Back to resultsPerimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing
Primary Purpose
Sensorineural Hearing Loss, Low-Frequency Residual Hearing
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CI632 Slim Modiolar 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
- Georgetown UniversityRecruiting
- UMass Memorial Medical CenterRecruiting
- Midwest Ear InstituteRecruiting
- New York University
- Cleveland ClinicRecruiting
- University HospitalsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CI632 Slim Modiolar Electrode
Arm Description
Outcomes
Primary Outcome Measures
To characterize hearing performance of the CI632 in an adult population under expanded indications for use.
To characterize hearing performance of the CI632 using CNC word recognition in quiet scores with percentage correct words.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04741009
Brief Title
Perimodiolar 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 CI632 in Adults With Low-frequency Residual Hearing.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (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 CI632 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
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CI632 Slim Modiolar Electrode
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CI632 Slim Modiolar Electrode
Intervention Description
Cochlear Ltd CI632 cochlear implant with Slim Modiolar Electrode
Primary Outcome Measure Information:
Title
To characterize hearing performance of the CI632 in an adult population under expanded indications for use.
Description
To characterize hearing performance of the CI632 using CNC word recognition in quiet scores with percentage correct words.
Time Frame
14 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 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 greater than or equal to 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Reinhart
Phone
612-456-1621
Email
preinhart@cochlear.com
Facility Information:
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Hoa, MD
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Remenschneider, MD
Facility Name
Midwest Ear Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Cullen, MD
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Sydlowski, AuD, PhD, MBA
Facility Name
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Mowry, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing
We'll reach out to this number within 24 hrs