Clinical trials: Hearing Disorders and Deafness
Hearing Loss
AutoFocus360 Sound Quality Preference and Claims Study
This study aims to generate clinical evidence to substantiate performance claims for the AutoFocus 360 feature in Sonova hearing aid products.
- Trial name
- AF360 (NCT07224919)
- Testing
- AutoFocus 360, Fixed directional microphone
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Jonathan Vaisberg
Hearing Loss, Hearing Impairment
Performance and Effectiveness of a Self-fitting Over-the-counter Hearing Aid
Hearing loss significantly affects quality of life, with sensorineural hearing loss being the most common type among adults. Hearing aids are a proven intervention, yet barriers like access and affordability limit their adoption…
- Trial name
- Lexie (NCT06942325)
- Testing
- OTC self-fitting hearing aid, Prescription hearing aid
- Sponsor
- HearX SA
Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe
Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users
On June 23, 2021, the Oticon Medical Neuro Cochlear Implant System (NCIS) was granted premarket approval (PMA) in the US to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who…
- Conditions
- Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe, Sensorineural Hearing Loss, Profound
- Trial name
- PACIFIC (NCT05154188)
- Testing
- Neuro Cochlear Implant system
- Volunteers
- 60 people
- Sponsor
- Oticon Medical
Sensorineural Hearing Loss, Bilateral, Bilateral Hearing Loss
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting
Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.
- Trial name
- NCT05955469
- Testing
- FS4 then TFS4 (cochlear implant), TFS4 then FS4 (cochlear implant)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Severe to Profound Hearing Loss
Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants.
This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized.
- Trial name
- BELPS (NCT07777562)
- Testing
- Cochlear implantation
- Where
- Switzerland
- Volunteers
- 700 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Tinnitus, Hearing Loss, Bilateral or Unilateral
Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss
This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software.
- Conditions
- Tinnitus, Hearing Loss, Bilateral or Unilateral, Normal Hearing
- Trial name
- TINIS (NCT06641999)
- Testing
- Tinnitus Implant System
- Where
- 2 sites in Belgium, Netherlands
- Volunteers
- 16 people
- Sponsor
- Cochlear
Hearing Loss
A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid
The aim of this study is to investigate the performance of the hearing aid under laboratory as well as everyday conditions. In addition, the performance data of the hearing aid are compared with a Bernafon hearing aid already…
- Trial name
- NCT03086018
- Testing
- Successor hearing aid to Juna
- Where
- Switzerland
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bernafon AG
Hearing Loss, Ear Diseases
Baseline Performance and Fitting Parameters for Sonova Products
The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.
- Conditions
- Hearing Loss, Ear Diseases, Hearing Disorders, Otolaryngological Disease
- Trial name
- NCT05859568
- Testing
- Pinna-located microphone, Pinna-simulated microphone algorithm
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Advanced Bionics
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
Retinitis Pigmentosa (RP), Usher Syndrome Type 2
Study to Evaluate Ultevursen in Subjects With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene
The purpose of this Phase 2b study is to evaluate the safety and tolerability of ultevursen administered via intravitreal injection (IVT) in subjects with Retinitis Pigmentosa (RP) due to mutations in exon 13 of the USH2A gene.
- Conditions
- Retinitis Pigmentosa (RP), Usher Syndrome Type 2, Deaf Blind, Retinal Disease
- Trial name
- LUNA (NCT06627179)
- Testing
- Intravitreal Injection of Ultevursen, No intervention, will not receive any active study intervention
- Where
- 26 sites in United States, Belgium and 8 more
- Volunteers
- 81 people
- Sponsor
- Laboratoires Thea
Hearing Loss, Sensorineural
Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05
Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner.
- Trial name
- NCT03751891
- Testing
- Phonak Audéo B90-Direct, HearingAid_A, HearingAid_B
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- Sonova AG
OTOF Gene Mutation, DFNB9
A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations
This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.
- Conditions
- OTOF Gene Mutation, DFNB9, Congenital Deafness, Hearing Disorders
- Trial name
- AUDIOGENE (NCT06370351)
- Testing
- SENS-501 administration
- Where
- 2 sites in Australia, France
- Volunteers
- 12 people
- Sponsor
- Sensorion
Sensorineural Hearing Loss, Bilateral
Comparison of Speech Understanding Between Tonotopy-based Fitting and Setting Based on Evolutionary Algorithms
Main objective: Compare speech recognition in noise with tonotopic setting (FS4T) and with tonotopic fitting modified by evolutionary algorithm (EAFS4T) in adult patients implanted for 6 months or more with a MED-EL cochlear…
- Trial name
- NCT06737185
- Testing
- EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting
- Where
- France
- Volunteers
- 22 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Mild to Moderate Sensorineural Hearing Loss
Study of SelfFit Mobile Medical App for Hearing Loss Diagnostics and Hearing Device Fitting / Fine Tuning
The purpose of this clinical study is to validate the comparability of prescription formula fitting of hearing aids based on full diagnostic audiometry and SelfFit interactive fitting of hearing aids based on hearing loss…
- Trial name
- SelfFit (NCT01877317)
- Testing
- SelfFit adjusted hearing device
- Where
- Netherlands
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Two Pi Signalprocessing Applications GmbH
Hearing Loss, Sensorineural
Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
The purpose of this investigation is to demonstrate the safety and effectiveness of MED-EL cochlear implants in children 7 months to 5 years, 11 months of age who fall outside the current FDA-approved candidacy criteria and, yet…
- Trial name
- NCT03900897
- Testing
- MED-EL SYNCHRONY PIN Cochlear Implant, Cochlear Implant
- Where
- 8 sites in United States
- Volunteers
- 247 people
- Sponsor
- Med-El Corporation
Conductive Hearing Loss, Mixed Hearing Loss
Post-Market Registry Study for Vibrant Hearing Solutions
This observational registry collects retrospective and prospective, data from children and adults who use CE-marked MED-EL implantable (PMEI, BCI, or AMEI) or non-implantable (BCD) hearing solutions as part of routine care.
- Conditions
- Conductive Hearing Loss, Mixed Hearing Loss, Sensorineural Hearing Loss, Single Sided Deafness
- Trial name
- NCT07906314
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss
Clinical Evaluation of Bass and Treble Controls for CI Subjects
The clinical study is designed to evaluate the safety and effectiveness of recipient controlled Bass and Treble.
- Trial name
- CLASS (NCT02908737)
- Testing
- Bass and Treble
- Where
- 2 sites in Australia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Low-Frequency Residual Hearing
Hearing Implant Performance in Adults With Low-Frequency Residual Hearing
The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI624 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.
- Trial name
- NCT04741048
- Testing
- CI624 Slim 20 Electrode
- Where
- United States
- 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
Pediatric Performance and Satisfaction of Oticon Medical Ponto on Softband.
The study is a non-interventional, observational, study on users of Ponto sound processors who use their sound processors on a softband solution.
- Trial name
- NCT06638840
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Oticon Medical