Hearing Loss, SensorineuralACENCT06293482
Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population
A study testing Cochlear™ Nucleus® System in people with Hearing Loss, Sensorineural and Hearing Loss, Bilateral, run by Cochlear at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral
- What is being tested?
- Cochlear™ Nucleus® System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesUnited States
- Study dates
- 17 Sep 2024to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Cleveland Clinic
Cleveland, Ohio, 44195
University of Miami
Coral Gables, Florida, 33146
Indiana University
Indianapolis, Indiana, 46202
Midwest Ear Institute
Kansas City, Missouri, 64111
New York University
New York, New York, 10016
University of Pennsylvania Hospitals
Philadelphia, Pennsylvania, 19104
Barrow Neurological Institute
Phoenix, Arizona, 85013
Pacific Neuroscience Institute
Santa Monica, California, 90404
Centre for Neurosciences
Tucson, Arizona, 85718
About this study
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
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.
- Being tested
- Cochlear™ Nucleus® System
- Keywords
- Cochlear implant, Sensorineural hearing loss, Safety, Efficacy
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear™ Nucleus® SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cochlear™ Nucleus® System | Experimental | Participants will be implanted with a commercially approved Cochlear™ Nucleus® implant. Receives: Device: Cochlear™ Nucleus® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of device and procedure-related adverse events and serious adverse events
Events will be summarized by type, frequency, and severity.
Measured: 6-months post-activation
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.
Measured: Pre-operative baseline, 6 months post-activation
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.
Measured: Pre-operative baseline, 6 months post-activation
Secondary outcomes (7)
Number of device and procedure related adverse events and serious adverse events
Events will be summarized by type, frequency, and severity.
Measured: 36-Months post-activation
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.
Measured: Pre-operative baseline, 6 months post-activation
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.
Measured: Pre-operative baseline, 6 months post-activation
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.
Measured: Pre-operative baseline, 3 months post-activation
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.
Measured: Pre-operative baseline, 3 months post-activation
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.
Measured: 6 months post-activation
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.
Measured: 6 months post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start17 Sep 2024
- Primary completion16 Apr 2026
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA, LWB Consulting, Althea Anagnostopoulos Harrington, MV Clinical Research, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293482
- Sponsor's protocol ID
- CAM5850
- Acronym
- ACE
- Status last verified
- Apr 2026
- First submitted
- 28 Feb 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06293482
- Acronym / sponsor ID
- ACE / CAM5850
- Keywords
- Cochlear implant, Sensorineural hearing loss, Safety, Efficacy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA, LWB Consulting, Althea Anagnostopoulos Harrington, MV Clinical Research, LLC
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- Oct 2028 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear™ Nucleus® System | Experimental | Device: Cochlear™ Nucleus® SystemParticipants will be implanted with a commercially approved Cochlear™ Nucleus® implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear™ Nucleus® SystemThe 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. | Device | Cochlear™ Nucleus® System |
Primary outcome
Number of device and procedure-related adverse events and serious adverse events
Time frame: 6-months post-activation
Events will be summarized by type, frequency, and severity.
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
Time frame: Pre-operative baseline, 6 months post-activation
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.
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
Time frame: Pre-operative baseline, 6 months post-activation
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.
7 secondary outcomes
Number of device and procedure related adverse events and serious adverse events
Time frame: 36-Months post-activation
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
Time frame: Pre-operative baseline, 6 months post-activation
Mean change on the Tinnitus Handicap Inventory (THI) score at 6-months post-activation compared to preoperative baseline will exceed a 7-point improvement
Time frame: Pre-operative baseline, 6 months post-activation
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
Time frame: Pre-operative baseline, 3 months post-activation
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
Time frame: Pre-operative baseline, 3 months post-activation
Percentage correct on aided word recognition in the unilateral condition in the implanted ear in the post-operative everyday listening condition
Time frame: 6 months post-activation
Percentage correct on AzBio sentences in noise in the post-operative everyday listening condition
Time frame: 6 months post-activation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear™ Nucleus® System in people with Hearing Loss, Sensorineural and Hearing Loss, Bilateral, run by Cochlear at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of device and procedure-related adverse events and serious adverse events (time frame: 6-months post-activation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.