Clinical trials: Mixed Conductive-sensorineural Hearing Loss
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
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
Conductive Hearing Loss, Mixed Hearing Loss
Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation
A bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness.
- Conditions
- Conductive Hearing Loss, Mixed Hearing Loss, Single Sided Deafness
- Trial name
- NCT02064478
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Oticon Medical
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
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
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, 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
Mixed Hearing Loss, Conductive Hearing Loss
Comparative Study of Non-surgical Hearing Devices Based on Bone Conduction
This study will investigate the performance of four non-surgical bone conduction devices.
- Trial name
- NCT07580287
- Testing
- Bone conduction devices
- Where
- Sweden
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Oticon Medical
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
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 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
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
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, 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
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
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
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
Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
The primary objective of the study is to evaluate OID hearing intervention on cognition among patients who could vs. do utilize an OID.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Deafness, Unilateral
- Trial name
- NCT04899037
- Testing
- No intervention
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of South Florida
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