Clinical trials: Deafness One Ear
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, Sensorineural, Hearing Loss, Bilateral
iotaSOFT Pediatric Study
Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Unilateral
- Trial name
- NCT06106373
- Testing
- iotaSOFT Insertion System
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- iotaMotion, 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 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
Unilateral Deafness
Evaluation of BiCROS Fitting Benefits
22 candidates for BiCROS hearing aids will be recruited and fitted with a hearing aid and a CROS device. Following a real-world trial, each participant will be tested on a range of outcome measures including speech recognition in…
- Trial name
- NCT05379231
- Testing
- Hearing aid fitting
- Where
- 2 sites in Canada
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Sonova AG
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, 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
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, 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, 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, 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, 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.
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
Hearing Loss, Conductive, Hearing Loss Mixed
Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear
The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device is the CE-marked Ponto 3 SuperPower (available on the market since December 2016) already fitted to the subjects, and data is…
- Conditions
- Hearing Loss, Conductive, Hearing Loss Mixed, Hearing Disability, Conductive Hearing Loss
- Trial name
- NCT04803279
- Testing
- Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower, Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower, Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower
- Where
- United Kingdom
- Volunteers
- 57 people
- Sponsor
- Oticon Medical
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
Hearing Loss, Bilateral, Hearing Loss, Unilateral
PRINCE22 System Complete Performance Study
The investigation proposes to compare a narrow reference beamformer to a novel beamformer approach, when the talker is not in front of the hearing aid user and in the presence of background noise.
- Trial name
- NCT05656313
- Testing
- Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test), Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test), Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test)
- Where
- Germany
- Volunteers
- 22 people
- Sponsor
- Sonova AG
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
Unilateral Severe to Profound Hearing Loss OR Bilateral Severe to Profound Hearing Loss
Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss
The goal of the study was to evaluate the safety, tolerability, and the potential ability of CGF166 delivered through IL-infusion to improve hearing.
- Trial name
- NCT02132130
- Testing
- CGF166
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals