Clinical trials: Middle Ear Disease
Middle Ear Disease
Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts
Prospectively analyze the use of 3D subtraction CAD/CAM in the operating room environment. Study participants, requiring middle ear surgery and ossicular reconstruction, will be implanted with one of two middle ear implants.
- Trial name
- NCT03297736
- Testing
- 3D CAD/CAM autograft prosthesis, Control device
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Nitinetics LLC
Tinnitus
Sub-chronic Neurostimulation Delivered in the Middle Ear for Tinnitus Suppression
The objectives of this study are to evaluate the safety and efficacy of applying electrical stimulation on the promontorium (EPS) for the suppression of tinnitus in a sub-chronic stimulation regimen.
- Trial name
- NCT01549145
- Testing
- Nimbus Multifunctional Stimulator
- Where
- Israel
- Volunteers
- 14 people
- Sponsor
- EstimME Ltd.
Otitis Media, Middle Ear Infections
Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube Device
The purpose of this project is to collect information from the doctor notes about the use of the device, to monitor the tubes after surgery, and collect information from patients and parents/guardians about their views on the…
- Trial name
- NCT07029997
- Testing
- Solo+ Tympanostomy Tube Device (Solo+ TTD)
- Where
- Italy
- Volunteers
- 160 people
- Sponsor
- AventaMed DAC
Otitis Media
A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat
The purpose of the study is to assess the rate of elimination of bacteria by levofloxacin in middle ear fluid of children with a rapid and severe onset of infection and inflammation of the middle ear who are at high risk for…
- Trial name
- NCT00044473
- Testing
- levofloxacin
- Volunteers
- 206 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Mixed Hearing Loss
Long Term Results With the Vibrant Soundbridge in Patients With Mixed Hearing Loss: a 60-month Longitudinal Study
Vibrant Soundbridge (VSB, MED-EL, Innsbruck) Active middle ear implants (AMEI) can benefit patients who are unable to use conventional hearing aids (HA) due to medical reasons, discomfort or unsuccessful rehabilitation.
- Trial name
- NCT05793580
- Testing
- Vibrant Soundbridge active middle ear implant
- Where
- France
- Volunteers
- 31 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Acute Otitis Media
Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
The purpose of this study is to determine if the combination of DF289 plus DF277 is safe and effective in treating middle ear infections in children with ear tubes.
- Trial name
- NCT01395966
- Testing
- DF289, DF277, DF289 plus DF277
- Where
- Spain
- Volunteers
- 331 people
- Sponsor
- Salvat
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.
Bone Conduction Deafness, Unilateral Deafness
Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)
The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and…
- Conditions
- Bone Conduction Deafness, Unilateral Deafness, Middle Ear Deafness, Mixed Hearing Loss
- Trial name
- NCT03281967
- Testing
- Minimally Invasive Ponto Surgery
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Oticon Medical
Bone Conduction Deafness, Unilateral Deafness
Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration
The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and…
- Conditions
- Bone Conduction Deafness, Unilateral Deafness, Middle Ear Deafness, Mixed Hearing Loss
- Trial name
- NCT03807713
- Testing
- Minimally Invasive Ponto Surgery
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Oticon Medical
Hearing Disorders
Middle-ear Reflex Testing Using Wideband Acoustic Immittance
This project will assess the middle-ear muscle reflex using wideband acoustic immittance which is a valuable method for evaluating infants, children, and adults.
- Trial name
- WAI-MEMR (NCT04875637)
- Testing
- WAI-MEMR
- Where
- United States
- Volunteers
- 326 people, healthy volunteers welcome
- Sponsor
- Mimosa Acoustics
Acute Otitis Media
Study to Compare Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01007)
Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops.
- Trial name
- NCT02074007
- Testing
- AR01
- Where
- 21 sites in United States
- Volunteers
- 178 people
- Sponsor
- Arbor Pharmaceuticals, Inc.
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
Otitis Media With Effusion
A Non-invasive Device to Remove Fluid From the Middle Ear
A feasibility study for evaluating efficacy and satisfaction is treated using a non-invasive device for middle ear ventilation. The study is designed to test the device's effectiveness by encouraging the evacuation of fluid from…
- Trial name
- NCT03978195
- Testing
- Non-invasive device for middle ear ventilation
- Volunteers
- 40 people
- Sponsor
- Yuinvent Innovations Ltd.
Pre-existing Condition
PMEI Post-Market Clinical Follow-Up
Confirm safety and performance of passive middle ear implants (PMEIs) in subjects with pre-existing condition which made the implantation of a MED-EL PMEI necessary
- Trial name
- NCT05565339
- Testing
- PMEIs
- Where
- 11 sites in Austria, Germany and 1 more
- Volunteers
- 497 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Disorder of Middle Ear, Otosclerosis of Middle Ear
Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively
Feasibility of the objective measurement of the ossicular chain mobility, by using a force-measuring device based on a fiber optics sensors (PalpEar).
- Conditions
- Disorder of Middle Ear, Otosclerosis of Middle Ear, Cholesteatoma, Middle Ear
- Trial name
- PalpEar (NCT02554422)
- Testing
- PalpEar
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sensoptic SA
Otitis Media With Effusion, Middle Ear Effusion
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
The study has three objectives: 1. To determine if the device can detect if middle ear fluid is present in children who are scheduled for tube placement (myringotomy) 2.
- Trial name
- NCT01421199
- Testing
- Myringotomy
- Volunteers
- 125 people
- Sponsor
- OtoSonics Inc.
Hearing Loss
Evaluation of New Feedback Canceller for Carina™ Implant
The purpose of this study is to evaluate audio quality benefit for the patient implanted with a Cochlear or Otologics Carina implant with the new firmware (feedback canceller algorithm) whatever the patient environment is and to…
- Trial name
- NCT02309541
- Testing
- feedback canceller algorithm (Firmware)
- Where
- 3 sites in France
- Volunteers
- 12 people
- Sponsor
- Cochlear
Hearing Loss, Partial Deafness
Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness
The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with…
- Conditions
- Hearing Loss, Partial Deafness, Hearing Disorders, Ear Diseases
- Trial name
- NCT02189798
- Testing
- HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode, EAS sound processor
- Where
- 11 sites in United States
- Volunteers
- 67 people
- Sponsor
- Advanced Bionics
Acute Otitis Media
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating middle ear infections in children with ear tubes.
- Trial name
- NCT01404611
- Testing
- DF289, DF277, DF289 plus DF277
- Where
- Spain
- Volunteers
- 331 people
- Sponsor
- Salvat
Otitis Media, Otitis Media With Effusion
Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media
The aim of this study is to assess in France the impact of Prevenar on the possible evolution of the pneumococcal serotypes distribution and antibiotic resistance in NP samples of children with AOM.
- Conditions
- Otitis Media, Otitis Media With Effusion, Pneumococcal Infections
- Trial name
- NCT00195611
- Testing
- Prevenar
- Where
- 35 sites in France
- Volunteers
- 3,293 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer