Back to resultsHearing Implant Performance in Adults With Low-Frequency Residual Hearing
Primary Purpose
Sensorineural Hearing Loss, Low-Frequency Residual Hearing
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CI624 Slim 20 Electrode
Sponsored by
About this trial
This is an interventional device feasibility trial for Sensorineural Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- 18 years-of-age or older at the time of surgery.
- Low-frequency threshold at 500 Hz ≤ 50 dB HL and high-frequency pure-tone average (PTA), 2000-8000 Hz ≥ 65 dB HL in the ear to be implanted.
- Pure-tone average (PTA) (0.5k, 1k, 2k Hz) > 30 dB HL in the contralateral ear.
- CNC word recognition scores (mean of two lists) ≤ 60% in the ear to be implanted and ≤ 80% in the contralateral ear.
- English spoken as a primary language.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Individuals older than 70 years at the time of surgery.
- Duration of severe to profound sensorineural hearing loss > 20 years per self-report.
- Onset of sensorineural hearing loss, for the purpose of this study, prior to 5 years-of-age.
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- Conductive overlay of 15 dB or greater at two or more frequencies, in the range of 250 through 1000 Hz in the ear to be implanted.
- Hearing loss of neural or central origin.
- Diagnosis of Auditory Neuropathy.
- Active middle-ear infection.
- Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator.
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the device and/or procedure, as determined by the Investigator.
- Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator.
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- Investigator site personnel directly affiliated with this study and/or their immediate family (spouse, parent, child, or sibling).
- Cochlear employees or employees of a Contract Research Organization (CRO) or contractors engaged by Cochlear for the purposes of this investigation.
- Currently participating, or has participated in the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Sites / Locations
- Jacksonville Hearing and Balance
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CI624 Slim 20 Electrode
Arm Description
Outcomes
Primary Outcome Measures
Characterize hearing performance of the CI624.
Hearing performance of the CI624 will characterized using Constant Nucleus Constant (CNC) word recognition in quiet. Performance is scored as percent correct words.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04741048
Brief Title
Hearing Implant Performance in Adults With Low-Frequency Residual Hearing
Official Title
A Pre-market, Open-label Feasibility, Prospective, Single-arm Multicenter Feasibility Investigation of Hearing Performance Using the CI624 in Adults With Low-frequency Residual Hearing.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decided to cancel the study prior to any subjects being enrolled/consented due to the lack of CMS coverage and an internal staffing shortage.
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI624 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss, Low-Frequency Residual Hearing
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CI624 Slim 20 Electrode
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CI624 Slim 20 Electrode
Intervention Description
Cochlear Ltd CI624 cochlear implant with Slim 20 Electrode
Primary Outcome Measure Information:
Title
Characterize hearing performance of the CI624.
Description
Hearing performance of the CI624 will characterized using Constant Nucleus Constant (CNC) word recognition in quiet. Performance is scored as percent correct words.
Time Frame
14 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years-of-age or older at the time of surgery.
Low-frequency threshold at 500 Hz ≤ 50 dB HL and high-frequency pure-tone average (PTA), 2000-8000 Hz ≥ 65 dB HL in the ear to be implanted.
Pure-tone average (PTA) (0.5k, 1k, 2k Hz) > 30 dB HL in the contralateral ear.
CNC word recognition scores (mean of two lists) ≤ 60% in the ear to be implanted and ≤ 80% in the contralateral ear.
English spoken as a primary language.
Willing and able to provide written informed consent.
Exclusion Criteria:
Individuals older than 70 years at the time of surgery.
Duration of severe to profound sensorineural hearing loss > 20 years per self-report.
Onset of sensorineural hearing loss, for the purpose of this study, prior to 5 years-of-age.
Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
Conductive overlay of 15 dB or greater at two or more frequencies, in the range of 250 through 1000 Hz in the ear to be implanted.
Hearing loss of neural or central origin.
Diagnosis of Auditory Neuropathy.
Active middle-ear infection.
Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator.
Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the device and/or procedure, as determined by the Investigator.
Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator.
Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
Investigator site personnel directly affiliated with this study and/or their immediate family (spouse, parent, child, or sibling).
Cochlear employees or employees of a Contract Research Organization (CRO) or contractors engaged by Cochlear for the purposes of this investigation.
Currently participating, or has participated in the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Facility Information:
Facility Name
Jacksonville Hearing and Balance
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Hearing Implant Performance in Adults With Low-Frequency Residual Hearing
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