Clinical trials: Unilateral Partial Deafness
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
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
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
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
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
Hearing Loss
AM-111 in the Treatment of Acute Inner Ear Hearing Loss
The purpose of this research study is to test the effectiveness and safety of the study drug, AM-111. AM-111 is tested for the treatment of sudden sensorineural hearing loss where the cause is unknown.
- Trial name
- HEALOS (NCT02561091)
- Testing
- AM-111 0.4 mg/ml, AM-111 0.8 mg/ml
- Where
- Bulgaria
- Volunteers
- 256 people
- Sponsor
- Auris Medical AG
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
Hearing Loss, Unilateral, Cochlear Implants
Impact of Anatomy-Based Cochlear Implant Programming on Early Performance
The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to…
- Conditions
- Hearing Loss, Unilateral, Cochlear Implants, Hearing Loss, Sensorineural, Single-Sided Deafness (SSD)
- Trial name
- NCT06734039
- Testing
- Programming of cochlear implant audio processor frequency settings
- Where
- 6 sites in United States
- Volunteers
- 50 people
- Sponsor
- Med-El Corporation
Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children/Infants, Adolescents and Adults With Hearing Loss Due to Otoferlin Mutations
Regeneron is conducting a study of an investigational new drug called DB-OTO. DB-OTO is a gene therapy that is being developed to treat pediatric and adult participants who have severe-to profound and profound hearing loss due to…
- Trial name
- CHORD (NCT05788536)
- Testing
- DB-OTO
- Where
- 17 sites in United States, Germany and 3 more
- Volunteers
- 36 people
- Sponsor
- Regeneron Pharmaceuticals
Single Sided Sensorineural Deafness, Mixed Hearing Loss, Unilateral
Evaluation of Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System
The aim of this clinical investigation is to evaluate objective and subjective hearing performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System, compared to the unaided hearing performance.
- Trial name
- NCT02722330
- Testing
- Baha 5 SuperPower on Baha Attract System
- Where
- 4 sites in Belgium, Denmark and 2 more
- Volunteers
- 23 people
- Sponsor
- Cochlear Bone Anchored Solutions
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
Hearing Loss, Conductive, Hearing Loss, Mixed
Clinical Investigation Study of Safety and Performance of the Sentio System.
Prospective, open label, single-arm, multi-centre investigation, designed to follow clinical practice for Sentio bone conduction devices in 50 subjects, during 10 clinical visits, and 24 months follow-up.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral
- Trial name
- NCT05166265
- Testing
- Active transcutaneous bone conduction hearing system
- Where
- 6 sites in Germany, Netherlands and 1 more
- Volunteers
- 51 people
- Sponsor
- Oticon Medical
Single Sided Deafness, Conductive Hearing Loss
SoundBite Hearing System Long Term Multi Site Patient Use Study
This study is designed to collect data about the SoundBite™ Hearing System to answer specific questions. The hearing system has been cleared for commercial distribution by the Food and Drug Administration (FDA).
- Trial name
- NCT01445977
- Where
- 13 sites in United States
- Volunteers
- 150 people
- Sponsor
- Sonitus Medical Inc
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
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
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, 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, Conductive Hearing Loss
SoundBite Hearing System 24 Month Multi Site Patient Use Study
The objective of this multi-site observational study is to further assess the long-term patient use of the Sonitus SoundBite Hearing System.
- Trial name
- NCT01807559
- Testing
- SoundBite Hearing System
- Where
- 7 sites in United States
- Volunteers
- 75 people
- Sponsor
- Sonitus Medical Inc
Hearing Loss, Unilateral, Hearing Loss, Sensorineural
Single-Sided Deafness and Asymmetric Hearing Loss
The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.
- Trial name
- NCT04506853
- Testing
- MED-EL Cochlear Implant System
- Where
- 5 sites in United States, Canada
- Volunteers
- 65 people
- Sponsor
- Med-El Corporation
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