Clinical trials: Hearing Impairment, Conductive
Hearing Loss, Conductive Hearing Loss
Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
The purpose of this study is to in a proactive manner collect high quality data from a pediatric patients who have undergone a bone anchored hearing solution, using the Ponto BHX implant, in clinical practice.
- Conditions
- Hearing Loss, Conductive Hearing Loss, Atresia
- Trial name
- NCT03723161
- Testing
- Bone Achored Hearing surgery
- Where
- Sweden
- Volunteers
- 15 people
- Sponsor
- Oticon Medical
Otosclerosis, Tympanic Membrane Perforation
Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease
We study audiometric parameters including Transient Otoacoustic emissions, pure-tone audiometry for air- and bone-conduction, and spondaic speech recognition thresholds for air- and bone conduction in a pre- and postoperative…
- Trial name
- NCT00222417
- Testing
- myringoplasty, Stapes surgery
- Where
- Norway
- Sponsor
- University Hospital of North Norway
Hearing Loss, Conductive, Hearing Loss, Mixed
Expanded Indications in the Pediatric BONEBRIDGE Population
This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.
- Trial name
- NCT05615649
- Testing
- MED-EL BONEBRIDGE Bone Conduction Implant
- Where
- 6 sites in United States
- Volunteers
- 36 people
- Sponsor
- Med-El Corporation
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
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
Otitis Media, Conductive Hearing Loss
Hearing for Learning Initiative - a Health Facilitator Model for Otitis Media
The Hearing for Learning Initiative is a stepped-wedge cluster randomised controlled trial. The HfLI will implement and rigorously evaluate an innovative community-based service-enhancement model of ear and hearing health, in…
- Trial name
- HfLI (NCT03916029)
- Testing
- facilitator
- Where
- 20 sites in Australia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Menzies School of Health Research
Conductive Hearing Loss
Quality of Life With Bone Conduction Hearing Device
The aim of this study is to compare the audiological and quality of life performance patients have with an ADHEAR (adhesive bone conduction device) compared to no hearing device.
- Trial name
- NCT03864731
- Testing
- Bone conduction device (ADHEAR)
- Where
- Austria
- Volunteers
- 24 people
- Sponsor
- Medical University of Vienna
Conductive Hearing Loss
Audiological Benefit and Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Contact Mini
Patients with conductive hearing loss fitting the inclusion criteria will be asked to participate in the study. All subjects will be randomized to wear either first the adhesive or the conventional bone conduction hearing aid.
- Trial name
- NCT03746548
- Testing
- Adhear, Contact Mini (CM)
- Where
- Austria
- Volunteers
- 13 people
- Sponsor
- Dominik Riss
Hearing Impairment, Conductive, Hearing Impaired Children
Single-stage Surgery Using the BHX Implant
Over the last few decades, the classical two-stage surgical procedure for inserting bone-anchored hearing implants (BAHIs) has been modified in adults into a single-stage procedure.
- Trial name
- NCT04039802
- Testing
- Single-stage surgery, Two-stage surgery
- Where
- Netherlands
- Volunteers
- 70 people
- Sponsor
- Radboud University Medical Center
Hearing Loss, Conductive, Hearing Loss, Mixed
Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid
The study is a combined retrospective (fitting visit) and prospective (study visit), multi-center, single arm study The study is part of the Post Market Clinical Follow (PMCF) activity.
- Trial name
- NCT04761926
- Testing
- Audiometry
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Oticon Medical
Secretory Otitis Media
A Comparison of Surgical and a New Non-Surgical Treatment Methods for Secretory Otitis Media in Children
Secretory otitis media (SOM) or middle ear effusion is a common finding affecting children in the age of 4-5 years. It is usually associated with 5-15 deci Bells hearing loss.
- Trial name
- NCT02546518
- Testing
- Moniri Otovent, Tympanostomy tube in the ear drum
- Where
- Sweden
- Volunteers
- 80 people
- Sponsor
- Vastra Gotaland Region
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
Mixed Hearing Loss, Single-Sided Deafness
Osia 2 Pediatric Expansion Study
The CochlearTM Osia®2 System was cleared by the Food and Drug Administration November 15, 2019 (K191921) for individuals aged 12 years and older who present with conductive or mixed hearing loss (up to 55 dB HL) or…
- Conditions
- Mixed Hearing Loss, Single-Sided Deafness, Conductive Hearing Loss
- Trial name
- NCT05000931
- Testing
- Osia 2 System
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cochlear
Conductive Hearing Loss, Single Sided Deafness
Use of ADHEAR, a Non-Implantable Bone Conduction Hearing System, in Children With Single Sided Deafness and/or Conductive Hearing Loss
A hearing loss affects the quality of life and the natural development of children. The new generation of hearing devices provides a huge number of options to them.
- Trial name
- NCT03327194
- Testing
- ADHEAR Audio Processor
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- Queen Fabiola Children's University Hospital
Chronic Otitis Media With Effusion, Conductive Hearing Loss
Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled Study
The purpose of our double-blind, placebo controlled study is to test the hypothesis that montelukast therapy might be associated with improved hearing in certain sub populations of children suffering from OME.
- Trial name
- COME (NCT01967498)
- Testing
- Montelukast
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Tel-Aviv Sourasky Medical Center
Hearing Loss, Hearing Disorders in Children
Preschool Hearing Screening
Children who are deaf or hard-of-hearing (D/HH) are at risk of speech and language delays, which can be mitigated through early identification and intervention.
- Conditions
- Hearing Loss, Hearing Disorders in Children, Hearing Loss, Sensorineural, Hearing Loss, Conductive
- Trial name
- NCT06058767
- Testing
- Otoacoustic Emissions Testing, Pure Tone Audiometry
- Where
- United States
- Volunteers
- 13,764 people
- Sponsor
- University of California, San Francisco
Conductive Hearing Loss, Mixed Hearing Loss
Evaluation of Sound Processor for a Transcutaneous System
A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and speech intelligibility and…
- Trial name
- NCT03374787
- Testing
- Fusion Sound Processor
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Oticon Medical
Bone Conduction Deafness, Hearing Loss, Conductive
Audiological Benefit and Improved Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Bonebridge in Experienced Users
Patients implanted with a Bonebridge will be asked to be part of the study. The study subjects are enrolled into the study according to inclusion criteria.
- Trial name
- NCT03766152
- Testing
- Adhesive bone conduction hearing aid (ADHEAR - Med El)
- Where
- Austria
- Volunteers
- 19 people
- Sponsor
- Dominik Riss
Hearing Loss, Conductive, Hearing Loss, Mixed
Evaluating the Safety of BONEBRIDGE Implants in Children Under Five Years Old: This Study Looks at Children Under Five Who Got BONEBRIDGE BCI 602 Implants. It Collects Information on Any Problems With the Device or the Surgery to See if it is Safe Within the First Year After the Operation.
This study, titled "The BONEBRIDGE in Children Under Five: Premarket Clinical Investigation" (Study ID 2023BB006), looks at kids under five who have received the BONEBRIDGE BCI 602 hearing implant.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Children Under 5 Years
- Trial name
- 2023BB006 (NCT06634784)
- Testing
- Bone Conduction Implant (BCI)
- Where
- 2 sites in Germany
- Volunteers
- 9 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss, Conductive
Remote Microphone (RM) - A Comparative Study
The purpose of this investigation is to evaluate objective outcomes in pediatric bone conduction hearing device (often termed "BAHA") users with and without remote microphone (RM) technology.
- Trial name
- NCT04147611
- Testing
- BAHA, Wireless Audio Streaming Accessory, Digital Adaptive RM System
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- University of Miami