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Not recruiting

Cochlear Implantation

Sponsor:

Cochlear

Code:

NCT06293482

Conditions

Hearing Loss, Sensorineural

Hearing Loss, Bilateral

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cochlear™ Nucleus® System

Study Details

Brief summary:

This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits.

Conditions

Hearing Loss, Sensorineural

Hearing Loss, Bilateral

Study ID

NCT06293482

Start date

Sep 17, 2024

Status verified date

Mar, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Individuals 18 or older at the time of consent
  • Meets the following audiometric criteria for the ear to be implanted: clinically established sensorineural hearing loss (SNHL) defined by a four frequency pure tone average (PTA) at 500, 1000, 2000, \& 4000 Hz of: ≥60 dB HL and compromised functional hearing in the aided condition defined as <50% correct on a word recognition test
  • Meets the following audiometric criteria for the non-implanted contralateral ear: clinically established SNHL defined by a four frequency PTA at 500, 1000, 2000, \& 4000 Hz of >30 dB HL
  • Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Meets current indications on audiometric thresholds for traditional adult CI candidates (i.e., bilateral moderate to profound hearing loss in the low frequencies and profound \[≥ 90 dB HL\] hearing loss in the mid to high speech frequencies)
  • Absence of cochlea development or a cochlear nerve
  • Presence of active middle ear infection in the ear to be implanted
  • Tympanic membrane perforation in the presence of active middle ear disease in the ear to be implanted
  • Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation.
  • Existing contralateral cochlear implant or medical plan to implant a contralateral cochlear implant during the clinical investigation.
  • Pregnant or breastfeeding women. Women who plan to become pregnant during the course of the clinical investigation.
  • Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the investigator.
  • Additional disabilities that may affect the participant's participation of safety during the clinical investigation.
  • Unable or unwilling to comply with all of 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.
  • Employees of Cochlear.
  • Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cochlear™ Nucleus® System

Participants will be implanted with a commercially approved Cochlear™ Nucleus® implant.

Interventions

Cochlear™ Nucleus® System

The Cochlear™ Nucleus ® System is a commercially available system intended for restoration of hearing sensation through electrical stimulation of the auditory nerve in adult patients with bilateral symmetrical sensorineural hearing loss.

Primary outcome measure

  • Number of device and procedure-related adverse events and serious adverse events [ Time Frame: 6-months post-activation ]
  • Mean change on aided word recognition in the unilateral CI alone listening condition at 6 months post-activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted [ Time Frame: Pre-operative baseline, 6 months post-activation ]
  • Mean change on AzBio sentences in noise at 6 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition [ Time Frame: Pre-operative baseline, 6 months post-activation ]

Central Contacts and Locations

Central contacts

Lavin Entwisle

605-354-2917lentwisle@cochlear.com

Locations

Barrow Neurological Institute

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Shawn Stevens

shawn.stevens@commonspirit.org

Centre for Neurosciences

Recruiting

Tucson, Arizona, United States, 85718

Contacts

Gwendolyn Grabiec

520-795-0229GGrabiec@neurotucson.com

Pacific Neuroscience Institute

Recruiting

Santa Monica, California, United States, 90404

Contacts

Courtney Voelker, MD

Courtney.Voelker@providence.org

University of Miami

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Meredith Holcomb

meredith.holcomb@med.miami.edu

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Rick Nelson, MD

ricnelso@iupui.edu

Midwest Ear Institute

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Sarah Zlomke

sking@saint-lukes.org

New York University

Recruiting

New York, New York, United States, 10016

Contacts

William Shapiro

william.shapiro@nyulangone.org

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Sarah Sydlowski

sydlows@ccf.org

University of Pennsylvania Hospitals

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Tiffany Hwa

tiffany.hwa@pennmedicine.upenn.edu

More Information

Sponsor

Cochlear

Last update posted

Jul 25, 2025

Last verified

Mar, 2025

Keywords

  • Cochlear implant
  • Sensorineural hearing loss
  • Safety
  • Efficacy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Cochlear on 2025-07-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.