Clinical trials: Mixed Hearing Loss
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
Hearing Loss, Conductive, Hearing Loss, Mixed
BONEBRIDGE Bone Conduction Implant in Adults
Approximately thirty subjects with mixed or conductive hearing loss, meeting FDA-cleared candidacy criteria for the BONEBRIDGE, will be implanted and followed for three (3) months post-activation to assess safety and…
- Trial name
- NCT03859648
- Testing
- BONEBRIDGE
- Where
- 3 sites in United States, Canada
- Volunteers
- 9 people
- Sponsor
- Med-El Corporation
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
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
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
Mixed Hearing Loss
Objective Measures in Implantable Hearing Devices
The purpose of this study is to measure objectively the coupling from direct acoustic cochlear stimulation to the inner ear with a non-invasive technique of auditory evoked potentials.
- Trial name
- NCT01780025
- Testing
- Auditory evoked potentials and audiometry, Auditory evoked potentials
- Where
- Belgium
- Volunteers
- 15 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Conductive Hearing Loss, Mixed Hearing Loss
Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha)
A bone-anchored hearing aid (Baha) consists of a titanium implant located at the mastoid, and a sound processor connected with the implant.
- Conditions
- Conductive Hearing Loss, Mixed Hearing Loss, Unilateral Deafness
- Trial name
- Baha (NCT01264510)
- Testing
- audiological test battery
- Where
- Belgium
- Sponsor
- University Hospital, Ghent
Conductive Hearing Loss, Mixed Hearing Loss
Osia CPT Code Study
To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.
- Trial name
- NCT04320407
- Testing
- Osia 2 System
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Cochlear
Bone Conduction Deafness, Unilateral Deafness
Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration
The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and…
- Conditions
- Bone Conduction Deafness, Unilateral Deafness, Middle Ear Deafness, Mixed Hearing Loss
- Trial name
- NCT03807713
- Testing
- Minimally Invasive Ponto Surgery
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Oticon Medical
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
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
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
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
Deafness; Sensoneural Single Sided, Conductive Hearing Loss
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
The aim of this clinical investigation is to investigate the subject´s overall preference, hearing performance and self-reported assessments with the Investigational device and its precursor Sound Processor (Comparator) after 6…
- Conditions
- Deafness; Sensoneural Single Sided, Conductive Hearing Loss, Mixed Hearing Loss
- Trial name
- NCT03848910
- Testing
- Investigational device - Sound Processor
- Where
- Australia
- Volunteers
- 11 people
- Sponsor
- Cochlear
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, Sensorineural, Hearing Loss, Conductive
Wide Frequency Band Test of Hearing in Veterans
The accurate assessment of auditory status is critical for planning treatment for Veterans with hearing loss to include medical and audiological management.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Otosclerosis
- Trial name
- CWTBAFV (NCT02019888)
- Where
- 2 sites in United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Bone Conduction Deafness, Unilateral Deafness
Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)
The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and…
- Conditions
- Bone Conduction Deafness, Unilateral Deafness, Middle Ear Deafness, Mixed Hearing Loss
- Trial name
- NCT03281967
- Testing
- Minimally Invasive Ponto Surgery
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Oticon Medical
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
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
Single Sided Sensorineural Deafness, Mixed Hearing Loss, Unilateral
Evaluation of Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System
The aim of this clinical investigation is to evaluate objective and subjective hearing performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System, compared to the unaided hearing performance.
- Trial name
- NCT02722330
- Testing
- Baha 5 SuperPower on Baha Attract System
- Where
- 4 sites in Belgium, Denmark and 2 more
- Volunteers
- 23 people
- Sponsor
- Cochlear Bone Anchored Solutions