Clinical trials: Hearing Loss, Mixed
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
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided…
- Trial name
- NCT04041700
- Testing
- Osia 2 system
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 29 people
- 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
Mixed Conductive and Sensorineural Hearing Loss, Bilateral
Middle-Ear Implant With MET V Transducer (Aka MET V System)
The purpose and objective of this study is to evaluate the safety and efficacy of the MET V System for the treatment of individuals with mixed hearing loss.
- Trial name
- NCT01529333
- Testing
- Middle Ear Implant with MET V Transducer
- Volunteers
- 130 people
- Sponsor
- Otologics LLC
Hearing Loss, Conductive, Hearing Loss, Mixed
Clinical Investigation Study of Safety and Performance of the Sentio System.
Prospective, open label, single-arm, multi-centre investigation, designed to follow clinical practice for Sentio bone conduction devices in 50 subjects, during 10 clinical visits, and 24 months follow-up.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral
- Trial name
- NCT05166265
- Testing
- Active transcutaneous bone conduction hearing system
- Where
- 6 sites in Germany, Netherlands and 1 more
- Volunteers
- 51 people
- Sponsor
- Oticon Medical
Hearing Loss, Mixed Conductive-Sensorineural, Hearing Loss, Conductive
Clinical Performance of the Osia 3 Sound Processor Compared With the Osia 2 Sound Processor in Adult Osia Implant Users
This study aims to investigate the clinical performance of the Osia 3 Sound Processor in comparison to the Osia 2 Sound Processor in adults with mixed or conductive hearing loss or single-sided deafness implanted with an Osia…
- Trial name
- RECONNECT (NCT06338670)
- Testing
- Cochlear Osia 3 Sound Processor, Cochlear™ Osia® 2 Sound Processor
- Where
- Australia
- Volunteers
- 12 people
- Sponsor
- Cochlear
Hearing Loss, Age-Related
Hearing-physical Activity Intervention
Background By 2050, approximately 2.5 billion people are expected to experience some degree of age-related hearing loss (ARHL). Greater ARHL is associated with decreased communication, reduced physical activity and social…
- Trial name
- NCT07071168
- Testing
- hearing-physical activity training
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- The Hong Kong Polytechnic University
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
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751.
- Trial name
- NCT04754477
- Testing
- Active Osseointegrated Steady-State Implant System (OSI)
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 20 people
- Sponsor
- Cochlear
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
Hearing Loss, Mixed, Hearing Loss, Conductive
Hearing Outcomes With the Osia 3 Sound Processor Compared to the Osia 2 Sound Processor in Adult Osia Implant Recipients
The goal of this interventional study is to evaluate the clinical performance and sound quality of the Osia 3 Sound Processor and to demonstrate its superiority compared with the Osia 2 Sound Processor in adults with mixed…
- Conditions
- Hearing Loss, Mixed, Hearing Loss, Conductive, Single-Sided Deafness, Bone Conduction
- Trial name
- SONUS (NCT07156461)
- Testing
- Cochlear™ Osia® System (Osia® 2), Cochlear™ Osia® System (Osia® 3)
- Where
- 3 sites in United States, Australia
- Volunteers
- 29 people
- Sponsor
- Cochlear
Conductive Hearing Loss, Mixed Hearing Loss
Clinical Survey of Oticon Medical Healing Cap
This study investigates the use of a new healing cap which, through altered design and choice of material, has been improved when it comes to minimizing the risk of it falling off as well as increasing patient comfort.
- Conditions
- Conductive Hearing Loss, Mixed Hearing Loss, Unilateral Partial Deafness
- Trial name
- NCT02274129
- Testing
- Healing cap II
- Where
- 2 sites in Denmark
- Volunteers
- 32 people
- Sponsor
- Oticon Medical
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
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
Mixed Hearing Loss
Long Term Results With the Vibrant Soundbridge in Patients With Mixed Hearing Loss: a 60-month Longitudinal Study
Vibrant Soundbridge (VSB, MED-EL, Innsbruck) Active middle ear implants (AMEI) can benefit patients who are unable to use conventional hearing aids (HA) due to medical reasons, discomfort or unsuccessful rehabilitation.
- Trial name
- NCT05793580
- Testing
- Vibrant Soundbridge active middle ear implant
- Where
- France
- Volunteers
- 31 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss, Conductive, Hearing Loss Mixed
Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear
The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device is the CE-marked Ponto 3 SuperPower (available on the market since December 2016) already fitted to the subjects, and data is…
- Conditions
- Hearing Loss, Conductive, Hearing Loss Mixed, Hearing Disability, Conductive Hearing Loss
- Trial name
- NCT04803279
- Testing
- Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower, Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower, Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower
- Where
- United Kingdom
- Volunteers
- 57 people
- Sponsor
- Oticon Medical
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
Conductive Hearing Loss, Unilateral Partial Deafness
Clinical Survey of Different Abutment Topologies
This study is designed to compare two different surfaces of bone anchored hearing aid abutments in terms of bacterial colonization, inflammatory response and skin reactions.
- Conditions
- Conductive Hearing Loss, Unilateral Partial Deafness, Mixed Hearing Loss
- Trial name
- NCT02304692
- Testing
- Bone anchored hearing aid
- Where
- Sweden
- Volunteers
- 14 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
Bone Conduction Deafness, Quality of Life
Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies
The Bonebridge (BB) is a partially implantable active transcutaneous bone conduction hearing system manufactured by MED-EL Elektromedizinische Geräte Gesellschaft m.b.H. (MED-EL, Innsbruck, Austria).
- Conditions
- Bone Conduction Deafness, Quality of Life, Hearing Loss, Mixed
- Trial name
- NCT06039332
- Testing
- Fitting of the audioprocessor with the auditory implant BCI602
- Where
- Spain
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario La Paz