Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population

Hearing Loss, Sensorineural Clinical Trial

— ACE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06293482
• Other study ID #: CAM5850
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: June 2028

Study information

• Verified date: June 2024
• Source: Cochlear
• Contact: Lavin Entwisle
• Phone: 605-354-2917
• Email: lentwisle[@]cochlear.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2028
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
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	University of Pennsylvania Hospitals	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Pacific Neuroscience Institute	Santa Monica	California
United States	Virginia Mason	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Cochlear	LWB Consulting, NAMSA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of device and procedure-related adverse events and serious adverse events	Events will be summarized by type, frequency, and severity.	6-months post-activation
Primary	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	The CNC word recognition test (for English speakers) and Spanish Bisyllabic word test (for Spanish speakers) will be administered in quiet at a level equal to 60dBA in the sound field. The tests will be scored as total number of words correct, which will be expressed as a percentage correct for this study.	Pre-operative baseline, 6 months post-activation
Primary	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	The AzBio sentence test (for English speakers) and the Spanish AzBio sentence test (for Spanish speakers) will be utilised. These are validated tests to assess the open-set sentence recognition in quiet or in the presence of competing noise. For this study, the target sentences will be presented at a fixed level of 65dBA starting at a +10 dB signal-to-noise ratio using multi-talker babble as the competing signal. Each word in the sentence counts towards the overall score, which will be expressed as a percent correct for this study.	Pre-operative baseline, 6 months post-activation
Secondary	Number of device and procedure related adverse events and serious adverse events	Events will be summarized by type, frequency, and severity.	36-Months post-activation
Secondary	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	The SSQ12 is a self-administered questionnaire designed to measure auditory disability across three categories: speech perception, spatial hearing, and qualities of hearing. Respondents rate their perceived ability or experience for each scenario questioned on a 'ruler' (horizontal line) that is numbered, left to right, from '0' corresponding to no ability, to '10,' corresponding to complete ability. Higher scores represent greater ability.	Pre-operative baseline, 6 months post-activation
Secondary	Mean change on the Tinnitus Handicap Inventory (THI) score at 6-months post-activation compared to preoperative baseline will exceed a 7-point improvement	The THI is a 25-item self-assessment questionnaire used to assess the impact of tinnitus on a patient's quality of life. Items are grouped into functional, emotional, and catastrophic domains. A "yes" response is scored with 4 points; "sometimes" with 2 points; and "no" with zero points. Scores for the total scale range from 0 to 100 points, with higher scores representing greater perceived handicap.	Pre-operative baseline, 6 months post-activation
Secondary	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	The CNC word recognition test (for English speakers) and Spanish Bisyllabic word test (for Spanish speakers) will be administered in quiet at a level equal to 60dBA in the sound field. The tests will be scored as total number of words correct, which will be expressed as a percentage correct for this study.	Pre-operative baseline, 3 months post-activation
Secondary	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	The AzBio sentence test (for English speakers) and the Spanish AzBio sentence test (for Spanish speakers) will be utilised. These are validated tests to assess the open-set sentence recognition in quiet or in the presence of competing noise. For this study, the target sentences will be presented at a fixed level of 65dBA starting at a +10 dB signal-to-noise ratio using multi-talker babble as the competing signal. Each word in the sentence counts towards the overall score, which will be expressed as a percent correct for this study.	Pre-operative baseline, 3 months post-activation
Secondary	Percentage correct on aided word recognition in the unilateral condition in the implanted ear in the post-operative everyday listening condition	This will be evaluated for those participants who have a LFPTA (125-500 Hz) <80 dB HL versus those participants who have a LFPTA (125-500 Hz) = 80 dB HL.	6 months post-activation
Secondary	Percentage correct on AzBio sentences in noise in the post-operative everyday listening condition	This will be evaluated for those participants who have a LFPTA (125-500 Hz) <80 dB HL versus those participants who have a LFPTA (125-500 Hz) = 80 dB HL.	6 months post-activation