Clinical trials: Conductive Hearing Loss
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
Hearing Loss, Hearing Loss, Conductive
The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study
The Bonebridge system using the BCI 601 is marketed since 2012. Previous prospective, multi-center, non-randomized studies on the BCI 601 Bonebridge performed in adult and paediatric populations have shown a significant…
- Conditions
- Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral
- Trial name
- NCT04427033
- Testing
- Bone Conduction Implant
- Where
- 8 sites in Austria, Germany and 1 more
- Volunteers
- 52 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Tympanic Membrane Perforation, Conductive Hearing Loss
Outcomes of Cartilage Tympanoplasty in Children
This study evaluates the anatomical and hearing outcomes of cartilage tympanoplasty in pediatric patients with chronic tympanic membrane perforations.
- Conditions
- Tympanic Membrane Perforation, Conductive Hearing Loss, Chronic Otitis Media
- Trial name
- NCT07866222
- Testing
- Cartilage Tympanoplasty
- Volunteers
- 35 people
- Sponsor
- Assiut University
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
The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents
This study is a post-market, multicentre, prospective, single arm investigation aimed to systematically collect safety and performance data on the Sentio system, when used as intended for adolescents (12-17 years inclusive).
- Trial name
- NCT06844071
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Oticon Medical
Hearing Loss, Conductive, Hearing Loss, Unilateral
Adhear Bone Conduction System
The purpose of this research study is to learn about the hearing outcomes of adult and pediatric patients who are treated with or are candidates for bone conductive devices (also termed "BAHA").
- Trial name
- NCT03533686
- Testing
- Adhear Bone Conduction System, Bone anchored hearing aid (BAHA)
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- University of Miami
Hearing Loss, Conductive, Hearing Loss, Mixed
Pediatric Expansion Study of the Sentio System
This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Single Sided Deafness
- Trial name
- BC119 (NCT06976086)
- Testing
- Active transcutaneous bone conduction system
- Where
- 8 sites in Netherlands, Spain and 1 more
- Volunteers
- 50 people
- Sponsor
- Oticon Medical
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
Conductive Hearing Loss, Unilateral
Surgical-Clinical Correlation in Unilateral Conductive Hearing Loss With Intact Tympanic Membrane
Unilateral conductive hearing loss (UCHL) in the presence of an intact tympanic membrane represents a diagnostic challenge in otologic practice.
- Trial name
- NCT07431125
- Testing
- Exporlation Tympanotomy
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Al-Azhar University
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
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
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
Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis), Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side
Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population
To study the initial experience with implanting and fitting a new Bone Conduction system in pediatric patient population with conductive, mixed or single-sided deafness.
- Trial name
- OSIA Pediatric (NCT03509974)
- Testing
- Osseointegrated Steady State Implant
- Where
- Canada
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Cochlear
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
Evaluation of the BHX Implant in Children with a BAHS
The purpose of this study is to in a proactive manner collect high quality data from pediatric patients who have undergone a bone anchored hearing surgery, using the Ponto BHX implant, in clinical practice.
- Trial name
- NCT03742089
- Testing
- Bone Anchored Hearing Surgery
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Oticon Medical
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
Hearing Impaired Children, Hearing Impairment, Conductive
Single-stage Surgery Using the BI300 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
- NCT04038216
- Testing
- Single-stage surgery, Two-stage surgery
- Where
- Netherlands
- Volunteers
- 70 people
- Sponsor
- Radboud University Medical Center
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
Chronic Otitis Media, Tympanic Membrane Perforation
Comparison of Postoperative Outcomes of Interlay vs Underlay Graft in Tympanoplasty
Chronic otitis media is a long-term ear infection that may cause a hole in the eardrum, leading to repeated ear discharge and hearing loss.
- Conditions
- Chronic Otitis Media, Tympanic Membrane Perforation, Conductive Hearing Loss
- Trial name
- NCT07149480
- Testing
- Underlay Tympanoplasty, Interlay Tympanoplasty
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Shaikh Zayed Hospital, Lahore
Hearing Loss, Bilateral or Unilateral, Hearing Loss, Conductive
Sentio Systematic Evaluation
The study is designed as an international, multi-center, single-armed, non-interventional/observational study including subjects who has received or are planned to receive the Sentio system as part of normal clinical practice.
- Conditions
- Hearing Loss, Bilateral or Unilateral, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Single Sided Deafness
- Trial name
- SENSE (NCT07161154)
- Testing
- Transcutaneous bone conduction hearing system
- Volunteers
- 100 people
- Sponsor
- Oticon Medical