Clinical trials: Mixed Hearing Loss
Hearing Loss, Hearing Loss, Conductive
Investigation of an Updated Bone-anchored Sound Processor
The study is a prospective, single-center, comparative, cross-over study with within-subject control design. In the investigation an updated sound processor will be tested at compared to the CE marked Ponto 3 SuperPower sound…
- Conditions
- Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Disorders
- Trial name
- NCT05086809
- Testing
- Device A, Device B
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Oticon Medical
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
Hearing Loss Mixed
A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy
Following informed consent signature and upon verification of eligibility and execution of informed consent, subjects will be assigned a study code. The study comprises two groups.
- Trial name
- NCT07282028
- Testing
- Spectacle Hearing Aid
- Where
- Israel
- Volunteers
- 89 people
- Sponsor
- Nuance Hearing
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
Safety and Efficacy of the Vibrant Soundbridge (VSB) for Mixed and Conductive Hearing Losses
The purpose of this investigation is to collect feasibility data to assess the safety and efficacy of the Vibrant Soundbridge (VSB), a medical device designed to provide benefit in aided hearing thresholds, speech perception and…
- Trial name
- VSBRW (NCT00748540)
- Testing
- Vibrant Soundbridge
- Where
- 11 sites in United States
- Volunteers
- 50 people
- Sponsor
- Med-El Corporation
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
Conductive Hearing Loss, Unilateral Partial Deafness
Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants
The objective of this study is to make a comparison between two surgical techniques used when implanting a Ponto bone anchored hearing system.
- Conditions
- Conductive Hearing Loss, Unilateral Partial Deafness, Mixed Conductive-sensorineural Hearing Loss
- Trial name
- C50 (NCT02438618)
- Testing
- Surgery for Ponto bone anchored hearing aids
- Where
- Netherlands
- Volunteers
- 64 people
- Sponsor
- Oticon Medical
Mixed Hearing Loss
Evaluation of Actual Maximum Gain in Bone Anchored Devices
This study will look at how much sound amplification (gain) different bone-anchored hearing devices can provide. The goal is to understand if there are differences between devices and whether these differences affect how well the…
- Trial name
- NCT07294976
- Testing
- Bone Anchored Device A, Bone Anchored Device B, Bone Anchored Device C
- Where
- Sweden
- 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
Deafness; Sensoneural Single Sided, Conductive Hearing Loss
Clinical Performance of a New Implant System for Bone Conduction Hearing
To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.
- Conditions
- Deafness; Sensoneural Single Sided, Conductive Hearing Loss, Mixed Hearing Loss
- Trial name
- NCT03086135
- Testing
- Osia System
- Where
- 5 sites in United States, Australia and 3 more
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Cochlear
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
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
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
Deafness, Hearing Loss
Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique
To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection, overgrowth, pain and numbness at the site of…
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
- Trial name
- NCT01796236
- Testing
- Minimally invasive surgery and BA400, Traditional surgery and BA300
- Where
- 7 sites in France, Netherlands and 2 more
- Volunteers
- 106 people
- Sponsor
- Cochlear Bone Anchored Solutions
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
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
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
Home Test of New Sound Processor
The purpose of this clinical investigation is to test a new Sound Processor (SP) to compare hearing performance of the new Sound Processor with unaided hearing and Baha 5 SP in adult subjects and to investigate which device (new…
- Trial name
- NCT04559282
- Testing
- New Sound Processor
- Where
- Sweden
- Volunteers
- 16 people
- Sponsor
- Cochlear
Bone Conduction, Hearing Loss, Conductive
Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
The goal of this interventional study is to confirm the safety and performance of the latest generation Osia System and to examine its benefits compared to the Baha Connect System in adults with mixed or conductive hearing loss…
- Conditions
- Bone Conduction, Hearing Loss, Conductive, Hearing Loss, Mixed
- Trial name
- OSIRIS (NCT07130136)
- Testing
- Cochlear™ Osia® System, Cochlear™ Baha® System
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Cochlear
Conductive Hearing Loss, Mixed Hearing Loss
Evaluation of a Hearing Device for Transmitting Sound to the Inner Ear
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 self-evaluation…
- Trial name
- NCT05628285
- Testing
- Sentio 1
- Where
- Sweden
- Volunteers
- 11 people
- Sponsor
- Oticon Medical