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
R
Rick Nelson, MD
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
N/A
40 participants needed
2 Locations
Brief description of study
What is the purpose of this study?
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.
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential study participants will be referred for this study by the site investigative team members [e.g., physician(s), audiologist(s), delegated team member(s)] if they feel that the patient qualifies for entry into the study based upon the inclusion/exclusion criteria and is expected to be a suitable candidate. If a patient is thought to be a candidate for the study, the investigator will approach them to explain the nature of the investigation, the procedures to be performed, and the potential risks associated with the procedures.
Detailed description of study
What will happen during the study?
The Cochlear TM 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. In this study, a commercially available device will be used in an expanded population of adults with bilateral sensorineural hearing loss who do not meet current FDA indications, including individuals with asymmetric hearing loss, and those who demonstrate word aided recognition scores up to 50% in their ear to be implanted.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Sensorineural Hearing Loss, SNHL
-
Age: 18 years - 100 years
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Gender: All
Inclusion Criteria:
- 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.
Updated on
03 Mar 2025.
Study ID: OTHN-CAM-ACE, 23684
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