Clinical trials: Sensorineural Hearing Loss (Disorder)
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
Sensorineural Hearing Loss, Bilateral, Cochlear Implants
Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults.
This clinical investigation aims to collect data on the use of the Mi2000 system, a totally implantable cochlear implant system, for the first time in human subjects.
- Trial name
- TICI (NCT04571333)
- Testing
- Mi2000 Totally Implantable Cochlear Implant
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 6 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss, Cochlear
Effects of Pulses on Loudness
The aim of this study is to investigate the effect of varying additional factors on loudness summation in Neuro Zti Cochlear Implant users.
- Trial name
- EfPuL (NCT04010721)
- Testing
- Experiment 1, Experiment 2:, Experiment 3
- Where
- France
- 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
Sensorineural Hearing Loss, Perceived Hearing Loss
Clinical Evaluation of Hearing Aid OTC Self-Assessment Methods for Adults With Perceived Mild-to-Moderate Hearing Loss
The goal of this clinical trial is to compare two methods of self assessment of hearing with conventional audiometry in an OTC Hearing Aid for adults with perceived mild to moderate hearing loss.
- Conditions
- Sensorineural Hearing Loss, Perceived Hearing Loss, Hearing Impairment
- Trial name
- NCT07738237
- Testing
- OTC Hearing Aid Self Fitting App, Audiometry
- Where
- Australia
- Volunteers
- 24 people
- Sponsor
- Rehear Audiology Company LTD
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
Hearing Loss
The Esteem® Hearing Implant Post Approval Study
The purpose of this study is to evaluate the long-term safety and efficacy of the Esteem® Hearing Implant in subjects suffering from moderate to severe hearing loss.
- Trial name
- NCT02666222
- Testing
- The Esteem Hearing Implant
- Where
- 5 sites in United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Envoy Medical Corporation
Mild to Severe Sensorineural Hearing Loss
Esteem Totally Implantable Hearing System
To evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from mild to severe hearing loss.
- Trial name
- NCT01092910
- Testing
- Esteem Totally Implantable Hearing System
- Where
- 5 sites in United States
- Volunteers
- 57 people
- Sponsor
- Envoy Medical Corporation
Hearing Loss, Sensorineural
Efficacy and Safety of AC102 Compared to Steroids in Adults With Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)
The purpose of this Phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of AC102 administered as single intratympanic injection compared to oral steroid treatment in patients with Idiopathic Sudden…
- Trial name
- NCT05776459
- Testing
- AC102 gel, Prednisolone
- Where
- 39 sites in Austria, Czechia and 4 more
- Volunteers
- 210 people
- Sponsor
- AudioCure Pharma GmbH
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, Sensorineural, Hearing Loss, Bilateral
Investigating Hearing Aid Frequency Response Curves 2
Internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve.
- Trial name
- NCT05828017
- Testing
- Hearing Aid - Standard Curve under Program 1, Hearing Aid - Variation #1 under Program 1, Hearing Aid - Variation #2 under Program 5 - Streaming Only
- Where
- Canada
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Sonova AG
Hearing Impairment, Sensorineural
A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.
The purpose of this early feasibility study is to explore several facets of hearing performance of Focused Multipolar stimulation in adult cochlear implant users.
- Trial name
- SASC (NCT05641155)
- Testing
- Focused Multipolar Stimulation (FMS) strategy
- Where
- 5 sites in United States, Belgium
- Volunteers
- 18 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural
Expanded Indications in the Adult Cochlear Implant Population
The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit…
- Trial name
- NCT03236909
- Testing
- MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System
- Where
- 5 sites in United States, Canada
- Volunteers
- 44 people
- Sponsor
- Med-El Corporation
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
Congenital Hearing Loss Secondary to Biallelic Mutations in the Otoferlin Gene (OTOF), Biallelic Mutations in the Gap Junction Beta 2 (GJB2) Gene
A Natural History Study in Pediatric Participants With Hearing Loss Due to OTOF, GJB2, or GJB2/GJB6 Mutations
This is an observational study to examine the characteristics of gene-related hearing loss in pediatric participants with biallelic otoferlin (OTOF) Mutations, Gap Junction Beta 2 (GJB2) Mutations, or Digenic GJB2/Gap Junction…
- Conditions
- Congenital Hearing Loss Secondary to Biallelic Mutations in the Otoferlin Gene (OTOF), Biallelic Mutations in the Gap Junction Beta 2 (GJB2) Gene, Digenic Mutations in GJB2/Gap Junction Beta 6 (GJB6) Genes
- Trial name
- ENSEMBLE (NCT06019481)
- Where
- 2 sites in United States
- Sponsor
- Regeneron Pharmaceuticals
Autoimmune Inner Ear Disease
The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease
The purpose of this study is to determine if gevokizumab therapy may be an alternate therapy in patients with steroid resistant Autoimmune Inner Ear Disease.
- Trial name
- NCT01950312
- Testing
- gevokizumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- XOMA (US) LLC
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 Impairment, Sensorineural, Perceived Hearing Loss
Clinical Evaluation of the RH210 Hearing Aid
The RH210A is an air-conduction hearing aid designed for adults with perceived mild-to-moderate sensorineural hearing loss. The purpose of this clinical investigation is to generate objective and subjective evidence of the…
- Trial name
- NCT07572357
- Testing
- Investigational device (RH210A), Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)
- Where
- Australia
- Volunteers
- 24 people
- Sponsor
- Rehear Audiology Company LTD
Hearing Loss, Sensorineural, Cochlear Implantation
Comparison of Performance Using MED-EL Automatic Sound Management
This study will evaluate the speech perception ability of adult cochlear implant users in background noise using various MED-EL Automatic Sound Management (ASM) features.
- Trial name
- NCT07500311
- Testing
- Automatic Sound Management Fixed Directionality, Automatic Sound Management Adaptive, Omnidirectional Settings
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Med-El Corporation
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