Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness

Part of paid clinical trials in Palo Alto, California.

Sponsor
Cochlear
Study ID
NCT05318417
Status
Recruiting
Apply to this trial

Conditions

  • Deafness, Unilateral
  • Hearing Loss, Unilateral

Eligibility Criteria

Sex
ALL
Age
5 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The Cochlear™ Nucleus® Cochlear Implant (CI) System — DEVICE
    The Cochlear™ Nucleus® CI systems are designed to provide useful hearing. The system works by converting sound in the environment into electric pulses that stimulate the auditory nerve, allowing the brain to perceive sound. The Cochlear™ Nucleus® CI system has implanted and external components. Implanted component: The CI is surgically implanted under the skin behind the ear. It includes a receiver/stimulator to receive and decode the electrical signals from the sound processor and an electrode to deliver these signals to the cochlear. External components: The external components include a sound processor, and associated accessories and cables. The system is programmed by a Cochlear proprietary programming system, Custom Sound®.

Study Details

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 use.

Key Dates

Start date
Aug 19, 2022
Status verified
May 2025
Primary completion
May 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Children and adults with unilateral hearing loss/single-sided deafness

Primary Outcome Measure

Change in sentence in noise scores at 12 months post-activation in the binaural (CI and normal hearing (NH)) listening condition compared to preoperatively in the best listening (NH alone or NH and hearing aid) condition in 3 speaker configurations. [ Time Frame: pre-implantation, 12 months post-activation ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Jennifer C Alyono, MD (PRINCIPAL_INVESTIGATOR)
Rocky Mountain Ear CenterEnglewoodColorado80113
Allison Biever, AuD
[email protected]
303-806-6293
University of IowaIowa CityIowa52242
Camille Dunn, PhD
[email protected]
319-353-8776
New York Eye and Ear InfirmaryNew YorkNew York10003
Namrata Marjit
[email protected]
929-489-9611
University of North CarolinaChapel HillNorth Carolina27517
[email protected]
919-966-5251
Kevin Brown, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205-
University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck SurgeryDallasTexas75390-
Virginia Mason Medical CenterSeattleWashington98101
Leslie Stevens
[email protected]
206-287-6267

Find similar trials in Palo Alto, CA

By research site
Stanford University· Palo Alto, CARocky Mountain Ear Center· Englewood, COUniversity of Iowa· Iowa City, IANew York Eye and Ear Infirmary· New York, NYUniversity of North Carolina· Chapel Hill, NCNationwide Children's Hospital· Columbus, OH

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