Back to resultsClinical Utility of Residual Hearing in the Cochlear Implant Ear
Primary Purpose
Hearing Loss, Sensorineural, Hearing Loss, Hearing Loss, Bilateral
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrocochleography
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Sensorineural
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated informed consent form.
- Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.
- Minimum of 30 days experience with appropriately fit binaural amplification (standardized National Acoustic Laboratories (NAL) fitting method) verified with real ear measurements within 5 dB SPL of targets.
Limited benefit from conventional amplification in the best aided condition as defined by test scores of:
- The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct)
- Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct)
- Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted.
- Severe to profound mid to high-frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted.
- Low frequency PTA ≤ 55 dB HL sloping to moderately severe to profound mid-to high frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, 4000 Hz ≥ 60 dB) in the contralateral ear.
- Proficient in English.
Undergoing implantation with a current generation CI device from either Cochlear Limited or Advanced Bionics AG.
- Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624
- Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala
- Stated willingness and ability to complete testing and all associated study visits.
Exclusion Criteria:
- Previous cochlear implantation.
- Prelingual onset of hearing loss.
- Abnormal inner ear anatomy on CT imaging.
- Auditory neuropathy spectrum disorder.
- Retrocochlear pathology such as a vestibular schwannoma or stroke.
- Unwillingness or inability to comply with all investigational requirements including the randomization process.
- Additional medical, or social barriers that would prevent completion of all study requirements.
- Medical condition contraindicated for surgery.
- Device selection of Med El CI (per the patient's selection).
Sites / Locations
- University of IowaRecruiting
- Mayo ClinicRecruiting
- Washington University in St. LouisRecruiting
- University of North Carolina, Chapel HillRecruiting
- Ohio State University Eye and Ear InstituteRecruiting
- Vanderbilt UniversityRecruiting
- Medical College of WisconsinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ECochG monitoring
Control Group
Arm Description
For those randomized to the experimental group, the CI surgery will proceed in a standard fashion. However, the surgeon will utilize ECochG-guided monitoring by placing the external device coil and processor over the receiver/stimulator of the implanted components. Also, a sound applicator (i.e. speaker) will be placed in the external auditory canal by the surgeon. During electrode insertion the surgeon will utilize the ECochG feedback to adjust insertion if needed. That is, once the electrode has been inserted at least 75% (75% of the electrode contacts inside the cochlea), the surgeon may proceed to full insertion if indicated during ECochG feedback or may modify and/or cease electrode insertion if indicated by the ECochG feedback in attempts to preserve RH.
For those randomized to the control group, they will receive their CI per the standard of care. That is, all procedures that take place during a routine CI surgery will be the same for those in the control group. As such, no ECochG monitoring will be performed. However, all study surgeons will be asked to adhere to soft surgical principles (non-traumatic cochlear opening, slow electrode insertions) to enhance HP outcomes even in the absence of intraoperative ECochG monitoring. Further, the standard of care for cochlear implantation is to perform full electrode insertions with all electrode contacts inside of the cochlea. Thus, for subjects in the control group, surgeons will be asked to perform full electrode insertions.
Outcomes
Primary Outcome Measures
Preservation Advantage
Determine the hearing preservation advantage, by measuring low tone audiometry at the 3, 6,12 and 24 month timepoints, in hertz.
Secondary Outcome Measures
Full Information
NCT ID
NCT04707885
First Posted
January 11, 2021
Last Updated
June 21, 2023
Sponsor
Ohio State University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT04707885
Brief Title
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Official Title
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI).
Detailed Description
The clinical importance of residual acoustic hearing in CI remains unclear. It is estimated that only five percent of adult candidates undergo CI. A major barrier is the loss of residual hearing associated with surgery, meaning most patients lose any or all residual hearing as a result of the CI surgery, especially since the majority of today's candidates do not suffer from complete deafness. Hence, many candidates are faced with the decision to relinquish their remaining acoustic hearing in exchange for electric hearing via the CI, as CI surgery often results in complete loss of any residual hearing. However, recent developments in hearing monitoring systems during CI surgery have shown promise for providing the surgeon with live feedback of how the cochlear implant insertion process is proceeding, allowing the surgeon to make intraoperative adjustments during the insertion, potentially minimizing any trauma caused by the insertion of the implant, ultimately helping preserve residual hearing. This ultimately could lead to improvements in the rates of hearing preservation. Therefore, the current study seeks to investigate: 1) the advantage of using a hearing monitoring system (electrocochleography) monitoring guided CI surgery on hearing preservation rates, 2) determine the benefit that hearing aid/cochlear implant combined hearing provides participants over non-hearing preservation CI (electric-only stimulation from the CI) on measures of speech perception and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural, Hearing Loss, Hearing Loss, Bilateral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ECochG monitoring
Arm Type
Experimental
Arm Description
For those randomized to the experimental group, the CI surgery will proceed in a standard fashion. However, the surgeon will utilize ECochG-guided monitoring by placing the external device coil and processor over the receiver/stimulator of the implanted components. Also, a sound applicator (i.e. speaker) will be placed in the external auditory canal by the surgeon. During electrode insertion the surgeon will utilize the ECochG feedback to adjust insertion if needed. That is, once the electrode has been inserted at least 75% (75% of the electrode contacts inside the cochlea), the surgeon may proceed to full insertion if indicated during ECochG feedback or may modify and/or cease electrode insertion if indicated by the ECochG feedback in attempts to preserve RH.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
For those randomized to the control group, they will receive their CI per the standard of care. That is, all procedures that take place during a routine CI surgery will be the same for those in the control group. As such, no ECochG monitoring will be performed. However, all study surgeons will be asked to adhere to soft surgical principles (non-traumatic cochlear opening, slow electrode insertions) to enhance HP outcomes even in the absence of intraoperative ECochG monitoring. Further, the standard of care for cochlear implantation is to perform full electrode insertions with all electrode contacts inside of the cochlea. Thus, for subjects in the control group, surgeons will be asked to perform full electrode insertions.
Intervention Type
Device
Intervention Name(s)
Electrocochleography
Other Intervention Name(s)
ECochG
Intervention Description
The use of ECochG monitoring will be employed. This will be conducted intraoperatively during the entire portion of the CI electrode insertion component.
For the purposes of this clinical trial, the stimulus will consist of a 500 Hz tone burst presented at ~105-110 dB SPL. This was chosen due to the time and resource limitations in the operating room. Hence, the surgical team can only utilize a very limited dataset for intraoperative decision making and previous studies have demonstrated that 500 Hz stimulation offers the most robust, reliable, and useful ECochG signal during electrode insertions.
Primary Outcome Measure Information:
Title
Preservation Advantage
Description
Determine the hearing preservation advantage, by measuring low tone audiometry at the 3, 6,12 and 24 month timepoints, in hertz.
Time Frame
3, 6, 12, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated informed consent form.
Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.
Minimum of 30 days experience with appropriately fit binaural amplification (standardized National Acoustic Laboratories (NAL) fitting method) verified with real ear measurements within 5 dB SPL of targets.
Limited benefit from conventional amplification in the best aided condition as defined by test scores of:
The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct)
Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct)
Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted.
Severe to profound mid to high-frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted.
Low frequency PTA ≤ 55 dB HL sloping to moderately severe to profound mid-to high frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, 4000 Hz ≥ 60 dB) in the contralateral ear.
Proficient in English.
Undergoing implantation with a current generation CI device from either Cochlear Limited or Advanced Bionics AG.
Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624
Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala
Stated willingness and ability to complete testing and all associated study visits.
Exclusion Criteria:
Previous cochlear implantation.
Prelingual onset of hearing loss.
Abnormal inner ear anatomy on CT imaging.
Auditory neuropathy spectrum disorder.
Retrocochlear pathology such as a vestibular schwannoma or stroke.
Unwillingness or inability to comply with all investigational requirements including the randomization process.
Additional medical, or social barriers that would prevent completion of all study requirements.
Medical condition contraindicated for surgery.
Device selection of Med El CI (per the patient's selection).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beth Miles-Markley
Phone
614-366-9244
Email
beth.miles-markley@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Meghan Hiss, AuD
Email
meghan.hiss@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Adunka, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amanda Ortmann, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille Dunn, PhD
Email
camille-dunn@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Bruce Gantz, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Orr
Email
orr.paula@mayo.edu
First Name & Middle Initial & Last Name & Degree
Colin Driscoll, MD
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Kukuljan
Email
kukuljas@wustl.edu
First Name & Middle Initial & Last Name & Degree
Amanda Ortmann, PhD
Facility Name
University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Brown, MD
Email
k_d_brown@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Kevin Brown, MD
Facility Name
Ohio State University Eye and Ear Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leah Kofmehl
Email
leah.kofmehl@osumc.edu
First Name & Middle Initial & Last Name & Degree
Edward Dodson, MD
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenya Collins
Email
kenya.collins.1@vumc.org
First Name & Middle Initial & Last Name & Degree
Kelley Corcoran, AuD
Email
kelley.corcoran@vumc.org
First Name & Middle Initial & Last Name & Degree
Elizabeth Perkins, MD
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Mleziva
Email
smleziva@mcw.edu
First Name & Middle Initial & Last Name & Degree
Michael Harris, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinical Utility of Residual Hearing in the Cochlear Implant Ear
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