Sensorineural Hearing LossNCT03858647
Electrode Placement and Audiologic Outcomes With the Advanced Bionics HiFocus L23 Electrode
An observational study of Sensorineural Hearing Loss, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The goal of this study is to measure patient performance after cochlear implantation with the Food and Drug Administration (FDA) approved Advanced Bionics HiFocus L23 device. The specific aims of the project are as follows: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All clinically confirmed sensorineural hearing loss patients who meet criteria for cochlear implantation using the Advanced Bionics HiFocus L23 electrode are eligible for enrollment.
Who may be able to join
- Male or female 18 years of age and above.
- Sensorineural hearing loss meeting criteria for cochlear implants, assessed no greater than three months prior to cochlear implant surgery
- Patient schedule to undergo CI surgery using Advanced Bionics SlimJ/L23 device.
- Ability to undergo adequate audiology follow-up or planned follow up for those participants undergoing scanning in the OR.
- Competent in decision making process and able to read and sign a written informed consent form.
- English language proficiency.
- If the patient has already had a fine resolution CT or a fpVCT of the head (more than likely as a participant of another research study) the scan will not be repeated, the images from the previous scan will be used for the purposes of this study.
- If the patient has undergone a conventional CT scan of the head after cochlear implantation as part of their routine care, this scan may be used in place of the research scan or in addition to the research scan.
Who cannot join
- Patients who weigh over 300 lbs (when Xoran xCAT headboard is being used). Otherwise, weight is not exclusionary.
- Females who are pregnant. All females of child-bearing age in the study will undergo a pregnancy test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Multi-Center Assessment of Electrode Placement and Audiologic Outcomes in Cochlear Implantation With the Advanced Bionics HiFocus L23 Electrode
The goal of this study is to measure patient performance after cochlear implantation with the Food and Drug Administration (FDA) approved Advanced Bionics HiFocus L23 device.
The specific aims of the project are as follows:
- To measure implant audiologic performance as defined by speech performance in standard cochlear implant speech test batteries.
- To determine scalar location after insertion through either intraoperative or postoperative imaging and correlate this with audiologic outcomes.
- To assess the rates of preservation of residual acoustic hearing and correlate those with scalar location as determined in specific aim 2 and audiologic performance as determined in specific aim 1.
- To correlate speech outcomes with quality of life measures, as defined by validated questionnaires including the Tinnitus Handicap Index (THI), Speech and Spatial Qualities (SSQ) Questionnaire, and Nijmegen Questionnaire.
- To evaluate intraoperative ease of insertion from the surgeon's perspective and correlate this with postoperative electrode location and audiologic performance.
Read the detailed description
Cochlear implants (CI) are biomechanical sense prostheses approved by the FDA for the treatment of sensorineural hearing loss. CI's function by bypassing the absent or dysfunctional cochlear end organs to directly electrically stimulate the spiral ganglion and cochlear nerve. A variety of commercially available FDA-approved implants exist for the treatment of severe to profound deafness. Implants are typically designed in two broad categories: lateral wall electrodes and perimodiolar. Perimodiolar electrodes are precurved electrodes that are designed to hug the center of the cochlea (modiolus) after insertion. Lateral wall electrodes are slim and straight, hugging the lateral wall on insertion.
Recent studies have shown that electrode design and location within the cochlea impact patient performance. Specifically, electrodes located completely within the scala tympani are associated with better outcomes than those that cross over from the scala tympani to the scala vestibuli during insertion. The same study has shown that lateral wall electrodes are less likely than perimodiolar electrodes to have scalar excursion to the scala vestibuli. Location matters with these implants because electrode position completely within the scala tympani is associated with higher rates of preservation of residual hearing. Minimizing cochlear trauma allows for preservation of residual acoustic hearing particularly in low frequencies. While this low frequency hearing is of little benefit independently, when combined with the electrical stimulation from the cochlear implant patients have improved performance.
