Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population

NCT ID: NCT06293482

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-17
• Study Completion Date: 2028-10-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cochlear™ Nucleus® System

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

Group Type: EXPERIMENTAL

Cochlear™ Nucleus® System

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NAMSA

OTHER

Sponsor Role: collaborator

LWB Consulting

UNKNOWN

Sponsor Role: collaborator

Althea Anagnostopoulos Harrington

UNKNOWN

Sponsor Role: collaborator

MV Clinical Research, LLC

UNKNOWN

Sponsor Role: collaborator

Cochlear

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Barrow Neurological Institute

Phoenix, Arizona, United States

Centre for Neurosciences

Tucson, Arizona, United States

Pacific Neuroscience Institute

Santa Monica, California, United States

University of Miami

Coral Gables, Florida, United States

Indiana University

Indianapolis, Indiana, United States

Midwest Ear Institute

Kansas City, Missouri, United States

New York University

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Pennsylvania Hospitals

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

CAM5850

Identifier Type: -

Identifier Source: org_study_id