Clinical trials: Conductive and Sensorineural 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
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
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, Sensorineural Hearing Loss
Middle Ear Optical Coherence Tomography Imaging and Vibrometry in Patients With Hearing Loss
This study involves imaging ears with hearing loss with a new system that allows the user to see the middle ear bones and measure their movement in response to sound.
- Trial name
- NCT07732920
- Testing
- OCT - clear
- Where
- 2 sites in Canada
- Volunteers
- 500 people
- Sponsor
- Audioptics Medical Incorporated
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
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
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
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
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, 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
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
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
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
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, 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
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, 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