ACTIVE_NOT_RECRUITING

Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population

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Conditions

Hearing Loss, SensorineuralHearing Loss, BilateralCochlear implantSensorineural hearing lossSafetyEfficacy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pivotal, Prospective, Open-label, Multi-center Study of Safety and Effectiveness of Cochlear Implantation in an Expanded Population of Adults With Bilateral Sensorineural Hearing Loss

Quick Facts

Study Start:2024-09-17
Study Completion:2028-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06293482

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals 18 or older at the time of consent
  2. * 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
  3. * 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
  4. * Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator.
  5. * Willing and able to provide written informed consent.
  1. * 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)
  2. * Absence of cochlea development or a cochlear nerve
  3. * Presence of active middle ear infection in the ear to be implanted
  4. * Tympanic membrane perforation in the presence of active middle ear disease in the ear to be implanted
  5. * Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation.
  6. * Existing contralateral cochlear implant or medical plan to implant a contralateral cochlear implant during the clinical investigation.
  7. * Pregnant or breastfeeding women. Women who plan to become pregnant during the course of the clinical investigation.
  8. * 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.
  9. * Additional disabilities that may affect the participant's participation of safety during the clinical investigation.
  10. * Unable or unwilling to comply with all of the requirements of the clinical investigation as determined by the investigator.
  11. * Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
  12. * Employees of Cochlear.
  13. * 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.

Contacts and Locations

Study Locations (Sites)

Barrow Neurological Institute
Phoenix, Arizona, 85013
United States
Centre for Neurosciences
Tucson, Arizona, 85718
United States
Pacific Neuroscience Institute
Santa Monica, California, 90404
United States
University of Miami
Coral Gables, Florida, 33146
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Midwest Ear Institute
Kansas City, Missouri, 64111
United States
New York University
New York, New York, 10016
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
University of Pennsylvania Hospitals
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Cochlear

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-17
Study Completion Date2028-10

Study Record Updates

Study Start Date2024-09-17
Study Completion Date2028-10

Terms related to this study

Keywords Provided by Researchers

  • Cochlear implant
  • Sensorineural hearing loss
  • Safety
  • Efficacy

Additional Relevant MeSH Terms

  • Hearing Loss, Sensorineural
  • Hearing Loss, Bilateral