Clinical trials: Sensori-Neural Deafness
Conductive Hearing Loss, Mixed Hearing Loss
Post-Market Registry Study for Vibrant Hearing Solutions
This observational registry collects retrospective and prospective, data from children and adults who use CE-marked MED-EL implantable (PMEI, BCI, or AMEI) or non-implantable (BCD) hearing solutions as part of routine care.
- Conditions
- Conductive Hearing Loss, Mixed Hearing Loss, Sensorineural Hearing Loss, Single Sided Deafness
- Trial name
- NCT07906314
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Alport Syndrome
Alport Syndrome Treatments and Outcomes Registry
ASTOR's primary purpose is to enroll families and patients with a history of Alport syndrome in a central registry. The information we gather will be used as a basis for studies designed to test potential treatments for Alport…
- Trial name
- ASTOR (NCT00481130)
- Where
- United States
- Volunteers
- 655 people
- Sponsor
- University of Minnesota
Sudden Sensorineural Hearing Loss (SSNHL)
Intratympanic Injection of Dexamethasone With Hyaluronic Acid in Treatment of Sudden Sensorineural Hearing Loss
To evaluate efficacy of intratympanic injection of dexamethasone and hyaluronic acid mixture as a treatment modality in cases of sudden sensorineural hearing loss (SSNHL).
- Trial name
- NCT06878599
- Testing
- Hyaluronic Acid (HA), Dexamethasone
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Assiut University
Mild to Moderate Sensorineural Hearing Loss
Study of SelfFit Mobile Medical App for Hearing Loss Diagnostics and Hearing Device Fitting / Fine Tuning
The purpose of this clinical study is to validate the comparability of prescription formula fitting of hearing aids based on full diagnostic audiometry and SelfFit interactive fitting of hearing aids based on hearing loss…
- Trial name
- SelfFit (NCT01877317)
- Testing
- SelfFit adjusted hearing device
- Where
- Netherlands
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Two Pi Signalprocessing Applications GmbH
Severe Unilateral Sensorineural Hearing Loss
Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss
Do adults and children over 7 years of age with unilateral or assymetric hearing loss benefit from cochlear implantation on the worst hearing side.
- Trial name
- CI and SSD (NCT02105441)
- Testing
- Cochlear implant
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Mayo Clinic
Hearing Loss, Sudden
Establishment of a Trans-round Window Inner Ear Continuous Drug Delivery System for the Treatment of Severe-to-profound Sudden Sensorineural Hearing Loss
The investigators enrolled patients with total sudden deafness who had failed treatment with systemic combined intra-dural hormone injections.
- Trial name
- NCT05455398
- Testing
- Surgical treatment of round window niche enlargement via round window for inner ear drug delivery, Drum chamber drug injection
- Where
- China
- Volunteers
- 218 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe
Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users
On June 23, 2021, the Oticon Medical Neuro Cochlear Implant System (NCIS) was granted premarket approval (PMA) in the US to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who…
- Conditions
- Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe, Sensorineural Hearing Loss, Profound
- Trial name
- PACIFIC (NCT05154188)
- Testing
- Neuro Cochlear Implant system
- Volunteers
- 60 people
- Sponsor
- Oticon Medical
Sensorineural Hearing Loss, Bilateral
Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy
Main objective: Investigate on new cochlear implanted patients whether the FineHearing strategy of the MED-EL cochlear implant gives better results on musical perception if the depth of stimulation (stimulation or not of the…
- Trial name
- NCT04591093
- Testing
- FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated
- Where
- France
- Volunteers
- 32 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss, Cochlear, Cochlear Implantation
Post-Market Clinical Investigation of the IotaSOFT Insertion System
The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject
- Conditions
- Hearing Loss, Cochlear, Cochlear Implantation, Hearing Loss, Sensorineural
- Trial name
- ACE (NCT06664697)
- Testing
- Cochlear Implantation with Robotic-Assisted Insertion System
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- iotaMotion, Inc.
Sensorineural Hearing Loss, Bilateral Hearing Loss
Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants
This research study is evaluating two different methods of cochlear implant (CI) insertion - robotic-assisted insertion and manual insertion - to better understand how they affect hearing outcomes.
- Conditions
- Sensorineural Hearing Loss, Bilateral Hearing Loss, Cochlear Implantation, Hearing Disorders
- Trial name
- NCT07081542
- Testing
- IotaSoft Robotic Insertion System, Manual Cochlear Implant Insertion
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- AdventHealth
Congenital CMV Infection, Sensorineural Hearing Loss
Long-Term Outcomes of Children With Congenital CMV in New York State
PROACTIVE NYS is a long-term follow-up study of all infants who test positive for congenital Cytomegalovirus infection (CMV) throughout New York State on the Newborn Screen.
- Trial name
- PROACTIVE NYS (NCT06226558)
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Stony Brook University
Sudden Hearing Loss, Extracellular Vesicles
Study on the Safety and Efficacy of Intratympanic Injection of Small Extracellular Vesicles Derived From Mesenchymal Stem Cells in Severe and Profound Sudden Sensorineural Hearing Loss
The goal of this clinical trial is to learn if small extracellular vesicles derived from mesenchymal stem cells work to treat severe and above sudden sensorineural hearing loss.