The HiFocus L23 electrode is manufactured by Advanced Bionics (Valencia, California), and is FDA approved for the treatment of sensorineural hearing loss in adult and pediatric patients. It is designed as a slim and straight lateral wall electrode that can be inserted with low force to minimize intracochlear trauma. While pre-market studies were performed by Advanced Bionics as a part of its approval for use by the FDA, no post-market studies have been performed to assess the audiologic outcomes, electrode location after insertion, and hearing preservation rates when using this electrode. These aims will be accomplished through several means. Audiologic speech performance will be assessed through a standardized clinical/audiometric protocol currently followed by the Vanderbilt University Medical Center cochlear implant team. Electrode location for all participants will be determined using novel software created by Vanderbilt engineering faculty and graduate students that uses computerized tomography (CT) images obtained as a part of practice postoperatively or intraoperatively using an FDA approved Xoran xCAT® device, a portable flat panel volume computerized tomography (fpVCT) machine (Vanderbilt) or regular CT scan at participating institutions as applicable. These images can be registered to existing pre-operative conventional CT scans and used to produce 3-dimensional models of electrode placement within each patient's cochlea. This software is investigational and used in other research studies for the same purpose.
The extent to which the electrode remains in the desired location (scala tympani) will then be correlated with audiologic outcomes as obtained above. Residual hearing rates and quality of life measures will be obtained as a part of audiologic testing.
If a fine resolution, high quality conventional head CT has been previously obtained, or is obtained as part of routine care this scan may be used in place of the fpVCT or in addition to the fpVCT scan. The option of having a conventional head CT performed in radiology for research purposes in place of the fpVCT head CT scan will also be available.
Surgeons will complete surveys after each case concludes to evaluate the ease of insertion and will record the insertion via standard recording techniques in the operating room that are available for any microscopic case. These videos for all surgeries will be blinded and reviewed at Vanderbilt for ease and speed of insertion.
- Conditions
- Sensorineural Hearing Loss
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sensorineural hearing loss patients post cochlear implant | Patients who have documented sensorineural hearing loss and have received cochlear implantation (per standard of care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Effectiveness-Consonant Nucleus Consonant (CNC) word test
Audiologic speech performance as measured by CNC word recognition. CNC word tests consist of a 50 word list. Subjects repeat as much of each word as possible. Word scores will be calculated as percent correct at baseline through 24 months and reported as percentage points improved.
Measured: 2 years
Treatment Effectiveness-AzBio sentence test
Audiologic speech performance as measured by AzBio sentence recognition. AzBio consists of 20 sentence list spoken by different talkers (two male, two female). Subjects repeat as much of each sentence as possible. Each word correctly repeated counts towards the overall score, reported as an overall percentage correct at baseline through 24 months.
Measured: 2 years
Treatment Effectiveness-Air-conduction thresholds
Audiologic speech performance as measured by air-conduction thresholds. Threshold values will be obtained for 125, 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000, and 8000 Hz using insert earphones. Post-operative hearing thresholds will be compared to pre-operative hearing thresholds to assess amount of residual hearing. Greater post-operative thresholds is associated with poorer hearing preservation.
Measured: 2 years
Secondary outcomes (6)
Treatment Effectiveness
Determine scalar location after electrode insertion using intraoperative or postoperative imaging to then correlate imaging with audiologic outcomes as collected above.
Measured: 2 years
Treatment Effectiveness - Audiologic outcomes
Percentage of residual acoustic hearing for each subject as measured by the audiologic outcomes as collected above.
Measured: 2 years
QOL Tinnitus Handicap Index (THI)
Patient quality of life assessment: tinnitus compared post-implant to pre-implant. The sum of all responses to 25 questions is the THI score, with a range from 0-100. The higher the score, the more handicap the subject has due to tinnitus.
Measured: 2 years
QOL Speech, Spatial and Qualities of Hearing scale (SSQ 12)
Patient quality of life assessment: hearing and listening ability compared post implant to pre-implant. The SSQ 12 survey uses a visual analog rating scale from 0-10 over three listening domains: speech understanding in various listening conditions; spatial hearing associated with distance, movement, and direction; and the overall quality of speech including clarity and naturalness of sound. The higher the score, the better speech understanding, spatial hearing, and sound quality a subject has.
