Clinical trial NCT06293482: Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Keywords: Cochlear implant
Sensorineural hearing loss
Safety
Efficacy
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
name: LWB Consulting
name: Althea Anagnostopoulos Harrington
name: MV Clinical Research, LLC
First posted: 2024-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of device and procedure-related adverse events and serious adverse events
timeFrame: 6-months post-activation
measure: 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
timeFrame: Pre-operative baseline, 6 months post-activation
measure: 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
timeFrame: Pre-operative baseline, 6 months post-activation
Secondary outcomes:
measure: Number of device and procedure related adverse events and serious adverse events
timeFrame: 36-Months post-activation
measure: Proportion of participants who demonstrate a change score of +1 or greater on the Speech, Spatial and Qualities of Hearing Scale (SSQ12) at 6-months post-activation compared to preoperative baseline
timeFrame: Pre-operative baseline, 6 months post-activation
measure: Mean change on the Tinnitus Handicap Inventory (THI) score at 6-months post-activation compared to preoperative baseline will exceed a 7-point improvement
timeFrame: Pre-operative baseline, 6 months post-activation
measure: Mean change on aided word recognition in the unilateral CI alone listening condition at 3 months post activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted
timeFrame: Pre-operative baseline, 3 months post-activation
measure: Mean change on AzBio sentences in noise at 3 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition
timeFrame: Pre-operative baseline, 3 months post-activation
measure: Percentage correct on aided word recognition in the unilateral condition in the implanted ear in the post-operative everyday listening condition
timeFrame: 6 months post-activation
measure: Percentage correct on AzBio sentences in noise in the post-operative everyday listening condition
timeFrame: 6 months post-activation
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Tucson
country: United States
facility: Centre for Neurosciences
state: Arizona
city: Santa Monica
country: United States
facility: Pacific Neuroscience Institute
state: California
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Kansas City
country: United States
facility: Midwest Ear Institute
state: Missouri
city: New York
country: United States
facility: New York University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospitals
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason
state: Washington
Study officials:
References: