlear Carina System.
- Trial name
- CAMSEN (NCT04271761)
- Testing
- Non-interventional, post-market, pilot study of Carina Cochlear System
- Where
- Portugal
- Volunteers
- 14 people
- Sponsor
- Cochlear
Hearing Loss
Quality Control of CE-Certified Phonak Hearing Aids - 2020_43
Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner.
- Trial name
- NCT04723173
- Testing
- Feature for noise reduction (on), Feature for noise reduction (off)
- Where
- Switzerland
- Volunteers
- 10 people
- Sponsor
- Sonova AG
Hearing Loss, Sensorineural, Cochlear Implant
Remote Support for Cochlear Implant Recipients: Evaluation of the HearCare MED-EL App
This clinical investigation intends to assess safety and performance of the HearCare MED-EL App, a remote care option for recipients of MED-EL cochlear implants
- Trial name
- HCARE (NCT06543953)
- Testing
- HearCare MED-EL App
- Where
- 3 sites in Germany
- Volunteers
- 120 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk Hepatoblastoma
A Compassionate Use Program to Provide Access to Sodium Thiosulfate
This is a CUP which is designed to provide treatment access of STS to pediatric patients for the protection from Cisplatin-Induced Hearing Loss in children who had standard-risk hepatoblastoma.
- Trial name
- NCT04132882
- Testing
- Sodium Thiosulfate (STS)
- Where
- Turkey (Türkiye)
- Sponsor
- TRPHARM
Speech Intelligibility in Noise
Study of a Signal-processing Algorithm Aiming at Improving Speech-in-noise Intelligibility in Normal-hearing and Hearing-impaired Persons
Nearly half a billion people suffer from disabling hearing loss. The most common form of hearing loss in adults is age-related hearing loss (ARHL), which causes a reduced ability to understand speech in noisy environments.
- Trial name
- AUDIOCAP 1 (NCT04775810)
- Testing
- The device is an algorithm designed to enhance speech intelligibility of speech-in-noise signals
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Archean Technologies