- Trial name
- NCT07404709
- Testing
- Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at low doses, Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at moderate doses, Tympanic injection of hUC-MSC-sEV-003 (small extracellular vesicles) at high doses
- Where
- 5 sites in China
- Volunteers
- 9 people
- Sponsor
- The Affiliated Hospital of Qingdao University
Sensorineural Hearing Loss, Vestibular Hypofunction
Optimizing Cochlear Implant Laterality in Patients With Unilateral Vestibular Weakness
In patients with symmetric hearing loss who meet traditional cochlear implant candidacy criteria yet demonstrate pre-operative unilateral vestibular weakness, the choice of which ear to implant may impact their post-operative…
- Trial name
- NCT07452653
- Testing
- Ipsilateral cochlear implantation in patients with unilateral vestibular hypofunction, Contralateral cochlear implantation in patients with unilateral vestibular hypofunction
- Volunteers
- 10 people
- Sponsor
- University of Virginia
Sensorineural Hearing Loss
The Effect of Sound Stimulation on Pure-tone Hearing Threshold
The purpose of this study is to investigate if sound stimulation could improve pure-tone hearing threshold. In the late 1990s, researchers discovered that acoustic stimuli slow progressive sensorineural hearing loss and exposure…
- Trial name
- NCT01184248
- Testing
- Sound stimulation
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Earlogic Korea, Inc.
Hearing Loss, Sensorineural
Investigating Electrical Categorical Loudness Scaling Using a Mobile Research App in Experienced Adult Cochlear Implant Participants
This clinical study will evaluate a feature of the investigational Nexus Research System used for programming cochlear implants.
- Trial name
- ELSA (NCT07077070)
- Testing
- Standard Electrical Categorical Loudness Scaling task (Standard-ELS), Fast Electrical Categorical Loudness Scaling task (Fast-ELS)
- Where
- 3 sites in United States, Belgium
- Volunteers
- 20 people
- Sponsor
- Cochlear
Bilateral Sensorineural Hearing Loss, Unilateral Sensorineural Hearing Loss
Pupillometry Techniques Usage to Quantify the Programming Parameters Effect in the Auditory Effort in Zti Opticon Cochlear Implant Adult Users
The aim of this study is to establish the connection between the cochlear implant programming parameters with the auditory effort associated with the speech perception evaluated by pupillometry techniques in different audiometric…
- Trial name
- NCT05300230
- Testing
- Neuro Zti cochlear implant and Neuro 2 sound processor
- Where
- Spain
- Volunteers
- 25 people
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sensorineural Hearing Loss (Disorder)
Single-sided Deafness and Cochlear Implants
As the left and right hemisphere are specialized for different auditory tasks, the proposed study aims at demonstrating different consequences of right or left-sided deafness for the affected individual.
- Trial name
- NCT01749592
- Testing
- cochlear implant
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- University of Zurich
Cmv Congenital, CMV
Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants
The overall goal of this study is to determine the clinical benefit and safety of antiviral therapy for asymptomatic congenital cytomegalovirus (cCMV) infected hearing-impaired infants.
- Conditions
- Cmv Congenital, CMV, Congenital Cmv, SNHL
- Trial name
- ValEAR (NCT03107871)
- Testing
- Valganciclovir, Simple Syrup
- Where
- 30 sites in United States
- Volunteers
- 10 people
- Sponsor
- Albert Park
Meniere's Disease, Meniere Disease
Expanded Access Protocol for SPI-1005
The purpose of this protocol is to facilitate expanded access ("compassionate use") of SPI-1005 to Meniere's disease (MD) or sudden sensorineural hearing loss (SSNHL) patients who cannot gain access through ongoing clinical…
- Conditions
- Meniere's Disease, Meniere Disease, Meniere´s Disease, Meniere's Disease Aggravated
- Trial name
- NCT07873281
- Testing
- Ebselen
- Sponsor
- Sound Pharmaceuticals, Incorporated
Congenital Hearing Loss Secondary to Biallelic Mutations in the Otoferlin Gene (OTOF), Biallelic Mutations in the Gap Junction Beta 2 (GJB2) Gene
A Natural History Study in Pediatric Participants With Hearing Loss Due to OTOF, GJB2, or GJB2/GJB6 Mutations
This is an observational study to examine the characteristics of gene-related hearing loss in pediatric participants with biallelic otoferlin (OTOF) Mutations, Gap Junction Beta 2 (GJB2) Mutations, or Digenic GJB2/Gap Junction…
- Conditions
- Congenital Hearing Loss Secondary to Biallelic Mutations in the Otoferlin Gene (OTOF), Biallelic Mutations in the Gap Junction Beta 2 (GJB2) Gene, Digenic Mutations in GJB2/Gap Junction Beta 6 (GJB6) Genes
- Trial name
- ENSEMBLE (NCT06019481)
- Where
- 2 sites in United States
- Sponsor
- Regeneron Pharmaceuticals