Clinical trials: Otologic Disease
Hearing Loss
AM-111 in the Treatment of Acute Inner Ear Hearing Loss
The purpose of this research study is to test the effectiveness and safety of the study drug, AM-111. AM-111 is tested for the treatment of sudden sensorineural hearing loss where the cause is unknown.
- Trial name
- HEALOS (NCT02561091)
- Testing
- AM-111 0.4 mg/ml, AM-111 0.8 mg/ml
- Where
- Bulgaria
- Volunteers
- 256 people
- Sponsor
- Auris Medical AG
Hearing Loss
Sound Processing Innovations in Adult and Paediatric Cochlear Implant Recipients.
This is a feasibility, prospective with sequential enrolment, multicenter, clinical investigation in adults and paediatrics with a CE approved Nucleus cochlear implant. Subjects older than 5 years will be included.
- Trial name
- NCT05476328
- Testing
- SPACE, OPAL-SPACE, ACE
- Where
- 5 sites in Australia, Belgium
- Volunteers
- 8 people
- Sponsor
- Cochlear
Unilateral Deafness
Evaluation of BiCROS Fitting Benefits
22 candidates for BiCROS hearing aids will be recruited and fitted with a hearing aid and a CROS device. Following a real-world trial, each participant will be tested on a range of outcome measures including speech recognition in…
- Trial name
- NCT05379231
- Testing
- Hearing aid fitting
- Where
- 2 sites in Canada
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Sonova AG
Hearing Loss
Clinical Validation of the Lexie Lumen Hearing Aid
More than half a billion people globally have hearing loss. Most hearing loss is sensorineural, meaning that the hearing loss is irreversible and requires rehabilitation.
- Trial name
- NCT05337748
- Testing
- Lexie Self Test and Fit Group, Lexie Professional Test and Fit Group
- Where
- South Africa
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- hearX Group
Retinitis Pigmentosa, Usher Syndrome Type 2
Study to Evaluate the Efficacy Safety and Tolerability of QR-421a in Subjects With RP Due to Mutations in Exon 13 of the USH2A Gene With Early to Moderate Vision Loss (Celeste)
The purpose of this study is to evaluate the efficacy safety and tolerability of QR-421a administered via intravitreal injection (IVT) in subjects with Retinitis Pigmentosa (RP) due to mutations in exon 13 of the USH2A gene with…
- Conditions
- Retinitis Pigmentosa, Usher Syndrome Type 2, Deaf Blind, Retinal Disease
- Trial name
- NCT05176717
- Testing
- QR-421a
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 5 people
- Sponsor
- Laboratoires Thea
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
A Monocentric Study Evaluating Pupillometry as an Objective Measurement for CI Fittings
This trial is a monocentric, prospective and controlled study of the pupil response to detect hearing threshold and comfortable loudness of normal-hearing (NH) and CI-subjects.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Cochlear Hearing Loss, Hearing Loss, Cochlear
- Trial name
- PupillOM (NCT05586555)
- Testing
- Pupillometry (Eve-tracking measurements)
- Where
- France
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Oticon Medical
Central Nervous System (CNS) Lesions, Brain Metastases
Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent
This Phase 2 clinical trial will study RVP-001, a new manganese-based MRI contrast agent, in people who are known to have gadolinium-enhancing central nervous system (CNS) lesions, for example brain tumors or multiple sclerosis.
- Conditions
- Central Nervous System (CNS) Lesions, Brain Metastases, Brain Neoplasms, Brain Neoplasms, Benign
- Trial name
- NCT06322342
- Testing
- RVP-001
- Where
- 5 sites in United States
- Volunteers
- 18 people
- Sponsor
- Reveal Pharmaceuticals Inc.
Infections, Streptococcal, Streptococcus Pneumoniae
Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease
The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A), administered according to different vaccination schedules, against invasive disease caused by S.
- Trial name
- FinIP (NCT00861380)
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine), GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)
- Where
- Finland
- Volunteers
- 41,188 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Conductive Hearing Loss, Mixed Hearing Loss
Clinical Survey of Oticon Medical Healing Cap
This study investigates the use of a new healing cap which, through altered design and choice of material, has been improved when it comes to minimizing the risk of it falling off as well as increasing patient comfort.
