Clinical trials: Hearing Loss, Mixed Conductive-Sensorineural
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
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
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
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
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, 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
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, 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
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
Conductive Hearing Loss, Single-Sided Deafness
Ambispective Clinical Evaluation of Sophono™
Study to accumulate post-market clinical evidence for the safety and effectiveness of the Sophono Alpha 2 and Alpha 2 Maximum Power Output (MPO) systems in subjects diagnosed with conductive hearing loss, single-sided deafness…
- Conditions
- Conductive Hearing Loss, Single-Sided Deafness, Mixed Hearing Loss
- Trial name
- ACES (NCT03143257)
- Testing
- Sophono Bone Conduction Hearing Systems
- Where
- 6 sites in United States
- Volunteers
- 71 people
- Sponsor
- Medtronic Surgical Technologies