Clinical trials: Bilateral Hearing Loss
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, Hearing Loss, Sensorineural
Front-End Processing 3.0
This study investigated the impact of Automatic Sound Management 3.0 (i.e. ambient noise reduction, transient noise reduction and an adaptive intelligence) as implemented in the SONNET2 on CI users' speech performance and their…
- Conditions
- Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Bilateral
- Trial name
- FEP3 (NCT03861442)
- Testing
- Audio processor SONNET, SONNET 2: Configuration 1, SONNET 2: Configuration 2
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Bilateral
Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults
The aim of this study is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition score in adults using currently a Nucleus cochlear implant.
- Trial name
- PROGRESS (NCT05265260)
- Where
- France
- Volunteers
- 32 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
A Monocentric Study Evaluating Pupillometry as an Objective Measurement for CI Fittings
This trial is a monocentric, prospective and controlled study of the pupil response to detect hearing threshold and comfortable loudness of normal-hearing (NH) and CI-subjects.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Cochlear Hearing Loss, Hearing Loss, Cochlear
- Trial name
- PupillOM (NCT05586555)
- Testing
- Pupillometry (Eve-tracking measurements)
- Where
- France
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Oticon Medical
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
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
An Actual Use, Open-label Study Assessing Usability of Remote Assist to Program Cochlear Implant Recipients
Clinical management of cochlear implant (CI) recipients involve programming, counselling, performance evaluation and habilitation.
- Trial name
- RAL (NCT04987021)
- Testing
- Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants
- Where
- Australia
- Volunteers
- 15 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Optimizing Soft Speech Recognition in Children With Hearing Loss
Overhearing is important for vocabulary learning and speech and language development in young children. However, contemporary hearing aids are generally unable to provide adequate access to low-level auditory inputs from multiple…
- Trial name
- SoftSpeech (NCT05299892)
- Testing
- Phonak Audeo P or Naida P hearing aid
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Sonova AG
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
Sensorineural Hearing Loss, Bilateral
Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure
The objectives of this study are to explore the efficacy and safety of a robotic procedure for a minimally invasive cochlear implantation.
- Trial name
- NCT04777565
- Testing
- Robotic surgery
- Where
- France
- Volunteers
- 10 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Hearing Loss in Older Adults Study
This is a prospective, 1:1 randomized controlled trial of immediate versus delayed cochlear implantation (CI) on hearing handicap, communicative function, loneliness, mental wellbeing, and cognitive functioning.
- Trial name
- NCT03382769
- Testing
- Cochlear implantation
- Where
- 8 sites in United States
- Volunteers
- 1 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral
Study of Music and Speech Perception in New Cochlear Implanted Subjects Using or Not a Tonotopy Based Fitting
Main objective: Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the perception speech in noise.
- Trial name
- NCT04922619
- Testing
- tonotopy based fitting then default fitting, default fitting then tonotopy based fitting
- Where
- France
- Volunteers
- 26 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
Sensorineural Hearing Loss, Bilateral, Cochlear Implant
Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
- Trial name
- NCT03304106
- Testing
- Commercially available cochlear implant and AI system
- Where
- 9 sites in United States
- Volunteers
- 102 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral
An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.
- Trial name
- NCT03904420
- Testing
- Clinical Education and Treatment Model, Traditional Model
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Cochlear
Bilateral Hearing Loss
Evaluation of the Benefits of Bilateral Fitting in BAHS Users
The purpose of this study is to evaluate the benefit of bilateral implantation with bone-anchored hearing systems (BAHS), in terms of sound localization abilities, as well as auditory working memory.
- Trial name
- NCT04006132
- Testing
- Fitting of Ponto 3 SuperPower
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Oticon Medical
Sensorineural Hearing Loss, Bilateral
Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy
Main objective: Show the superiority of Fine Structure (FS4) strategy compared to Continuous Interleaved Sampling (HDCIS) strategy on the qualitative preference for the listening of musical pieces.
- Trial name
- NCT03993899
- Testing
- FineHearing strategy or HDCIS strategy
- Where
- France
- Volunteers
- 19 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss, Bilateral or Unilateral
Evaluation of New Custom Made Hearing Product Technology and Shell Modification
The purpose of this evaluation is to receive the greatest benefit of new custom made hearing product technology and shell modification for the end customer and to continual improve the custom made hearing products.
- Trial name
- CPS (NCT02545569)
- Testing
- hearing aid (MD class IIa) - ITE, BTE, RIC
- Where
- Switzerland
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Phonak AG, Switzerland
Sensorineural Hearing Loss, Bilateral
CI532 - Early Experience Study
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.
- Trial name
- NCT02755935
- Testing
- Cochlear Nucleus CI532
- Where
- 6 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cochlear
Hearing Loss, Bilateral Sensorineural, Progressive
Quality Control of CE-Certified Phonak Hearing Aids - 2017_27
A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch.
- Trial name
- NCT03253003
- Testing
- Line extension of the Phonak Audéo B product family
- Where
- Switzerland
- Volunteers
- 19 people
- Sponsor
- Sonova AG
Hearing Loss, Bilateral Sensorineural, Progressive
Quality Control of CE-Certified Phonak Hearing Aids - 2017_13
A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch.
- Trial name
- NCT03131557
- Testing
- Line extension of the Phonak Audéo B product family, Phonak Audéo B
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- Sonova AG