- Conditions
- Conductive Hearing Loss, Mixed Hearing Loss, Unilateral Partial Deafness
- Trial name
- NCT02274129
- Testing
- Healing cap II
- Where
- 2 sites in Denmark
- Volunteers
- 32 people
- Sponsor
- Oticon Medical
Neurofibromatosis Type 2
Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas
This is a two-staged, Phase 2/3, randomized, multi-center study to investigate the efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas.
- Trial name
- POPLAR-NF2 (NCT05130866)
- Testing
- REC-2282
- Where
- 15 sites in United States, United Kingdom
- Volunteers
- 25 people
- Sponsor
- Recursion Pharmaceuticals Inc.
Tinnitus
The Akloma Tinnitus Patch in Patients With Manifested Tinnitus
OBJECTIVES: Primary Objective The primary objective will be a decrease of inconvenience with at least 10% for at least 50% of the subjects.
- Trial name
- Aktin (NCT01226108)
- Testing
- Patch
- Where
- Sweden
- Volunteers
- 16 people
- Sponsor
- Akloma Bioscience AB
Sensorineural Hearing Loss, Tinnitus
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
The purpose of this study is to investigate the degree of benefit to tinnitus symptoms by using a Totally Implantable cochlear implant (TICI) in a group of patients who have moderate-to-severe tinnitus pre-operatively.
- Trial name
- EXCITE (NCT07893860)
- Testing
- Cochlear implant
- Where
- Spain
- Volunteers
- 14 people
- Sponsor
- Cochlear
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.
Hearing Loss
Evaluation of Novel Noise Reduction Principles in Hearing Instruments
In the study, the speech intelligibility in noise (Outcome) between a novel noise reduction algorithm (Intervention) versus the standard noise reduction (Comparator) will be tested in adults with a N3-N4 hearing loss (Population)…
- Trial name
- NCT05582408
- Testing
- Measures of Standard Noise Reduction NR1, Measures of Noise Reduction Principle NR2, Measure of Noise Reduction Principle NR3
- Where
- Germany
- Volunteers
- 26 people
- Sponsor
- Sonova AG
Acute Otitis Media
A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
The purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.
- Trial name
- NCT00578474
- Testing
- Moxidex otic solution, Ofloxacin otic solution, Tympanostomy tubes
- Volunteers
- 911 people
- Sponsor
- Alcon Research
Hearing Loss
Exploration of the Functional Effect of Modified Gain Precalculation on Soft Speech Intelligibility
An exploratory investigation of gain precalculation principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants.
- Trial name
- NCT07388784
- Testing
- Competitor device, hearing aid with standard gain precalculation principle, Hearing aid with gain precalculation principle 1, Hearing aid with gain precalculation principle 2
- Where
- Switzerland
- Volunteers
- 14 people
- Sponsor
- Sebastian Griepentrog
Otitis Media With Effusion
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
- Trial name
- NCT01949155
- Testing
- OTO-201
- Where
- United States
- Volunteers
- 266 people
- Sponsor
- Otonomy, Inc.
Hearing Loss
Hearing Aid Transmitter Performance Study - SRF-366
Sonova 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
- NCT04774185
- Testing
- New hearing aid loudspeaker, Standard hearing aid loudspeaker
- Where
- Australia
- Volunteers
- 23 people
- Sponsor
- Sonova AG
Conductive Hearing Loss, Middle Ear
Ossiview Normative Mobility Data Collection Protocol
The goal of this observational study is to learn about the sound-induced vibration level of certain structures in the middle ear in the normal-hearing population.
- Trial name
- NCT06310278
- Testing
- Ossicular mobility measurement
- Where
- Canada
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Audioptics Medical Incorporated
Sensorineural Hearing Loss, Bilateral, Cochlear Implants
Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults.
This clinical investigation aims to collect data on the use of the Mi2000 system, a totally implantable cochlear implant system, for the first time in human subjects.
- Trial name
- TICI (NCT04571333)
- Testing
- Mi2000 Totally Implantable Cochlear Implant
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 6 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH