Clinical trials: Otologic Disease
Hearing Loss
Quality Control of CE-Certified Phonak Hearing Aids - 2016_05
A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of hearing participants to grant quality control prior to product launch.
- Trial name
- NCT02951247
- Testing
- Hearing Aid
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- Sonova AG
Acute Otitis Media (AOM)
Safety and Efficacy of wSp Vaccine in Young Children
The goal of this clinical trial is to evaluate whether the wSp vaccine can prevent nasopharyngeal colonization by pneumococcal bacteria in healthy young children who have received routine PCV15 or PCV20 vaccination.
- Trial name
- wSp005 (NCT07216430)
- Testing
- wSp vaccine, Saline (0.9% NaCl)
- Where
- 7 sites in United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Serum Life Science Europe GmbH
Hearing Loss
Intracochlear Potentials: Volta Study
Collection of normative voltage tomography data during and/or immediately after electrode insertion into the cochlea using Surgical Assistant (SA16) research software and postoperatively at activation, three and twelve months…
- Trial name
- CLTD5663 (NCT02852330)
- Testing
- SA16 research software, CS19 (1.6.2)
- Where
- 2 sites in Australia
- Volunteers
- 20 people
- Sponsor
- Cochlear
Otitis Media
Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media
Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media
- Trial name
- NCT00768534
- Where
- Germany
- Volunteers
- 2,138 people
- Sponsor
- Pfizer
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
Hearing Impairment, Hearing Loss
My Hearing Experience - a Study About the Effect of Personality and Lifestyle on Everyday Hearing
The primary purpose of this study is to investigate how personality, motivation \& auditory lifestyle relate to hearing aid satisfaction \& acceptance for first-time hearing aid users.
- Trial name
- NCT05465564
- Where
- Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- WSAUD A/S
Unilateral Hearing Loss
Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness
The purpose of this study is to determine the safety and efficacy of using bone conduction via the teeth to treat Single-Sided Deafness (SSD).
- Trial name
- NCT00977314
- Testing
- The Sonitus Bone Conduction Hearing System, SoundBite, SoundBite Hearing System
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Sonitus Medical Inc
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, Conductive, Hearing Loss, Mixed
Evaluation of the Baha SoundArc in Pediatric Patients
The purpose of this study is to gather clinical performance data on the Baha SoundArc
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral
- Trial name
- NCT03333577
- Testing
- SoundArc
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- Cochlear
Hearing Loss
AutoFocus360 Sound Quality Preference and Claims Study
This study aims to generate clinical evidence to substantiate performance claims for the AutoFocus 360 feature in Sonova hearing aid products.
- Trial name
- AF360 (NCT07224919)
- Testing
- AutoFocus 360, Fixed directional microphone
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Jonathan Vaisberg
Hearing Loss, Hearing Impairment
Performance and Effectiveness of a Self-fitting Over-the-counter Hearing Aid
Hearing loss significantly affects quality of life, with sensorineural hearing loss being the most common type among adults. Hearing aids are a proven intervention, yet barriers like access and affordability limit their adoption…
- Trial name
- Lexie (NCT06942325)
- Testing
- OTC self-fitting hearing aid, Prescription hearing aid
- Sponsor
- HearX SA
Tinnitus, Subjective, Cupping Therapy
Wet Cupping Therapy as an Integrative Medicine Treatment for Subjective Tinnitus
Cupping therapy is an ancient complementary medicine therapy. It was a cornerstone in many ancient healing systems, including Traditional Chinese Medicine, Unani Medicine, Traditional Korean Medicine, and Islamic Medicine.
- Trial name
- NCT07685171
- Testing
- Wet Cupping Therapy plus Usual care, usual care only
- Volunteers
- 142 people
- Sponsor
- Hamad Medical Corporation
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, Bilateral Hearing Loss
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting
Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.
- Trial name
- NCT05955469
- Testing
- FS4 then TFS4 (cochlear implant), TFS4 then FS4 (cochlear implant)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Severe to Profound Hearing Loss
Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants.
This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized.
- Trial name
- BELPS (NCT07777562)
- Testing
- Cochlear implantation
- Where
- Switzerland
- Volunteers
- 700 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Tinnitus, Hearing Loss, Bilateral or Unilateral
Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss
This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software.
- Conditions
- Tinnitus, Hearing Loss, Bilateral or Unilateral, Normal Hearing
- Trial name
- TINIS (NCT06641999)
- Testing
- Tinnitus Implant System
- Where
- 2 sites in Belgium, Netherlands
- Volunteers
- 16 people
- Sponsor
- Cochlear
Hearing Loss
A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid
The aim of this study is to investigate the performance of the hearing aid under laboratory as well as everyday conditions. In addition, the performance data of the hearing aid are compared with a Bernafon hearing aid already…
- Trial name
- NCT03086018
- Testing
- Successor hearing aid to Juna
- Where
- Switzerland
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bernafon AG
Hearing Loss, Ear Diseases
Baseline Performance and Fitting Parameters for Sonova Products
The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.
- Conditions
- Hearing Loss, Ear Diseases, Hearing Disorders, Otolaryngological Disease
- Trial name
- NCT05859568
- Testing
- Pinna-located microphone, Pinna-simulated microphone algorithm
- Where
- United States
- Volunteers
- 20 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
Acute Otitis Media (AOM)
V114 and Acute Otitis Media (V114-032/PNEU-ERA)
The primary objective is to evaluate V114 in the prevention of vaccine-type acute otitis media (VT-AOM) and the safety of V114 with respect to the proportion of participants with serious adverse events (SAEs) through completion…
- Trial name
- NCT04193215
- Testing
- V114, Pediatric vaccines
- Where
- 13 sites in Thailand
- Volunteers
- 7,119 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC