Recruiting

Cochlear Implantation

Sponsor:

Cochlear

Code:

NCT05318417

Conditions

Hearing Loss, Unilateral

Deafness, Unilateral

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Interventions

The Cochlear™ Nucleus® Cochlear Implant (CI) System

Study Details

Brief summary:

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.

Conditions

Hearing Loss, Unilateral

Deafness, Unilateral

Study ID

NCT05318417

Start date

Aug 19, 2022

Status verified date

May, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Inclusion Criteria:

• Individuals 18 years or older (Group A)

Ear to be Implanted:

Severe sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and

Normal Hearing Ear:

Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL

• Children 5 years to 17 years, 11 months (Group B)

Ear to be Implanted:

Severe sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL; Aided CNC score ≤5% and

Normal Hearing Ear:

Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL

  • Previous experience with a current conventional treatment option for unilateral \[SSD\] HL (HA, bone-conduction device, or CROS technology), if no previous experience a minimum trial period of two weeks is required
  • English spoken as a primary language
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array
  • Previous cochlear implantation
  • Hearing loss of neural or central origin, including auditory neuropathy
  • Duration of profound sensorineural HL >10 years per self-report
  • Active / chronic middle-ear infection; conductive HL in either ear
  • Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
  • Unrealistic expectations on the part of the participant/family, regarding the possible benefits, risks, and limitations that are inherent as determined by the Investigator
  • Evidence of and/or suspected cognitive or developmental concern
  • Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
  • Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling
  • Cochlear employees or employees of Contract Research Organizations (CROs) or contractors engaged by Cochlear for the purposes of this investigation
  • Pregnant or breastfeeding women
  • Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

The Cochlear™ Nucleus® Cochlear Implant (CI) System

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®.

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 ]
  • Number of procedure and device related adverse events classified by type, frequency and severity. [ Time Frame: 36 months post-activation ]

Central Contacts and Locations

Central contacts

PRS Specialist

+612294286555cltd-prs-admin@cochlear.com

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Principal Investigator:

Jennifer C Alyono, MD

Rocky Mountain Ear Center

Recruiting

Englewood, Colorado, United States, 80113

Contacts

Allison Biever, AuD

303-806-6293allisonb@rockymountainearcenter.com

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Camille Dunn, PhD

319-353-8776Camille_dunn@uiowa.edu

New York Eye and Ear Infirmary

Recruiting

New York, New York, United States, 10003

Contacts

Namrata Marjit

929-489-9611Namrata.Marjit@mountsinai.org

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27517

Contacts

919-966-5251ciresearch@unc.edu

Principal Investigator:

Kevin Brown, MD

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Leslie Stevens

206-287-6267Leslie.stevens@virginiamason.org

More Information

Sponsor

Cochlear

Last update posted

Sep 2, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cochlear on 2025-09-02.