Clinical trials: Conductive Hearing Loss
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
Deafness, Hearing Loss
Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)
The rationale behind this post-market clinical follow-up investigation is to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that are candidates for…
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive
- Trial name
- NCT02022085
- Testing
- Baha Attract System
- Where
- 6 sites in United States, Netherlands and 2 more
- Volunteers
- 54 people
- Sponsor
- Cochlear Bone Anchored Solutions
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, 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 Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)
The rationale behind this clinical performance investigation is to collect data regarding the usability of the Baha Attract System in patients with hearing impairment that are candidates for Baha surgery: To describe the expected…
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive
- Trial name
- NCT01822119
- Testing
- Baha Attract System
- Where
- 4 sites in Australia, Chile and 2 more
- Volunteers
- 27 people
- Sponsor
- Cochlear Bone Anchored Solutions
Conductive Hearing Loss
Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System
An international multicentre, open, comparative, parallel group, prospective clinical investigation with a single 5 year follow up visit.
- Trial name
- NCT02092610
- Testing
- Novel Implant BI300, Standard Implant BI300
- Where
- 4 sites in Netherlands, Sweden and 1 more
- Volunteers
- 77 people
- Sponsor
- Cochlear Bone Anchored Solutions
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
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, Hearing Loss, Conductive
Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors
The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon…
- Conditions
- Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Unilateral
- Trial name
- BC112 (NCT05356221)
- Testing
- Ponto Sound processor
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Oticon Medical
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
Conductive Hearing Loss, Conductive and Sensori-neural Hearing Loss in the Same Ear
Wide Diameter Bone Anchored Implant Study
To assess implant stability, implant loss, adverse skin reactions, and Quality of Life Benefit following implantation of the Ponto 4.5mm Wide Diameter implant.
- Conditions
- Conductive Hearing Loss, Conductive and Sensori-neural Hearing Loss in the Same Ear, Unilateral, Profound Sensori-neural Hearing Loss
- Trial name
- NCT01671176
- Testing
- Wide diameter bone anchored implant
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- 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, 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
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
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
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, 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
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, 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
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