Clinical trials: Deafness, Perception
Sensorineural Hearing Loss, Bilateral Hearing Loss
Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
- Trial name
- CI-DEX-LTFU (NCT06936449)
- Testing
- CI632D, CI632
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural
Hearing Aid Signal Processing Comparative Study
Participants will be fit with each of two hearing instruments in an ABA cross-over design. The study will consist of a total of three approximately 10-day home trials with the devices.
- Trial name
- NCT04839289
- Testing
- Receiver-in-canal hearing instrument; Manufacturer A, Receiver-in-canal hearing instrument; Manufacturer B
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Sonova AG
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
Sensorineural Hearing Loss
Implantation of the Cochlear™ Nucleus® Hybrid S Round Window (S-RW) in Adults
Evaluate the Cochlear™ Nucleus® S-Round Window (S-RW) implant in newly implanted adults with broader requirements to be considered an eligible candidate.
- Trial name
- NCT02638883
- Testing
- Hybrid SRW cochlear implant
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Cochlear
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
Hearing Loss, Sensorineural Hearing Loss
Non-significant Risk Study of a Cochlear Implant Headpiece
This study aims to evaluate a cochlear implant headpiece.
- Trial name
- NCT05488535
- Testing
- cochlear implant headpiece
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Advanced Bionics
Hearing Loss, Sensorineural, Sensorineural Hearing Loss, Bilateral
Benefits of Bimodal Streaming With MED-EL Cochlear Implants and Starkey Hearing Aids
This study will evaluate sound quality and user satisfaction with Bluetooth streaming using a new bimodal streaming option for individuals who use a MED-EL cochlear implant and Starkey hearing aid.
- Conditions
- Hearing Loss, Sensorineural, Sensorineural Hearing Loss, Bilateral, Cochlear Implant Recipients, Asymmetric Hearing Loss
- Trial name
- NCT07028619
- Testing
- Bimodal Streaming Configuration
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Med-El Corporation
Hearing Loss, Sensorineural, Sensorineural Hearing Loss
Dexamethasone-Eluting Cochlear Implant Electrode
A newly developed MED-EL Cochlear Implant incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array.
- Trial name
- CIDEX (NCT04450290)
- Testing
- CIDEXEL implant
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensori-Neural Deafness, Sensorineural Hearing Loss
Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant
The goal of this clinical trial is to learn if the Acclaim CI works to treat severe to profound sensorineural hearing loss in adults. It was also learn about the safety of the Acclaim CI implant.
- Conditions
- Sensori-Neural Deafness, Sensorineural Hearing Loss, Sensorineural Hearing Loss (Disorder), Sensorineural Hearing Loss, Bilateral
- Trial name
- NCT06699797
- Testing
- Acclaim Cochlear Implant
- Where
- 7 sites in United States
- Volunteers
- 56 people
- Sponsor
- Envoy Medical Corporation
Hearing Loss, Sensorineural
A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss
The objective of this study is to examine the safety, tolerability, and effects on hearing thresholds of two single doses of PF-04958242 and placebo in subjects with age-related hearing loss.
- Trial name
- NCT01518920
- Testing
- PF-04958242
- Where
- 11 sites in United States
- Volunteers
- 44 people
- Sponsor
- Biogen
Hearing Loss, Sensorineural
First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss
This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss.
- Trial name
- NCT05664100
- Testing
- FX-345
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Frequency Therapeutics
Hearing Loss, Sensorineural
Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients
This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.
- Trial name
- DUAL (NCT06298396)
- Testing
- Program using default MAP, Program using low-power 1 (LP1) MAP, Program using low-power 2 (LP2) MAP
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural, Noise Induced Hearing Loss
FX-322 in Adults With Severe Sensorineural Hearing Loss
This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with severe sensorineural hearing loss.
- Conditions
- Hearing Loss, Sensorineural, Noise Induced Hearing Loss, Sudden Hearing Loss
- Trial name
- NCT04629664
- Testing
- FX-322
- Where
- 7 sites in United States
- Volunteers
- 31 people
- Sponsor
- Frequency Therapeutics
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 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
Speech Perception
Improving Perception of Speech in Noise in Children With Communication Disorders
Smarty Ears has developed a prototype of an innovative therapeutic training system to improve speech perception in noise by training children on interrupted noise (which has silent intervals that allow for fragments of the target…
- Trial name
- L2F (NCT04473729)
- Testing
- Audiovisual speech training in noise for children
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Smarty Ears
Sensorineural Hearing Loss
Esteem New Subject Enrollment Post Approval Study
The New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe hearing loss.
- Trial name
- NCT02689349
- Testing
- Implantation of Esteem
- Where
- 6 sites in United States
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Envoy Medical Corporation
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
Sensorineural Hearing Loss, Bilateral
Study of Sound and Speech Perception in New Cochlear Implanted Subjects Using or Not an Anatomy-based Fitting
Main objective: Compare the recognition of environmental sounds with an anatomy-based fitting and with a default fitting adult patients newly implanted with a MED-EL cochlear implant.
- Trial name
- NCT05230498
- Testing
- anatomy-based fitting then default fitting, default fitting then anatomy-based fitting
- Where
- France
- Volunteers
- 17 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Bilateral
Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss
Part A of this trial evaluated the safety and tolerability of a single surgical administration procedure in one or both ear(s) with one of two dose levels of AAVAnc80-hOTOF (LY888891) and evaluated the Akouos Delivery Device…
- Trial name
- NCT05821959
- Testing
- AAVAnc80-hOTOF via Akouos Delivery Device, AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 48 people
- Sponsor
- Eli Lilly and Company