Measured: 2 years
QOL Nijmegen
Patient quality of life assessment: hearing ability scores compared post-implant to pre-implant. The Nijmegen is a 60 question survey covering three general domains: physical, psychological, and social functioning. Subjects rate each question on a scale of how often they can hear an event as noted. The subdomain mean score for each subject is derived by assigning values to survey items as follows: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and then calculating the quantitative mean scores across the subdomains.
Measured: 2 years
Evaluation of intraoperative ease of electrode insertion as assessed by surgeon.
Surgeon survey
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start21 Feb 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: device under study complication-due to PI departure, study closed and will not reopen
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert F. Labadie, Vanderbilt University Medical Center
- Investigators
- Alejandro Rivas, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858647
- Sponsor's protocol ID
- 181904
- Status last verified
- Jan 2022
- First submitted
- 12 Feb 2019
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Assessment of Electrode Placement and Audiologic Outcomes in Cochlear Implantation With the Advanced Bionics HiFocus L23 Electrode
- ClinicalTrials.gov ID
- NCT03858647
- Acronym / sponsor ID
- 181904
- Conditions
- Sensorineural Hearing Loss
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: device under study complication-due to PI departure, study closed and will not reopen
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Mar 2019 (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.
The goal of this study is to measure patient performance after cochlear implantation with the Food and Drug Administration (FDA) approved Advanced Bionics HiFocus L23 device.
The specific aims of the project are as follows:
- To measure implant audiologic performance as defined by speech performance in standard cochlear implant speech test batteries.
- To determine scalar location after insertion through either intraoperative or postoperative imaging and correlate this with audiologic outcomes.
- To assess the rates of preservation of residual acoustic hearing and correlate those with scalar location as determined in specific aim 2 and audiologic performance as determined in specific aim 1.
- To correlate speech outcomes with quality of life measures, as defined by validated questionnaires including the Tinnitus Handicap Index (THI), Speech and Spatial Qualities (SSQ) Questionnaire, and Nijmegen Questionnaire.
- To evaluate intraoperative ease of insertion from the surgeon's perspective and correlate this with postoperative electrode location and audiologic performance.
Detailed description
Cochlear implants (CI) are biomechanical sense prostheses approved by the FDA for the treatment of sensorineural hearing loss. CI's function by bypassing the absent or dysfunctional cochlear end organs to directly electrically stimulate the spiral ganglion and cochlear nerve. A variety of commercially available FDA-approved implants exist for the treatment of severe to profound deafness. Implants are typically designed in two broad categories: lateral wall electrodes and perimodiolar. Perimodiolar electrodes are precurved electrodes that are designed to hug the center of the cochlea (modiolus) after insertion. Lateral wall electrodes are slim and straight, hugging the lateral wall on insertion.
Recent studies have shown that electrode design and location within the cochlea impact patient performance. Specifically, electrodes located completely within the scala tympani are associated with better outcomes than those that cross over from the scala tympani to the scala vestibuli during insertion. The same study has shown that lateral wall electrodes are less likely than perimodiolar electrodes to have scalar excursion to the scala vestibuli. Location matters with these implants because electrode position completely within the scala tympani is associated with higher rates of preservation of residual hearing. Minimizing cochlear trauma allows for preservation of residual acoustic hearing particularly in low frequencies. While this low frequency hearing is of little benefit independently, when combined with the electrical stimulation from the cochlear implant patients have improved performance.
The HiFocus L23 electrode is manufactured by Advanced Bionics (Valencia, California), and is FDA approved for the treatment of sensorineural hearing loss in adult and pediatric patients. It is designed as a slim and straight lateral wall electrode that can be inserted with low force to minimize intracochlear trauma. While pre-market studies were performed by Advanced Bionics as a part of its approval for use by the FDA, no post-market studies have been performed to assess the audiologic outcomes, electrode location after insertion, and hearing preservation rates when using this electrode. These aims will be accomplished through several means. Audiologic speech performance will be assessed through a standardized clinical/audiometric protocol currently followed by the Vanderbilt University Medical Center cochlear implant team. Electrode location for all participants will be determined using novel software created by Vanderbilt engineering faculty and graduate students that uses computerized tomography (CT) images obtained as a part of practice postoperatively or intraoperatively using an FDA approved Xoran xCAT® device, a portable flat panel volume computerized tomography (fpVCT) machine (Vanderbilt) or regular CT scan at participating institutions as applicable. These images can be registered to existing pre-operative conventional CT scans and used to produce 3-dimensional models of electrode placement within each patient's cochlea. This software is investigational and used in other research studies for the same purpose.
