Electrode Placement and Audiologic Outcomes With the Advanced Bionics HiFocus L23 Electrode

NCT03858647 | Terminated

• 1 other identifier: 181904
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 1.To measure implant audiologic performance as defined by speech performance in standard cochlear implant speech test batteries.
2. 2.To determine scalar location after insertion through either intraoperative or postoperative imaging and correlate this with audiologic outcomes.
3. 3.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.
4. 4.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.
5. 5.To evaluate intraoperative ease of insertion from the surgeon's perspective and correlate this with postoperative electrode location and audiologic performance.

Conditions

Sensorineural Hearing Loss

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  2 years

Secondary Outcomes (6)

• Treatment Effectiveness

  2 years

• Treatment Effectiveness - Audiologic outcomes

  2 years

• QOL Tinnitus Handicap Index (THI)

  2 years

• QOL Speech, Spatial and Qualities of Hearing scale (SSQ 12)

  2 years

• QOL Nijmegen

  2 years

Study Arms (1)

Sensorineural hearing loss patients post cochlear implant

Patients who have documented sensorineural hearing loss and have received cochlear implantation (per standard of care).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Females who are pregnant. All females of child-bearing age in the study will undergo a pregnancy test.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alejandro Rivas, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: March 1, 2019
• Study Start: February 21, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 2, 2022

Record last verified: 2022-01

Locations

US (1)