Clinical trials: Unilateral Deafness
Hearing Loss, Idiopathic Sudden Sensorineural
Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).
- Trial name
- ASSENT (NCT02809118)
- Testing
- AM-111 0.4 mg/ml, AM-111 0.8 mg/ml
- Where
- 51 sites in United States, Canada and 1 more
- Volunteers
- 56 people
- Sponsor
- Auris Medical, Inc.
Single Sided Deafness
Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance ("SoundBite")
The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.
- Trial name
- NCT01933386
- Testing
- SoundBite
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Sonitus Medical Inc
Vestibular Schwannoma
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product…
- Trial name
- NCT06517888
- Testing
- AAVAnc80-antiVEGF via Akouos Delivery Device
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Akouos, Inc.
Hearing Impaired (Partially), Hearing Impairment, Conductive
Clinical Survey of Oticon Medical Ponto BHX Implant
Investigation of stability of the BHX implant in adult patients indicated and counselled for a bone anchored hearing aid system. Patients are followed according to clinical practice for a total of 12 months in the study.
- Conditions
- Hearing Impaired (Partially), Hearing Impairment, Conductive, Deafness Unilateral
- Trial name
- NCT03289845
- Testing
- BHX implant (Bone anchored hearing system)
- Where
- 2 sites in Denmark
- Volunteers
- 36 people
- Sponsor
- Oticon Medical
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
GJB2-mediated Hearing Loss, GJB2 Gene Mutation
Open-label Study of SKY-GJB2 in Pediatric Subjects With GJB2-mediated Hearing Loss
Skylark Bio is conducting a study of an investigational new drug called SKY-GJB2 and its delivery device, the SKY-CAT. SKY-GJB2 is a gene therapy that is being developed to treat children who have hearing loss due to changes in…
- Conditions
- GJB2-mediated Hearing Loss, GJB2 Gene Mutation, DFNB1A
- Trial name
- SONIX (NCT07627971)
- Testing
- SKY-GJB2
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Skylark Bio Inc.
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
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, Unilateral, Deafness, Unilateral
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for…
- Trial name
- PAS-SSD (NCT05318417)
- Testing
- The Cochlear™ Nucleus® Cochlear Implant (CI) System
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Cochlear
Single Sided Deafness
Implantation of the Cochlear® Nucleus® System in Adults With Single-Sided Deafness
The objective of this feasibility study is to obtain preliminary safety and efficacy data associated with cochlear implantation in individuals with severe to profound sensorineural hearing loss contralateral to an ear with…
- Trial name
- NCT01670006
- Testing
- Cochlear Nucleus Cochlear Implant System
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cochlear
Hearing Loss, Hearing Impairment
Evaluating Possible Improvement in Speech and Hearing Tests After 28 Days of Dosing of the Study Drug AUT00063 Compared to Placebo (QuicKfire)
The objective of this pilot study is to explore whether repeat doses of AUT00063 can provide an indication of improvement in performance of tests across a battery of speech and hearing assessments in cochlear implant users.
- Trial name
- NCT02832128
- Testing
- AUT00063
- Where
- 4 sites in United Kingdom
- Volunteers
- 15 people
- Sponsor
- Autifony Therapeutics Limited
Hearing Loss, Bilateral or Unilateral
Effectiveness of Speech Therapy for Lip-reading in Patients With Hearing Aids: SCED Study
This study aims to investigate whether lip reading rehabilitation improves viseme recognition in individuals with hearing impairments who use hearing aids.
- Trial name
- SCEDuLL (NCT07028658)
- Testing
- Speechreading training
- Where
- France
- Volunteers
- 8 people
- Sponsor
- Institut Pasteur
Meniere's Disease
OTO-104 for Meniere's Disease
The purpose of this study is to evaluate the safety of OTO-104 in subjects with unilateral Meniere's disease. The effectiveness of OTO-104 to reduce the symptoms of Meniere's disease will also be evaluated.
- Trial name
- NCT01084525
- Testing
- OTO-104 (steroid) 3 mg, OTO-104 (steroid) 12 mg
- Where
- 15 sites in United States
- Volunteers
- 44 people
- Sponsor
- Otonomy, Inc.
Hearing Loss, Unilateral
Single-Sided Deafness in the Medicare Population
The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.
- Trial name
- NCT05250414
- Testing
- MED-EL Cochlear Implant System
- Where
- 3 sites in United States, Canada
- Volunteers
- 18 people, healthy volunteers welcome
- 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
Sensorineural Hearing Loss
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss
This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.
- Trial name
- NCT04462198
- Testing
- PIPE-505
- Where
- 8 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Contineum Therapeutics
Cochlear Implant, Hearing Loss, Bilateral or Unilateral
The Performance of Different Sound Paths in Adult NeuroZti CI-users
The goal of this clinical trial is to compare speech perception and user satisfaction between two sound paths, Nuc8 (Cochlear Nucleus sound path) and Neu2 (Neuro 2 sound path), in adult users of the NeuroZti cochlear implant.
- Trial name
- Percepolis (NCT07033130)
- Testing
- OMRP R2 + Percepolis Accessory Software, Nuc8 Sound Path, Neu2 Sound Path
- Where
- France
- Volunteers
- 4 people
- Sponsor
- Cochlear
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
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, Unilateral Hearing Loss
Long Term Safety of the Sonitus SoundBite System
The objective of this study is to assess the long-term safety and quality of life improvement of the Sonitus SoundBite Hearing System.
- Conditions
- Hearing Loss, Unilateral Hearing Loss, Total Unilateral Deafness
- Trial name
- NCT01108406
- Testing
- Sonitus SoundBite System, SoundBite Hearing System
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Sonitus Medical Inc