The extent to which the electrode remains in the desired location (scala tympani) will then be correlated with audiologic outcomes as obtained above. Residual hearing rates and quality of life measures will be obtained as a part of audiologic testing.
If a fine resolution, high quality conventional head CT has been previously obtained, or is obtained as part of routine care this scan may be used in place of the fpVCT or in addition to the fpVCT scan. The option of having a conventional head CT performed in radiology for research purposes in place of the fpVCT head CT scan will also be available.
Surgeons will complete surveys after each case concludes to evaluate the ease of insertion and will record the insertion via standard recording techniques in the operating room that are available for any microscopic case. These videos for all surgeries will be blinded and reviewed at Vanderbilt for ease and speed of insertion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sensorineural hearing loss patients post cochlear implant | – | –Patients who have documented sensorineural hearing loss and have received cochlear implantation (per standard of care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All clinically confirmed sensorineural hearing loss patients who meet criteria for cochlear implantation using the Advanced Bionics HiFocus L23 electrode are eligible for enrollment.
Key inclusion criteria (8 listed)
- Male or female 18 years of age and above.
- Sensorineural hearing loss meeting criteria for cochlear implants, assessed no greater than three months prior to cochlear implant surgery
- Patient schedule to undergo CI surgery using Advanced Bionics SlimJ/L23 device.
- Ability to undergo adequate audiology follow-up or planned follow up for those participants undergoing scanning in the OR.
- Competent in decision making process and able to read and sign a written informed consent form.
Key exclusion criteria (2 listed)
- Patients who weigh over 300 lbs (when Xoran xCAT headboard is being used). Otherwise, weight is not exclusionary.
- Females who are pregnant. All females of child-bearing age in the study will undergo a pregnancy test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment Effectiveness-Consonant Nucleus Consonant (CNC) word test
Time frame: 2 years
Audiologic speech performance as measured by CNC word recognition. CNC word tests consist of a 50 word list. Subjects repeat as much of each word as possible. Word scores will be calculated as percent correct at baseline through 24 months and reported as percentage points improved.
Treatment Effectiveness-AzBio sentence test
Time frame: 2 years
Audiologic speech performance as measured by AzBio sentence recognition. AzBio consists of 20 sentence list spoken by different talkers (two male, two female). Subjects repeat as much of each sentence as possible. Each word correctly repeated counts towards the overall score, reported as an overall percentage correct at baseline through 24 months.
Treatment Effectiveness-Air-conduction thresholds
Time frame: 2 years
Audiologic speech performance as measured by air-conduction thresholds. Threshold values will be obtained for 125, 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000, and 8000 Hz using insert earphones. Post-operative hearing thresholds will be compared to pre-operative hearing thresholds to assess amount of residual hearing. Greater post-operative thresholds is associated with poorer hearing preservation.
6 secondary outcomes
Treatment Effectiveness
Time frame: 2 years
Treatment Effectiveness - Audiologic outcomes
Time frame: 2 years
QOL Tinnitus Handicap Index (THI)
Time frame: 2 years
QOL Speech, Spatial and Qualities of Hearing scale (SSQ 12)
Time frame: 2 years
QOL Nijmegen
Time frame: 2 years
Evaluation of intraoperative ease of electrode insertion as assessed by surgeon.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: device under study complication-due to PI departure, study closed and will not reopen). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Alejandro Rivas, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensorineural Hearing Loss, run by Vanderbilt University Medical Center at 1 site 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 8 inclusion and 2 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: stopped early, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: device under study complication-due to PI departure, study closed and will not reopen). Results are not available in the source record.
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?
Treatment Effectiveness-Consonant Nucleus Consonant (CNC) word test (time frame: 2 years). 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 2 Feb 2022.